0A4F4F9BD490A749D5437F821CF06DF1

Decree 4/2009 (III. 17)

https://leaux.net/URLS/General/Hungary_2009_Decree_42009_III._17.pdf

http://leaux.net/URLS/ConvertAPI Text Files/B5C1E805393C7ED73CC6242BA0934DB1.en.txt

Examining the file media/Synopses/B5C1E805393C7ED73CC6242BA0934DB1.html:

This file was generated: 2020-07-14 08:44:23

Indicators in focus are typically shown highlighted in yellow; Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalpolitical affiliationparty3
Politicalvulnerablevulnerability1
HealthCognitive Impairmentimpairment1
HealthDrug Usagedrug1
HealthDrug Usageinfluence2
HealthDrug Usagesubstance37
HealthMentally Disableddisabled4
HealthMentally Disableddisability1
HealthMotherhood/Familyfamily1
HealthPhysically Disabledillness2
HealthPregnantpregnant1
HealthTerminally Illterminal1
Healthbreastfeedingbreastfeeding1
SocialAccess to Social Goodsaccess1
SocialAgeage2
SocialChildchildren1
SocialIncarceratedrestricted2
SocialLinguistic Proficiencylanguage3
SocialMarital Statussingle13
SocialPolice Officerofficer5
SocialProperty Ownershipproperty1
SocialThreat of Stigmathreat1
SocialTrade Union Membershipunion6
Socialeducationeducation1
Socialgendergender2
Socialphilosophical differences/differences of opinionopinion33
General/OtherNatural Hazardshazard1
General/OtherRelationship to Authorityauthority30

Political / political affiliation

Searching for indicator party:

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p.000003: 12. *
p.000003: manufacturer: the natural or legal person
p.000003: (a) which devices are designed, manufactured, packaged and labeled under their own responsibility before being used on their own
p.000003: marketing or conducting a clinical trial under his name, whether or not they are
p.000003: operations are carried out by himself or on his behalf,
p.000003: (b) which assembles, packs, processes, refurbishes a device for placing on the market under its own name,
p.000003: label and mark them for the purpose of use, unless they are assembling devices already on the market,
p.000003: or adaptive to a particular patient during their treatment according to their intended use
p.000003: according to your individual needs;
p.000003: 13. *
p.000003: authorized representative: resident in an EEA Member State, or
p.000003: a natural or legal person established by the manufacturer
p.000003: authorizes it to act on its behalf in relation to obligations under this Regulation; or
p.000003: to whom the authorities and bodies may turn instead of the manufacturer;
p.000003: 14. *
p.000003: distributor: the natural or legal person who places on the market
p.000003: the device is provided free of charge until it is handed over to the end user after use
p.000003: made available to it, in particular by the importer, distributor or reseller;
p.000003: 15. purpose of use: the use of the device by the manufacturer on the label in the instructions for use
p.000003: or the purpose stated in the advertisement;
p.000003: 16. Intended use: by the manufacturer of the device in order to achieve the intended use
p.000003: use in accordance with the specified indication and in the manner and under the conditions specified by the manufacturer;
p.000003: 17. EEA State: a Member State of the European Union and a party to the Agreement on the European Economic Area
p.000003: another State and a State of which the European Community and its Member States are nationals, and
p.000003: An international agreement concluded between a State not party to the Agreement on the European Economic Area
p.000003: the same status as a national of a State party to the Agreement on the European Economic Area
p.000003: enjoy;
p.000003: 18. *
p.000003: placing on the market: custom-made, intended for clinical trials
p.000003: with the exception of making the asset available for the first time, whether in return for payment or free of charge, to the European Economic Area
p.000003: In the European Economic Area (hereinafter referred to as the EEA) or with the European Community or the EEA
p.000003: in a State having the same status as an EEA Member State in respect of assets under the Treaty (hereinafter
p.000003: together: EEA Member State) for distribution or use, regardless of whether the device is new or
p.000003: renovated;
p.000003: 19. putting into service: in the EEA Member State, the device can be used as intended as a product
p.000003: making it available to the end user for the first time;
p.000003: 20. notified body: under the specific legislation, by assessing the conformity of the device and
p.000003: designated to carry out certification tasks and the European Commission (hereinafter
p.000003: Commission), as well as the body notified to the EEA Member States and other conformity
p.000003: notified to the Commission for evaluation tasks
p.000003: an organization with a specific identification number;
p.000003: 21. *
p.000003: 22. localized harmonized standard: adopted by the European standardization organizations and the European Union
p.000003: Harmonized European standard published in the Official Journal of the European Union and published in accordance with Hungarian procedures
p.000003: published as a national standard;
p.000003: 23. clinical data: derived from the use of a device, its
p.000003: safety and performance information;
p.000003: 24. *
p.000003: unexpected event, accident: occurred in connection with the asset
...

Political / vulnerable

Searching for indicator vulnerability:

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p.000003: to maintain biological functions and structures in connection with the treatment or alleviation of injury or disability,
p.000003: to change, replace or restore.
p.000003: 1.6. Active diagnostic tool: An active tool used alone or in combination with another device to provide information
p.000003: to diagnose a physiological condition, disease or congenital anomaly,
p.000003: to monitor or manage.
p.000003: 1.7. Central circulatory system:
p.000003: For the purposes of this Annex, the central circulatory system means the following vessels:
p.000003: arteriae pulmonales, aortic aorta, arcus aortae, descending aorta bifurcatio aortae, arteriae
p.000003: coronariae, common carotid artery, external carotid artery, internal carotid artery,
p.000003: arteriae cerebrales, truncus brachiocephalicus, cord vein, pulmonary vein, superior vena cava,
p.000003: inferior vein.
p.000003: 1.8. Central nervous system: for the purposes of this Annex, the brain, meninges and spinal cord.
p.000003: II. Implementing rules
p.000003: 2. Implementing rules
p.000003: 2.1. The application of the classification rules is determined by the intended purpose of the asset.
p.000003: 2.2. If the asset is intended to be used in combination with another asset, the classification rules apply to the asset
p.000003: shall be applied to each of them separately. Accessories must be classified in their own right, regardless of
p.000003: the means by which they are used.
p.000003: 2.3. The software that controls the device or affects the use of the device is in the same
p.000003: belongs to the class as the device.
p.000003: 2.4. If the device is not exclusively or primarily not in a specific part of the body
p.000003: shall be judged and classified on the basis of the highest use
p.000003: contains a level of vulnerability.
p.000003: 2.5. If there are multiple rules for the same device based on the performance specified by the manufacturer
p.000003: the strictest rule resulting in a higher classification shall apply.
p.000003: 2.6. Chapter I, Section 1.1. in calculating the period referred to in point
p.000003: use means the uninterrupted actual use of the device for its intended purpose. When
p.000003: the device is discontinued in order to be immediately replaced by the same device or replaced by the same device,
p.000003: then this should be considered as an extension of the continuous use of the tool.
p.000003: III. Classification
p.000003: 1. Non-invasive devices
p.000003: 1.1. Rule 1
p.000003: All non-invasive devices are in Class I, unless otherwise specified below
p.000003: rule applies to it.
p.000003: 1.2. Rule 2
p.000003: Any non-invasive device intended to contain blood, body fluids or body tissues, liquids or gases
p.000003: for the purpose of final injection, administration or introduction into the body, in accordance with Annex II.a.
p.000003: belongs to class if
p.000003: (a) can be connected to an active device in Class IIa or higher, or
p.000003: b) its purpose is to store or conduct blood or other body fluids, or organs, parts of organs
p.000003: or storage of body tissues. In all other cases, it is in Class I.
p.000003: 1.3. Rule 3
p.000003: Any non-invasive device intended for blood, other body fluids as well
p.000003: modification of the biological or chemical composition of other fluids entering the body by infusion, II.b
p.000003: unless the treatment involves filtration, centrifugation or gas or heat exchange.
p.000003: because in these cases it belongs to class II.a.
p.000003: 1.4. Rule 4
p.000003: Non-invasive devices that come in contact with a damaged skin surface
p.000003: (a) are in Class I if they are intended to form a mechanical barrier or compression,
p.000003: swallow secretions,
...

Health / Cognitive Impairment

Searching for indicator impairment:

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p.000003: notified to the Commission for evaluation tasks
p.000003: an organization with a specific identification number;
p.000003: 21. *
p.000003: 22. localized harmonized standard: adopted by the European standardization organizations and the European Union
p.000003: Harmonized European standard published in the Official Journal of the European Union and published in accordance with Hungarian procedures
p.000003: published as a national standard;
p.000003: 23. clinical data: derived from the use of a device, its
p.000003: safety and performance information;
p.000003: 24. *
p.000003: unexpected event, accident: occurred in connection with the asset
p.000003: an event in which any malfunction, characteristics, or performance of the device occurs
p.000003: malfunction or deterioration of the label and any deficiencies in the label or instructions for use, or
p.000003: insufficiency for the death or serious deterioration of the health of the patient, the operator of the device or another person
p.000003: led or could have led;
p.000003: 25. on-site safety corrective action (FSCA): on a device in circulation or in use
p.000003: the action taken by the manufacturer to reduce the risk of an unexpected event;
p.000003: 26. *
p.000003: responsible for the accident: the medical director of the health care provider or his
p.000003: in the absence of an appropriate professional manager, who shall report the incident, accident,
p.000003: performs tasks related to the investigation;
p.000003: 27. *
p.000003: severe deterioration in health:
p.000003: a) life-threatening illness,
p.000003: b) permanent impairment of physiological function or health,
p.000003: (c) a condition requiring medical or surgical intervention in accordance with (a);
p.000003: and (b),
p.000003: (d) diagnostic or in vitro diagnostic instructions used in accordance with the manufacturer 's instructions
p.000003: damage caused by an erroneous result of a device test,
p.000003: (e) fetal harm, fetal death or congenital or birth-related
p.000003: disorder;
p.000003: 28. *
p.000003: serious risk to public health: any unforeseen event or
p.000003: an accident resulting in the death or serious health of several people
p.000003: may lead to deterioration.
p.000003: (2) *
p.000003: In addition to the provisions of paragraph 1, for the purposes of this Decree, the Eütv. Third
p.000003: Shall be taken into account.
p.000003: Basic provisions
p.000003: § 5 (1) *
p.000003: Device, other than custom-made, intended for clinical trials -
p.000003: may be placed on the market or put into service if it complies with the requirements of paragraph 2
p.000003: is marked.
p.000003: A device may bear the CE marking if:
p.000003: a) meets the essential requirements pursuant to Section 11, and
p.000003: (b) the requirements of point (a) have been verified in accordance with Section 13 of the EC
p.000003: conformity assessment procedure.
p.000003: (3) *
p.000003: The manufacturer or his authorized representative has already placed it on the market
p.000003: at the time of production, have proof of compliance with paragraph 2 (a) and (b), e
p.000003: documents with the content specified in this Regulation.
p.000003: (4) *
p.000003: By placing the device on the market or putting it into service
p.000003: compliance with the provisions relating to the placing on the market or putting into service
...

Health / Drug Usage

Searching for indicator drug:

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p.000003: 4/2009. (III. 17.) EüM on medical devices
p.000003: CLIV of 1997 on health. on the basis of the authorization contained in Section 247 (2) (k) of Act no
p.000003: 161/2006 on the duties and powers of the Minister of Health (VII. 28.) Government Decree § 1 a)
p.000003: Acting in the scope of duties specified in point 1, I order the following:
p.000003: Scope of the Regulation
p.000003: § 1 (1) *
p.000003: ✖
p.000003: The scope of this Regulation shall be as set out in paragraph 2
p.000003: Medical devices manufactured, distributed and used in Hungary
p.000003: devices and accessories.
p.000003: (Http: //landing.wolte
p.000003: 2. This Regulation shall not apply to:
p.000003: (a) in vitro diagnostic devices;
p.000003: Jogtár demo?
p.000003: utm_source = netjogta
p.000003: b) human blood, blood products, plasma or blood cells of human origin, or in accordance with Section 2 (1)
p.000003: (e) a device containing human blood products, plasma or blood cells at the time of placing on the market;
p.000003: c) *
p.000003: except for the assets included in Section 2 (2) (d)
p.000003: devices containing human tissue or cells, transplants of human origin,
p.000003: tissues or cells or preparations thereof;
p.000003: d) for devices containing tissues or cells of animal origin, with the exception of Section 2 (1) (b),
p.000003: transplants, tissues or cells of animal origin;
p.000003: e) *
p.000003: with the exception of § 2 (2) c) and d) for human use
p.000003: and other amendments to the laws governing the pharmaceutical market
p.000003: XCV of 2005 (hereinafter: Gytv.) for a product that qualifies as a medicinal product, including the
p.000003: medicinal products derived from human blood derivatives, where this is justified by the main mode of action of the product;
p.000003: f) *
p.000003: for devices in which the device and the drug are single
p.000003: forms a single product intended exclusively for use in that combination and which
p.000003: cannot be reused. For this single unit product, Gytv. shall apply. On this
p.000003: products are subject to the essential requirements set out in Annex 1 in so far as they are concerned
p.000003: the safety and performance characteristics of the device;
p.000003: (g) a cosmetic product covered by specific legislation.
p.000003: (3) This Regulation concerns the authorization of advanced therapy medicinal products and Regulation (EC) No 2001/83
p.000003: European Parliament and of the Council of 13 November 2007 amending Directive 726/2004 / EC and Regulation (EC) No 726/2004
p.000003: shall apply subject to a Regulation of the European Parliament and of the Council.
p.000003: Interpretative provisions
p.000003: § 2 *
p.000003: 1. For the purposes of this Regulation, a medical device (hereinafter referred to as
p.000003: CLIV of 1997 on health. § (hereinafter: Eütv.) § 3
p.000003: (h) an instrument as defined in points (ha) to (d).
p.000003: (2) To be considered as a medical device
p.000003: (a) a device manufactured utilizing a tissue or cell of inanimate animal origin;
p.000003: (b) a device for administering the medicinal product;
p.000003: (c) a device of which an integral part is a substance which, when used alone, is a medicinal product,
p.000003: which, in addition to the device, acts on the human body;
p.000003: (d) a device of which an integral part is derived from human blood or human plasma alone
...

Searching for indicator influence:

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p.000003: EMA for the manufacturing process and the incorporation of the substance into the device by the notified body
p.000003: take into account the data established.
p.000003: When it is done in an additional material that is part of the device - especially related to the manufacturing process
p.000003: change, the notified body must be informed and the competent authority must be consulted (ie the first
p.000003: consultation) with the pharmaceutical authority to confirm that the supplement
p.000003: material quality is unchanged and remains safe. The competent authority shall take this into account
p.000003: the usefulness of incorporating the substance into the device by the notified body
p.000003: specified data to ensure that the changes are not adversely affected
p.000003: the benefit / risk balance of adding the substance to the device.
p.000003: If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
p.000003: information that the additive has been incorporated into the device
p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that this information is existing in connection with the incorporation of the additional substance into the device
p.000003: benefit / risk ratio. The notified body shall take the updated scientific opinion into account
p.000003: and review its assessment in the conformity assessment procedure accordingly.
p.000003: 7.5. Devices must be designed and manufactured in such a way as to minimize them from the device
p.000003: risk due to leaking materials. Particular attention must be paid in the European Union
p.000003: 3/2006 on the list of classified dangerous substances (I. 26.) EüM Decree No. 1
p.000003: carcinogenic, mutagenic or teratogenic substances in accordance with Annex
p.000003: Where parts of a device (or the device itself) intended for medicinal products,
p.000003: the introduction and / or removal of body fluids or other substances from the body, or
p.000003: if they are intended for the transport of such body fluids or substances in accordance with Regulation 3/2006.
p.000003: (I. 26.) EüM Decree No. 1 or 2 carcinogen, mutagen or
p.000003: contain phthalates classified as teratogenic, on the device itself and / or on each unit
p.000003: The label on the sales package and, where appropriate, on the sales packaging shall indicate that:
p.000003: the device contains phthalates.
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p.000003: including the clinical benefit / risk of incorporating the human blood product into the device
p.000003: money. When commenting on the EMA, the manufacturing process and the material took place in the device
p.000003: data specified by the notified body on the usefulness of its incorporation.
p.000003: When it is done in an additional material that is part of the device - especially related to the manufacturing process
p.000003: change, the notified body must be informed and the competent authority must be consulted (ie the first
p.000003: consultation) with the pharmaceutical authority to confirm that the supplement
p.000003: material quality is unchanged and remains safe. The competent authority shall take this into account
p.000003: the usefulness of incorporating the substance into the device by the notified body
p.000003: specified data to ensure that the changes are not adversely affected
p.000003: the benefit / risk balance of adding the substance to the device.
p.000003: If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
p.000003: information that the additive has been incorporated into the device
p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that the benefit / risk balance associated with the incorporation of the additional substance into the device
p.000003: It can affect. The notified body shall take the updated scientific opinion into account and the EC
p.000003: review its assessment in the conformity assessment procedure on that basis.
p.000003: 11. Devices and, where appropriate, their components must be identifiable in such a way as to:
p.000003: that any potential risk associated with the device and its components is discovered
p.000003: allow all necessary measures to be taken.
p.000003: 12. Devices must bear a code by which the devices (in particular the type of device and
p.000003: year of manufacture) and their manufacturer can be clearly identified. This code is surgical if necessary
p.000003: can be read without intervention.
p.000003: 13. If a device or accessory has instructions that
p.000003: display of operating or control parameters required for the operation of the device
p.000003: such information must be easy for the user and
p.000003: where appropriate, for the patient.
p.000003: 14. Each device must bear the following particulars, in letters grouped on the same side, legibly and indelibly marked
p.000003: data, where appropriate in the form of commonly known symbols:
p.000003: 14.1. On the sterile package:
p.000003: (a) the method of sterilization;
p.000003: (b) a mark enabling the packaging in question to be identified by
p.000003: sterility;
p.000003: (c) the name and address of the manufacturer;
...

Searching for indicator substance:

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p.000003: medicinal products derived from human blood derivatives, where this is justified by the main mode of action of the product;
p.000003: f) *
p.000003: for devices in which the device and the drug are single
p.000003: forms a single product intended exclusively for use in that combination and which
p.000003: cannot be reused. For this single unit product, Gytv. shall apply. On this
p.000003: products are subject to the essential requirements set out in Annex 1 in so far as they are concerned
p.000003: the safety and performance characteristics of the device;
p.000003: (g) a cosmetic product covered by specific legislation.
p.000003: (3) This Regulation concerns the authorization of advanced therapy medicinal products and Regulation (EC) No 2001/83
p.000003: European Parliament and of the Council of 13 November 2007 amending Directive 726/2004 / EC and Regulation (EC) No 726/2004
p.000003: shall apply subject to a Regulation of the European Parliament and of the Council.
p.000003: Interpretative provisions
p.000003: § 2 *
p.000003: 1. For the purposes of this Regulation, a medical device (hereinafter referred to as
p.000003: CLIV of 1997 on health. § (hereinafter: Eütv.) § 3
p.000003: (h) an instrument as defined in points (ha) to (d).
p.000003: (2) To be considered as a medical device
p.000003: (a) a device manufactured utilizing a tissue or cell of inanimate animal origin;
p.000003: (b) a device for administering the medicinal product;
p.000003: (c) a device of which an integral part is a substance which, when used alone, is a medicinal product,
p.000003: which, in addition to the device, acts on the human body;
p.000003: (d) a device of which an integral part is derived from human blood or human plasma alone
p.000003: when used, a substance that is a medicinal component or a medicinal product that acts in addition to the device
p.000003: the human body (hereinafter referred to as "human blood derivative"),
p.000003: if its purpose complies with the provisions of the Eütv. § 3 h) point ha) -hd)
p.000003: as set out in
p.000003: (3) *
p.000003: (4) In the case of devices referred to in clauses (2) c) -d), in addition to this Decree, the Gytv. provisions of this Regulation
p.000003: apply to medicinal products.
p.000003: (5) *
p.000003: As to whether a given product qualifies as an asset, in case of doubt, the
p.000003: The National Institute of Pharmacy and Food Health (hereinafter: OGYÉI) decides.
p.000003: Section 3 (1) Annex 1 sets out the basic general and design and construction
p.000003: requirements with which all devices placed on the market or put into service must comply.
p.000003: 2. Annex 2 sets out the requirements for classified and active implantable devices, a
p.000003: the full quality assurance system that the manufacturer has chosen as the EC conformity assessment procedure
p.000003: rules of procedure.
p.000003: 3. Annex 3 sets out the requirements for classified and active implantable devices, a
p.000003: the rules for the EC type-examination procedure to be chosen by the manufacturer as the EC conformity assessment procedure.
p.000003: (4) Annex 4 sets out the requirements for classified and active implantable devices, a
p.000003: the rules for the EC product verification procedure to be chosen by the manufacturer as the EC conformity assessment procedure.
p.000003: (5) Annex 5 sets out the requirements for classified and active implantable devices, a
p.000003: the production quality assurance procedure that the manufacturer has chosen as the EC conformity assessment procedure
p.000003: rules.
p.000003: (6) Annex 6 sets out the EC conformity assessment of devices by the manufacturer
...

p.000003: 7.1. The device must be designed and constructed in such a way as to ensure compliance with the general requirements.
p.000003: features and services in accordance with Particular attention should be paid
p.000003: (a) the choice of materials used, in particular toxicity, and where necessary flammability
p.000003: point of view;
p.000003: (b) the compatibility of the materials used with biological tissues, cells and body fluids, taking into account
p.000003: taking into account the purpose for which the device is used;
p.000003: (c) the results of biophysical or modeling research which has previously been validated
p.000003: proved if it can be interpreted for the device.
p.000003: 7.2. The device must be designed, manufactured and packaged in such a way that harmful substances and
p.000003: their residues present the lowest possible risk during transport, storage and disposal of the asset
p.000003: persons involved in its use, as well as patients, taking into account the purpose for which the device is used. Strange
p.000003: attention should be paid to the human tissues involved and to the duration and frequency of use.
p.000003: 7.3. The device must be designed and manufactured in such a way that it can be used safely with
p.000003: substances, media and gases with which it is used during normal use or during routine procedures
p.000003: comes into contact. If the device is intended for the administration of medicinal products, it must be designed and manufactured in such a way that:
p.000003: to be compatible with the medicinal product in question, subject to the provisions relating to the medicinal product, and
p.000003: restrictions as well as its performance according to the intended use.
p.000003: 7.4. *
p.000003: If an integral part of the device is a substance that is on its own
p.000003: used - Gytv. as a medicinal product and suitable for the device
p.000003: have an additional effect on the human body compared to its effect, the quality and safety of the substance
p.000003: and its usefulness in Regulation 52/2005 on the placing on the market of medicinal products for human use. (XI. 18.)
p.000003: It must be certified on the basis of the methods specified in Annex 1 of the EüM Decree.
p.000003: For the substances referred to in the first paragraph, the notified body shall be satisfied that:
p.000003: the usefulness of the substance as part of the device, taking into account the purpose of the device,
p.000003: seek a scientific opinion from one of the competent authorities designated by the Member States or
p.000003: primarily from the European Medicines Agency (EMA) under Regulation (EC) No 726/2004
p.000003: quality and safety - including the clinical benefit / risk of incorporation of the substance into the device
p.000003: proportion. When issuing its opinion
p.000003: the competent authority or the EMA has the manufacturing process and the substance has been placed in the device
p.000003: data established by the notified body on the usefulness of its incorporation.
p.000003: If the device also includes human blood products as an integral part, the designated body after
p.000003: convinced of the usefulness of the substance as part of the tool and considering the tool
p.000003: scientific opinion from the EMA on the quality and safety of the substance, including human
p.000003: clinical benefit / risk of incorporation of a blood product into a device. When commenting on the
p.000003: EMA for the manufacturing process and the incorporation of the substance into the device by the notified body
p.000003: take into account the data established.
p.000003: When it is done in an additional material that is part of the device - especially related to the manufacturing process
p.000003: change, the notified body must be informed and the competent authority must be consulted (ie the first
p.000003: consultation) with the pharmaceutical authority to confirm that the supplement
p.000003: material quality is unchanged and remains safe. The competent authority shall take this into account
p.000003: the usefulness of incorporating the substance into the device by the notified body
p.000003: specified data to ensure that the changes are not adversely affected
p.000003: the benefit / risk balance of adding the substance to the device.
p.000003: If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
p.000003: information that the additive has been incorporated into the device
p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that this information is existing in connection with the incorporation of the additional substance into the device
p.000003: benefit / risk ratio. The notified body shall take the updated scientific opinion into account
p.000003: and review its assessment in the conformity assessment procedure accordingly.
p.000003: 7.5. Devices must be designed and manufactured in such a way as to minimize them from the device
p.000003: risk due to leaking materials. Particular attention must be paid in the European Union
p.000003: 3/2006 on the list of classified dangerous substances (I. 26.) EüM Decree No. 1
p.000003: carcinogenic, mutagenic or teratogenic substances in accordance with Annex
p.000003: Where parts of a device (or the device itself) intended for medicinal products,
p.000003: the introduction and / or removal of body fluids or other substances from the body, or
p.000003: if they are intended for the transport of such body fluids or substances in accordance with Regulation 3/2006.
p.000003: (I. 26.) EüM Decree No. 1 or 2 carcinogen, mutagen or
p.000003: contain phthalates classified as teratogenic, on the device itself and / or on each unit
p.000003: The label on the sales package and, where appropriate, on the sales packaging shall indicate that:
p.000003: the device contains phthalates.
p.000003: Where such devices are intended for children or pregnant or breastfeeding mothers
p.000003: the manufacturer’s technical documentation and instructions for use
p.000003: explicitly justify the use of these substances, in particular this paragraph
...

p.000003: meet the requirements of Chapter I. If there is an indication on the device that the device is once
p.000003: used, information on the known characteristics and technical factors known to the manufacturer,
p.000003: which may pose a risk if the device is reused. If
p.000003: 13.1. no instructions for use are required, the information shall be made available to the user on request
p.000003: made;
p.000003: (i) if necessary, additional steps to be taken before the device is put into service (eg sterilization,
p.000003: final assembly, etc.);
p.000003: (j) in the case of devices emitting radiation for medical purposes, the nature, type, intensity and
p.000003: distribution.
p.000003: The instructions for use must also contain the information on the basis of which it is
p.000003: Contraindications and necessary precautions can be briefly informed by medical staff a
p.000003: patients. This information must include:
p.000003: (k) precautions to be taken in the event of a change in the performance of the device;
p.000003: (l) effects under reasonably foreseeable environmental conditions, such as magnetic fields, external
p.000003: electrical effects, electrostatic discharges, pressure and pressure changes, acceleration, self-ignition
p.000003: risk of warming, etc. precautionary measures in the event of
p.000003: (m) information on the medicinal products or medicinal products for which administration is sought
p.000003: intended, including any restrictions on such substances;
p.000003: (n) precautions against any special, unusual hazards associated with the waste of the device;
p.000003: (o) the information contained in paragraph 7.4. Therapeutic substance or human substance present as an integral part of the device in accordance with
p.000003: to mark a blood product;
p.000003: (p) in the case of devices with a measuring function, the accuracy required of the device;
p.000003: (q) the date of issue or the latest revision of the instructions for use.
p.000003: 13.7. A 13.1-13.6. The end user of the device must be listed in Hungarian
p.000003: available to them. For controls, located directly next to them
p.000003: foreign language labels are considered symbols if they have the meaning of use
p.000003: guide explains in detail.
p.000003: B. For active implantable devices
p.000003: I. General requirements
p.000003: 1. The device must be designed and manufactured in such a way as to be suitable for the purpose and conditions of use
p.000003: implantation should not endanger the health or safety of patients. The device poses no danger
p.000003: it must not be reported to the implanter or any other person.
p.000003: 2. The device must be as intended by the manufacturer
p.000003: performance, that is to say, it must be designed and manufactured in such a way as to be suitable for the
p.000003: § (1).
p.000003: 3. The characteristics and performances of the device referred to in points 1 and 2, as specified by the manufacturer
p.000003: during life and under normal conditions of use - do not change
p.000003: adversely affect the health status of patients and, where appropriate, other persons
p.000003: and endanger your safety.
p.000003: 4. The device must be designed, manufactured and packaged in such a way that its characteristics and
p.000003: storage and transport conditions (temperature,
p.000003: moisture content, etc.).
p.000003: 5. Possible undesirable side effects, in comparison with the intended performance, are acceptable
p.000003: risk.
...

p.000003: ionizing radiation related to medical exposure
p.000003: safety requirements in specific legislation on the protection of human health against
p.000003: ionizing radiation from radioactive materials in the device
p.000003: emerging risks;
p.000003: (f) the risks that may arise if maintenance and calibration are impossible,
p.000003: including
p.000003: fa) excessive increase of fault currents,
p.000003: (fb) the aging of the materials used,
p.000003: fc) excessive heating of the device,
p.000003: (fd) a decrease in the accuracy of any measuring or control mechanism.
p.000003: 9. Devices must be designed and manufactured in such a way as to guarantee compliance with the 'I. general
p.000003: requirements and performance referred to in the section "requirements", in particular:
p.000003: (a) the choice of substances used, in particular as regards toxicity;
p.000003: (b) interactions between the materials used and biological tissues, cells and body fluids
p.000003: compatibility with regard to the intended use of the device;
p.000003: (c) the compatibility of the devices with the materials to be administered;
p.000003: (d) quality of contacts, in particular safety;
p.000003: (e) reliability of the energy source;
p.000003: (f) where applicable, adequate tightness;
p.000003: (g) programming, control and monitoring systems, including software;
p.000003: proper functioning.
p.000003: In the case of a device that contains software or a device that is medical software in its own right, the software is a
p.000003: be validated by methods appropriate to the state of the art, taking into account developments
p.000003: principles of lifetime, risk management, validation and control.
p.000003: 10. *
p.000003: If the device is an integral part of a substance which, if by itself
p.000003: used - the Gytv. which is considered to be a medicinal product and which is suitable for
p.000003: have an additional effect on the human body compared to the effect of the device, the quality, safety and safety of the substance
p.000003: 52/2005 on the placing on the market of medicinal products for human use. (XI. 18.) EüM
p.000003: shall be certified in accordance with the methods set out in Annex 1 to this Regulation.
p.000003: With regard to the substances referred to in the first paragraph, the notified body shall, after having ascertained the substance as
p.000003: request a scientific opinion on the usefulness of the part of the device, taking into account its purpose
p.000003: from one of the competent authorities designated by the Member State or from the ERF in accordance with Regulation (EC) No 726/2004
p.000003: regarding the quality and safety of the material, including when the material is incorporated into the device
p.000003: clinical benefit / risk. When giving an opinion, the competent authority or the EMA shall
p.000003: process and the usefulness of the incorporation of the substance into the device by the notified body
p.000003: takes into account the data specified by the
p.000003: If a device contains human blood products as an integral part, the designated body after
p.000003: convinced of the usefulness of the substance as part of the device, taking into account the device
p.000003: request a scientific opinion from the EMA on the quality and safety of the substance,
p.000003: including the clinical benefit / risk of incorporating the human blood product into the device
p.000003: money. When commenting on the EMA, the manufacturing process and the material took place in the device
p.000003: data specified by the notified body on the usefulness of its incorporation.
p.000003: When it is done in an additional material that is part of the device - especially related to the manufacturing process
p.000003: change, the notified body must be informed and the competent authority must be consulted (ie the first
p.000003: consultation) with the pharmaceutical authority to confirm that the supplement
p.000003: material quality is unchanged and remains safe. The competent authority shall take this into account
p.000003: the usefulness of incorporating the substance into the device by the notified body
p.000003: specified data to ensure that the changes are not adversely affected
p.000003: the benefit / risk balance of adding the substance to the device.
p.000003: If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
p.000003: information that the additive has been incorporated into the device
p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that the benefit / risk balance associated with the incorporation of the additional substance into the device
p.000003: It can affect. The notified body shall take the updated scientific opinion into account and the EC
p.000003: review its assessment in the conformity assessment procedure on that basis.
p.000003: 11. Devices and, where appropriate, their components must be identifiable in such a way as to:
p.000003: that any potential risk associated with the device and its components is discovered
p.000003: allow all necessary measures to be taken.
p.000003: 12. Devices must bear a code by which the devices (in particular the type of device and
p.000003: year of manufacture) and their manufacturer can be clearly identified. This code is surgical if necessary
p.000003: can be read without intervention.
p.000003: 13. If a device or accessory has instructions that
p.000003: display of operating or control parameters required for the operation of the device
p.000003: such information must be easy for the user and
p.000003: where appropriate, for the patient.
p.000003: 14. Each device must bear the following particulars, in letters grouped on the same side, legibly and indelibly marked
p.000003: data, where appropriate in the form of commonly known symbols:
p.000003: 14.1. On the sterile package:
p.000003: (a) the method of sterilization;
p.000003: (b) a mark enabling the packaging in question to be identified by
p.000003: sterility;
p.000003: (c) the name and address of the manufacturer;
p.000003: (d) the name of the asset;
p.000003: (e) on a device intended for clinical investigations, the words "for clinical investigations only";
p.000003: (f) in the case of a custom-made device, the words "custom-made device";
p.000003: (g) an indication that the implantable device is in a sterile state;
p.000003: (h) month and year of manufacture;
...

p.000003: production quality,
p.000003: (bb) the effectiveness of the quality system, in particular the design and manufacturing quality which it intends to achieve
p.000003: means of verifying the suitability of non-compliant products
p.000003: also,
p.000003: (bc) the means of monitoring the effective operation of the quality system where:
p.000003: the design, manufacture and / or acceptance inspection and testing of the product or of any of its components
p.000003: carried out by the organization, highlighting the method used to audit the external organization and its level of detail;
p.000003: (c) the procedures for directing and controlling the design of the product, including the appropriate
p.000003: documentation, in particular:
p.000003: (ca) a general description of the product, including any variants planned and its intended use,
p.000003: (cb) the design documentation, including applicable standards and risk analysis
p.000003: and to meet the essential requirements of the product
p.000003: a description of the solutions, if applicable
p.000003: nationalized harmonized standards are not fully implemented,
p.000003: (cc) the design examination and checking techniques, processes and procedures that will be used when designing the product; and
p.000003: systematic measures,
p.000003: (cd) if the device must be connected to other device (s) in order to function properly for its intended purpose,
p.000003: proof that it has the characteristics specified by the manufacturer for any device (s)
p.000003: meets the essential requirements
p.000003: (ce) a statement as to whether the device incorporates, as an integral part, Annex 1, Part A.II. point
p.000003: 7.4. substance or human blood derivative referred to in
p.000003: to evaluate the safety, quality and usefulness of the substance or human blood derivative
p.000003: data from tests carried out taking into account the purpose for which the device is used,
p.000003: cf) *
p.000003: a statement that the device is in accordance with Council Directive 90/385 / EEC
p.000003: active implantable medical devices manufactured utilizing tissues of animals
p.000003: animal tissues and Council Directive 93/42 / EEC
p.000003: requirements for medical devices manufactured using
p.000003: Commission Regulation (EU) No 722/2012 laying down specific requirements
p.000003: hereinafter referred to as Commission Regulation (EU) No 722/2012) using tissue of animal origin,
p.000003: (cg) Annex 1, A.I. solutions applied in accordance with point 2 of
p.000003: ch) assessment of suitability for clinical trial,
p.000003: (ci) a clinical evaluation in accordance with Annex 10,
p.000003: (cj) the draft label and, if any, the instructions for use;
p.000003: (d) the inspection and quality assurance techniques at the manufacturing stage, in particular:
p.000003: the methods and procedures used, in particular as regards sterilization, procurement and relevant
p.000003: documentation,
p.000003: - the product identification procedures at all stages of manufacture, from drawings, descriptions or other relevant documents
p.000003: compiled from documents and kept up to date;
p.000003: (e) the examinations and tests that will be carried out before, during and after manufacture, the frequency with which they will be carried out,
p.000003: used test equipment. The verification of test equipment must be duly substantiated
p.000003: be.
p.000003: 3.3. The notified body must examine the quality system to determine whether:
p.000003: does it comply with 3.2. requirements referred to in The relevant
p.000003: quality systems complying with harmonized standards meet these requirements.
...

p.000003: such as quality programs, quality plans, quality manuals and quality records.
p.000003: They shall contain in particular the appropriate documentation, data and data from the procedures referred to in point (c)
p.000003: records.
p.000003: The documentation must contain in particular:
p.000003: (a) the manufacturer 's quality objectives;
p.000003: (b) the organization of the undertaking, in particular:
p.000003: (ba) the organizational structure, responsibilities of the management staff,
p.000003: and its organizational responsibilities for the quality of the design and manufacture of the products,
p.000003: (bb) the effectiveness of the quality system, in particular the design and manufacturing quality which it intends to achieve
p.000003: means of verifying the suitability of non-compliant products
p.000003: also,
p.000003: (bc) the means of monitoring the effective operation of the quality system where:
p.000003: the design, manufacture and / or acceptance inspection and testing of the product or of any of its components
p.000003: carried out by the organization, highlighting the method used to audit the external organization and its level of detail;
p.000003: (c) the procedures for the management and control of the design of the products, in particular:
p.000003: (ca) the design specifications, including applicable standards, and solutions
p.000003: used to meet the essential requirements for the product,
p.000003: if the standards referred to in Article 4 are not applied or are not applied in full,
p.000003: (cb) the design examination and verification techniques, processes and product design procedures used; and
p.000003: systematic measures,
p.000003: (cc) a statement as to whether the device incorporates, as an integral part, Annex 1, Part A.II. point
p.000003: 7.4. substance or human blood derivative referred to in
p.000003: to evaluate the safety, quality and usefulness of the substance or human blood derivative
p.000003: data from tests carried out taking into account the purpose for which the device is used,
p.000003: cd) assessment of suitability for clinical trial,
p.000003: (ce) the clinical evaluation in accordance with Annex 10;
p.000003: (d) the inspection and quality assurance techniques at the manufacturing stage, in particular:
p.000003: (da) the methods and procedures used, in particular sterilization, procurement of materials and
p.000003: in connection with the relevant documentation,
p.000003: (db) the product identification procedures at all stages of manufacture, from drawings, descriptions or other relevant
p.000003: compiled from documents and kept up to date;
p.000003: (e) the examinations and tests that will be carried out before, during and after manufacture, the frequency with which they will be carried out,
p.000003: used test equipment.
p.000003: 3.3. The notified body must examine the quality system to determine whether:
p.000003: does it comply with 3.2. requirements referred to in The relevant
p.000003: quality systems complying with harmonized standards meet these requirements.
p.000003: At least one member of the assessment team must have experience of assessment in the technology concerned
p.000003: on. The assessment procedure must include the manufacturer 's premises and, in duly substantiated cases
p.000003: - inspection of the premises of suppliers and / or subcontractors, inspection of production processes
p.000003: order.
p.000003: The decision must be notified to the manufacturer after the last inspection. This should include what was deducted from the audit
p.000003: conclusions and justification for the evaluation
p.000003: 3.4. The manufacturer must keep the notified body that has approved the quality system informed of any intended updating of the quality system
p.000003: planned change in the quality system. The notified body must examine the proposed
p.000003: changes and verify that the requirements of paragraph 3.2 are still met. requirements referred to in point. The decision
p.000003: communicated to the manufacturer. This decision must include the information deducted from the audit
p.000003: conclusions and justification for the evaluation.
p.000003: 4. Examination of the product design
p.000003: 4.1. In addition to the obligations imposed by point 3, the manufacturer must lodge an application with a notified body
p.000003: intended for manufacture and 3.1. for a product belonging to the product group referred to in point
p.000003: examination of the relevant design documentation.
p.000003: 4.2. The application must cover the design, manufacture and services of the product in question, and
p.000003: it must contain all the documents necessary to establish that the product satisfies the requirements of
p.000003: the requirements of this Regulation, in particular 3.2. the requirements of subparagraphs (c) and (d).
p.000003: The application must include, inter alia:
p.000003: (a) the design specifications, including standards, that have been applied; these standards
p.000003: necessary proof of its applicability, in particular in the case referred to in Article 4
p.000003: standards have not been applied in full
p.000003: degree. This certificate must contain the information required by the manufacturer or under his responsibility
p.000003: the results of appropriate tests;
p.000003: (b) information on whether the product contains as an integral part of the product
p.000003: The substance referred to in Annex 1, Part B, point 10, which interacts with the device in question
p.000003: may result in the entry of the substance into physiological processes, the relevant experiments performed
p.000003: together with data;
p.000003: (c) the clinical evaluation in accordance with Annex 10;
p.000003: (d) the draft instructions for use.
p.000003: 4.3. *
p.000003: The notified body shall examine the application and the product concerned
p.000003: meets the relevant requirements of this Regulation, shall issue an EC design examination certificate to the applicant. THE
p.000003: the notified body may request further tests or trials to supplement the application,
p.000003: to assess compliance with the requirements of this Regulation. The certificate must include the
p.000003: the conclusions of the examination, conditions for its validity, to identify the approved plan
p.000003: the necessary particulars and, where appropriate, a description of the intended use of the product. Annex 1, Part B.
p.000003: In the case of devices referred to in the second paragraph of point 10, the notified body must take decisions
p.000003: referred to in the first paragraph of point 10 of Part B of Annex 1
p.000003: the opinion of the competent body authorized to register medicinal products or the EMA,
p.000003: that the registrant has received the relevant documentation from the date of receipt
p.000003: You must provide an opinion within 210 days. The documentation concerning the device must include:
p.000003: the scientific opinion of the registrant or the EMA. The notified body must:
p.000003: it must take its decision after considering the opinion of the registrant, and
p.000003: you must also inform the registrant.
p.000003: In the case of devices referred to in the third paragraph of point 10 of Part B of Annex 1, the
...

p.000003: 2. The application shall include:
p.000003: (a) the name and address of the manufacturer and, if the application is lodged by the authorized representative,
p.000003: application;
p.000003: (b) the documentation described in point 3, representative of the production envisaged and hereinafter called
p.000003: type) to assess compliance with the requirements of this Regulation. THE
p.000003: the applicant must place the type at the disposal of the notified body. The designated organization
p.000003: may request additional samples if necessary;
p.000003: (c) a written declaration that no other notified body has been notified for the same type
p.000003: have submitted an application.
p.000003: 3. The documentation must enable the design, manufacture and product services to be carried out
p.000003: and should include:
p.000003: (a) the type, including any variants planned, and its intended use
p.000003: a general description of its application (s);
p.000003: (b) design drawings, methods of manufacture envisaged, in particular as regards sterilization; the
p.000003: parts, components, circuits, etc. drawings;
p.000003: (c) descriptions necessary for an understanding of the said drawings and diagrams and the operation of the product; and
p.000003: explanations;
p.000003: (d) a list of the national harmonized standards applied in full or in part; and
p.000003: a description of the solutions adopted to meet the essential requirements,
p.000003: if the localized standards referred to are not fully implemented;
p.000003: (e) design calculations, risk analyzes, technical examinations, etc. results;
p.000003: (f) a statement as to whether the device incorporates, as an integral part, Annex 1, Part A.II. point 7.4.
p.000003: or a human blood derivative and the substance or
p.000003: the tool for evaluating the safety, quality and usefulness of a human blood derivative
p.000003: data from tests performed taking into account its intended use;
p.000003: g) *
p.000003: a statement that the instrument is covered by Commission Regulation (EU) No 722/2012
p.000003: has been made using the tissue of animal origin referred to;
p.000003: (h) Annex 1, A.I. the solutions adopted as referred to in point 2;
p.000003: (i) pre-clinical evaluation;
p.000003: (j) clinical data in accordance with Annex 10;
p.000003: (k) the design of the label and, if necessary, the instructions for use.
p.000003: 4. The notified body must:
p.000003: 4.1. examine and evaluate the documentation and verify that the type:
p.000003: manufactured in accordance with the documentation; keep records of the items that the
p.000003: designed in accordance with the relevant requirements of national harmonized standards and those which are not;
p.000003: 4.2. perform or have performed the appropriate examinations and necessary tests
p.000003: necessary to verify that the solutions adopted by the manufacturer satisfy the requirements set out in Annex 1
p.000003: essential requirements if the nationalized harmonized standards are not fully applied. If the
p.000003: the product must be connected to other devices in order to function properly as intended
p.000003: make sure that this is done with another device having the characteristics specified by the manufacturer
p.000003: when combined, it meets the essential requirements;
p.000003: 4.3. perform or have performed the appropriate examinations and necessary tests which:
p.000003: they are necessary to verify that, if the manufacturer has chosen the appropriate standards to be used, they have been applied
p.000003: actually applied it;
p.000003: 4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out.
p.000003: 5. *
...

p.000003: The application must include:
p.000003: (a) the name and address of the manufacturer and, if the application is lodged by the authorized representative,
p.000003: application;
p.000003: (b) a written declaration that no other notified body has been notified for the same type
p.000003: an application has been submitted;
p.000003: (c) the documentation described in point 3, representative of the production envisaged (hereinafter referred to as
p.000003: type) to assess compliance with the requirements of this Regulation.
p.000003: The applicant must place the type at the disposal of the notified body. A designated organization is required
p.000003: You may request additional samples.
p.000003: 3. The documentation must enable the design, manufacture and services of the device to be obtained
p.000003: and should include:
p.000003: (a) a general description of the type, all variants planned and its intended use (s)
p.000003: a description;
p.000003: (b) design drawings, methods of manufacture envisaged, in particular as regards sterilization, and
p.000003: parts, components, circuits, etc. drawings;
p.000003: (c) descriptions and explanations necessary for the understanding of said drawings and diagrams and the operation of the product;
p.000003: (d) a list of the national harmonized standards applied in full or in part; and
p.000003: a description of the solutions adopted to meet the essential requirements,
p.000003: if the nationalized harmonized standards are not fully implemented;
p.000003: (e) design calculations, risk analyzes, technical examinations, etc. results;
p.000003: (f) a statement as to whether the device incorporates, as an integral part, Annex 1, point B.II 10.
p.000003: or a human blood derivative and the substance prescribed in this connection
p.000003: or the tool for evaluating the safety, quality and usefulness of a human blood derivative
p.000003: data from tests performed taking into account its intended use;
p.000003: (g) pre-clinical evaluation;
p.000003: (h) clinical data in accordance with Annex 10;
p.000003: (i) the draft instructions for use.
p.000003: 4. The notified body must, during the EC type-examination procedure:
p.000003: 4.1. examine and evaluate the documentation and verify that the type conforms to the documentation
p.000003: They manufactured; lays down the items covered by the nationalized harmonized standards
p.000003: designed in accordance with the relevant requirements of this Regulation and those that are not;
p.000003: 4.2. perform or have performed the appropriate examinations and necessary tests to check that:
p.000003: the solutions adopted by the manufacturer meet the essential requirements of Annex 1 if a
p.000003: nationalized harmonized standards are not fully implemented;
p.000003: 4.3. perform or have performed the appropriate examinations and necessary tests to check that,
p.000003: that if the manufacturer has chosen the appropriate standards to be used, he has actually applied them;
p.000003: 4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out.
p.000003: 5. *
p.000003: If the type meets the requirements of this Regulation, the notified body
p.000003: It shall issue an EC type - examination certificate to the applicant. The certificate must include the
p.000003: the name and address of the manufacturer, the conclusions of the examination,
p.000003: the conditions of validity and the particulars necessary for identification of the approved type
p.000003: required. The relevant parts of the documentation must be attached to the certificate and a copy designated
p.000003: organization must retain.
...

p.000003: 3. Additional rules for active assets
p.000003: 3.1. Rule 9
p.000003: All active therapeutic devices intended to transmit or exchange energy are in Class IIa.
p.000003: unless it has the characteristics of transmitting energy to the human body, or
p.000003: energy exchange with the human body, the nature, density and
p.000003: potentially hazardous given its application environment; in this case the
p.000003: It belongs to class II.b.
p.000003: Any active device intended to be active therapeutic in Class IIb
p.000003: monitor or control the operation of such devices or are intended to operate such devices
p.000003: class II.b.
p.000003: 3.2. Rule 10
p.000003: All active diagnostic tools are in Class IIa that are intended to:
p.000003: (a) release the energy absorbed by the human body, except for the patient's body in the visible spectrum
p.000003: means used to illuminate the
p.000003: b) represents the distribution of radiological preparations in vivo,
p.000003: (c) allow the direct diagnosis and monitoring of vital physiological processes, unless:
p.000003: was specifically designed to monitor vital physiological parameters that
p.000003: may result in an immediate hazard to the patient (eg cardiac function, respiration,
p.000003: changes in central nervous system activity); in this case it is in Class II.b.
p.000003: Active devices intended to emit ionizing radiation and for radiological diagnosis or therapy,
p.000003: including devices which control or monitor them and which directly affect their operation, in accordance with Annex II.b.
p.000003: belong to class.
p.000003: 3.3. Rule 11
p.000003: Any active device that is used to inject drugs, body fluids, or other substances into the body
p.000003: intended for administration or removal from the body is in Class IIa, unless the substance so requires
p.000003: potentially hazardous in nature, the part of the body concerned or the route of administration
p.000003: performs; in this case it is in Class II.b.
p.000003: 3.4. Rule 12
p.000003: All other active devices are in Class I.
p.000003: 4. Special rules
p.000003: 4.1. Rule 13
p.000003: Any device which, as an integral part, contains a material which, when used separately, is
p.000003: 52/2005 on the placing on the market of medicinal products for human use (XI. 18.) EüM decree
p.000003: which is considered to be a medicinal product and which complements the action of the device on the human body, in accordance with Annex III. classes
p.000003: belongs to.
p.000003: Any device that contains a human blood derivative as an integral part is listed in Annex III. belongs to class.
p.000003: 4.2. Rule 14
p.000003: Any device used for contraception or the prevention of the sexual transmission of diseases shall be
p.000003: unless it is an implantable or long-term invasive device; in such cases a
p.000003: III. belongs to class.
p.000003: 4.3. Rule 15
p.000003: Specially for disinfecting, cleaning, rinsing and, if necessary, moistening contact lenses
p.000003: intended for use are in Class II.b.
p.000003: Devices specifically intended for the disinfection of devices are in Class II.a. Except
p.000003: if used for specifically invasive device disinfection, in which case Class IIb
p.000003: belongs to.
p.000003: This rule does not apply to products other than contact lenses
p.000003: intended for the physical cleaning of equipment.
p.000003: 4.4. Rule 16
p.000003: Devices specifically intended for the recording of X-ray diagnostic images are in Class II.a.
p.000003: 4.5. Rule 17
p.000003: Any device manufactured utilizing non-viable animal tissues or derivatives shall be as set out in Annex III. classes
p.000003: unless such device is intended to come into contact with intact skin only.
...

p.000003: ! Annex 14 to Regulation 4/2009 (III. 17.) EüM *
p.000003: ! NOTIFICATION FORM
p.000003: For the National Center for Public Health
p.000003: devices in Class IIa specifically intended for the disinfection of medical devices
p.000003: on the placing on the market in Hungary
p.000003: Details of the manufacturer, distributor, authorized representative Notifier (company)
p.000003: name:
p.000003: .................................................. .................................................. ....................
p.000003: ..............................
p.000003: Headquarter: _ _ _
p.000003: _
p.000003: .................................................. .................................................. ....................
p.000003: ..........
p.000003: Site address: _ _ _ _ ........................................... .............
p.000003: County:
p.000003: .................................................. .
p.000003: Phone: .................................... Fax:
p.000003: ................................... E-mail:
p.000003: .................................................. ..
p.000003: Contact person
p.000003: name:
p.000003: .................................................. .................................................. ............
p.000003: Contact address: _ _ _
p.000003: _
p.000003: .................................................. .................................................. ..................
p.000003: Phone: ..................................... Fax:
p.000003: ................................... E-mail:
p.000003: .................................................. .
p.000003: Data on the marketed medical device (disinfectant)
p.000003: Name of Product
p.000003: Name of the biocidal active substance (s)
p.000003: Stripping
p.000003: Active substance content
p.000003: Current year:
p.000003: Notes:
p.000003: Company signature, company stamp, date:
p.000003: Annex 15 to Regulation 4/2009 (III. 17.) EüM *
p.000003: Annex 16 to Regulation 4/2009 (III. 17.) EüM *
p.000003: 4/2009 on medical devices. (III. 17.) EüM Decree, manufacturer and equipment declaration
p.000003: Form
p.000003: 1. Details of the Office
p.000003: Competent Authority code HU / CA / 01
p.000003: Competent Authority name
p.000003: Medical Registration and Training Center Medical Technology Department
p.000003: Country code HU
p.000003: Postal code 1051
p.000003: Street, number Zrínyi.
p.000003: e-mail amd@eekh.hu
p.000003: City / City Budapest
p.000003: Mailbox / P.O.B. 1380 P.O.Box 1188
p.000003: Fax / Fax number
p.000003: +36 1 269 1255
p.000003: 2. Identification of the registration
p.000003: Date of registration
p.000003: Registration number
p.000003: Reason of the registration
p.000003: □ first
p.000003: first registration
p.000003: □ tool for performance evaluation
p.000003: Change of address and / or name of the manufacturer or his authorized representative
p.000003: address and / or name of the manufacturer or the authorized representative
p.000003: □ distribution
p.000003: discontinuation by manufacturer
p.000003: □ withdrawal of the product from the market
p.000003: Competent Authority
p.000003: In case of change, suspension or revocation number of the previous notification
p.000003: discontinuation or withdrawal, provide number of the previous registration
p.000003: Status of the organization making this registration application
p.000003: □ Manufacturer / Authorized Representative /
p.000003: Authorized representative
p.000003: 3. Identification of the manufacturer Full name of the manufacturer
...

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p.000003: Regulation and
p.000003: (b) Commission Decision 2010/227 / EU of 19 April 2010 on the European Databank for Medical Devices (EUDAMED)
p.000003: Decision
p.000003: c) *
p.000003: as regards Council Directive 90/385 / EEC, animal tissues
p.000003: for active implantable medical devices manufactured using
p.000003: As regards Council Directive 93/42 / EEC, medical devices manufactured utilizing tissues of animal origin
p.000003: on specific requirements for equipment
p.000003: Commission Regulation (EU) No 722/2012 of 8 August 2012
p.000003: lays down the provisions necessary for its implementation.
p.000003: Annex 1 to Regulation 4/2009 (III. 17.) EüM
p.000003: Essential requirements
p.000003: A. For class assets
p.000003: I. General requirements
p.000003: 1. The device must be designed and manufactured in such a way as to be specified by the manufacturer
p.000003: when used as intended, do not endanger the health of patients
p.000003: the safety or security of users and, where appropriate, other persons, and
p.000003: provided that all risks associated with its intended use
p.000003: acceptable in relation to the benefits to the patient and compatible
p.000003: with a high level of health and safety requirements. This includes:
p.000003: (a) minimizing the risk of operational error that is
p.000003: arises from the ergonomic features of the device and the environment in which the device is intended to be used
p.000003: (patient safety design), and
p.000003: (b) the technical knowledge, experience, education and training of the target users and appropriate
p.000003: taking into account, where appropriate, his medical and physical condition (lay, professional, disabled or disabled)
p.000003: design that takes other users into account).
p.000003: 2. The design and manufacturing solutions applied by the manufacturer must comply with the safety principles,
p.000003: taking into account generally accepted technical standards. The most suitable solutions
p.000003: the manufacturer must apply the following principles in the order in which they are listed:
p.000003: (a) elimination or reduction of risk (safe design and construction per se);
p.000003: (b) the application of adequate protection measures in respect of unavoidable risks,
p.000003: including an alarm if necessary;
p.000003: (c) informing users of any deficiencies in the security measures adopted is maintained
p.000003: risk.
p.000003: 3. The device must have the performance intended by the manufacturer and be designed and manufactured
p.000003: and packaged to suit one or more of the specifications referred to in Section 2 (1) specified by the manufacturer
p.000003: function.
p.000003: 4. Device characteristics and performance referred to in points 1, 2 and 3 - specified by the manufacturer
p.000003: during life and under normal conditions of use - do not change
p.000003: adversely affect the health status of patients and, where appropriate, other persons
p.000003: and endanger your safety.
p.000003: 5. The device must be designed, manufactured and packaged in such a way that it is suitable for its intended purpose
p.000003: provided during use of the characteristics and performance of transport and storage conditions do not
p.000003: taking into account the instructions and information provided by the manufacturer.
...

p.000003: 3. Identification of the manufacturer Full name of the manufacturer
p.000003: The manufacturer
p.000003: short name
p.000003: The manufacturer
p.000003: tax number
p.000003: The manufacturer
p.000003: Headquarters
p.000003: Country / Country
p.000003: Postal code
p.000003: Street, house number / Street, number
p.000003: Contact details
p.000003: Name / Name
p.000003: Fax / Fax number
p.000003: City / City
p.000003: Mailbox / P.O.B.
p.000003: Telephone number
p.000003: e-mail
p.000003: 4. Identification of the authorized representative
p.000003: Full name of the authorized representative
p.000003: Short name of the authorized representative
p.000003: Authorized representative 's registered office. Registered office of the authorized representative
p.000003: Postal code City / City Street, house number / Street, number Mailbox / P.O.B. THE
p.000003: contact details
p.000003: Name Telephone name
p.000003: Fax / Fax number e-mail
p.000003: 5. Identification of the device concerned Code and name of the device category
p.000003: code Name
p.000003: □ 01 Active implantable devices
p.000003: □ 02 Anesthetic and respiratory equipment
p.000003: Anesthetic and respiratory devices
p.000003: □ 03 Dental devices
p.000003: □ 04 Electromechanical devices Electro-medical
p.000003: mechanical devices
p.000003: □ 05 Hospital equipment and devices qualifying as medical devices
p.000003: □ 06 In vitro diagnostic medical devices
p.000003: □ 07 Inactive implantable devices
p.000003: Hospital hardware
p.000003: In vitro diagnostic medical devices
p.000003: Non-active implanatble devices
p.000003: □ 08 Ophthalmic and optical
p.000003: devices
p.000003: □ 09 Reusable instruments Reusable instruments
p.000003: □ 10 Disposable devices Single use devices
p.000003: □ 11 Technical aids for the disabled
p.000003: □ 12 Radiodiagnostic and therapeutic devices
p.000003: Technical aids for disabled persons
p.000003: Diagnostic and therapeutic radiation devices
p.000003: CE marking □ yes □ no
p.000003: GMDN code (if it's available)
p.000003: Description of the device in Hungarian and in English
p.000003: Classification of the device (s)
p.000003: □ Class I device (non-sterile, without measuring function)
p.000003: sterile device and that with measuring function
p.000003: □ Class IIa device
p.000003: □ Class IIb device
p.000003: □ III. Class III device
p.000003: □ Active implant / Active implant
p.000003: □ Class I device with measuring function
p.000003: □ Class I device, sterile
p.000003: □ In vitro diagnostic medical device other than in vitro diagnostic medical device
p.000003: 8/2003 on instruments (III. 13.) ESzCsM Decree No. 2 and the
p.000003: In vitro diagnostic medical device except devices listed in IVDD Annex II
p.000003: and those intended for self testing
p.000003: □ 8/2003 on in vitro diagnostic medical devices. (III. 13.) ESzCsM decree
p.000003: Devices according to list “A” in Annex 2, point 1 under
p.000003: list A of IVDD Annex II
p.000003: □ 8/2003 on in vitro diagnostic medical devices. (III. 13.) ESzCsM decree
p.000003: Devices under list B of IVDD Annex II
p.000003: □ 8/2003 on in vitro diagnostic medical devices. (III. 13.) ESzCsM Decree No. 2
p.000003: Self-monitoring devices not listed in Annex IV and intended
p.000003: for self testing
p.000003: Trade name of the device
p.000003: Alternative make of the device (if the device may be marketed under another name)
p.000003: Device type
p.000003: The device complies with Regulation 4/2009 on medical devices. (III. 17.) EüM Decree § 4 (1)
p.000003: Custom made device, MDD Article 6
p.000003: The device complies with Regulation 4/2009 on medical devices. (III. 17.) EüM decree
p.000003: Placed on the market as a system or procedure pack, MDD Article 12
p.000003: The device is marketed as sterile
...

Searching for indicator disability:

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p.000003: it penetrates the body completely.
p.000003: Body orifice: a natural orifice on the skin, including the outer surface of the eyeball, or by any surgical procedure
p.000003: created a permanent opening, such as a stoma.
p.000003: Surgical invasive device: An invasive device that travels through the surface of the body through surgery
p.000003: or enters the body in connection therewith.
p.000003: Implantable device (implant): any device that is used to perform a surgical procedure
p.000003: fully introduced into the body, or
p.000003: - replace the epidermis or eye surface and remain in place after the procedure.
p.000003: The means by which they are partially introduced by surgery are
p.000003: into the human body and which remain in place for at least 30 days after the intervention shall be an implantable device
p.000003: to view.
p.000003: 1.3. Reusable surgical instrument: an instrument that can be used for cutting during surgical procedures,
p.000003: for drilling, sawing, scraping, coupling, clamping, spreading, etc. serve without
p.000003: that it is connected to any active device and that can be reused after proper procedures have been performed.
p.000003: 1.4. Active device: a device whose operation depends on electricity or other energy, here
p.000003: not including energy directly from the human body or gravity.
p.000003: Devices that are intended to be energy and matter between the patient and the active device are not considered to be active devices
p.000003: or transmitting other parameters without undergoing a substantial change. Standalone software is active
p.000003: considered as an asset.
p.000003: 1.5. Active therapeutic device: an active device used alone or in combination with other devices that is a disease,
p.000003: to maintain biological functions and structures in connection with the treatment or alleviation of injury or disability,
p.000003: to change, replace or restore.
p.000003: 1.6. Active diagnostic tool: An active tool used alone or in combination with another device to provide information
p.000003: to diagnose a physiological condition, disease or congenital anomaly,
p.000003: to monitor or manage.
p.000003: 1.7. Central circulatory system:
p.000003: For the purposes of this Annex, the central circulatory system means the following vessels:
p.000003: arteriae pulmonales, aortic aorta, arcus aortae, descending aorta bifurcatio aortae, arteriae
p.000003: coronariae, common carotid artery, external carotid artery, internal carotid artery,
p.000003: arteriae cerebrales, truncus brachiocephalicus, cord vein, pulmonary vein, superior vena cava,
p.000003: inferior vein.
p.000003: 1.8. Central nervous system: for the purposes of this Annex, the brain, meninges and spinal cord.
p.000003: II. Implementing rules
p.000003: 2. Implementing rules
p.000003: 2.1. The application of the classification rules is determined by the intended purpose of the asset.
p.000003: 2.2. If the asset is intended to be used in combination with another asset, the classification rules apply to the asset
p.000003: shall be applied to each of them separately. Accessories must be classified in their own right, regardless of
p.000003: the means by which they are used.
p.000003: 2.3. The software that controls the device or affects the use of the device is in the same
p.000003: belongs to the class as the device.
p.000003: 2.4. If the device is not exclusively or primarily not in a specific part of the body
p.000003: shall be judged and classified on the basis of the highest use
p.000003: contains a level of vulnerability.
p.000003: 2.5. If there are multiple rules for the same device based on the performance specified by the manufacturer
...

Health / Motherhood/Family

Searching for indicator family:

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p.000003: 16. Confirmation that the device, under the intended conditions of use, a
p.000003: in terms of characteristics and performance. General Requirements ”
p.000003: requirements and an assessment of side effects or adverse reactions is provided in Annex 10
p.000003: should be based on clinical data determined in accordance with
p.000003: Annex 2 to Regulation 4/2009 (III. 17.) EüM
p.000003: EC declaration of conformity
p.000003: (Full quality assurance system)
p.000003: A. For class assets
p.000003: 1. The manufacturer must, for the purposes of the manufacture and final inspection of the products concerned,
p.000003: apply the quality system as specified in point 3 and undertake the quality system as specified in point 3.3. and the
p.000003: The examination (audit) provided for in point 4 and the review provided for in point 5.
p.000003: 2. The obligations laid down in point 1 of the EC declaration of conformity procedure
p.000003: manufacturer shall ensure that the products in question comply with the provisions of this Regulation that apply to them
p.000003: requirements and make a statement to that effect.
p.000003: The manufacturer must affix the CE marking and written conformity in accordance with § 5
p.000003: must make a declaration. This statement must relate to one or more specific instruments, clearly
p.000003: identifying the product (s) by the name, type designation or other unambiguous identifier of the product and
p.000003: must be retained by the manufacturer.
p.000003: 3. Quality system
p.000003: 3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body. The application shall:
p.000003: must include:
p.000003: (a) the name and address of the manufacturer and the address of each premises of the quality system concerned;
p.000003: (b) any information relating to the product or family of products covered by the procedure;
p.000003: (c) a written declaration of compliance with the quality system for the same products
p.000003: has not yet applied to another designated body;
p.000003: (d) the quality system documentation;
p.000003: (e) an undertaking by the manufacturer to fulfill the obligations arising out of the quality system as approved
p.000003: the following obligations;
p.000003: (f) an undertaking by the manufacturer to operate an approved quality system
p.000003: maintains it with sufficient efficiency;
p.000003: (g) an undertaking by the manufacturer to institute and maintain a systematic procedure
p.000003: up - to - date to review post - production experience with the device, including
p.000003: Provisions of Annex 10 - and shall make the necessary adjustments. This undertaking must also oblige the manufacturer to:
p.000003: to report without delay the events detailed therein in accordance with Section 21.
p.000003: 3.2. The application of the quality system must ensure that the product is designed from
p.000003: comply with the relevant requirements of this Regulation at all stages until the final inspection.
p.000003: All the elements, requirements and provisions adopted by the manufacturer for his quality system
p.000003: systematically and orderly, in the form of written policies and procedures such as quality programs,
p.000003: quality plans, quality manuals and quality records must be documented. They must include
p.000003: in particular the relevant documentation, data and records resulting from the procedures referred to in point (c).
p.000003: The documentation must contain in particular:
p.000003: (a) the manufacturer 's quality objectives;
p.000003: (b) the organization of the undertaking, in particular:
p.000003: (ba) the organizational structure, responsibilities and powers of the management with regard to product design and implementation;
...

Health / Physically Disabled

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p.000003: Commission), as well as the body notified to the EEA Member States and other conformity
p.000003: notified to the Commission for evaluation tasks
p.000003: an organization with a specific identification number;
p.000003: 21. *
p.000003: 22. localized harmonized standard: adopted by the European standardization organizations and the European Union
p.000003: Harmonized European standard published in the Official Journal of the European Union and published in accordance with Hungarian procedures
p.000003: published as a national standard;
p.000003: 23. clinical data: derived from the use of a device, its
p.000003: safety and performance information;
p.000003: 24. *
p.000003: unexpected event, accident: occurred in connection with the asset
p.000003: an event in which any malfunction, characteristics, or performance of the device occurs
p.000003: malfunction or deterioration of the label and any deficiencies in the label or instructions for use, or
p.000003: insufficiency for the death or serious deterioration of the health of the patient, the operator of the device or another person
p.000003: led or could have led;
p.000003: 25. on-site safety corrective action (FSCA): on a device in circulation or in use
p.000003: the action taken by the manufacturer to reduce the risk of an unexpected event;
p.000003: 26. *
p.000003: responsible for the accident: the medical director of the health care provider or his
p.000003: in the absence of an appropriate professional manager, who shall report the incident, accident,
p.000003: performs tasks related to the investigation;
p.000003: 27. *
p.000003: severe deterioration in health:
p.000003: a) life-threatening illness,
p.000003: b) permanent impairment of physiological function or health,
p.000003: (c) a condition requiring medical or surgical intervention in accordance with (a);
p.000003: and (b),
p.000003: (d) diagnostic or in vitro diagnostic instructions used in accordance with the manufacturer 's instructions
p.000003: damage caused by an erroneous result of a device test,
p.000003: (e) fetal harm, fetal death or congenital or birth-related
p.000003: disorder;
p.000003: 28. *
p.000003: serious risk to public health: any unforeseen event or
p.000003: an accident resulting in the death or serious health of several people
p.000003: may lead to deterioration.
p.000003: (2) *
p.000003: In addition to the provisions of paragraph 1, for the purposes of this Decree, the Eütv. Third
p.000003: Shall be taken into account.
p.000003: Basic provisions
p.000003: § 5 (1) *
p.000003: Device, other than custom-made, intended for clinical trials -
p.000003: may be placed on the market or put into service if it complies with the requirements of paragraph 2
p.000003: is marked.
p.000003: A device may bear the CE marking if:
p.000003: a) meets the essential requirements pursuant to Section 11, and
p.000003: (b) the requirements of point (a) have been verified in accordance with Section 13 of the EC
p.000003: conformity assessment procedure.
p.000003: (3) *
p.000003: The manufacturer or his authorized representative has already placed it on the market
p.000003: at the time of production, have proof of compliance with paragraph 2 (a) and (b), e
p.000003: documents with the content specified in this Regulation.
p.000003: (4) *
p.000003: By placing the device on the market or putting it into service
...

p.000003: Annex 11 to Regulation 4/2009 (III. 17.) EüM
p.000003: "CE" conformity marking
p.000003: The CE marking shall consist of the initials "CE" taking the following form:
p.000003: The above proportions must also be observed when using a reduced or enlarged signal.
p.000003: The two letters of the CE marking must have the same vertical dimension and may not be less than 5 mm.
p.000003: In the case of small devices, the minimum size requirement may be waived.
p.000003: Annex 12 to Regulation 4/2009 (III. 17.) EüM
p.000003: Medical device incidents and manufacturer's on-site safety corrective actions
p.000003: notification form
p.000003: A) * The healthcare provider, distributor, user
p.000003: notification form for an unforeseen event or accident involving a medical device
p.000003: Applicant details:
p.000003: Name of notifier:
p.000003: □ Distributor □ Distributor
p.000003: □ Importer □ User
p.000003: Street, house number or mailbox
p.000003: Postal code City Contact name
p.000003: Telephone Fax
p.000003: E-mail
p.000003: Name and contact details of the person responsible for the accident
p.000003: Device information:
p.000003: Trade name of the asset The risk class of the asset
p.000003: Device type or catalog number
p.000003: Serial number and / or serial number
p.000003: Device accessories
p.000003: Software version (if applicable)
p.000003: Manufacturer information:
p.000003: Manufacturer's name Street, house number
p.000003: Postcode City Country
p.000003: Telephone Fax
p.000003: E-mail
p.000003: Details of the manufacturer's authorized representative Other representation in Hungary
p.000003: Event Details: The date of the event
p.000003: Location of the event
p.000003: Description of the event
p.000003: Consequences (eg death, damage to health, illness BNO-10 code
p.000003: Measures taken in connection with the incident
p.000003: Operating data:
p.000003: Service construction (service contract: own service, brand service, eg Name and address of the service
p.000003: Date of last periodic review, details of medical technology
p.000003: Based on Annex 13
p.000003: Date of last logged service intervention Date of last logged overhaul
p.000003: Comment:
p.000003: This notification does not imply that the manufacturer, the authorized representative confirms or acknowledges that it is notified
p.000003: means of death or damage to the health of a person in any way, or indirectly
p.000003: I hereby declare that the above data are to the best of my knowledge
p.000003: Location: ................................................ Date: .............................................
p.000003: .................................................. .................................................. ....................
p.000003: ..........
p.000003: B) * Manufacturer's (authorized representative's) notification form
p.000003: - unforeseen events and accidents of which he becomes aware
p.000003: Report Form Manufacturer’s Incident Report
p.000003: Recipient
p.000003: Name of national competent authority (NCA)
p.000003: Address of national competent authority (NCA)
p.000003: Date of this report
p.000003: Reference number assigned by the manufacturer
p.000003: Reference number assigned by the national authority (if known) / Reference number assigned by NCA to whom sent (if
p.000003: Known)
p.000003: Type of report
p.000003: □ Initial report
p.000003: □ Follow-up report
p.000003: □ Combined initial and final report
p.000003: □ Final report
p.000003: Unexpected event classification
...

Health / Pregnant

Searching for indicator pregnant:

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p.000003: that this information is existing in connection with the incorporation of the additional substance into the device
p.000003: benefit / risk ratio. The notified body shall take the updated scientific opinion into account
p.000003: and review its assessment in the conformity assessment procedure accordingly.
p.000003: 7.5. Devices must be designed and manufactured in such a way as to minimize them from the device
p.000003: risk due to leaking materials. Particular attention must be paid in the European Union
p.000003: 3/2006 on the list of classified dangerous substances (I. 26.) EüM Decree No. 1
p.000003: carcinogenic, mutagenic or teratogenic substances in accordance with Annex
p.000003: Where parts of a device (or the device itself) intended for medicinal products,
p.000003: the introduction and / or removal of body fluids or other substances from the body, or
p.000003: if they are intended for the transport of such body fluids or substances in accordance with Regulation 3/2006.
p.000003: (I. 26.) EüM Decree No. 1 or 2 carcinogen, mutagen or
p.000003: contain phthalates classified as teratogenic, on the device itself and / or on each unit
p.000003: The label on the sales package and, where appropriate, on the sales packaging shall indicate that:
p.000003: the device contains phthalates.
p.000003: Where such devices are intended for children or pregnant or breastfeeding mothers
p.000003: the manufacturer’s technical documentation and instructions for use
p.000003: explicitly justify the use of these substances, in particular this paragraph
p.000003: compliance with its essential requirements and provide information to these user groups
p.000003: the residual risks and, if necessary, the appropriate precautions.
p.000003: 7.6. The device must be designed and manufactured in such a way that the materials which may enter the device from the environment
p.000003: the risk posed by the device and its environment should be kept to a minimum.
p.000003: 8. Infection and microbial contamination
p.000003: 8.1. The device and its manufacturing process should be designed to be as small as possible
p.000003: reduce the risk of infection for patients, users and third parties. The design
p.000003: allow easy handling of the device and minimize use during use where necessary
p.000003: reduce device contamination by patients or the patient device.
p.000003: 8.2. Tissues of animal origin are derived from animals that have previously been the tissues
p.000003: have been subjected to veterinary inspection and supervision approved in accordance with their intended use. The selected
p.000003: the organization must keep records of the geographical origin of the animals. Of animal origin
p.000003: the processing, preservation, testing and handling of tissues, cells and materials shall be carried out in such a way that:
p.000003: be optimally secure. Particular care should be taken to ensure that viruses are tested by validated procedures
p.000003: with viruses and other infectious pathogens during production
p.000003: protection against.
...

Health / Terminally Ill

Searching for indicator terminal:

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p.000003: public administration body shall notify it at the same time as ordering the suspension of the use of the given device
p.000003: OGYÉI and the National Health Insurance Fund Manager.
p.000003: (4) *
p.000003: The state health administration body shall comply with paragraphs 2 to 3
p.000003: decisions under the General Administrative Procedure Act
p.000003: there is a remedy.
p.000003: ! (5) *
p.000003: Manufacturer, distributor or authorized representative
p.000003: for the disinfection of devices in Class IIa specifically placed on the market during the previous calendar year
p.000003: by the first day of March of the year in question.
p.000003: shall inform the national chief medical officer by sending a form in accordance with Annex.
p.000003: Entry into force, transitional provisions
p.000003: Section 29 (1) This Decree shall enter into force on 21 March 2010.
p.000003: (2) The provisions of Section 12 (6) and Section 13 (12) after the entry into force of this Decree
p.000003: shall apply to proceedings initiated.
p.000003: (3) - (6) *
p.000003: (7) *
p.000003: (8) *
p.000003: § 30. *
p.000003: § 31 *
p.000003: This Regulation
p.000003: (a) the approximation of the laws of the Member States relating to active implantable medical devices
p.000003: Council Directive 90/385 / EEC of 20 June 1990 on the
p.000003: (b) Directives 87/404 / EEC (simple pressure vessels), 88/378 / EEC (safety of toys), 89/106 / EEC
p.000003: (construction products), 89/336 / EEC (electromagnetic compatibility), 89/392 / EEC (machinery), 89/686 / EEC
p.000003: (personal protective equipment), 90/384 / EEC (non-automatic weighing instruments), 90/385 / EEC (active
p.000003: implantable medical devices), 90/396 / EEC (gas appliances), 91/263 / EEC (telecommunications equipment),
p.000003: terminal equipment), 92/42 / EEC (new hot-water boilers fired with liquid or gaseous fuels) and
p.000003: 73/23 / EEC (electrical equipment designed for use within certain voltage limits)
p.000003: Council Directive 93/68 / EEC of 22 July 1993 amending Directive
p.000003: (c) Directive 93/42 / EEC of the European Parliament and of the Council of 14 June 1993 concerning medical devices
p.000003: Directive
p.000003: (d) Directive 98/79 / EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices;
p.000003: Council Directive
p.000003: (e) Council Directive 93/42 / EEC concerning medical devices incorporating stable preparations of human blood or plasma
p.000003: 2000/70 / EC of the European Parliament and of the Council of 16 November 2000 amending
p.000003: Directive
p.000003: (f) amending Council Directive 93/42 / EEC concerning medical devices
p.000003: Directive 2001/104 / EC of the European Parliament and of the Council of 7 December 2001
p.000003: (g) Directive 93/42 / EEC concerning medical devices and the reclassification of hip, knee and shoulder prostheses
p.000003: Commission Directive 2005/50 / EC of 11 August 2005 within the framework of Council Directive
p.000003: (h) Council Directive 93/42 / EEC concerning medical devices and the placing on the market of biocidal products
p.000003: 2007/47 / EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 98/8 / EC
p.000003: Directive of the European Parliament and of the Council
p.000003: for compliance.
p.000003: (2) This Regulation
p.000003: (a) the authorization of advanced therapy medicinal products and Directive 2001/83 / EC and
p.000003: Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 1 November 2007 amending Regulation (EC) No 726/2004
p.000003: Regulation and
...

Health / breastfeeding

Searching for indicator breastfeeding:

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p.000003: that this information is existing in connection with the incorporation of the additional substance into the device
p.000003: benefit / risk ratio. The notified body shall take the updated scientific opinion into account
p.000003: and review its assessment in the conformity assessment procedure accordingly.
p.000003: 7.5. Devices must be designed and manufactured in such a way as to minimize them from the device
p.000003: risk due to leaking materials. Particular attention must be paid in the European Union
p.000003: 3/2006 on the list of classified dangerous substances (I. 26.) EüM Decree No. 1
p.000003: carcinogenic, mutagenic or teratogenic substances in accordance with Annex
p.000003: Where parts of a device (or the device itself) intended for medicinal products,
p.000003: the introduction and / or removal of body fluids or other substances from the body, or
p.000003: if they are intended for the transport of such body fluids or substances in accordance with Regulation 3/2006.
p.000003: (I. 26.) EüM Decree No. 1 or 2 carcinogen, mutagen or
p.000003: contain phthalates classified as teratogenic, on the device itself and / or on each unit
p.000003: The label on the sales package and, where appropriate, on the sales packaging shall indicate that:
p.000003: the device contains phthalates.
p.000003: Where such devices are intended for children or pregnant or breastfeeding mothers
p.000003: the manufacturer’s technical documentation and instructions for use
p.000003: explicitly justify the use of these substances, in particular this paragraph
p.000003: compliance with its essential requirements and provide information to these user groups
p.000003: the residual risks and, if necessary, the appropriate precautions.
p.000003: 7.6. The device must be designed and manufactured in such a way that the materials which may enter the device from the environment
p.000003: the risk posed by the device and its environment should be kept to a minimum.
p.000003: 8. Infection and microbial contamination
p.000003: 8.1. The device and its manufacturing process should be designed to be as small as possible
p.000003: reduce the risk of infection for patients, users and third parties. The design
p.000003: allow easy handling of the device and minimize use during use where necessary
p.000003: reduce device contamination by patients or the patient device.
p.000003: 8.2. Tissues of animal origin are derived from animals that have previously been the tissues
p.000003: have been subjected to veterinary inspection and supervision approved in accordance with their intended use. The selected
p.000003: the organization must keep records of the geographical origin of the animals. Of animal origin
p.000003: the processing, preservation, testing and handling of tissues, cells and materials shall be carried out in such a way that:
p.000003: be optimally secure. Particular care should be taken to ensure that viruses are tested by validated procedures
p.000003: with viruses and other infectious pathogens during production
p.000003: protection against.
p.000003: 8.3. A device shipped in a sterile condition must be designed, manufactured and not reused
...

Social / Access to Social Goods

Searching for indicator access:

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p.000003: the method used to audit the external organization and its level of detail.
p.000003: The above tests do not apply to the manufacturing phases to ensure sterility.
p.000003: 3.3. The notified body must examine the quality system to determine whether it satisfies the
p.000003: whether it complies with 3.2. requirements referred to in The relevant
p.000003: quality systems complying with harmonized standards meet these requirements. The
p.000003: at least one member of the assessment team must have previous assessment experience on the technology concerned
p.000003: on. In order to control the manufacturing processes, the assessment procedure should be included
p.000003: inspections at the manufacturer's premises and, where appropriate, at the premises of the manufacturer's suppliers. The decision
p.000003: which must contain the conclusions of the examination and the reasoned assessment decision,
p.000003: it must be notified to the manufacturer after the last inspection.
p.000003: 3.4. The manufacturer must keep the notified body that has approved the quality system informed of any intended updating of the quality system
p.000003: planned significant change to the quality system. The notified body must
p.000003: examine the proposed changes and verify that the requirements of paragraph 3.2 are still met.
p.000003: referred to in point
p.000003: requirements. The decision to accept the notification, which shall include the
p.000003: the conclusions of the examination and the justification for the assessment must be communicated to the manufacturer.
p.000003: 4. Review
p.000003: 4.1. The purpose of the review is to make sure that the manufacturer maintains the approved quality system
p.000003: fulfill its obligations properly.
p.000003: 4.2. The manufacturer must allow the notified body entrance for inspection purposes
p.000003: have access to the premises used for inspection, testing and storage, and
p.000003: provide it with the necessary documents, in particular:
p.000003: (a) the quality system documentation;
p.000003: (b) the technical documentation;
p.000003: (c) the quality records, such as inspection reports and test data,
p.000003: calibration data, personnel qualification reports.
p.000003: 4.3. The notified body must periodically carry out audits and evaluations to ensure that:
p.000003: ensure that the manufacturer operates an approved quality system. Evaluator for the manufacturer
p.000003: you must report.
p.000003: 4.4. The notified body may pay unexpected visits to the manufacturer. Such visits
p.000003: may, if necessary, carry out tests or have them carried out on the correct operation of the quality system
p.000003: and to verify that production complies with the requirements of this Regulation
p.000003: requirements. For this purpose, a sufficient number of the final product shall be taken on site by the notified body
p.000003: sample shall be tested and the relevant localized harmonized
p.000003: tests specified in the standard (s) or equivalent. If one or more samples do not
p.000003: the notified body
p.000003: take the necessary measures. The manufacturer must be provided with the visit
p.000003: report or, if tests have been performed, the test report.
p.000003: 5. Administrative requirements
p.000003: 5.1. The manufacturer or his authorized representative shall, for a period ending at least 5 years after the last product has been manufactured,
p.000003: in the case of implantable devices, for at least 15 years, make available to the authorities on request:
p.000003: (a) the declaration of conformity;
p.000003: b) a 3.1. the documentation referred to in point (g);
p.000003: c) a 3.4. the changes referred to in point;
p.000003: (d) 4.3.4.4 of the notified body. its decisions and reports referred to in
...

Social / Age

Searching for indicator age:

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p.000003: □ Class I device / MDD Class I
p.000003: Nomenclature system (preferably GMDN)
p.000003: Code / Nomenclature code
p.000003: Code text name / Nomenclature text
p.000003: Commercial name, brand name / Commercial name / brand name / make
p.000003: Model and / or catalog number
p.000003: Serial number and / or batch number (s) and / or lot / batch number (s)
p.000003: Software version number (if applicable) / Software version number (if applicable)
p.000003: Date of manufacture / expiry date (if applicable) / Manufacturinq date / expiry date (if applicable)
p.000003: Accessory / associated device (if any)
p.000003: device (if applicable)
p.000003: Notified body ID number
p.000003: 6 Incident information
p.000003: Registration number of the application at the place of application (if applicable) / User facility report reference
p.000003: number, if applicable
p.000003: Manufacturer's awareness date
p.000003: Date of incident occurred
p.000003: Incident description narrative
p.000003: Number of persons involved (if known)
p.000003: Number of medical devices involved (if known)
p.000003: Medical device current location / disposition (if known)
p.000003: Operator of the medical device at the time of the incident
p.000003: □ Health care professional
p.000003: □ Patient / patient
p.000003: □ Other
p.000003: Usage of the medical device
p.000003: □ Initial use
p.000003: □ Reuse of a reusable medical device
p.000003: □ Other (please specify):
p.000003: □ Refurbished device / re-serviced / refurbished
p.000003: □ Before use
p.000003: problem noted prior use
p.000003: 7 Information on the persons involved
p.000003: Conditions of use of the device
p.000003: Care provided by the healthcare provider to the person concerned / Remediai action taken by the healthcare
p.000003: facility relevant to the care of the person involved
p.000003: Age of the person at the time of the incident (if known) / Age of the person at the time of the incident, if applicable
p.000003: Gender concerned (if known) / Gender (if applicable)
p.000003: □ Woman
p.000003: □ Male / Male
p.000003: Weight in kilograms (if applicable)
p.000003: 8 Healthcare facility information (where the event occurred) / Healthcare facility information
p.000003: Name of the healthcare facility Incident Contact person within the
p.000003: facility Address
p.000003: Postal code
p.000003: Phone number / Phone E-mail / E-mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: 9 Manufacturer's preliminary remarks (in case of prior and follow-up notification) / Manufacturer's
p.000003: preliminary comments (Initial / Follow-up report)
p.000003: Manufacturer's preliminary analysis
p.000003: Preliminary corrective actions / preventive actions by the manufacturer
p.000003: implemented by the manufacturer
p.000003: Expected date of next report
p.000003: 10 Results of manufacturers final investigation (Final report)
p.000003: The manufacturer’s device analysis results
p.000003: Corrective action / remedial action / preventive action / on-site safety corrective action /
p.000003: Remedies action / corrective action / preventive action / Field Safety Corrective Action
p.000003: Note: to be completed from medical devices in case of on-site safety corrective action
p.000003: C: Annex C of the Decree on the submission of the FSCA
p.000003: to fill in the FSCA report form of this annex
p.000003: Time Schedule for the implementation of the identified
p.000003: action
p.000003: Manufacturer's comments on the measures / Final comments from the manufacturer
p.000003: Further investigations
p.000003: Is the manufacturer aware of events related to the device for similar reasons?
...

Social / Child

Searching for indicator children:

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p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that this information is existing in connection with the incorporation of the additional substance into the device
p.000003: benefit / risk ratio. The notified body shall take the updated scientific opinion into account
p.000003: and review its assessment in the conformity assessment procedure accordingly.
p.000003: 7.5. Devices must be designed and manufactured in such a way as to minimize them from the device
p.000003: risk due to leaking materials. Particular attention must be paid in the European Union
p.000003: 3/2006 on the list of classified dangerous substances (I. 26.) EüM Decree No. 1
p.000003: carcinogenic, mutagenic or teratogenic substances in accordance with Annex
p.000003: Where parts of a device (or the device itself) intended for medicinal products,
p.000003: the introduction and / or removal of body fluids or other substances from the body, or
p.000003: if they are intended for the transport of such body fluids or substances in accordance with Regulation 3/2006.
p.000003: (I. 26.) EüM Decree No. 1 or 2 carcinogen, mutagen or
p.000003: contain phthalates classified as teratogenic, on the device itself and / or on each unit
p.000003: The label on the sales package and, where appropriate, on the sales packaging shall indicate that:
p.000003: the device contains phthalates.
p.000003: Where such devices are intended for children or pregnant or breastfeeding mothers
p.000003: the manufacturer’s technical documentation and instructions for use
p.000003: explicitly justify the use of these substances, in particular this paragraph
p.000003: compliance with its essential requirements and provide information to these user groups
p.000003: the residual risks and, if necessary, the appropriate precautions.
p.000003: 7.6. The device must be designed and manufactured in such a way that the materials which may enter the device from the environment
p.000003: the risk posed by the device and its environment should be kept to a minimum.
p.000003: 8. Infection and microbial contamination
p.000003: 8.1. The device and its manufacturing process should be designed to be as small as possible
p.000003: reduce the risk of infection for patients, users and third parties. The design
p.000003: allow easy handling of the device and minimize use during use where necessary
p.000003: reduce device contamination by patients or the patient device.
p.000003: 8.2. Tissues of animal origin are derived from animals that have previously been the tissues
p.000003: have been subjected to veterinary inspection and supervision approved in accordance with their intended use. The selected
p.000003: the organization must keep records of the geographical origin of the animals. Of animal origin
p.000003: the processing, preservation, testing and handling of tissues, cells and materials shall be carried out in such a way that:
p.000003: be optimally secure. Particular care should be taken to ensure that viruses are tested by validated procedures
p.000003: with viruses and other infectious pathogens during production
...

Social / Incarcerated

Searching for indicator restricted:

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p.000003: for the chosen procedure of conformity assessment, verification, certification and certification
p.000003: necessary to maintain its validity. The documents required for the procedure pursuant to Section 13 (1) - (8)
p.000003: in Hungarian or in an official language of another EEA Member State accepted by the notified body
p.000003: shall be made available to the notified body.
p.000003: (2) Annexes 2, 3, 5 and 6 may be actively implanted by the notified body
p.000003: in the case of a device, its certificate issued in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of 5 years.
p.000003: Before the expiration of the certificate - on the date specified in the agreement between the parties
p.000003: in the absence of a request submitted at least 3 months before the expiry date - a further maximum of 5 years
p.000003: periods, the certificate may be extended.
p.000003: 3. The manufacturer or his authorized representative and the notified body must
p.000003: The conditions for carrying out the evaluations and tests in accordance with Annex 6 in the contract
p.000003: record.
p.000003: (4) Where the notified body is involved in the EC conformity assessment procedure
p.000003: necessary and several organizations have been designated to carry out the procedure, one of which is the manufacturer or
p.000003: acting by an authorized representative.
p.000003: 5. Where a notified body finds that the manufacturer does not meet the requirements of this Regulation
p.000003: requirements or the EC certificate of conformity could not have been issued,
p.000003: the notified body shall, taking into account all the circumstances of the case, suspend or limit the
p.000003: certificate of conformity issued by it.
p.000003: (6) If, at the request of the notified body, the certificate is suspended or restricted,
p.000003: within the appropriate time limit therein - the manufacturer has not taken the appropriate measures
p.000003: ensure compliance with this Regulation and the issue of the EC certificate of conformity
p.000003: necessary conditions, the notified body shall withdraw the certificate.
p.000003: (7) *
p.000003: The designated organization shall be notified by OGYÉI within 15 days of its decision
p.000003: inform OGYÉI on a regular form of all issued, amended, supplemented,
p.000003: suspended, revoked or refused certificate and shall inform the other notified bodies of all
p.000003: suspended, revoked or refused certificate and, upon request,
p.000003: issued
p.000003: certificates. OGYÉI shall notify the Commission, the EEA, on the basis of the information of the notified body
p.000003: States. The notified body shall make available to OGYÉI, at its request, everything related to its activities
p.000003: other related information.
p.000003: (8) *
p.000003: If OGYÉI 's market surveillance procedure involves market surveillance
p.000003: 6/2013 on the detailed rules of activity (I. 18.) Government Decree 6 / A. § (1) or 6 / C. §
p.000003: (1), the designated organization which conducted the decision pursuant to Section 13
p.000003: review the procedure pursuant to § 13 in the light of the provisions of the decision.
p.000003: Separate procedure for kits and multi-instrument systems and sterilization procedure
p.000003: § 15. (1) Unlike the procedures pursuant to § 13, the sets of devices and the systems consisting of several devices shall be
p.000003: Paragraphs 2 to 6 shall apply.
p.000003: (2) *
p.000003: Any natural or legal person that is placing on the market
p.000003: devices bearing the CE marking for their intended purpose and specified by their manufacturer
p.000003: used as part of a set of uses, compiles it into a kit or set of tools, issues a statement,
p.000003: certifying that
...

p.000003: OGYÉI - if possible with the manufacturer or his authorized representative
p.000003: in cooperation with its representative - investigates the unexpected event, accident, and after the investigation is completed
p.000003: notify the Commission and the partner authorities without delay in accordance with Article 22
p.000003: and to reduce the risk of the cases specified in Section 21 (1)
p.000003: measures taken or planned.
p.000003: (5) *
p.000003: If the unexpected event or corrective action a
p.000003: certification, the manufacturer shall inform the authorized person of the reports sent to OGYÉI
p.000003: representative, the dealer authorized to distribute the device and the notified body.
p.000003: (6) The preliminary incident report shall not be construed as acknowledging by the notifier that the device is
p.000003: was the cause of an unexpected event, an accident.
p.000003: (7) The manufacturer or his authorized representative shall be obliged to cover events related to the device
p.000003: record and make changes necessary for the safe use of the device.
p.000003: 21 / B. § *
p.000003: The name of the head of the health care provider responsible for the accident,
p.000003: position, contact details, name of the health care provider, occurred in the data
p.000003: changes must be notified to OGYÉI in writing or electronically within 30 days.
p.000003: 22-23 / A. § *
p.000003: Specific public health measures
p.000003: § 24. (1) *
p.000003: If OGYÉI in connection with a product or a group of products
p.000003: finds that the protection of health and safety or compliance with public health regulations
p.000003: such products should be withdrawn from the market or placed on the market and used
p.000003: be prohibited, restricted or subject to special requirements necessary and appropriate
p.000003: take a reasonable transitional measure within its competence.
p.000003: (2) *
p.000003: OGYÉI on the measure taken pursuant to paragraph (1) - its
p.000003: shall inform the partner authorities and the Commission.
p.000003: § 25 *
p.000003: If not with the other device in circulation, the individual device is not
p.000003: substitutable for public health purposes, at the medically justified request, by the Ethics Committee
p.000003: after receiving its opinion on the effectiveness and substitutability of
p.000003: for a maximum period of 1 year for use by a specific healthcare provider,
p.000003: or, in the case of an implant, OGYÉI may exceptionally authorize it for use on a specific person
p.000003: the occasional putting into service and use of a specific device, provided that the device is safe
p.000003: which has not been subject to the procedures under Section 13 (1) - (8).
p.000003: Cooperation with EU partner authorities and the Commission
p.000003: § 26 (1) *
p.000003: OGYÉI for assets in the member states of the European Union
p.000003: Member States shall cooperate in order to maintain the uniform application of harmonized legislation
p.000003: competent authorities (partner authorities) and the Commission.
p.000003: 2. The essential purpose of the exchange of information and data in the course of cooperation shall be to ensure the security of assets.
p.000003: (3) *
p.000003: In its decisions, OGYÉI takes into account the information provided by the Commission
p.000003: data, information and resolution provided.
p.000003: (4) *
p.000003: OGYÉI public data provided by the Commission,
...

Social / Linguistic Proficiency

Searching for indicator language:

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p.000003: process.
p.000003: (8) *
p.000003: In the case of a custom-made device, the manufacturer shall act in accordance with Annex 8. The
p.000003: Before placing a device on the market, the manufacturer shall issue a certificate in accordance with section 2.1 of Annex 8, point A or B.
p.000003: (e) and draw up a declaration in accordance with Annex 8, point A or B, point 3.1.
p.000003: the documentation specified in The documentation must be kept for 5 years and it
p.000003: shall be made available upon request to OGYÉI. These devices are not CE marked
p.000003: may be indicated.
p.000003: (9) During the EC conformity assessment procedure, the manufacturer or the notified body
p.000003: take into account all the examinations and evaluations that will be carried out at an intermediate stage of manufacture e
p.000003: carried out in accordance with this Regulation.
p.000003: 10. The procedures set out in Annexes 3, 4, 7 and 8 may also be initiated by the authorized representative of the manufacturer
p.000003: behalf.
p.000003: (11) *
p.000003: If, according to OGYÉI, the manufacturer for a particular device or series of devices
p.000003: did not select and proceed with the appropriate procedure, OGYÉI - the appropriate procedure
p.000003: may request the Commission.
p.000003: (12) *
p.000003: In the case referred to in paragraph 11, after the decision of the Commission, the OGYÉI
p.000003: act in accordance with the decision.
p.000003: Designated organization and procedures
p.000003: Section 14 (1) The notified body may, in justified cases, require any information or data which:
p.000003: for the chosen procedure of conformity assessment, verification, certification and certification
p.000003: necessary to maintain its validity. The documents required for the procedure pursuant to Section 13 (1) - (8)
p.000003: in Hungarian or in an official language of another EEA Member State accepted by the notified body
p.000003: shall be made available to the notified body.
p.000003: (2) Annexes 2, 3, 5 and 6 may be actively implanted by the notified body
p.000003: in the case of a device, its certificate issued in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of 5 years.
p.000003: Before the expiration of the certificate - on the date specified in the agreement between the parties
p.000003: in the absence of a request submitted at least 3 months before the expiry date - a further maximum of 5 years
p.000003: periods, the certificate may be extended.
p.000003: 3. The manufacturer or his authorized representative and the notified body must
p.000003: The conditions for carrying out the evaluations and tests in accordance with Annex 6 in the contract
p.000003: record.
p.000003: (4) Where the notified body is involved in the EC conformity assessment procedure
p.000003: necessary and several organizations have been designated to carry out the procedure, one of which is the manufacturer or
p.000003: acting by an authorized representative.
p.000003: 5. Where a notified body finds that the manufacturer does not meet the requirements of this Regulation
p.000003: requirements or the EC certificate of conformity could not have been issued,
p.000003: the notified body shall, taking into account all the circumstances of the case, suspend or limit the
p.000003: certificate of conformity issued by it.
p.000003: (6) If, at the request of the notified body, the certificate is suspended or restricted,
p.000003: within the appropriate time limit therein - the manufacturer has not taken the appropriate measures
p.000003: ensure compliance with this Regulation and the issue of the EC certificate of conformity
p.000003: necessary conditions, the notified body shall withdraw the certificate.
p.000003: (7) *
...

p.000003: final assembly, etc.);
p.000003: (j) in the case of devices emitting radiation for medical purposes, the nature, type, intensity and
p.000003: distribution.
p.000003: The instructions for use must also contain the information on the basis of which it is
p.000003: Contraindications and necessary precautions can be briefly informed by medical staff a
p.000003: patients. This information must include:
p.000003: (k) precautions to be taken in the event of a change in the performance of the device;
p.000003: (l) effects under reasonably foreseeable environmental conditions, such as magnetic fields, external
p.000003: electrical effects, electrostatic discharges, pressure and pressure changes, acceleration, self-ignition
p.000003: risk of warming, etc. precautionary measures in the event of
p.000003: (m) information on the medicinal products or medicinal products for which administration is sought
p.000003: intended, including any restrictions on such substances;
p.000003: (n) precautions against any special, unusual hazards associated with the waste of the device;
p.000003: (o) the information contained in paragraph 7.4. Therapeutic substance or human substance present as an integral part of the device in accordance with
p.000003: to mark a blood product;
p.000003: (p) in the case of devices with a measuring function, the accuracy required of the device;
p.000003: (q) the date of issue or the latest revision of the instructions for use.
p.000003: 13.7. A 13.1-13.6. The end user of the device must be listed in Hungarian
p.000003: available to them. For controls, located directly next to them
p.000003: foreign language labels are considered symbols if they have the meaning of use
p.000003: guide explains in detail.
p.000003: B. For active implantable devices
p.000003: I. General requirements
p.000003: 1. The device must be designed and manufactured in such a way as to be suitable for the purpose and conditions of use
p.000003: implantation should not endanger the health or safety of patients. The device poses no danger
p.000003: it must not be reported to the implanter or any other person.
p.000003: 2. The device must be as intended by the manufacturer
p.000003: performance, that is to say, it must be designed and manufactured in such a way as to be suitable for the
p.000003: § (1).
p.000003: 3. The characteristics and performances of the device referred to in points 1 and 2, as specified by the manufacturer
p.000003: during life and under normal conditions of use - do not change
p.000003: adversely affect the health status of patients and, where appropriate, other persons
p.000003: and endanger your safety.
p.000003: 4. The device must be designed, manufactured and packaged in such a way that its characteristics and
p.000003: storage and transport conditions (temperature,
p.000003: moisture content, etc.).
p.000003: 5. Possible undesirable side effects, in comparison with the intended performance, are acceptable
p.000003: risk.
p.000003: 5a. Demonstration of compliance with the essential requirements shall be in accordance with Annex 10
p.000003: clinical evaluation.
p.000003: II. Design and construction requirements
p.000003: 6. The design and manufacturing solutions applied by the manufacturer must comply with the safety principles,
p.000003: taking into account generally accepted technical standards.
p.000003: 7. An implantable device shall be designed, constructed and packaged in non-reusable packaging that:
...

p.000003: Address
p.000003: Postal code
p.000003: E - mail address / E - mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: 5 National contact point information
p.000003: National contact point name
p.000003: Name of the contact person
p.000003: Postal code
p.000003: E - mail address / E - mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: 6 Medical device information
p.000003: Class
p.000003: □ Active implantable medical device / AIMD Active implants
p.000003: □ III. Class III device / MDD Class III
p.000003: □ Class II.b device / MDD Class IIb
p.000003: □ Class II.a device / MDD Class IIa
p.000003: □ Class I device / MDD Class I
p.000003: Nomenclature system (preferable GMDN) Code / Nomenclature code
p.000003: Text name of the code / Nomenclature text Commercial, brand name / Commercial name / brand name / make Model- and
p.000003: catalog number / Model and / or catalog number
p.000003: Serial number and / or lot or batch number (s) and / or lot / batch number (s)
p.000003: Software version number (if applicable) / Software version number (if applicable)
p.000003: Manufacturing date / expiry date (if known)
p.000003: applicable)
p.000003: Accessories / associated device (if any)
p.000003: (if applicable)
p.000003: Notified body ID number
p.000003: 7 Description of the on - site safety corrective action (FSCA)
p.000003: Reason and background information of on - site security corrective actions
p.000003: for the FSCA
p.000003: Description and justification of the procedure (corrective / preventive)
p.000003: action (corrective / preventive)
p.000003: Propose the necessary measures to the distributor and the user
p.000003: to be taken by the distributor and the user
p.000003: Attachments please find
p.000003: □ Field Safety Notice (FSN) in English
p.000003: □ FSN in national language
p.000003: □ Others (please specify):
p.000003: Time schedule for the implementation of the different
p.000003: actions
p.000003: States concerned by on - site security corrective actions (Member States, EEA States)
p.000003: within the EEA are affected by this FSCA
p.000003: These countries outside the EEA and Switzerland are affected by this FSCA
p.000003: 8 Comments
p.000003: I declare that I have provided the above information to the best of my knowledge./ I affirm that the
p.000003: The information given above is correct to the best of my knowledge.
p.000003: .................................................. ..............
p.000003: Signature
p.000003: Name / Name City / City Date / Date
p.000003: Submission of this notification does not in itself mean that the manufacturer and / or his authorized representative are either
p.000003: the competent national authority acknowledges that the submission of the notification is a complete solution or that
p.000003: the notified device would have contributed in any way to the death of the person involved in the incident,
p.000003: or would have been the direct cause of the damage.
p.000003: Submission of this report does not, in itself, represent a conclusion by the manufacturer and / or
p.000003: authorized representative or the national competent authority that the content of this report is
p.000003: complete or accurate that the medical device (s) listed failed in any continent and / or that the medical
p.000003: device (s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
p.000003: Annex 13 to Regulation 4/2009 (III. 17.) EüM *
p.000003: Periodic review
p.000003: I. Scope of products subject to periodic review, frequency of review
p.000003: 1. Defibrillator 1
p.000003: annually
...

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p.000003: CLIV of 1997 on health. on the basis of the authorization contained in Section 247 (2) (k) of Act no
p.000003: 161/2006 on the duties and powers of the Minister of Health (VII. 28.) Government Decree § 1 a)
p.000003: Acting in the scope of duties specified in point 1, I order the following:
p.000003: Scope of the Regulation
p.000003: § 1 (1) *
p.000003: ✖
p.000003: The scope of this Regulation shall be as set out in paragraph 2
p.000003: Medical devices manufactured, distributed and used in Hungary
p.000003: devices and accessories.
p.000003: (Http: //landing.wolte
p.000003: 2. This Regulation shall not apply to:
p.000003: (a) in vitro diagnostic devices;
p.000003: Jogtár demo?
p.000003: utm_source = netjogta
p.000003: b) human blood, blood products, plasma or blood cells of human origin, or in accordance with Section 2 (1)
p.000003: (e) a device containing human blood products, plasma or blood cells at the time of placing on the market;
p.000003: c) *
p.000003: except for the assets included in Section 2 (2) (d)
p.000003: devices containing human tissue or cells, transplants of human origin,
p.000003: tissues or cells or preparations thereof;
p.000003: d) for devices containing tissues or cells of animal origin, with the exception of Section 2 (1) (b),
p.000003: transplants, tissues or cells of animal origin;
p.000003: e) *
p.000003: with the exception of § 2 (2) c) and d) for human use
p.000003: and other amendments to the laws governing the pharmaceutical market
p.000003: XCV of 2005 (hereinafter: Gytv.) for a product that qualifies as a medicinal product, including the
p.000003: medicinal products derived from human blood derivatives, where this is justified by the main mode of action of the product;
p.000003: f) *
p.000003: for devices in which the device and the drug are single
p.000003: forms a single product intended exclusively for use in that combination and which
p.000003: cannot be reused. For this single unit product, Gytv. shall apply. On this
p.000003: products are subject to the essential requirements set out in Annex 1 in so far as they are concerned
p.000003: the safety and performance characteristics of the device;
p.000003: (g) a cosmetic product covered by specific legislation.
p.000003: (3) This Regulation concerns the authorization of advanced therapy medicinal products and Regulation (EC) No 2001/83
p.000003: European Parliament and of the Council of 13 November 2007 amending Directive 726/2004 / EC and Regulation (EC) No 726/2004
p.000003: shall apply subject to a Regulation of the European Parliament and of the Council.
p.000003: Interpretative provisions
p.000003: § 2 *
p.000003: 1. For the purposes of this Regulation, a medical device (hereinafter referred to as
p.000003: CLIV of 1997 on health. § (hereinafter: Eütv.) § 3
p.000003: (h) an instrument as defined in points (ha) to (d).
p.000003: (2) To be considered as a medical device
p.000003: (a) a device manufactured utilizing a tissue or cell of inanimate animal origin;
p.000003: (b) a device for administering the medicinal product;
p.000003: (c) a device of which an integral part is a substance which, when used alone, is a medicinal product,
p.000003: which, in addition to the device, acts on the human body;
p.000003: (d) a device of which an integral part is derived from human blood or human plasma alone
p.000003: when used, a substance that is a medicinal component or a medicinal product that acts in addition to the device
p.000003: the human body (hereinafter referred to as "human blood derivative"),
p.000003: if its purpose complies with the provisions of the Eütv. § 3 h) point ha) -hd)
p.000003: as set out in
p.000003: (3) *
...

p.000003: dental filling material, orthetic device) which is adapted to a specific requirement;
p.000003: 3. device intended for clinical investigation: any device which is approved by an appropriately qualified
p.000003: made available to an authorized person for the purposes specified in the separate legislation
p.000003: conduct a clinical trial to achieve this;
p.000003: 4. active device: any device whose operation - by the human body or by gravity
p.000003: other than directly generated energy, depends on other external energy sources;
p.000003: 5. active implant: any active implantable device that has undergone surgical or other medical intervention
p.000003: is partially or completely introduced into the human body or into a natural orifice thereof, and
p.000003: it remains in place after the intervention;
p.000003: 6. Hip, knee and shoulder prosthesis: components of a complete joint implantable prosthesis, not including
p.000003: including auxiliary components such as bolts, wedges, plates and tools, which
p.000003: similar to a natural hip, knee, or shoulder joint;
p.000003: Sub-category 7: a group of devices that share a common area of ​​use or technology;
p.000003: 8. generic device group: a group of devices that have the same or similar uses
p.000003: their area or technology shows a similarity that allows for unique characteristics that do not reflect general characteristics
p.000003: their classifications;
p.000003: Device group 9: products of a generic device group from a manufacturer;
p.000003: 10. "specific instrument" means an instrument of a specified type number that has not been subject to conformity assessment
p.000003: which could not be placed on the market but in a specified number in accordance with
p.000003: may be used in accordance with this Regulation;
p.000003: 11. "single-use device" means a device intended by the manufacturer for a single patient and for single use;
p.000003: 12. *
p.000003: manufacturer: the natural or legal person
p.000003: (a) which devices are designed, manufactured, packaged and labeled under their own responsibility before being used on their own
p.000003: marketing or conducting a clinical trial under his name, whether or not they are
p.000003: operations are carried out by himself or on his behalf,
p.000003: (b) which assembles, packs, processes, refurbishes a device for placing on the market under its own name,
p.000003: label and mark them for the purpose of use, unless they are assembling devices already on the market,
p.000003: or adaptive to a particular patient during their treatment according to their intended use
p.000003: according to your individual needs;
p.000003: 13. *
p.000003: authorized representative: resident in an EEA Member State, or
p.000003: a natural or legal person established by the manufacturer
p.000003: authorizes it to act on its behalf in relation to obligations under this Regulation; or
p.000003: to whom the authorities and bodies may turn instead of the manufacturer;
p.000003: 14. *
p.000003: distributor: the natural or legal person who places on the market
p.000003: the device is provided free of charge until it is handed over to the end user after use
p.000003: made available to it, in particular by the importer, distributor or reseller;
p.000003: 15. purpose of use: the use of the device by the manufacturer on the label in the instructions for use
p.000003: or the purpose stated in the advertisement;
p.000003: 16. Intended use: by the manufacturer of the device in order to achieve the intended use
p.000003: use in accordance with the specified indication and in the manner and under the conditions specified by the manufacturer;
...

p.000003: reduce the risk of contamination to a minimum and the packaging must be suitable for the manufacturer's instructions
p.000003: sterilization method.
p.000003: 8.7. The packaging or label of the device should allow it to be available in sterile and non-sterile condition
p.000003: discrimination between identical or similar products.
p.000003: 9. Structural and environmental properties
p.000003: 9.1. If the device is intended to be used in conjunction with other devices or equipment, it is complete
p.000003: assembly, including connections, be secure and do not damage the devices specified
p.000003: performance. Any restrictions on use shall be indicated on the label or on the label
p.000003: instructions for use.
p.000003: 9.2. The device must be so designed and constructed that it can be removed as far as possible, and
p.000003: minimize it
p.000003: (a) its physical characteristics, including volume / pressure ratio, dimensional characteristics and, where
p.000003: justified - the risk of injuries related to ergonomic features;
p.000003: (b) with reasonably foreseeable environmental effects (eg magnetic fields, external electricity
p.000003: influences, electrostatic discharge, pressure, temperature or pressure and
p.000003: acceleration changes);
p.000003: (c) interference with other means normally used for certain examinations or treatments
p.000003: risk;
p.000003: (d) the aging of the materials used or the measuring or checking equipment
p.000003: risks due to the lack of maintenance and calibration
p.000003: (eg for implants).
p.000003: 9.3. The device must be designed and constructed in such a way that it is used as intended
p.000003: in the event of a single fault condition, the risk of fire and explosion must be kept to a minimum.
p.000003: This is especially true for devices that are flammable or inflammatory
p.000003: exposed.
p.000003: 10. Devices with a measuring function
p.000003: 10.1. A device with a measuring function must be designed and manufactured in such a way that the device is intended for its intended use
p.000003: satisfactory accuracy and stability of the measured values ​​are ensured within appropriate accuracy limits
p.000003: be. The accuracy limits must be indicated by the manufacturer.
p.000003: 10.2. Measuring, operating and display units must comply with ergonomic principles
p.000003: designed taking into account the purpose of the device.
p.000003: 10.3. The results of measurements made with a device with a measuring function are defined in Act XLV of 1991 on Measurement.
p.000003: be expressed in legal units of law.
p.000003: 11. Radiation protection
p.000003: 11.1. General requirement
p.000003: 11.1.1. The device must be designed and constructed in such a way that patients, users and
p.000003: exposure of other persons is compatible with the intended use
p.000003: be kept to a minimum without limiting the dose level prescribed for therapeutic or diagnostic purposes.
p.000003: 11.2. Intended radiation
p.000003: 11.2.1. If the device is designed to be of a hazardous level for a specific medical purpose
p.000003: emits radiation the benefits of which outweigh the risks inherent in the emission, the user must
p.000003: be able to control emissions. The design and construction of such devices must be such as to
p.000003: to ensure repeatability and tolerance of relevant variable parameters.
p.000003: 11.2.2. Devices that emit potentially hazardous, visible or invisible radiation - if required
...

p.000003: performance. THE
p.000003: In the event of an individual error in the system, solutions shall be applied which:
p.000003: eliminate or reduce potential risks as far as possible.
p.000003: 12.1.2. A device that contains software or a device that is medical software in itself
p.000003: software must be validated by modern methods, taking into account the development
p.000003: principles of lifetime, risk management, validation and control.
p.000003: 12.2. A device in which the safety of the patient depends on the internal power supply must be provided with
p.000003: means for determining the state of the energy source.
p.000003: 12.3. A device in which the safety of the patient depends on an external power supply shall have an alarm system
p.000003: indicating any failure of the power supply.
p.000003: 12.4. A device designed to monitor one or more clinical parameters of a patient
p.000003: it must have an appropriate alarm system to alert the user in the event of the death of the patient, or
p.000003: in situations threatening a serious deterioration in his health.
p.000003: 12.5. The design and construction of the device must be such as to minimize such
p.000003: the risk of electromagnetic fields being generated by other devices in the normal environment
p.000003: or may adversely affect the operation of equipment.
p.000003: 12.6. Protection against electrical hazards
p.000003: The device must be designed and constructed in such a way as to be avoidable as far as possible
p.000003: there is a risk of accidental electric shock when used and installed properly, and
p.000003: in a single fault condition.
p.000003: 12.7. Protection against mechanical and thermal risks
p.000003: 12.7.1. The device should be designed and constructed to meet the needs of patients and users
p.000003: be protected against mechanical hazards such as inadequate strength
p.000003: and stability and hazards associated with moving parts.
p.000003: 12.7.2. The device must be so designed and constructed that, taking account of technical progress:
p.000003: to the lowest possible level of vibrations caused by non-intended operation
p.000003: danger from. To this end, vibration reduction methods, especially vibrations, should be applied
p.000003: place of origin.
p.000003: 12.7.3. The device must be designed and constructed to be as low as possible
p.000003: emissions from the device that are not intended to function properly
p.000003: noise hazards, taking into account technical progress and available - in particular
p.000003: noise abatement solutions.
p.000003: 12.7.4. It is connected to the supply of electrical, gas, hydraulic or pneumatic energy
p.000003: connectors and fittings that must be handled by the user are designed and constructed
p.000003: so that all risks are kept to a minimum.
p.000003: 12.7.5. Accessible parts of the device and their surroundings (except those parts which:
p.000003: intended to supply heat or reach a certain temperature) do not reach dangerous temperatures during normal use.
p.000003: 12.8. Protection against the risks arising from the transfer of substances or energy to patients
p.000003: 12.8.1. The device for delivering energy or substances to patients should be designed so that the amount delivered is a
p.000003: be set with sufficient precision for patient and user safety and that this setting is not changed.
...

p.000003: necessary information primarily on the device itself or on an individual, where appropriate commercial basis
p.000003: should also be indicated on the packaging if practicable. If individual packaging is not possible, the
p.000003: information shall be provided in the prospectus supplied with the devices (one or more devices). All
p.000003: each device must include instructions for use in the packaging. Indispensable for use
p.000003: guidance for Class I or Class IIa devices, if complete without such guidance
p.000003: can be used safely.
p.000003: 13.2. The information on the label should preferably be given in symbols. All symbols and
p.000003: identification color in accordance with harmonized standards. In areas where there are no standards,
p.000003: the symbols and colors must be described in the documentation supplied with the device.
p.000003: 13.3. The label must contain the following information:
p.000003: (a) the name or trade name and address of the manufacturer. For the purpose of distribution in the Community
p.000003: In the case of a device imported into the Community, if the manufacturer does not have a registered office a
p.000003: Community, on the label or on the outer packaging or in the instructions for use
p.000003: the name and address of the authorized representative must be indicated;
p.000003: (b) to identify the device and the contents of the packaging, in particular for the user
p.000003: essential details that are essential;
p.000003: (c) where appropriate, the word "STERILE";
p.000003: (d) where appropriate, the batch number preceded by the word "LOT" or the serial number;
p.000003: (e) where appropriate, the expiry date of the safe use of the device, expressed in years and months;
p.000003: (f) where applicable, an indication that the device is intended for single use. The manufacturer is one-time
p.000003: its indication of use should be uniform throughout the Community;
p.000003: (g) in the case of custom-made devices, the words "custom-made device";
p.000003: (h) in the case of devices intended for clinical investigations, the words "for clinical investigations only";
p.000003: (i) any special storage conditions or handling requirements;
p.000003: (j) any special operating instructions;
p.000003: (k) all necessary warnings and instructions for precautions to be taken;
p.000003: (l) for active devices not covered by point (e), the year of manufacture, including the batch or serial number
p.000003: It may comprise;
p.000003: (m) where appropriate, the method of sterilization;
p.000003: n) in the case of assets falling under Section 2 (1) (e), an indication that the
p.000003: device contains a human blood derivative.
p.000003: 13.4. If the intended purpose of the device is not obvious to the user, to the manufacturer
p.000003: you must clearly indicate this on the label and in the instructions for use.
p.000003: 13.5. Where appropriate and feasible, assets should be identified and detachable
p.000003: components, in series if necessary, so that all necessary measures can be taken
p.000003: to identify any potential hazards posed by the devices and detachable parts
p.000003: order.
p.000003: 13.6. The instructions for use must contain the following information, as the case may be
p.000003: logically:
p.000003: (a) with the exception of points (d) and (e), 13.3. described in point;
p.000003: (b) the performance referred to in point 3 and any undesirable side effects;
p.000003: (c) if the device is used with other medical devices or equipment in order to ensure its intended use
p.000003: should be linked, the data needed to form a secure combination a
p.000003: to select appropriate tools or equipment;
...

p.000003: In addition, in the case of also provided for in
p.000003: which, however, apply only to those stages of manufacture which are sterilization and sterility
p.000003: serve to maintain.
p.000003: 3. The manufacturer must undertake to set up and keep up to date a system with which
p.000003: evaluate the experience gained with the device in the post-production phase, including Annex 10
p.000003: and shall arrange for the necessary amendments to be made. This undertaking must also oblige the manufacturer to:
p.000003: Report the events detailed therein in accordance with Section 21 without delay.
p.000003: 4. The notified body must carry out the appropriate examinations in order to verify the conformity of the product with this Regulation
p.000003: compliance with the requirements of this Regulation by examination of each product at the choice of the manufacturer.
p.000003: or by examining the products on a statistical basis in accordance with point 6. The
p.000003: the checks mentioned above do not apply to ensuring the sterility of the manufacturing process
p.000003: steps.
p.000003: 5. Inspection and testing of each product (piece test)
p.000003: 5.1. Each product shall be individually examined in accordance with the relevant national harmonized standards or
p.000003: with these equivalent tests to determine whether they are equivalent to EC type-examination
p.000003: with the model described in the certificate and complies with the relevant requirements of this Regulation.
p.000003: 5.2. The notified body must affix, or cause to be affixed, its identification mark on each approved product
p.000003: and issue a written certificate of the tests performed.
p.000003: 6. Statistical verification
p.000003: 6.1. The manufacturer must produce and present the products as a single lot.
p.000003: 6.2. A random sample shall be taken from each lot. The sample products are individually
p.000003: shall be examined in accordance with or with the relevant national harmonized standards
p.000003: equivalent tests to determine whether they correspond to EC type-examination
p.000003: with the model described in the certificate. Whether the lot is acceptable or should be returned depends on the outcome of the test
p.000003: to instruct.
p.000003: 6.3. Statistical control of assets is based on characteristics and / or variables that are high
p.000003: operating to ensure safety and state-of-the-art performance
p.000003: shall be determined by sampling from systems with From the systems
p.000003: sampling shall be determined by nationalized harmonized standards, taking into account orally
p.000003: the specific nature of the rotating product categories.
p.000003: 6.4. If the lot is accepted, the notified body shall indicate on each product or
p.000003: indicate its identification number and issue a written certificate of conformity
p.000003: tests. All products in the lot may be put on the market except those in the sample
p.000003: proven products.
p.000003: If a lot is rejected, the notified body must take appropriate measures
p.000003: to prevent the product from being placed on the market. For frequent item rejections a
p.000003: the notified body may suspend the statistical verification.
p.000003: The manufacturer may, under the responsibility of the notified body, affix the notified body during the manufacturing process
p.000003: identification number.
p.000003: 7. *
p.000003: Administrative requirements
p.000003: It may be implanted by the manufacturer or his authorized representative for a period ending at least five years after the last product has been manufactured
p.000003: in the case of assets, you must be able to provide OGYÉI with at least fifteen years:
...

p.000003: to ensure that the manufacturing process produces a product which complies with EC
p.000003: the type as described in the type-examination certificate and the relevant requirements of this Regulation. THE
p.000003: the manufacturer or his authorized representative must affix the CE marking in accordance with § 5 to all devices
p.000003: and issue a declaration of conformity.
p.000003: 3. The manufacturer must, before production begins, draw up documentation which:
p.000003: records the manufacturing processes, in particular sterilization, as well as all, already
p.000003: previously formulated specification, which serves to ensure the manufacture
p.000003: the conformity of the products with the type as described in the EC type-examination certificate and e
p.000003: with the relevant provisions of this Regulation.
p.000003: 4. The manufacturer must undertake to comply with the provisions referred to in Annex 10
p.000003: establishes and maintains an up - to - date system for evaluating
p.000003: experience gained in the post-production phase and arrange for any necessary modifications
p.000003: implementation. This undertaking also obliges the manufacturer to comply with Article 21 without delay
p.000003: report the events detailed there.
p.000003: 5. The notified body shall certify the conformity of the device with the requirements of this Regulation
p.000003: perform the appropriate examinations by statistical verification of the device in accordance with point 6
p.000003: and rehearsals. The manufacturer must authorize the notified body to take the measures referred to in point 2
p.000003: evaluate the effectiveness of the measures by means of an actual product inspection (product audit).
p.000003: 6. Statistical verification
p.000003: 6.1. The manufacturer must produce and present the products as a single batch and must do everything in his power to do so
p.000003: necessary measures to ensure that the manufacturing process ensures all batches produced
p.000003: uniformity.
p.000003: 6.2. A random sample shall be taken from each lot. The products in the sample must be examined individually,
p.000003: and the appropriate tests as provided for in the relevant national harmonized standards, or
p.000003: equivalent tests must be carried out to determine whether the devices
p.000003: correspond to the model described in the EC type-examination certificate. It depends on the result of the test that a
p.000003: is acceptable or should be rejected.
p.000003: 6.3. The statistical control of an asset is based on characteristics and / or variables that are of a high degree
p.000003: operating to ensure safety and state-of-the-art performance
p.000003: shall be determined by sampling from systems with The sampling procedure is localized
p.000003: shall be determined on the basis of harmonized standards, taking into account the
p.000003: the specific nature of product categories.
p.000003: 6.4. If the lot is accepted, the notified body shall indicate on each product or
p.000003: indicate its identification number and issue a written certificate of conformity
p.000003: tests. All products in the lot may be put on the market except those in the sample
p.000003: proven products.
p.000003: If the lot is rejected, the notified body must take appropriate measures
p.000003: to prevent the product from being placed on the market. For frequent item rejections a
p.000003: a designated body may suspend the statistical verification.
p.000003: The manufacturer may, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.
p.000003: 6.5. The manufacturer or his authorized representative must ensure compliance with the notified body's requirements on request
...

p.000003: (i) the clinical evaluation in accordance with Annex 10;
p.000003: (j) the label and instructions for use.
p.000003: 4. *
p.000003: The manufacturer must undertake to establish and maintain a systematic procedure
p.000003: up to date to review the device after manufacture and in accordance with the requirements of annex 10
p.000003: experience gained and shall make the necessary adjustments to make the necessary adjustments,
p.000003: taking into account the nature of the instrument and the risks involved in its use. This undertaking must also oblige the manufacturer to:
p.000003: to immediately report the events detailed therein to OGYÉI in accordance with the provisions of Section 21.
p.000003: 5. Class I devices placed on the market in a sterile state or with a measuring function
p.000003: the manufacturer need not only comply with the requirements set out in this Annex
p.000003: but also one of the procedures referred to in Annexes 2, 4, 5 or 6. These a
p.000003: The application of Annexes I and II and the involvement of the notified body shall be limited to:
p.000003: (a) in the case of products placed on the market in a sterile state, only to ensure a sterile state; and
p.000003: production processes to maintain
p.000003: (b) in the case of devices with a measuring function, only the measurement technology of the products
p.000003: manufacturing processes for compliance with the requirements.
p.000003: Section 6.1 of this Annex. shall apply.
p.000003: 6. Application to Group IIa assets
p.000003: In accordance with Section 13 (2), this Annex may apply to Group II.a.
p.000003: products with the following derogation:
p.000003: 6.1. Where this Annex is used in conjunction with the procedure referred to in Annex 4, 5 or 6
p.000003: the declarations of conformity referred to in them and in this Annex
p.000003: shall be issued in the form of a single declaration. If this statement is based on this Annex, the
p.000003: the manufacturer must ensure and declare that the products are designed to comply with this Regulation
p.000003: relevant requirements.
p.000003: Annex 8 to Regulation 4/2009 (III. 17.) EüM *
p.000003: A. Ordered Equipment Statement *
p.000003: 1. In the case of custom-made devices or devices intended for clinical investigations, the manufacturer or his authorized representative
p.000003: shall draw up a declaration containing the information specified in point 2.
p.000003: 2. The declaration (certificate of workmanship) must contain the following information:
p.000003: 2.1. For custom-made devices:
p.000003: (a) the name and address of the manufacturer;
p.000003: (b) data enabling the device to be identified;
p.000003: (c) a statement that the device is intended for the exclusive use of a specific named patient;
p.000003: (d) the name of the specialist or other authorized person who ordered the device and, where applicable, the
p.000003: the name of the healthcare provider;
p.000003: (e) the specific characteristics of the device in accordance with the specifications set out in the order;
p.000003: (f) a statement that the device meets the essential requirements set out in Annex 1,
p.000003: indicating those, if any, which have not been fully complied with, together with the reasons therefor.
p.000003: 2.2. *
p.000003: 3. *
p.000003: The manufacturer must undertake to make available to OGYÉI:
p.000003: 3.1. In the case of custom-made devices, documentation indicating the place of manufacture
p.000003: (locations) and enables the design, manufacture and performances of the device to be understood,
p.000003: including the required performance to enable compliance with the requirements of this Regulation
p.000003: to assess compliance.
...

p.000003: □ Manufacturer / Authorized Representative /
p.000003: Authorized representative
p.000003: 3. Identification of the manufacturer Full name of the manufacturer
p.000003: The manufacturer
p.000003: short name
p.000003: The manufacturer
p.000003: tax number
p.000003: The manufacturer
p.000003: Headquarters
p.000003: Country / Country
p.000003: Postal code
p.000003: Street, house number / Street, number
p.000003: Contact details
p.000003: Name / Name
p.000003: Fax / Fax number
p.000003: City / City
p.000003: Mailbox / P.O.B.
p.000003: Telephone number
p.000003: e-mail
p.000003: 4. Identification of the authorized representative
p.000003: Full name of the authorized representative
p.000003: Short name of the authorized representative
p.000003: Authorized representative 's registered office. Registered office of the authorized representative
p.000003: Postal code City / City Street, house number / Street, number Mailbox / P.O.B. THE
p.000003: contact details
p.000003: Name Telephone name
p.000003: Fax / Fax number e-mail
p.000003: 5. Identification of the device concerned Code and name of the device category
p.000003: code Name
p.000003: □ 01 Active implantable devices
p.000003: □ 02 Anesthetic and respiratory equipment
p.000003: Anesthetic and respiratory devices
p.000003: □ 03 Dental devices
p.000003: □ 04 Electromechanical devices Electro-medical
p.000003: mechanical devices
p.000003: □ 05 Hospital equipment and devices qualifying as medical devices
p.000003: □ 06 In vitro diagnostic medical devices
p.000003: □ 07 Inactive implantable devices
p.000003: Hospital hardware
p.000003: In vitro diagnostic medical devices
p.000003: Non-active implanatble devices
p.000003: □ 08 Ophthalmic and optical
p.000003: devices
p.000003: □ 09 Reusable instruments Reusable instruments
p.000003: □ 10 Disposable devices Single use devices
p.000003: □ 11 Technical aids for the disabled
p.000003: □ 12 Radiodiagnostic and therapeutic devices
p.000003: Technical aids for disabled persons
p.000003: Diagnostic and therapeutic radiation devices
p.000003: CE marking □ yes □ no
p.000003: GMDN code (if it's available)
p.000003: Description of the device in Hungarian and in English
p.000003: Classification of the device (s)
p.000003: □ Class I device (non-sterile, without measuring function)
p.000003: sterile device and that with measuring function
p.000003: □ Class IIa device
p.000003: □ Class IIb device
p.000003: □ III. Class III device
p.000003: □ Active implant / Active implant
p.000003: □ Class I device with measuring function
p.000003: □ Class I device, sterile
p.000003: □ In vitro diagnostic medical device other than in vitro diagnostic medical device
p.000003: 8/2003 on instruments (III. 13.) ESzCsM Decree No. 2 and the
p.000003: In vitro diagnostic medical device except devices listed in IVDD Annex II
p.000003: and those intended for self testing
p.000003: □ 8/2003 on in vitro diagnostic medical devices. (III. 13.) ESzCsM decree
p.000003: Devices according to list “A” in Annex 2, point 1 under
p.000003: list A of IVDD Annex II
p.000003: □ 8/2003 on in vitro diagnostic medical devices. (III. 13.) ESzCsM decree
p.000003: Devices under list B of IVDD Annex II
p.000003: □ 8/2003 on in vitro diagnostic medical devices. (III. 13.) ESzCsM Decree No. 2
p.000003: Self-monitoring devices not listed in Annex IV and intended
p.000003: for self testing
p.000003: Trade name of the device
p.000003: Alternative make of the device (if the device may be marketed under another name)
p.000003: Device type
p.000003: The device complies with Regulation 4/2009 on medical devices. (III. 17.) EüM Decree § 4 (1)
...

Social / Police Officer

Searching for indicator officer:

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p.000003: visibility and legibility of the marking.
p.000003: (4) *
p.000003: While retaining the original purpose of use, the device is as follows
p.000003: in the event of a change which affects the safe use of the device, the CE marking shall only be in accordance with § 13
p.000003: may be indicated after the procedures have been repeated.
p.000003: The notified body carrying out the EC conformity assessment shall decide whether the modification of the instrument will affect the
p.000003: safe use of the device. In the event of a dispute, OGYÉI will decide on this issue.
p.000003: 5. In addition to the CE marking, if the conformity assessment procedure 2, 4,
p.000003: Any of the procedures set out in Annex 5 or 6 - the notified body carrying out the procedure must be indicated
p.000003: identification mark.
p.000003: (6) It does not comply with the requirements of this Regulation at a trade fair, exhibition or demonstration
p.000003: a product may be displayed if this is indicated by a clearly visible sign indicating it
p.000003: that the required conformity assessment has not been carried out.
p.000003: (7) Where the device is subject to requirements other than those laid down in this Regulation
p.000003: provides for the use of the CE marking on the basis of different aspects, separate legislation is different
p.000003: In the absence of a provision, the CE conformity marking shall also indicate that the device conforms to the
p.000003: other relevant requirements.
p.000003: Reporting of unexpected events and accidents after the placing on the market
p.000003: § 21. *
p.000003: (1) *
p.000003: The manufacturer or his authorized representative and the
p.000003: distributor and the health care provider through the accident officer
p.000003: after the entry into force of Annexes I, II.a, II.b and III. unexpected occurrence in connection with a class I asset
p.000003: event, accident, if the unexpected event or accident
p.000003: (a) involves a serious risk to public health, immediately but not later than 2 days,
p.000003: (b) resulted in death or serious deterioration of health, immediately but no later than 10 days after detection,
p.000003: c) *
p.000003: not covered by points (a) or (b), without delay, but not later than
p.000003: must notify OGYÉI within 30 days of detection.
p.000003: (1a) *
p.000003: The user in connection with the medical device
p.000003: you can report an unexpected event or accident to OGYÉI.
p.000003: (2) The notification
p.000003: (a) by the distributor and the healthcare provider on the form set out in Part A of Annex 12,
p.000003: (b) by the manufacturer or his authorized representative on the form set out in Annex 12, Part B,
p.000003: (c) by the user on the form set out in Part A of Annex 12.
p.000003: (3) *
p.000003: The notification pursuant to paragraphs (1) - (1a) shall be notified to OGYÉI, if not the
p.000003: the manufacturer or his authorized representative has lodged the notification - the manufacturer or his authorized representative
p.000003: shall inform its representative immediately, but no later than 8 days after becoming aware of it.
p.000003: (4) *
p.000003: The manufacturer or his authorized representative must be informed
p.000003: event within 60 days and the results of the investigation to OGYÉI in the final report
p.000003: to report.
p.000003: (5) *
p.000003: Where the manufacturer or his authorized representative
p.000003: on the basis of the investigation pursuant to paragraph 1, it considers it justified to prevent the unexpected event, on-site security
...

p.000003: (3) *
p.000003: In its decisions, OGYÉI takes into account the information provided by the Commission
p.000003: data, information and resolution provided.
p.000003: (4) *
p.000003: OGYÉI public data provided by the Commission,
p.000003: publishes information, resolutions and recommendations on its website in Hungarian.
p.000003: (5) *
p.000003: OGYÉI in the provision of information and data to the recommendations
p.000003: follow an appropriate procedure.
p.000003: European Databank *
p.000003: 26 / A. § *
p.000003: OGYÉI by the designated organization pursuant to Section 14 (7)
p.000003: data sent in accordance with Section 17, Paragraphs (1) - (2), 21 / A. §
p.000003: It shall transmit the notifications referred to in paragraph 4 and the results of the investigations to the European Databank.
p.000003: Periodic review
p.000003: § 27. (1) The health care provider using the devices according to Annex 13 shall be regular
p.000003: shall be subject to periodic review in order to obtain adequate information
p.000003: available during use
p.000003: deterioration, possible changes in the specifications given in the documentation of the device,
p.000003: and the existence of proper and safe performance.
p.000003: (2) The frequency of the review and other requirements related to the review are set out in Annex 13
p.000003: Define.
p.000003: (3) *
p.000003: The review is a body authorized by OGYÉI to do so by OGYÉI
p.000003: based on a defined and published set of requirements.
p.000003: Inspection of healthcare providers
p.000003: § 28. (1) *
p.000003: To issue a health care provider's operating license
p.000003: competent public health function of the capital and county government office district
p.000003: (Capital District) Office, or the National Chief Medical Officer (hereinafter together referred to as the Health Officer)
p.000003: administrative body) the operating authorization procedure as well as the health
p.000003: During the regular inspection of the service provider, the available documents and protocols
p.000003: by checking that the user meets each device's intended and
p.000003: requirements for its safe performance and whether it exists
p.000003: accident officer designated.
p.000003: (2) *
p.000003: If the public health administration determines that the
p.000003: the healthcare provider using the device complies with his obligations under this Regulation,
p.000003: in particular its obligation under Section 27 - has not been complied with, the user has a reasonable period of time
p.000003: calls for the documentation of the device to be replaced accordingly,
p.000003: to restore its performance. If the user does not fulfill the obligation contained in the call
p.000003: meet the state health administration body - the general exercise of health services
p.000003: 96/2003 on the conditions of operation and the operating license procedure. (VII. 15.) Gov. Decree
p.000003: as provided for in
p.000003: suspending the provision of healthcare intended for or in connection with the use of a given device,
p.000003: or initiates the decommissioning of the given device at OGYÉI.
p.000003: (3) *
p.000003: If during the inspection there is a reasonable suspicion that the device is not
p.000003: meets the requirements of § 11 or has not or has not been properly carried out in accordance with § 13
p.000003: the EC conformity assessment procedure for the device in question
p.000003: public administration body shall notify it at the same time as ordering the suspension of the use of the given device
p.000003: OGYÉI and the National Health Insurance Fund Manager.
p.000003: (4) *
p.000003: The state health administration body shall comply with paragraphs 2 to 3
p.000003: decisions under the General Administrative Procedure Act
p.000003: there is a remedy.
p.000003: ! (5) *
p.000003: Manufacturer, distributor or authorized representative
p.000003: for the disinfection of devices in Class IIa specifically placed on the market during the previous calendar year
p.000003: by the first day of March of the year in question.
p.000003: shall inform the national chief medical officer by sending a form in accordance with Annex.
p.000003: Entry into force, transitional provisions
p.000003: Section 29 (1) This Decree shall enter into force on 21 March 2010.
p.000003: (2) The provisions of Section 12 (6) and Section 13 (12) after the entry into force of this Decree
p.000003: shall apply to proceedings initiated.
p.000003: (3) - (6) *
p.000003: (7) *
p.000003: (8) *
p.000003: § 30. *
p.000003: § 31 *
p.000003: This Regulation
p.000003: (a) the approximation of the laws of the Member States relating to active implantable medical devices
p.000003: Council Directive 90/385 / EEC of 20 June 1990 on the
p.000003: (b) Directives 87/404 / EEC (simple pressure vessels), 88/378 / EEC (safety of toys), 89/106 / EEC
p.000003: (construction products), 89/336 / EEC (electromagnetic compatibility), 89/392 / EEC (machinery), 89/686 / EEC
p.000003: (personal protective equipment), 90/384 / EEC (non-automatic weighing instruments), 90/385 / EEC (active
p.000003: implantable medical devices), 90/396 / EEC (gas appliances), 91/263 / EEC (telecommunications equipment),
p.000003: terminal equipment), 92/42 / EEC (new hot-water boilers fired with liquid or gaseous fuels) and
p.000003: 73/23 / EEC (electrical equipment designed for use within certain voltage limits)
p.000003: Council Directive 93/68 / EEC of 22 July 1993 amending Directive
p.000003: (c) Directive 93/42 / EEC of the European Parliament and of the Council of 14 June 1993 concerning medical devices
p.000003: Directive
p.000003: (d) Directive 98/79 / EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices;
p.000003: Council Directive
p.000003: (e) Council Directive 93/42 / EEC concerning medical devices incorporating stable preparations of human blood or plasma
...

Social / Property Ownership

Searching for indicator property:

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p.000003: 6. Dialysis equipment 1
p.000003: annually
p.000003: 7. Invasive and interventional X-rays. equipment 1
p.000003: annually
p.000003: 8. Operating table 2
p.000003: annually
p.000003: 9. Tonometer 2
p.000003: annually
p.000003: 10. X-ray examination and recording workplace 2
p.000003: annually
p.000003: 11. Surgical image intensifier 2
p.000003: annually
p.000003: 12. Surgical and surveillance monitor, ECG 2
p.000003: annually
p.000003: 13. Laser 2
p.000003: annually
p.000003: 14. Invasive Blood Pressure Monitor and Blood Flow Meter 2
p.000003: annually
p.000003: 15. Machine infusion device 3
p.000003: annually
p.000003: 16. Blood warming device 3
p.000003: annually
p.000003: 17. Sterilization equipment 3
p.000003: annually
p.000003: 18. Mains-operated electrotherapy device (stimulator, high-frequency device, etc.)
p.000003: 3
p.000003: annually
p.000003: 19. Medical gas supply equipment and complete system 3
p.000003: annually
p.000003: 20. Imaging Ultrasound Diagnostic Device 3
p.000003: annually
p.000003: II. Other specifications
p.000003: 1. *
p.000003: The result of the test must be recorded. The documentation of the institution
p.000003: The person in charge of the instrument is obliged to keep and, upon request, the person in charge of occupational safety, his supervisory organization, the
p.000003: to the state health administration body and OGYÉI. In addition to the test results
p.000003: the method of control must also be indicated.
p.000003: 2. In the case of equipment which is difficult or difficult to transport, or in the case of equipment which is temporary
p.000003: nor is it indispensable in the institution, a local control method must be provided.
p.000003: 3. The periodic inspection shall be performed after the service intervention following the failure
p.000003: also if the intervention extended to the property to be tested.
p.000003: 4. The periodic review shall not affect the competence of the other certification body
p.000003: referred to mandatory tests (eg scale verification).
p.000003: 5. The first periodic inspection after commissioning, depending on the required frequency 1, 2
p.000003: or after 3 years. The further review shall take effect from the date of the previous review.
p.000003: ! Annex 14 to Regulation 4/2009 (III. 17.) EüM *
p.000003: ! NOTIFICATION FORM
p.000003: For the National Center for Public Health
p.000003: devices in Class IIa specifically intended for the disinfection of medical devices
p.000003: on the placing on the market in Hungary
p.000003: Details of the manufacturer, distributor, authorized representative Notifier (company)
p.000003: name:
p.000003: .................................................. .................................................. ....................
p.000003: ..............................
p.000003: Headquarter: _ _ _
p.000003: _
p.000003: .................................................. .................................................. ....................
p.000003: ..........
p.000003: Site address: _ _ _ _ ........................................... .............
p.000003: County:
p.000003: .................................................. .
p.000003: Phone: .................................... Fax:
p.000003: ................................... E-mail:
p.000003: .................................................. ..
p.000003: Contact person
p.000003: name:
p.000003: .................................................. .................................................. ............
p.000003: Contact address: _ _ _
p.000003: _
p.000003: .................................................. .................................................. ..................
...

Social / Threat of Stigma

Searching for indicator threat:

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p.000003: Date of last periodic review, details of medical technology
p.000003: Based on Annex 13
p.000003: Date of last logged service intervention Date of last logged overhaul
p.000003: Comment:
p.000003: This notification does not imply that the manufacturer, the authorized representative confirms or acknowledges that it is notified
p.000003: means of death or damage to the health of a person in any way, or indirectly
p.000003: I hereby declare that the above data are to the best of my knowledge
p.000003: Location: ................................................ Date: .............................................
p.000003: .................................................. .................................................. ....................
p.000003: ..........
p.000003: B) * Manufacturer's (authorized representative's) notification form
p.000003: - unforeseen events and accidents of which he becomes aware
p.000003: Report Form Manufacturer’s Incident Report
p.000003: Recipient
p.000003: Name of national competent authority (NCA)
p.000003: Address of national competent authority (NCA)
p.000003: Date of this report
p.000003: Reference number assigned by the manufacturer
p.000003: Reference number assigned by the national authority (if known) / Reference number assigned by NCA to whom sent (if
p.000003: Known)
p.000003: Type of report
p.000003: □ Initial report
p.000003: □ Follow-up report
p.000003: □ Combined initial and final report
p.000003: □ Final report
p.000003: Unexpected event classification
p.000003: Event causing death
p.000003: □ Unanticipated serious deterioration in state of
p.000003: health
p.000003: □ Serious public health threat
p.000003: □ Other reportable incidents
p.000003: Name of other national authority (ies) that received the notification / Identify to what other NCAs this
p.000003: report was also sent
p.000003: 2 Information on submitter of the report
p.000003: Type of submitter
p.000003: □ Manufacturer
p.000003: □ Authorized representative in accordance with Section 4 (1) (13) of the EüM Decree on Medical Devices /
p.000003: Authorized representative within EEA and Switzerland
p.000003: 3 Manufacturer information / Manufacturer information Manufacturer name / Manufacturer name
p.000003: Manufacturer's Contact person
p.000003: Address
p.000003: Postal code
p.000003: E - mail address / E - mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: Authorized Representative information
p.000003: Name of the authorized representative
p.000003: The authorized representative’s Contact person
p.000003: Address
p.000003: Postal code
p.000003: E - mail address / E - mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: 5 Data related to the notified medical device
p.000003: Class
p.000003: □ Active implants / AIMD Active implants
p.000003: □ III. Class III device / MDD Class III
p.000003: □ Class II.b device / MDD Class IIb
p.000003: □ Class II.a device / MDD Class IIa
p.000003: □ Class I device / MDD Class I
p.000003: Nomenclature system (preferably GMDN)
p.000003: Code / Nomenclature code
p.000003: Code text name / Nomenclature text
p.000003: Commercial name, brand name / Commercial name / brand name / make
p.000003: Model and / or catalog number
p.000003: Serial number and / or batch number (s) and / or lot / batch number (s)
p.000003: Software version number (if applicable) / Software version number (if applicable)
p.000003: Date of manufacture / expiry date (if applicable) / Manufacturinq date / expiry date (if applicable)
...

Social / Trade Union Membership

Searching for indicator union:

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p.000003: 12. *
p.000003: manufacturer: the natural or legal person
p.000003: (a) which devices are designed, manufactured, packaged and labeled under their own responsibility before being used on their own
p.000003: marketing or conducting a clinical trial under his name, whether or not they are
p.000003: operations are carried out by himself or on his behalf,
p.000003: (b) which assembles, packs, processes, refurbishes a device for placing on the market under its own name,
p.000003: label and mark them for the purpose of use, unless they are assembling devices already on the market,
p.000003: or adaptive to a particular patient during their treatment according to their intended use
p.000003: according to your individual needs;
p.000003: 13. *
p.000003: authorized representative: resident in an EEA Member State, or
p.000003: a natural or legal person established by the manufacturer
p.000003: authorizes it to act on its behalf in relation to obligations under this Regulation; or
p.000003: to whom the authorities and bodies may turn instead of the manufacturer;
p.000003: 14. *
p.000003: distributor: the natural or legal person who places on the market
p.000003: the device is provided free of charge until it is handed over to the end user after use
p.000003: made available to it, in particular by the importer, distributor or reseller;
p.000003: 15. purpose of use: the use of the device by the manufacturer on the label in the instructions for use
p.000003: or the purpose stated in the advertisement;
p.000003: 16. Intended use: by the manufacturer of the device in order to achieve the intended use
p.000003: use in accordance with the specified indication and in the manner and under the conditions specified by the manufacturer;
p.000003: 17. EEA State: a Member State of the European Union and a party to the Agreement on the European Economic Area
p.000003: another State and a State of which the European Community and its Member States are nationals, and
p.000003: An international agreement concluded between a State not party to the Agreement on the European Economic Area
p.000003: the same status as a national of a State party to the Agreement on the European Economic Area
p.000003: enjoy;
p.000003: 18. *
p.000003: placing on the market: custom-made, intended for clinical trials
p.000003: with the exception of making the asset available for the first time, whether in return for payment or free of charge, to the European Economic Area
p.000003: In the European Economic Area (hereinafter referred to as the EEA) or with the European Community or the EEA
p.000003: in a State having the same status as an EEA Member State in respect of assets under the Treaty (hereinafter
p.000003: together: EEA Member State) for distribution or use, regardless of whether the device is new or
p.000003: renovated;
p.000003: 19. putting into service: in the EEA Member State, the device can be used as intended as a product
p.000003: making it available to the end user for the first time;
p.000003: 20. notified body: under the specific legislation, by assessing the conformity of the device and
p.000003: designated to carry out certification tasks and the European Commission (hereinafter
p.000003: Commission), as well as the body notified to the EEA Member States and other conformity
p.000003: notified to the Commission for evaluation tasks
p.000003: an organization with a specific identification number;
p.000003: 21. *
p.000003: 22. localized harmonized standard: adopted by the European standardization organizations and the European Union
p.000003: Harmonized European standard published in the Official Journal of the European Union and published in accordance with Hungarian procedures
p.000003: published as a national standard;
p.000003: 23. clinical data: derived from the use of a device, its
p.000003: safety and performance information;
p.000003: 24. *
p.000003: unexpected event, accident: occurred in connection with the asset
p.000003: an event in which any malfunction, characteristics, or performance of the device occurs
p.000003: malfunction or deterioration of the label and any deficiencies in the label or instructions for use, or
p.000003: insufficiency for the death or serious deterioration of the health of the patient, the operator of the device or another person
p.000003: led or could have led;
p.000003: 25. on-site safety corrective action (FSCA): on a device in circulation or in use
p.000003: the action taken by the manufacturer to reduce the risk of an unexpected event;
p.000003: 26. *
p.000003: responsible for the accident: the medical director of the health care provider or his
p.000003: in the absence of an appropriate professional manager, who shall report the incident, accident,
p.000003: performs tasks related to the investigation;
p.000003: 27. *
p.000003: severe deterioration in health:
p.000003: a) life-threatening illness,
p.000003: b) permanent impairment of physiological function or health,
p.000003: (c) a condition requiring medical or surgical intervention in accordance with (a);
p.000003: and (b),
p.000003: (d) diagnostic or in vitro diagnostic instructions used in accordance with the manufacturer 's instructions
p.000003: damage caused by an erroneous result of a device test,
p.000003: (e) fetal harm, fetal death or congenital or birth-related
p.000003: disorder;
p.000003: 28. *
...

p.000003: health and safety requirements.
p.000003: § 9 If the device is subject to personal protective equipment requirements and compliance
p.000003: 18/2008 on the certification of (XII. 3.) SZMM decree, it is considered a personal protective equipment, then
p.000003: it must also comply with the essential health and safety requirements contained therein.
p.000003: § 10 In addition to the provisions of this decree, the devices shall apply to the health of the population the ionizer
p.000003: laying down basic safety standards for protection against the dangers arising from radiation,
p.000003: and the dangers of ionizing radiation associated with medical exposure
p.000003: specific legislation on the protection of human health against
p.000003: Requirements for devices and examination of their conformity
p.000003: § 11. (1) All devices placed on the market or put into use must comply with their purpose
p.000003: essential requirements for that device in accordance with Annex 1.
p.000003: 2. A device which satisfies the requirements of the national harmonized standard shall be presumed to conform
p.000003: the part of the essential requirements set out in this Regulation for which it is
p.000003: standard applies. The list of localized harmonized standards is issued by the Hungarian Standards Body
p.000003: published in its Official Journal.
p.000003: (3) For the purposes of this Regulation, a reference to national harmonized standards
p.000003: in particular medicinal products and substances used in devices containing such medicinal products
p.000003: European Pharmacopoeia articles on the interaction between Member States, as published in the Official Journal of the European Union
p.000003: They were published.
p.000003: Classification
p.000003: Section 12 (1) The EC conformity assessment procedure for the selection of the device by the manufacturer - in Annex 9
p.000003: I., II.a, II.b or III. class.
p.000003: (2) The classification procedure shall not be performed for active implants and accessories. In those Article 13
p.000003: The EC conformity assessment procedure referred to in paragraph 7 shall be carried out.
p.000003: (3) *
p.000003: In the case of a question arising from the application of the classification rules,
p.000003: in case of doubt - decides in the OGYÉI decision.
p.000003: (4) Breast implants and hip, knee and shoulder prostheses are included in Annex III. shall be classified in class
p.000003: provided that the rules in Annex 9 do not apply.
p.000003: (5) *
p.000003: OGYÉI may address a request to the Commission if:
p.000003: (a) the classification of a particular asset or category of assets in Annex 9
p.000003: the application of the classification rules requires a Commission decision;
p.000003: (b) by way of derogation from the provisions of Annex 9, a particular device or series of devices
p.000003: should be listed;
p.000003: c) *
p.000003: a decision must be made as to whether a particular product or group of products
p.000003: complies with Section 2 (1) and Section 4 (1) 1-4. definitions set out in point
p.000003: one of; obsession
p.000003: (d) the classification rules in Annex 9 need to be amended.
p.000003: (6) *
p.000003: In the case of application of paragraph 5, OGYÉI shall be taken by the Commission
p.000003: act in accordance with this measure.
p.000003: EC conformity assessment procedures
p.000003: § 13. (1) In the case of devices classified in Class I, the manufacturer shall act in accordance with Annex 7 and before placing on the market
p.000003: manufacturers draw up an EC declaration of conformity.
...

p.000003: changes must be notified to OGYÉI in writing or electronically within 30 days.
p.000003: 22-23 / A. § *
p.000003: Specific public health measures
p.000003: § 24. (1) *
p.000003: If OGYÉI in connection with a product or a group of products
p.000003: finds that the protection of health and safety or compliance with public health regulations
p.000003: such products should be withdrawn from the market or placed on the market and used
p.000003: be prohibited, restricted or subject to special requirements necessary and appropriate
p.000003: take a reasonable transitional measure within its competence.
p.000003: (2) *
p.000003: OGYÉI on the measure taken pursuant to paragraph (1) - its
p.000003: shall inform the partner authorities and the Commission.
p.000003: § 25 *
p.000003: If not with the other device in circulation, the individual device is not
p.000003: substitutable for public health purposes, at the medically justified request, by the Ethics Committee
p.000003: after receiving its opinion on the effectiveness and substitutability of
p.000003: for a maximum period of 1 year for use by a specific healthcare provider,
p.000003: or, in the case of an implant, OGYÉI may exceptionally authorize it for use on a specific person
p.000003: the occasional putting into service and use of a specific device, provided that the device is safe
p.000003: which has not been subject to the procedures under Section 13 (1) - (8).
p.000003: Cooperation with EU partner authorities and the Commission
p.000003: § 26 (1) *
p.000003: OGYÉI for assets in the member states of the European Union
p.000003: Member States shall cooperate in order to maintain the uniform application of harmonized legislation
p.000003: competent authorities (partner authorities) and the Commission.
p.000003: 2. The essential purpose of the exchange of information and data in the course of cooperation shall be to ensure the security of assets.
p.000003: (3) *
p.000003: In its decisions, OGYÉI takes into account the information provided by the Commission
p.000003: data, information and resolution provided.
p.000003: (4) *
p.000003: OGYÉI public data provided by the Commission,
p.000003: publishes information, resolutions and recommendations on its website in Hungarian.
p.000003: (5) *
p.000003: OGYÉI in the provision of information and data to the recommendations
p.000003: follow an appropriate procedure.
p.000003: European Databank *
p.000003: 26 / A. § *
p.000003: OGYÉI by the designated organization pursuant to Section 14 (7)
p.000003: data sent in accordance with Section 17, Paragraphs (1) - (2), 21 / A. §
p.000003: It shall transmit the notifications referred to in paragraph 4 and the results of the investigations to the European Databank.
p.000003: Periodic review
p.000003: § 27. (1) The health care provider using the devices according to Annex 13 shall be regular
p.000003: shall be subject to periodic review in order to obtain adequate information
p.000003: available during use
p.000003: deterioration, possible changes in the specifications given in the documentation of the device,
p.000003: and the existence of proper and safe performance.
p.000003: (2) The frequency of the review and other requirements related to the review are set out in Annex 13
p.000003: Define.
p.000003: (3) *
p.000003: The review is a body authorized by OGYÉI to do so by OGYÉI
p.000003: based on a defined and published set of requirements.
p.000003: Inspection of healthcare providers
p.000003: § 28. (1) *
...

p.000003: material quality is unchanged and remains safe. The competent authority shall take this into account
p.000003: the usefulness of incorporating the substance into the device by the notified body
p.000003: specified data to ensure that the changes are not adversely affected
p.000003: the benefit / risk balance of adding the substance to the device.
p.000003: If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
p.000003: information that the additive has been incorporated into the device
p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that this information is existing in connection with the incorporation of the additional substance into the device
p.000003: benefit / risk ratio. The notified body shall take the updated scientific opinion into account
p.000003: and review its assessment in the conformity assessment procedure accordingly.
p.000003: 7.5. Devices must be designed and manufactured in such a way as to minimize them from the device
p.000003: risk due to leaking materials. Particular attention must be paid in the European Union
p.000003: 3/2006 on the list of classified dangerous substances (I. 26.) EüM Decree No. 1
p.000003: carcinogenic, mutagenic or teratogenic substances in accordance with Annex
p.000003: Where parts of a device (or the device itself) intended for medicinal products,
p.000003: the introduction and / or removal of body fluids or other substances from the body, or
p.000003: if they are intended for the transport of such body fluids or substances in accordance with Regulation 3/2006.
p.000003: (I. 26.) EüM Decree No. 1 or 2 carcinogen, mutagen or
p.000003: contain phthalates classified as teratogenic, on the device itself and / or on each unit
p.000003: The label on the sales package and, where appropriate, on the sales packaging shall indicate that:
p.000003: the device contains phthalates.
p.000003: Where such devices are intended for children or pregnant or breastfeeding mothers
p.000003: the manufacturer’s technical documentation and instructions for use
p.000003: explicitly justify the use of these substances, in particular this paragraph
p.000003: compliance with its essential requirements and provide information to these user groups
p.000003: the residual risks and, if necessary, the appropriate precautions.
p.000003: 7.6. The device must be designed and manufactured in such a way that the materials which may enter the device from the environment
p.000003: the risk posed by the device and its environment should be kept to a minimum.
p.000003: 8. Infection and microbial contamination
p.000003: 8.1. The device and its manufacturing process should be designed to be as small as possible
...

Social / education

Searching for indicator education:

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p.000003: (2) This Regulation
p.000003: (a) the authorization of advanced therapy medicinal products and Directive 2001/83 / EC and
p.000003: Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 1 November 2007 amending Regulation (EC) No 726/2004
p.000003: Regulation and
p.000003: (b) Commission Decision 2010/227 / EU of 19 April 2010 on the European Databank for Medical Devices (EUDAMED)
p.000003: Decision
p.000003: c) *
p.000003: as regards Council Directive 90/385 / EEC, animal tissues
p.000003: for active implantable medical devices manufactured using
p.000003: As regards Council Directive 93/42 / EEC, medical devices manufactured utilizing tissues of animal origin
p.000003: on specific requirements for equipment
p.000003: Commission Regulation (EU) No 722/2012 of 8 August 2012
p.000003: lays down the provisions necessary for its implementation.
p.000003: Annex 1 to Regulation 4/2009 (III. 17.) EüM
p.000003: Essential requirements
p.000003: A. For class assets
p.000003: I. General requirements
p.000003: 1. The device must be designed and manufactured in such a way as to be specified by the manufacturer
p.000003: when used as intended, do not endanger the health of patients
p.000003: the safety or security of users and, where appropriate, other persons, and
p.000003: provided that all risks associated with its intended use
p.000003: acceptable in relation to the benefits to the patient and compatible
p.000003: with a high level of health and safety requirements. This includes:
p.000003: (a) minimizing the risk of operational error that is
p.000003: arises from the ergonomic features of the device and the environment in which the device is intended to be used
p.000003: (patient safety design), and
p.000003: (b) the technical knowledge, experience, education and training of the target users and appropriate
p.000003: taking into account, where appropriate, his medical and physical condition (lay, professional, disabled or disabled)
p.000003: design that takes other users into account).
p.000003: 2. The design and manufacturing solutions applied by the manufacturer must comply with the safety principles,
p.000003: taking into account generally accepted technical standards. The most suitable solutions
p.000003: the manufacturer must apply the following principles in the order in which they are listed:
p.000003: (a) elimination or reduction of risk (safe design and construction per se);
p.000003: (b) the application of adequate protection measures in respect of unavoidable risks,
p.000003: including an alarm if necessary;
p.000003: (c) informing users of any deficiencies in the security measures adopted is maintained
p.000003: risk.
p.000003: 3. The device must have the performance intended by the manufacturer and be designed and manufactured
p.000003: and packaged to suit one or more of the specifications referred to in Section 2 (1) specified by the manufacturer
p.000003: function.
p.000003: 4. Device characteristics and performance referred to in points 1, 2 and 3 - specified by the manufacturer
p.000003: during life and under normal conditions of use - do not change
p.000003: adversely affect the health status of patients and, where appropriate, other persons
p.000003: and endanger your safety.
p.000003: 5. The device must be designed, manufactured and packaged in such a way that it is suitable for its intended purpose
...

Social / gender

Searching for indicator gender:

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p.000003: Model and / or catalog number
p.000003: Serial number and / or batch number (s) and / or lot / batch number (s)
p.000003: Software version number (if applicable) / Software version number (if applicable)
p.000003: Date of manufacture / expiry date (if applicable) / Manufacturinq date / expiry date (if applicable)
p.000003: Accessory / associated device (if any)
p.000003: device (if applicable)
p.000003: Notified body ID number
p.000003: 6 Incident information
p.000003: Registration number of the application at the place of application (if applicable) / User facility report reference
p.000003: number, if applicable
p.000003: Manufacturer's awareness date
p.000003: Date of incident occurred
p.000003: Incident description narrative
p.000003: Number of persons involved (if known)
p.000003: Number of medical devices involved (if known)
p.000003: Medical device current location / disposition (if known)
p.000003: Operator of the medical device at the time of the incident
p.000003: □ Health care professional
p.000003: □ Patient / patient
p.000003: □ Other
p.000003: Usage of the medical device
p.000003: □ Initial use
p.000003: □ Reuse of a reusable medical device
p.000003: □ Other (please specify):
p.000003: □ Refurbished device / re-serviced / refurbished
p.000003: □ Before use
p.000003: problem noted prior use
p.000003: 7 Information on the persons involved
p.000003: Conditions of use of the device
p.000003: Care provided by the healthcare provider to the person concerned / Remediai action taken by the healthcare
p.000003: facility relevant to the care of the person involved
p.000003: Age of the person at the time of the incident (if known) / Age of the person at the time of the incident, if applicable
p.000003: Gender concerned (if known) / Gender (if applicable)
p.000003: □ Woman
p.000003: □ Male / Male
p.000003: Weight in kilograms (if applicable)
p.000003: 8 Healthcare facility information (where the event occurred) / Healthcare facility information
p.000003: Name of the healthcare facility Incident Contact person within the
p.000003: facility Address
p.000003: Postal code
p.000003: Phone number / Phone E-mail / E-mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: 9 Manufacturer's preliminary remarks (in case of prior and follow-up notification) / Manufacturer's
p.000003: preliminary comments (Initial / Follow-up report)
p.000003: Manufacturer's preliminary analysis
p.000003: Preliminary corrective actions / preventive actions by the manufacturer
p.000003: implemented by the manufacturer
p.000003: Expected date of next report
p.000003: 10 Results of manufacturers final investigation (Final report)
p.000003: The manufacturer’s device analysis results
p.000003: Corrective action / remedial action / preventive action / on-site safety corrective action /
p.000003: Remedies action / corrective action / preventive action / Field Safety Corrective Action
p.000003: Note: to be completed from medical devices in case of on-site safety corrective action
p.000003: C: Annex C of the Decree on the submission of the FSCA
p.000003: to fill in the FSCA report form of this annex
p.000003: Time Schedule for the implementation of the identified
p.000003: action
p.000003: Manufacturer's comments on the measures / Final comments from the manufacturer
p.000003: Further investigations
p.000003: Is the manufacturer aware of events related to the device for similar reasons?
p.000003: aware of similar incidents with this type of medical device with a similar root cause?
p.000003: □ Yes
p.000003: □ No
p.000003: If yes, in which countries and the report number?
p.000003: reference numbers of the incidents
...

Social / philosophical differences/differences of opinion

Searching for indicator opinion:

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p.000003: representative, the dealer authorized to distribute the device and the notified body.
p.000003: (6) The preliminary incident report shall not be construed as acknowledging by the notifier that the device is
p.000003: was the cause of an unexpected event, an accident.
p.000003: (7) The manufacturer or his authorized representative shall be obliged to cover events related to the device
p.000003: record and make changes necessary for the safe use of the device.
p.000003: 21 / B. § *
p.000003: The name of the head of the health care provider responsible for the accident,
p.000003: position, contact details, name of the health care provider, occurred in the data
p.000003: changes must be notified to OGYÉI in writing or electronically within 30 days.
p.000003: 22-23 / A. § *
p.000003: Specific public health measures
p.000003: § 24. (1) *
p.000003: If OGYÉI in connection with a product or a group of products
p.000003: finds that the protection of health and safety or compliance with public health regulations
p.000003: such products should be withdrawn from the market or placed on the market and used
p.000003: be prohibited, restricted or subject to special requirements necessary and appropriate
p.000003: take a reasonable transitional measure within its competence.
p.000003: (2) *
p.000003: OGYÉI on the measure taken pursuant to paragraph (1) - its
p.000003: shall inform the partner authorities and the Commission.
p.000003: § 25 *
p.000003: If not with the other device in circulation, the individual device is not
p.000003: substitutable for public health purposes, at the medically justified request, by the Ethics Committee
p.000003: after receiving its opinion on the effectiveness and substitutability of
p.000003: for a maximum period of 1 year for use by a specific healthcare provider,
p.000003: or, in the case of an implant, OGYÉI may exceptionally authorize it for use on a specific person
p.000003: the occasional putting into service and use of a specific device, provided that the device is safe
p.000003: which has not been subject to the procedures under Section 13 (1) - (8).
p.000003: Cooperation with EU partner authorities and the Commission
p.000003: § 26 (1) *
p.000003: OGYÉI for assets in the member states of the European Union
p.000003: Member States shall cooperate in order to maintain the uniform application of harmonized legislation
p.000003: competent authorities (partner authorities) and the Commission.
p.000003: 2. The essential purpose of the exchange of information and data in the course of cooperation shall be to ensure the security of assets.
p.000003: (3) *
p.000003: In its decisions, OGYÉI takes into account the information provided by the Commission
p.000003: data, information and resolution provided.
p.000003: (4) *
p.000003: OGYÉI public data provided by the Commission,
p.000003: publishes information, resolutions and recommendations on its website in Hungarian.
p.000003: (5) *
p.000003: OGYÉI in the provision of information and data to the recommendations
p.000003: follow an appropriate procedure.
p.000003: European Databank *
p.000003: 26 / A. § *
p.000003: OGYÉI by the designated organization pursuant to Section 14 (7)
p.000003: data sent in accordance with Section 17, Paragraphs (1) - (2), 21 / A. §
p.000003: It shall transmit the notifications referred to in paragraph 4 and the results of the investigations to the European Databank.
p.000003: Periodic review
p.000003: § 27. (1) The health care provider using the devices according to Annex 13 shall be regular
...

p.000003: persons involved in its use, as well as patients, taking into account the purpose for which the device is used. Strange
p.000003: attention should be paid to the human tissues involved and to the duration and frequency of use.
p.000003: 7.3. The device must be designed and manufactured in such a way that it can be used safely with
p.000003: substances, media and gases with which it is used during normal use or during routine procedures
p.000003: comes into contact. If the device is intended for the administration of medicinal products, it must be designed and manufactured in such a way that:
p.000003: to be compatible with the medicinal product in question, subject to the provisions relating to the medicinal product, and
p.000003: restrictions as well as its performance according to the intended use.
p.000003: 7.4. *
p.000003: If an integral part of the device is a substance that is on its own
p.000003: used - Gytv. as a medicinal product and suitable for the device
p.000003: have an additional effect on the human body compared to its effect, the quality and safety of the substance
p.000003: and its usefulness in Regulation 52/2005 on the placing on the market of medicinal products for human use. (XI. 18.)
p.000003: It must be certified on the basis of the methods specified in Annex 1 of the EüM Decree.
p.000003: For the substances referred to in the first paragraph, the notified body shall be satisfied that:
p.000003: the usefulness of the substance as part of the device, taking into account the purpose of the device,
p.000003: seek a scientific opinion from one of the competent authorities designated by the Member States or
p.000003: primarily from the European Medicines Agency (EMA) under Regulation (EC) No 726/2004
p.000003: quality and safety - including the clinical benefit / risk of incorporation of the substance into the device
p.000003: proportion. When issuing its opinion
p.000003: the competent authority or the EMA has the manufacturing process and the substance has been placed in the device
p.000003: data established by the notified body on the usefulness of its incorporation.
p.000003: If the device also includes human blood products as an integral part, the designated body after
p.000003: convinced of the usefulness of the substance as part of the tool and considering the tool
p.000003: scientific opinion from the EMA on the quality and safety of the substance, including human
p.000003: clinical benefit / risk of incorporation of a blood product into a device. When commenting on the
p.000003: EMA for the manufacturing process and the incorporation of the substance into the device by the notified body
p.000003: take into account the data established.
p.000003: When it is done in an additional material that is part of the device - especially related to the manufacturing process
p.000003: change, the notified body must be informed and the competent authority must be consulted (ie the first
p.000003: consultation) with the pharmaceutical authority to confirm that the supplement
p.000003: material quality is unchanged and remains safe. The competent authority shall take this into account
p.000003: the usefulness of incorporating the substance into the device by the notified body
p.000003: specified data to ensure that the changes are not adversely affected
p.000003: the benefit / risk balance of adding the substance to the device.
p.000003: If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
p.000003: information that the additive has been incorporated into the device
p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that this information is existing in connection with the incorporation of the additional substance into the device
p.000003: benefit / risk ratio. The notified body shall take the updated scientific opinion into account
p.000003: and review its assessment in the conformity assessment procedure accordingly.
p.000003: 7.5. Devices must be designed and manufactured in such a way as to minimize them from the device
p.000003: risk due to leaking materials. Particular attention must be paid in the European Union
p.000003: 3/2006 on the list of classified dangerous substances (I. 26.) EüM Decree No. 1
p.000003: carcinogenic, mutagenic or teratogenic substances in accordance with Annex
p.000003: Where parts of a device (or the device itself) intended for medicinal products,
p.000003: the introduction and / or removal of body fluids or other substances from the body, or
p.000003: if they are intended for the transport of such body fluids or substances in accordance with Regulation 3/2006.
p.000003: (I. 26.) EüM Decree No. 1 or 2 carcinogen, mutagen or
p.000003: contain phthalates classified as teratogenic, on the device itself and / or on each unit
p.000003: The label on the sales package and, where appropriate, on the sales packaging shall indicate that:
p.000003: the device contains phthalates.
p.000003: Where such devices are intended for children or pregnant or breastfeeding mothers
p.000003: the manufacturer’s technical documentation and instructions for use
p.000003: explicitly justify the use of these substances, in particular this paragraph
p.000003: compliance with its essential requirements and provide information to these user groups
p.000003: the residual risks and, if necessary, the appropriate precautions.
...

p.000003: (a) the choice of substances used, in particular as regards toxicity;
p.000003: (b) interactions between the materials used and biological tissues, cells and body fluids
p.000003: compatibility with regard to the intended use of the device;
p.000003: (c) the compatibility of the devices with the materials to be administered;
p.000003: (d) quality of contacts, in particular safety;
p.000003: (e) reliability of the energy source;
p.000003: (f) where applicable, adequate tightness;
p.000003: (g) programming, control and monitoring systems, including software;
p.000003: proper functioning.
p.000003: In the case of a device that contains software or a device that is medical software in its own right, the software is a
p.000003: be validated by methods appropriate to the state of the art, taking into account developments
p.000003: principles of lifetime, risk management, validation and control.
p.000003: 10. *
p.000003: If the device is an integral part of a substance which, if by itself
p.000003: used - the Gytv. which is considered to be a medicinal product and which is suitable for
p.000003: have an additional effect on the human body compared to the effect of the device, the quality, safety and safety of the substance
p.000003: 52/2005 on the placing on the market of medicinal products for human use. (XI. 18.) EüM
p.000003: shall be certified in accordance with the methods set out in Annex 1 to this Regulation.
p.000003: With regard to the substances referred to in the first paragraph, the notified body shall, after having ascertained the substance as
p.000003: request a scientific opinion on the usefulness of the part of the device, taking into account its purpose
p.000003: from one of the competent authorities designated by the Member State or from the ERF in accordance with Regulation (EC) No 726/2004
p.000003: regarding the quality and safety of the material, including when the material is incorporated into the device
p.000003: clinical benefit / risk. When giving an opinion, the competent authority or the EMA shall
p.000003: process and the usefulness of the incorporation of the substance into the device by the notified body
p.000003: takes into account the data specified by the
p.000003: If a device contains human blood products as an integral part, the designated body after
p.000003: convinced of the usefulness of the substance as part of the device, taking into account the device
p.000003: request a scientific opinion from the EMA on the quality and safety of the substance,
p.000003: including the clinical benefit / risk of incorporating the human blood product into the device
p.000003: money. When commenting on the EMA, the manufacturing process and the material took place in the device
p.000003: data specified by the notified body on the usefulness of its incorporation.
p.000003: When it is done in an additional material that is part of the device - especially related to the manufacturing process
p.000003: change, the notified body must be informed and the competent authority must be consulted (ie the first
p.000003: consultation) with the pharmaceutical authority to confirm that the supplement
p.000003: material quality is unchanged and remains safe. The competent authority shall take this into account
p.000003: the usefulness of incorporating the substance into the device by the notified body
p.000003: specified data to ensure that the changes are not adversely affected
p.000003: the benefit / risk balance of adding the substance to the device.
p.000003: If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
p.000003: information that the additive has been incorporated into the device
p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that the benefit / risk balance associated with the incorporation of the additional substance into the device
p.000003: It can affect. The notified body shall take the updated scientific opinion into account and the EC
p.000003: review its assessment in the conformity assessment procedure on that basis.
p.000003: 11. Devices and, where appropriate, their components must be identifiable in such a way as to:
p.000003: that any potential risk associated with the device and its components is discovered
p.000003: allow all necessary measures to be taken.
p.000003: 12. Devices must bear a code by which the devices (in particular the type of device and
p.000003: year of manufacture) and their manufacturer can be clearly identified. This code is surgical if necessary
p.000003: can be read without intervention.
p.000003: 13. If a device or accessory has instructions that
p.000003: display of operating or control parameters required for the operation of the device
p.000003: such information must be easy for the user and
p.000003: where appropriate, for the patient.
p.000003: 14. Each device must bear the following particulars, in letters grouped on the same side, legibly and indelibly marked
p.000003: data, where appropriate in the form of commonly known symbols:
p.000003: 14.1. On the sterile package:
p.000003: (a) the method of sterilization;
p.000003: (b) a mark enabling the packaging in question to be identified by
p.000003: sterility;
p.000003: (c) the name and address of the manufacturer;
p.000003: (d) the name of the asset;
p.000003: (e) on a device intended for clinical investigations, the words "for clinical investigations only";
p.000003: (f) in the case of a custom-made device, the words "custom-made device";
p.000003: (g) an indication that the implantable device is in a sterile state;
p.000003: (h) month and year of manufacture;
p.000003: (i) the expiry date of the safe implantation of the device.
p.000003: 14.2. On the commercial packaging:
...

p.000003: the decision must be communicated to the manufacturer. This decision should include an audit
p.000003: conclusions drawn and the reasons for the assessment.
p.000003: 4. Examination of the product design
p.000003: 4.1. In addition to the obligations imposed by point 3, the manufacturer must lodge an application with a notified body
p.000003: intended for manufacture and 3.1. for a product belonging to the product group referred to in point
p.000003: examination of the relevant design documentation.
p.000003: 4.2. The application must include the plans, manufacture and services of the product in question. contain
p.000003: 3.2. the documents listed in point (c) which are necessary to establish that:
p.000003: whether the product satisfies the requirements of this Regulation.
p.000003: 4.3. *
p.000003: The notified body must examine the application and where:
p.000003: product complies with the relevant requirements of this Regulation, it shall issue a design examination certificate to the applicant. The selected
p.000003: may request that the application be supplemented by further tests or trials in order to:
p.000003: compliance with the requirements of this Regulation. The certificate must include the test
p.000003: conclusions, conditions for validity, data necessary to identify the approved plan
p.000003: and, where appropriate, a description of the intended use of the product. Annex 1, Part A, Section 7
p.000003: point 7.4. in the case of the devices referred to in the second subparagraph of
p.000003: before taking a decision, request Annex 1, Part A, point 7, point 7.4. in the first paragraph of
p.000003: the competent body authorized to register medicinal products or the EMA
p.000003: provided that the registrant has the appropriate documentation
p.000003: deliver its opinion within 210 days of receipt. For device documentation
p.000003: it must contain the scientific opinion of the registrant or the EMA. To the notified body
p.000003: make its decision taking into account the opinion of the registrant,
p.000003: and shall inform the registrant thereof.
p.000003: Annex 1, Part A, section 7 7.4. in the case of the devices referred to in the third subparagraph of
p.000003: The EMA shall include the scientific opinion of the EMA on the device. THE
p.000003: the notified body shall give due consideration to the expertise of the EMA when making its decision. The selected
p.000003: an organization may not issue a certificate if the EMA's opinion is unfavorable. The designated organization is the final one
p.000003: notify the EMA of its decision. In the case of devices manufactured utilizing tissues of animal origin:
p.000003: the notified body must follow the procedures provided for in Commission Regulation (EU) No 722/2012.
p.000003: 4.4. Any changes to the approved plan must be additionally approved by the designated certificate issuer
p.000003: these changes may affect compliance with the essential requirements of this Regulation
p.000003: compliance or conditions of use of the product. The applicant shall inform the
p.000003: The notified body which has issued the EC design examination certificate in respect of each design which it has approved
p.000003: change. The additional approval must be given in the form of an addition to the original EC design examination certificate.
p.000003: 5. Review
p.000003: 5.1. The review ensures that the manufacturer is in charge of the approved quality system
p.000003: fulfill its obligations properly.
p.000003: 5.2. The manufacturer must authorize the notified body for all necessary
p.000003: and provide it with all the necessary documents, in particular
p.000003: following:
p.000003: (a) the quality system documentation;
p.000003: (b) the data taken into account in the design part of the quality system, such as the
p.000003: with the results of analyzes, calculations, tests, Annex 1
p.000003: With the solutions applied as specified in point 2 of Part A, a
p.000003: clinical trial evaluation and clinical evaluation, placing on the market
p.000003: the clinical product follow-up plan and, where appropriate, the results thereof;
p.000003: (c) the data taken into account in the production part of the quality system, such as
p.000003: inspection reports, test data, calibration data, qualification of personnel
p.000003: reports.
...

p.000003: (a) the design specifications, including standards, that have been applied; these standards
p.000003: necessary proof of its applicability, in particular in the case referred to in Article 4
p.000003: standards have not been applied in full
p.000003: degree. This certificate must contain the information required by the manufacturer or under his responsibility
p.000003: the results of appropriate tests;
p.000003: (b) information on whether the product contains as an integral part of the product
p.000003: The substance referred to in Annex 1, Part B, point 10, which interacts with the device in question
p.000003: may result in the entry of the substance into physiological processes, the relevant experiments performed
p.000003: together with data;
p.000003: (c) the clinical evaluation in accordance with Annex 10;
p.000003: (d) the draft instructions for use.
p.000003: 4.3. *
p.000003: The notified body shall examine the application and the product concerned
p.000003: meets the relevant requirements of this Regulation, shall issue an EC design examination certificate to the applicant. THE
p.000003: the notified body may request further tests or trials to supplement the application,
p.000003: to assess compliance with the requirements of this Regulation. The certificate must include the
p.000003: the conclusions of the examination, conditions for its validity, to identify the approved plan
p.000003: the necessary particulars and, where appropriate, a description of the intended use of the product. Annex 1, Part B.
p.000003: In the case of devices referred to in the second paragraph of point 10, the notified body must take decisions
p.000003: referred to in the first paragraph of point 10 of Part B of Annex 1
p.000003: the opinion of the competent body authorized to register medicinal products or the EMA,
p.000003: that the registrant has received the relevant documentation from the date of receipt
p.000003: You must provide an opinion within 210 days. The documentation concerning the device must include:
p.000003: the scientific opinion of the registrant or the EMA. The notified body must:
p.000003: it must take its decision after considering the opinion of the registrant, and
p.000003: you must also inform the registrant.
p.000003: In the case of devices referred to in the third paragraph of point 10 of Part B of Annex 1, the
p.000003: the dossier shall include the EMA's scientific opinion on the device. The selected
p.000003: the organization shall give due consideration to the opinion of the EMA when making its decision. The notified body does not
p.000003: may issue the certificate if the EMA's opinion is unfavorable. The notified body shall make the final decision
p.000003: notify the EMA. In the case of a device made using tissues of animal origin, the designated
p.000003: organization shall follow the procedures provided for in Commission Regulation (EU) No 722/2012.
p.000003: 4.4. The manufacturer or the applicant must inform the issuer of the EC design examination certificate
p.000003: the notified body of any changes to the approved plan. These
p.000003: Changes must be approved in addition by the notified body which issued the certificate if these:
p.000003: changes may affect compliance with the requirements of this Regulation or the use of the product
p.000003: conditions. Additional acceptance shall take the form of an addition to the EC design-examination certificate
p.000003: taken.
p.000003: 5. Review
p.000003: 5.1. The review ensures that the manufacturer is in charge of the approved quality system
p.000003: fulfill its obligations properly.
p.000003: 5.2. The manufacturer must authorize the notified body for all necessary
p.000003: and provide it with all the necessary documents, in particular
p.000003: following:
p.000003: (a) the quality system documentation;
p.000003: (b) the data taken into account in the design part of the quality system, such as
p.000003: results of analyzes, calculations, tests, evaluation of admissibility for clinical trials and clinical
p.000003: post-marketing clinical product follow-up plan and, where appropriate
p.000003: with the results;
p.000003: (c) the data taken into account in the production part of the quality system, such as
p.000003: inspection reports, test data, calibration data, qualification of personnel
p.000003: reports.
p.000003: 5.3. The notified body must periodically carry out audits and assessments to make sure that:
p.000003: ensure that the manufacturer operates the approved quality system and provide the manufacturer with an assessment
...

p.000003: 4.2. perform or have performed the appropriate examinations and necessary tests
p.000003: necessary to verify that the solutions adopted by the manufacturer satisfy the requirements set out in Annex 1
p.000003: essential requirements if the nationalized harmonized standards are not fully applied. If the
p.000003: the product must be connected to other devices in order to function properly as intended
p.000003: make sure that this is done with another device having the characteristics specified by the manufacturer
p.000003: when combined, it meets the essential requirements;
p.000003: 4.3. perform or have performed the appropriate examinations and necessary tests which:
p.000003: they are necessary to verify that, if the manufacturer has chosen the appropriate standards to be used, they have been applied
p.000003: actually applied it;
p.000003: 4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out.
p.000003: 5. *
p.000003: If the type meets the requirements of this Regulation, the notified body
p.000003: It shall issue an EC type - examination certificate to the applicant. The certificate must include the
p.000003: the name and address of the manufacturer, conclusions of the examination, conditions for its validity and the
p.000003: data necessary to identify the approved type. The relevant parts of the documentation
p.000003: it must be attached to the certificate and a copy kept by the notified body. The 1.
p.000003: Annex I, Part A, point 7 7.4. in the case of the devices referred to in the second subparagraph of
p.000003: Before taking a decision, the organization shall request the information specified in Annex 1, Part A, point 7, paragraph 7.4. first subparagraph
p.000003: The competent body for the registration of medicinal products for the purposes of paragraph 1
p.000003: or the opinion of the EMA, provided that the registration body has the appropriate documentation
p.000003: deliver its opinion within 210 days of receipt. For device documentation
p.000003: it must contain the scientific opinion of the registrant or the EMA. The selected
p.000003: the registration body shall take its decision, taking into account the opinion of the registrant, and shall inform the
p.000003: it must also inform the registrant. Annex 1, Part A, section 7 7.4.
p.000003: in the case of devices referred to in the third subparagraph of point (a), the documentation concerning the device
p.000003: the EMA’s scientific opinion on the instrument. The notified body must:
p.000003: take due account of the opinion of the EMA when making its decision. The notified body does not
p.000003: may issue the certificate if the EMA's opinion is unfavorable. The notified body shall make the final decision
p.000003: notify the EMA. In the case of a device made using tissues of animal origin, the designated
p.000003: organization shall follow the procedures provided for in Commission Regulation (EU) No 722/2012.
p.000003: 6. The applicant must keep the notified body that has issued the EC type-examination certificate informed of:
p.000003: any substantial modification to an approved product. Modifications to the approved product are subject to type examination
p.000003: the notified body issuing the certificate must re - accept or supplement it if the
p.000003: Modifications may affect compliance with the essential requirements or the use of the product
p.000003: conditions. The new or additional approval, if any, shall be the original EC type-examination certificate
p.000003: as a supplement.
p.000003: 7. Administrative requirements
p.000003: 7.1. A copy of the EC type - examination certificates and their additions may be obtained from another notified body.
p.000003: The annexes to the certificates shall, upon reasoned request and after informing the manufacturer, be amended
p.000003: shall also be made available to a designated body.
p.000003: 7.2. The manufacturer or his authorized representative must, with the technical documentation,
p.000003: Copies of the EC type - examination certificates and their additions from the last production of the device at least
p.000003: for a period of five years. For implantable devices, this period is the last product
p.000003: at least fifteen years from the date of manufacture.
p.000003: B. For active implantable devices
p.000003: 1. EC type-examination is the procedure whereby a notified body ascertains and
p.000003: certify that a representative sample of the production envisaged meets the relevant requirements of this Regulation.
...

p.000003: 4.1. examine and evaluate the documentation and verify that the type conforms to the documentation
p.000003: They manufactured; lays down the items covered by the nationalized harmonized standards
p.000003: designed in accordance with the relevant requirements of this Regulation and those that are not;
p.000003: 4.2. perform or have performed the appropriate examinations and necessary tests to check that:
p.000003: the solutions adopted by the manufacturer meet the essential requirements of Annex 1 if a
p.000003: nationalized harmonized standards are not fully implemented;
p.000003: 4.3. perform or have performed the appropriate examinations and necessary tests to check that,
p.000003: that if the manufacturer has chosen the appropriate standards to be used, he has actually applied them;
p.000003: 4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out.
p.000003: 5. *
p.000003: If the type meets the requirements of this Regulation, the notified body
p.000003: It shall issue an EC type - examination certificate to the applicant. The certificate must include the
p.000003: the name and address of the manufacturer, the conclusions of the examination,
p.000003: the conditions of validity and the particulars necessary for identification of the approved type
p.000003: required. The relevant parts of the documentation must be attached to the certificate and a copy designated
p.000003: organization must retain.
p.000003: For devices referred to in Annex 1, Part B, point 10, second paragraph, the notified body is Annex 1
p.000003: With regard to the aspects referred to in point 10 of Part B - consult the Medicines Agency before taking a decision
p.000003: with the competent body authorized to register or with the EMA,
p.000003: the organization must issue an opinion within 210 days of receipt of the valid documentation. THE
p.000003: the scientific opinion of the registrant or the EMA in the dossier for the device
p.000003: must contain. The notified body shall give due consideration to the consultation when making its decision
p.000003: views expressed during the It shall communicate its final decision to the registrant concerned
p.000003: organizations.
p.000003: For the instruments referred to in the third paragraph of point 10 of Part B of Annex 1, the ERF is scientific
p.000003: Your opinion should be included in the documentation for the device. It is sufficient when the decision of the notified body is made
p.000003: carefully consider the opinion of the EMA. The notified body will not issue the certificate if the EMA
p.000003: its scientific opinion is unfavorable. The notified body shall communicate its final decision to the EMA.
p.000003: 6. The applicant must keep the notified body that has issued the EC type-examination certificate informed of:
p.000003: any modification to the approved product.
p.000003: These modifications shall be re-submitted to the notified body that issued the EC type-examination certificate
p.000003: if the amendments are likely to affect compliance with the essential requirements or
p.000003: the conditions prescribed for the use of the product. New acceptance, if warranted, of the original type examination
p.000003: certificate.
p.000003: 7. Administrative requirements
p.000003: 7.1. A copy of the EC type - examination certificates and their additions may be obtained from another notified body.
p.000003: The annexes to the certificates shall, upon reasoned request and after informing the manufacturer, be amended
p.000003: shall also be made available to a designated body.
p.000003: 7.2. The manufacturer or his authorized representative shall keep the EC type - examination certificates
p.000003: copies of its documentation and additions for a period ending at least fifteen years after the last device has been manufactured
p.000003: you have to keep it.
p.000003: 7.3. If the manufacturer does not have a registered office in an EEA Member State, the technical documentation is available
p.000003: the obligation of an authorized representative pursuant to Section 4 (1) (13).
p.000003: Annex 4 to Regulation 4/2009 (III. 17.) EüM *
p.000003: EC Product Inspection
p.000003: A. For class assets
p.000003: 1. EC product verification is the procedure whereby the manufacturer or his authorized representative certifies - and
p.000003: declares that the products subject to the procedure set out in point 4 conform to the EC type-examination certificate
...

General/Other / Natural Hazards

Searching for indicator hazard:

(return to top)
p.000003: All implantable devices and long - term surgically invasive devices a
p.000003: It is in Class II.b, unless intended
p.000003: (a) gets into the tooth; in this case it is in Class IIa,
p.000003: (b) in direct contact with the heart, the central circulatory system or the central nervous system
p.000003: use; in this case, Annex III. belongs to class
p.000003: (c) has a biological effect or is partially or completely absorbed; in this case, Annex III. classes
p.000003: belongs to,
p.000003: d) undergoes a chemical change in the body (unless it gets into the tooth) or for the administration of a medicine
p.000003: It serves; in this case, Annex III. belongs to class.
p.000003: 3. Additional rules for active assets
p.000003: 3.1. Rule 9
p.000003: All active therapeutic devices intended to transmit or exchange energy are in Class IIa.
p.000003: unless it has the characteristics of transmitting energy to the human body, or
p.000003: energy exchange with the human body, the nature, density and
p.000003: potentially hazardous given its application environment; in this case the
p.000003: It belongs to class II.b.
p.000003: Any active device intended to be active therapeutic in Class IIb
p.000003: monitor or control the operation of such devices or are intended to operate such devices
p.000003: class II.b.
p.000003: 3.2. Rule 10
p.000003: All active diagnostic tools are in Class IIa that are intended to:
p.000003: (a) release the energy absorbed by the human body, except for the patient's body in the visible spectrum
p.000003: means used to illuminate the
p.000003: b) represents the distribution of radiological preparations in vivo,
p.000003: (c) allow the direct diagnosis and monitoring of vital physiological processes, unless:
p.000003: was specifically designed to monitor vital physiological parameters that
p.000003: may result in an immediate hazard to the patient (eg cardiac function, respiration,
p.000003: changes in central nervous system activity); in this case it is in Class II.b.
p.000003: Active devices intended to emit ionizing radiation and for radiological diagnosis or therapy,
p.000003: including devices which control or monitor them and which directly affect their operation, in accordance with Annex II.b.
p.000003: belong to class.
p.000003: 3.3. Rule 11
p.000003: Any active device that is used to inject drugs, body fluids, or other substances into the body
p.000003: intended for administration or removal from the body is in Class IIa, unless the substance so requires
p.000003: potentially hazardous in nature, the part of the body concerned or the route of administration
p.000003: performs; in this case it is in Class II.b.
p.000003: 3.4. Rule 12
p.000003: All other active devices are in Class I.
p.000003: 4. Special rules
p.000003: 4.1. Rule 13
p.000003: Any device which, as an integral part, contains a material which, when used separately, is
p.000003: 52/2005 on the placing on the market of medicinal products for human use (XI. 18.) EüM decree
p.000003: which is considered to be a medicinal product and which complements the action of the device on the human body, in accordance with Annex III. classes
p.000003: belongs to.
p.000003: Any device that contains a human blood derivative as an integral part is listed in Annex III. belongs to class.
p.000003: 4.2. Rule 14
p.000003: Any device used for contraception or the prevention of the sexual transmission of diseases shall be
p.000003: unless it is an implantable or long-term invasive device; in such cases a
p.000003: III. belongs to class.
p.000003: 4.3. Rule 15
p.000003: Specially for disinfecting, cleaning, rinsing and, if necessary, moistening contact lenses
p.000003: intended for use are in Class II.b.
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.000003: to be compatible with the medicinal product in question, subject to the provisions relating to the medicinal product, and
p.000003: restrictions as well as its performance according to the intended use.
p.000003: 7.4. *
p.000003: If an integral part of the device is a substance that is on its own
p.000003: used - Gytv. as a medicinal product and suitable for the device
p.000003: have an additional effect on the human body compared to its effect, the quality and safety of the substance
p.000003: and its usefulness in Regulation 52/2005 on the placing on the market of medicinal products for human use. (XI. 18.)
p.000003: It must be certified on the basis of the methods specified in Annex 1 of the EüM Decree.
p.000003: For the substances referred to in the first paragraph, the notified body shall be satisfied that:
p.000003: the usefulness of the substance as part of the device, taking into account the purpose of the device,
p.000003: seek a scientific opinion from one of the competent authorities designated by the Member States or
p.000003: primarily from the European Medicines Agency (EMA) under Regulation (EC) No 726/2004
p.000003: quality and safety - including the clinical benefit / risk of incorporation of the substance into the device
p.000003: proportion. When issuing its opinion
p.000003: the competent authority or the EMA has the manufacturing process and the substance has been placed in the device
p.000003: data established by the notified body on the usefulness of its incorporation.
p.000003: If the device also includes human blood products as an integral part, the designated body after
p.000003: convinced of the usefulness of the substance as part of the tool and considering the tool
p.000003: scientific opinion from the EMA on the quality and safety of the substance, including human
p.000003: clinical benefit / risk of incorporation of a blood product into a device. When commenting on the
p.000003: EMA for the manufacturing process and the incorporation of the substance into the device by the notified body
p.000003: take into account the data established.
p.000003: When it is done in an additional material that is part of the device - especially related to the manufacturing process
p.000003: change, the notified body must be informed and the competent authority must be consulted (ie the first
p.000003: consultation) with the pharmaceutical authority to confirm that the supplement
p.000003: material quality is unchanged and remains safe. The competent authority shall take this into account
p.000003: the usefulness of incorporating the substance into the device by the notified body
p.000003: specified data to ensure that the changes are not adversely affected
p.000003: the benefit / risk balance of adding the substance to the device.
p.000003: If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
p.000003: information that the additive has been incorporated into the device
p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that this information is existing in connection with the incorporation of the additional substance into the device
p.000003: benefit / risk ratio. The notified body shall take the updated scientific opinion into account
p.000003: and review its assessment in the conformity assessment procedure accordingly.
p.000003: 7.5. Devices must be designed and manufactured in such a way as to minimize them from the device
p.000003: risk due to leaking materials. Particular attention must be paid in the European Union
p.000003: 3/2006 on the list of classified dangerous substances (I. 26.) EüM Decree No. 1
p.000003: carcinogenic, mutagenic or teratogenic substances in accordance with Annex
p.000003: Where parts of a device (or the device itself) intended for medicinal products,
p.000003: the introduction and / or removal of body fluids or other substances from the body, or
p.000003: if they are intended for the transport of such body fluids or substances in accordance with Regulation 3/2006.
p.000003: (I. 26.) EüM Decree No. 1 or 2 carcinogen, mutagen or
p.000003: contain phthalates classified as teratogenic, on the device itself and / or on each unit
...

p.000003: proper functioning.
p.000003: In the case of a device that contains software or a device that is medical software in its own right, the software is a
p.000003: be validated by methods appropriate to the state of the art, taking into account developments
p.000003: principles of lifetime, risk management, validation and control.
p.000003: 10. *
p.000003: If the device is an integral part of a substance which, if by itself
p.000003: used - the Gytv. which is considered to be a medicinal product and which is suitable for
p.000003: have an additional effect on the human body compared to the effect of the device, the quality, safety and safety of the substance
p.000003: 52/2005 on the placing on the market of medicinal products for human use. (XI. 18.) EüM
p.000003: shall be certified in accordance with the methods set out in Annex 1 to this Regulation.
p.000003: With regard to the substances referred to in the first paragraph, the notified body shall, after having ascertained the substance as
p.000003: request a scientific opinion on the usefulness of the part of the device, taking into account its purpose
p.000003: from one of the competent authorities designated by the Member State or from the ERF in accordance with Regulation (EC) No 726/2004
p.000003: regarding the quality and safety of the material, including when the material is incorporated into the device
p.000003: clinical benefit / risk. When giving an opinion, the competent authority or the EMA shall
p.000003: process and the usefulness of the incorporation of the substance into the device by the notified body
p.000003: takes into account the data specified by the
p.000003: If a device contains human blood products as an integral part, the designated body after
p.000003: convinced of the usefulness of the substance as part of the device, taking into account the device
p.000003: request a scientific opinion from the EMA on the quality and safety of the substance,
p.000003: including the clinical benefit / risk of incorporating the human blood product into the device
p.000003: money. When commenting on the EMA, the manufacturing process and the material took place in the device
p.000003: data specified by the notified body on the usefulness of its incorporation.
p.000003: When it is done in an additional material that is part of the device - especially related to the manufacturing process
p.000003: change, the notified body must be informed and the competent authority must be consulted (ie the first
p.000003: consultation) with the pharmaceutical authority to confirm that the supplement
p.000003: material quality is unchanged and remains safe. The competent authority shall take this into account
p.000003: the usefulness of incorporating the substance into the device by the notified body
p.000003: specified data to ensure that the changes are not adversely affected
p.000003: the benefit / risk balance of adding the substance to the device.
p.000003: If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
p.000003: information that the additive has been incorporated into the device
p.000003: may influence the benefit / risk balance associated with its incorporation, inform the notified body
p.000003: that the benefit / risk balance associated with the incorporation of the additional substance into the device
p.000003: It can affect. The notified body shall take the updated scientific opinion into account and the EC
p.000003: review its assessment in the conformity assessment procedure on that basis.
p.000003: 11. Devices and, where appropriate, their components must be identifiable in such a way as to:
p.000003: that any potential risk associated with the device and its components is discovered
p.000003: allow all necessary measures to be taken.
p.000003: 12. Devices must bear a code by which the devices (in particular the type of device and
p.000003: year of manufacture) and their manufacturer can be clearly identified. This code is surgical if necessary
p.000003: can be read without intervention.
p.000003: 13. If a device or accessory has instructions that
p.000003: display of operating or control parameters required for the operation of the device
p.000003: such information must be easy for the user and
p.000003: where appropriate, for the patient.
p.000003: 14. Each device must bear the following particulars, in letters grouped on the same side, legibly and indelibly marked
...

p.000003: in the case of implantable devices, for at least 15 years, make available to the authorities on request:
p.000003: (a) the declaration of conformity;
p.000003: b) a 3.1. the documentation referred to in point (d);
p.000003: c) 3.2. the documentation, data and records specified in point (b);
p.000003: d) and 3.4. the changes referred to in point;
p.000003: e) a 4.2. the documentation referred to in point.
p.000003: (f) the notified body in accordance with points 3.3, 4.3, 4.4, 5.3. and 5.4. and
p.000003: reports.
p.000003: 7. Application to devices in Classes IIa and IIb
p.000003: 7.1. In accordance with Section 13, Paragraphs (2) - (3), this Annex, with the exception of the provisions of Section 4,
p.000003: may also be applied to products in Classes IIa and IIb.
p.000003: 7.2. In the case of Class IIa devices, the notified body must:. described in point
p.000003: as part of the assessment (c), each asset class shall have at least one
p.000003: assess the conformity of the technical documentation with this Regulation for a representative sample.
p.000003: 7.3. The notified body must, in the case of devices in Class IIb: described in point
p.000003: as part of the assessment (c), all generic asset groups
p.000003: for at least one representative sample, the technical documentation shall assess the e
p.000003: compliance with this Regulation.
p.000003: 7.4. In selecting the representative sample, the notified body shall take into account the novelty of the technology,
p.000003: the similarity of the design, technological, manufacturing and sterilization procedures, the intended use,
p.000003: and previous (eg physical, chemical or biological) tests performed in accordance with this Regulation
p.000003: the results of evaluations). The notified body shall document the sampling
p.000003: and make them available to the authority.
p.000003: 7.5. Additional samples to be taken by the notified body as part of the surveillance assessment as specified in point 5
p.000003: assess.
p.000003: 8. Application to devices falling under Section 2 (1) (e)
p.000003: The production of all batches of devices falling under Section 2 (1) (e)
p.000003: upon completion, the manufacturer shall notify the notified body of the release of that batch, and
p.000003: send it the information set out in Annex 1, Part A, point 7.4 by the laboratory referred to in the third paragraph of
p.000003: issued an official certificate for the batch of human blood derivative used in the device
p.000003: the issue of.
p.000003: B. For active implantable devices
p.000003: 1. The manufacturer must be responsible for the design, manufacture and final inspection of the products concerned
p.000003: the quality system approved in accordance with points 3 and 4
p.000003: shall be subject to the review provided for in point 5.
p.000003: 2. The obligations laid down in point 1 for the EC declaration of conformity procedure
p.000003: manufacturer shall ensure that the products in question comply with the provisions of this Regulation that apply to them
p.000003: and make a statement to that effect.
p.000003: The manufacturer or his authorized representative must affix the CE marking in accordance with Article 5, and
p.000003: issue a written declaration of conformity. One or more specifics of this statement
p.000003: clearly identifying the device (s) by product name, type designation or other
p.000003: with a clear identifier and must be kept by the manufacturer.
p.000003: The CE marking must be supplemented by the identification mark of the competent notified body.
p.000003: 3. Quality system
p.000003: 3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body. The application shall:
p.000003: must include:
...

p.000003: in the case of implantable devices, for at least 15 years, make available to the authorities on request:
p.000003: (a) the declaration of conformity;
p.000003: b) a 3.1. the documentation referred to in point (d);
p.000003: c) a 3.1. the documentation referred to in point (g);
p.000003: d) and 3.4. the changes referred to in point;
p.000003: (e) the notified body must comply with points 4.3 to 4.4. its decisions and reports referred to in
p.000003: (f) where appropriate, the EC type-examination certificate referred to in Annex 3.
p.000003: 6. Application to devices in Class IIa
p.000003: In accordance with Section 13 (2), this Annex applies to Class IIa devices
p.000003: with the following exceptions:
p.000003: 6.1. Unlike Figures 2, 3.1-3.2. the manufacturer shall ensure and declare, by means of the declaration of conformity,
p.000003: that the products in Class IIa conform to the technical documentation referred to in point 3 of Annex 7
p.000003: and comply with the requirements of this Regulation that apply to them.
p.000003: 6.2. In the case of Class IIa devices, the notified body must:. described in point
p.000003: as part of the assessment, examine whether for each asset category in Annex 7, point 3
p.000003: at least one representative sample of the technical documentation specified in this Regulation complies with this Regulation.
p.000003: 6.3. In selecting the representative sample, the notified body shall take into account the novelty of the technology,
p.000003: the similarity of the design, technological, manufacturing and sterilization procedures, the intended use,
p.000003: and previous (eg physical, chemical or biological) tests performed in accordance with this Regulation
p.000003: the results of evaluations). The notified body shall document the sampling
p.000003: and make them available to the authority.
p.000003: 6.4. A 4.3. Additional samples shall be taken by the notified body as part of the surveillance assessment referred to in point
p.000003: assess.
p.000003: 7. Application to devices falling under Section 2 (1) (e)
p.000003: The production of all batches of devices falling under Section 2 (1) (e)
p.000003: upon completion, the manufacturer shall notify the notified body of the release of that batch, and
p.000003: send it the information listed in Annex 1, A.II. point
p.000003: 7.4. an official certificate issued by a laboratory in accordance with the third subparagraph of point
p.000003: on the release of a batch of a human blood derivative used in a device.
p.000003: B. For active implantable devices
p.000003: 1. The manufacturer must, for the purposes of the manufacture and final inspection of the products concerned,
p.000003: apply the quality system as specified in point 3 and undertake the quality system as specified in point 4
p.000003: review.
p.000003: 2. The EC declaration of conformity shall form part of the procedure whereby the manufacturer who satisfies the obligations of section 1.
p.000003: ensure and declare that the products concerned satisfy the obligations set out in
p.000003: Described in the EC type-examination certificate and satisfy the requirements of this Regulation that apply to them.
p.000003: The manufacturer or his authorized representative must affix the CE marking in accordance with Article 5, and
p.000003: issue a written declaration of conformity. One or more specifics of this statement
p.000003: clearly identifying the device (s) by product name, type designation or other
p.000003: with a clear identifier. The declaration must be kept by the manufacturer.
p.000003: 3. Quality system
p.000003: 3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body. The application shall:
p.000003: must include:
...

p.000003: in the case of implantable devices, for at least 15 years, make available to the authorities on request:
p.000003: (a) the declaration of conformity;
p.000003: b) a 3.1. the documentation referred to in point (g);
p.000003: c) a 3.4. the changes referred to in point;
p.000003: (d) 4.3.4.4 of the notified body. its decisions and reports referred to in
p.000003: (e) where appropriate, the EC type-examination certificate referred to in Annex 3.
p.000003: 6. Application to devices in Class IIa
p.000003: In accordance with Section 13 (2), this Annex applies to Class IIa devices
p.000003: with the following exceptions:
p.000003: 6.1. Unlike Figures 2, 3.1-3.2. the manufacturer shall ensure and declare, by means of the declaration of conformity,
p.000003: that the products in Class IIa conform to the technical documentation referred to in point 3 of Annex 7
p.000003: and comply with the requirements of this Regulation that apply to them.
p.000003: 6.2. In the case of Class IIa devices, the notified body must:. described in point
p.000003: as part of the assessment, examine whether for each asset category in Annex 7, point 3
p.000003: at least one representative sample of the technical documentation specified in this Regulation complies with this Regulation.
p.000003: 6.3. In selecting the representative sample, the notified body shall take into account the novelty of the technology,
p.000003: the similarity of the design, technological, manufacturing and sterilization procedures, the intended use,
p.000003: and this Regulation
p.000003: previous assessments (eg physical, chemical or biological) that have been properly performed
p.000003: results. The notified body shall document the sampling aspects and make them available
p.000003: for the authority.
p.000003: 6.4. A 4.3. Additional samples shall be taken by the notified body as part of the surveillance assessment referred to in point
p.000003: assess.
p.000003: Annex 7 to Regulation 4/2009 (III. 17.) EüM *
p.000003: Manufacturer 's EC declaration of conformity
p.000003: 1. The manufacturer's EC declaration of conformity is the procedure whereby the manufacturer or his authorized representative
p.000003: who fulfills the obligations referred to in point 2 and in a sterile condition or with a measuring function
p.000003: fulfills the obligations laid down in point 5 in respect of the placing on the market of
p.000003: ensure and declare that the products concerned satisfy the requirements of this Regulation that apply to them.
p.000003: 2. *
p.000003: The manufacturer must draw up the specifications listed in point 3
p.000003: documentation. The manufacturer or his authorized representative shall keep the documentation, which shall include the EC
p.000003: declaration of conformity, - upon request - made available to OGYÉI for inspection
p.000003: for at least 5 years after the last product has been manufactured and, in the case of implantable devices, the last product
p.000003: for at least 15 years from the date of manufacture. If neither the manufacturer nor his authorized representative is in Hungary
p.000003: the obligation to keep the above documentation rests with the distributor of the product.
p.000003: 3. The technical documentation must enable the conformity of the product with the requirements of this Regulation to be assessed
p.000003: It meets. The technical documentation must include:
p.000003: (a) a general description of the product, including any variants planned and its intended use
p.000003: application (s);
p.000003: b) design drawings, methods of manufacture envisaged, drawings of components, fittings and circuits;
...

p.000003: Serial number and / or serial number
p.000003: Device accessories
p.000003: Software version (if applicable)
p.000003: Manufacturer information:
p.000003: Manufacturer's name Street, house number
p.000003: Postcode City Country
p.000003: Telephone Fax
p.000003: E-mail
p.000003: Details of the manufacturer's authorized representative Other representation in Hungary
p.000003: Event Details: The date of the event
p.000003: Location of the event
p.000003: Description of the event
p.000003: Consequences (eg death, damage to health, illness BNO-10 code
p.000003: Measures taken in connection with the incident
p.000003: Operating data:
p.000003: Service construction (service contract: own service, brand service, eg Name and address of the service
p.000003: Date of last periodic review, details of medical technology
p.000003: Based on Annex 13
p.000003: Date of last logged service intervention Date of last logged overhaul
p.000003: Comment:
p.000003: This notification does not imply that the manufacturer, the authorized representative confirms or acknowledges that it is notified
p.000003: means of death or damage to the health of a person in any way, or indirectly
p.000003: I hereby declare that the above data are to the best of my knowledge
p.000003: Location: ................................................ Date: .............................................
p.000003: .................................................. .................................................. ....................
p.000003: ..........
p.000003: B) * Manufacturer's (authorized representative's) notification form
p.000003: - unforeseen events and accidents of which he becomes aware
p.000003: Report Form Manufacturer’s Incident Report
p.000003: Recipient
p.000003: Name of national competent authority (NCA)
p.000003: Address of national competent authority (NCA)
p.000003: Date of this report
p.000003: Reference number assigned by the manufacturer
p.000003: Reference number assigned by the national authority (if known) / Reference number assigned by NCA to whom sent (if
p.000003: Known)
p.000003: Type of report
p.000003: □ Initial report
p.000003: □ Follow-up report
p.000003: □ Combined initial and final report
p.000003: □ Final report
p.000003: Unexpected event classification
p.000003: Event causing death
p.000003: □ Unanticipated serious deterioration in state of
p.000003: health
p.000003: □ Serious public health threat
p.000003: □ Other reportable incidents
p.000003: Name of other national authority (ies) that received the notification / Identify to what other NCAs this
p.000003: report was also sent
p.000003: 2 Information on submitter of the report
p.000003: Type of submitter
p.000003: □ Manufacturer
p.000003: □ Authorized representative in accordance with Section 4 (1) (13) of the EüM Decree on Medical Devices /
p.000003: Authorized representative within EEA and Switzerland
p.000003: 3 Manufacturer information / Manufacturer information Manufacturer name / Manufacturer name
p.000003: Manufacturer's Contact person
p.000003: Address
p.000003: Postal code
p.000003: E - mail address / E - mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: Authorized Representative information
p.000003: Name of the authorized representative
p.000003: The authorized representative’s Contact person
p.000003: Address
p.000003: Postal code
p.000003: E - mail address / E - mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: 5 Data related to the notified medical device
p.000003: Class
p.000003: □ Active implants / AIMD Active implants
p.000003: □ III. Class III device / MDD Class III
p.000003: □ Class II.b device / MDD Class IIb
p.000003: □ Class II.a device / MDD Class IIa
p.000003: □ Class I device / MDD Class I
p.000003: Nomenclature system (preferably GMDN)
p.000003: Code / Nomenclature code
p.000003: Code text name / Nomenclature text
p.000003: Commercial name, brand name / Commercial name / brand name / make
p.000003: Model and / or catalog number
p.000003: Serial number and / or batch number (s) and / or lot / batch number (s)
p.000003: Software version number (if applicable) / Software version number (if applicable)
p.000003: Date of manufacture / expiry date (if applicable) / Manufacturinq date / expiry date (if applicable)
p.000003: Accessory / associated device (if any)
p.000003: device (if applicable)
p.000003: Notified body ID number
...

p.000003: implemented by the manufacturer
p.000003: Expected date of next report
p.000003: 10 Results of manufacturers final investigation (Final report)
p.000003: The manufacturer’s device analysis results
p.000003: Corrective action / remedial action / preventive action / on-site safety corrective action /
p.000003: Remedies action / corrective action / preventive action / Field Safety Corrective Action
p.000003: Note: to be completed from medical devices in case of on-site safety corrective action
p.000003: C: Annex C of the Decree on the submission of the FSCA
p.000003: to fill in the FSCA report form of this annex
p.000003: Time Schedule for the implementation of the identified
p.000003: action
p.000003: Manufacturer's comments on the measures / Final comments from the manufacturer
p.000003: Further investigations
p.000003: Is the manufacturer aware of events related to the device for similar reasons?
p.000003: aware of similar incidents with this type of medical device with a similar root cause?
p.000003: □ Yes
p.000003: □ No
p.000003: If yes, in which countries and the report number?
p.000003: reference numbers of the incidents
p.000003: To be completed only for final notification. The device is marketed in the following countries:
p.000003: report only. The medical device has been distributed to the following countries:
p.000003: 11 Comments
p.000003: I declare that I have provided the above information to the best of my knowledge./ I affirm that the
p.000003: The information given above is correct to the best of my knowledge.
p.000003: ..............................................
p.000003: Signature
p.000003: Name / Name
p.000003: City / City
p.000003: Date
p.000003: Submission of this notification does not in itself mean that the manufacturer and / or his authorized representative are either
p.000003: the competent national authority acknowledges that the submission of the notification is a complete solution and that:
p.000003: the notified device would have contributed in any way to the death of the person involved in the incident, or
p.000003: damage to health or would have been the direct cause of it.
p.000003: Submission of this report does not, in itself, represent a conclusion by the manufacturer and / or
p.000003: authorized representative or the national competent authority that the content of this report is complete or
p.000003: accurate, that the medical device (s) listed failed in any continent and / or that the medical device (s) caused or
p.000003: contributed to the alleged death ordeterioration in the state of health of any person.
p.000003: (C) Manufacturer's authorized representative's form for on-site corrective action
p.000003: Report Form
p.000003: Field Safety Corrective Action
p.000003: 1 Administrative information
p.000003: Name of national competent authority (NCA)
p.000003: Address of national competent authority (NCA)
p.000003: Date of this report
p.000003: Reference number assigned by the manufacturer
p.000003: For the unexpected event, accident reference number at the competent authority where the prior notification
p.000003: authority name (if known) / Incidence reference number and name of the co-ordinating national
p.000003: competent authority (if applicable)
p.000003: Name of other national authority (ies) that received the notification
p.000003: other national competent authorities this report was also sent
p.000003: 2 Information on submitter of the report
p.000003: Type of submitter
p.000003: □ Manufacturer
p.000003: □ Authorized representative within EEA
p.000003: □ Others (identify the role):
p.000003: 3 Manufacturer information
p.000003: Manufacturer name
p.000003: Name of contact person at the manufacturer
p.000003: Address
p.000003: Postal code
p.000003: E - mail address / E - mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: 4 Authorized representative information
p.000003: Name of the authorized representative
p.000003: The authorized representative’s contact person
p.000003: Address
p.000003: Postal code
p.000003: E - mail address / E - mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: 5 National contact point information
p.000003: National contact point name
p.000003: Name of the contact person
p.000003: Postal code
p.000003: E - mail address / E - mail
p.000003: City / City
p.000003: Fax / Fax Country / Country
p.000003: 6 Medical device information
p.000003: Class
p.000003: □ Active implantable medical device / AIMD Active implants
p.000003: □ III. Class III device / MDD Class III
p.000003: □ Class II.b device / MDD Class IIb
p.000003: □ Class II.a device / MDD Class IIa
p.000003: □ Class I device / MDD Class I
p.000003: Nomenclature system (preferable GMDN) Code / Nomenclature code
p.000003: Text name of the code / Nomenclature text Commercial, brand name / Commercial name / brand name / make Model- and
p.000003: catalog number / Model and / or catalog number
p.000003: Serial number and / or lot or batch number (s) and / or lot / batch number (s)
p.000003: Software version number (if applicable) / Software version number (if applicable)
p.000003: Manufacturing date / expiry date (if known)
p.000003: applicable)
p.000003: Accessories / associated device (if any)
p.000003: (if applicable)
p.000003: Notified body ID number
p.000003: 7 Description of the on - site safety corrective action (FSCA)
p.000003: Reason and background information of on - site security corrective actions
p.000003: for the FSCA
p.000003: Description and justification of the procedure (corrective / preventive)
p.000003: action (corrective / preventive)
p.000003: Propose the necessary measures to the distributor and the user
p.000003: to be taken by the distributor and the user
p.000003: Attachments please find
p.000003: □ Field Safety Notice (FSN) in English
p.000003: □ FSN in national language
p.000003: □ Others (please specify):
p.000003: Time schedule for the implementation of the different
p.000003: actions
p.000003: States concerned by on - site security corrective actions (Member States, EEA States)
p.000003: within the EEA are affected by this FSCA
p.000003: These countries outside the EEA and Switzerland are affected by this FSCA
p.000003: 8 Comments
p.000003: I declare that I have provided the above information to the best of my knowledge./ I affirm that the
p.000003: The information given above is correct to the best of my knowledge.
p.000003: .................................................. ..............
p.000003: Signature
p.000003: Name / Name City / City Date / Date
p.000003: Submission of this notification does not in itself mean that the manufacturer and / or his authorized representative are either
p.000003: the competent national authority acknowledges that the submission of the notification is a complete solution or that
p.000003: the notified device would have contributed in any way to the death of the person involved in the incident,
p.000003: or would have been the direct cause of the damage.
p.000003: Submission of this report does not, in itself, represent a conclusion by the manufacturer and / or
p.000003: authorized representative or the national competent authority that the content of this report is
p.000003: complete or accurate that the medical device (s) listed failed in any continent and / or that the medical
p.000003: device (s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
p.000003: Annex 13 to Regulation 4/2009 (III. 17.) EüM *
p.000003: Periodic review
p.000003: I. Scope of products subject to periodic review, frequency of review
p.000003: 1. Defibrillator 1
p.000003: annually
p.000003: 2. High Frequency Surgical Cutter 1
p.000003: annually
p.000003: 3. Incubator 1
p.000003: annually
p.000003: 4. Anesthetic breathing apparatus 1
p.000003: annually
p.000003: 5. Operating light 1
p.000003: annually
p.000003: 6. Dialysis equipment 1
p.000003: annually
p.000003: 7. Invasive and interventional X-rays. equipment 1
p.000003: annually
p.000003: 8. Operating table 2
p.000003: annually
p.000003: 9. Tonometer 2
p.000003: annually
p.000003: 10. X-ray examination and recording workplace 2
p.000003: annually
p.000003: 11. Surgical image intensifier 2
p.000003: annually
p.000003: 12. Surgical and surveillance monitor, ECG 2
p.000003: annually
p.000003: 13. Laser 2
p.000003: annually
p.000003: 14. Invasive Blood Pressure Monitor and Blood Flow Meter 2
p.000003: annually
p.000003: 15. Machine infusion device 3
p.000003: annually
p.000003: 16. Blood warming device 3
p.000003: annually
p.000003: 17. Sterilization equipment 3
p.000003: annually
p.000003: 18. Mains-operated electrotherapy device (stimulator, high-frequency device, etc.)
p.000003: 3
p.000003: annually
p.000003: 19. Medical gas supply equipment and complete system 3
p.000003: annually
p.000003: 20. Imaging Ultrasound Diagnostic Device 3
p.000003: annually
p.000003: II. Other specifications
p.000003: 1. *
p.000003: The result of the test must be recorded. The documentation of the institution
...

p.000003: Headquarter: _ _ _
p.000003: _
p.000003: .................................................. .................................................. ....................
p.000003: ..........
p.000003: Site address: _ _ _ _ ........................................... .............
p.000003: County:
p.000003: .................................................. .
p.000003: Phone: .................................... Fax:
p.000003: ................................... E-mail:
p.000003: .................................................. ..
p.000003: Contact person
p.000003: name:
p.000003: .................................................. .................................................. ............
p.000003: Contact address: _ _ _
p.000003: _
p.000003: .................................................. .................................................. ..................
p.000003: Phone: ..................................... Fax:
p.000003: ................................... E-mail:
p.000003: .................................................. .
p.000003: Data on the marketed medical device (disinfectant)
p.000003: Name of Product
p.000003: Name of the biocidal active substance (s)
p.000003: Stripping
p.000003: Active substance content
p.000003: Current year:
p.000003: Notes:
p.000003: Company signature, company stamp, date:
p.000003: Annex 15 to Regulation 4/2009 (III. 17.) EüM *
p.000003: Annex 16 to Regulation 4/2009 (III. 17.) EüM *
p.000003: 4/2009 on medical devices. (III. 17.) EüM Decree, manufacturer and equipment declaration
p.000003: Form
p.000003: 1. Details of the Office
p.000003: Competent Authority code HU / CA / 01
p.000003: Competent Authority name
p.000003: Medical Registration and Training Center Medical Technology Department
p.000003: Country code HU
p.000003: Postal code 1051
p.000003: Street, number Zrínyi.
p.000003: e-mail amd@eekh.hu
p.000003: City / City Budapest
p.000003: Mailbox / P.O.B. 1380 P.O.Box 1188
p.000003: Fax / Fax number
p.000003: +36 1 269 1255
p.000003: 2. Identification of the registration
p.000003: Date of registration
p.000003: Registration number
p.000003: Reason of the registration
p.000003: □ first
p.000003: first registration
p.000003: □ tool for performance evaluation
p.000003: Change of address and / or name of the manufacturer or his authorized representative
p.000003: address and / or name of the manufacturer or the authorized representative
p.000003: □ distribution
p.000003: discontinuation by manufacturer
p.000003: □ withdrawal of the product from the market
p.000003: Competent Authority
p.000003: In case of change, suspension or revocation number of the previous notification
p.000003: discontinuation or withdrawal, provide number of the previous registration
p.000003: Status of the organization making this registration application
p.000003: □ Manufacturer / Authorized Representative /
p.000003: Authorized representative
p.000003: 3. Identification of the manufacturer Full name of the manufacturer
p.000003: The manufacturer
p.000003: short name
p.000003: The manufacturer
p.000003: tax number
p.000003: The manufacturer
p.000003: Headquarters
p.000003: Country / Country
p.000003: Postal code
p.000003: Street, house number / Street, number
p.000003: Contact details
p.000003: Name / Name
p.000003: Fax / Fax number
p.000003: City / City
p.000003: Mailbox / P.O.B.
p.000003: Telephone number
p.000003: e-mail
p.000003: 4. Identification of the authorized representative
p.000003: Full name of the authorized representative
p.000003: Short name of the authorized representative
p.000003: Authorized representative 's registered office. Registered office of the authorized representative
p.000003: Postal code City / City Street, house number / Street, number Mailbox / P.O.B. THE
p.000003: contact details
p.000003: Name Telephone name
p.000003: Fax / Fax number e-mail
p.000003: 5. Identification of the device concerned Code and name of the device category
p.000003: code Name
p.000003: □ 01 Active implantable devices
p.000003: □ 02 Anesthetic and respiratory equipment
p.000003: Anesthetic and respiratory devices
p.000003: □ 03 Dental devices
p.000003: □ 04 Electromechanical devices Electro-medical
p.000003: mechanical devices
p.000003: □ 05 Hospital equipment and devices qualifying as medical devices
p.000003: □ 06 In vitro diagnostic medical devices
p.000003: □ 07 Inactive implantable devices
p.000003: Hospital hardware
p.000003: In vitro diagnostic medical devices
...


Orphaned Trigger Words



p.000003: Basic provisions
p.000003: § 5 (1) *
p.000003: Device, other than custom-made, intended for clinical trials -
p.000003: may be placed on the market or put into service if it complies with the requirements of paragraph 2
p.000003: is marked.
p.000003: A device may bear the CE marking if:
p.000003: a) meets the essential requirements pursuant to Section 11, and
p.000003: (b) the requirements of point (a) have been verified in accordance with Section 13 of the EC
p.000003: conformity assessment procedure.
p.000003: (3) *
p.000003: The manufacturer or his authorized representative has already placed it on the market
p.000003: at the time of production, have proof of compliance with paragraph 2 (a) and (b), e
p.000003: documents with the content specified in this Regulation.
p.000003: (4) *
p.000003: By placing the device on the market or putting it into service
p.000003: compliance with the provisions relating to the placing on the market or putting into service
p.000003: You can check the fulfillment of the requirements for the device during the market surveillance procedure of OGYÉI.
p.000003: § 6 *
p.000003: § 7 (1) *
p.000003: A device intended for clinical investigation in order to perform the investigation then
p.000003: may be made available to an authorized person with the appropriate professional qualifications if he complies with the
p.000003: The conditions set out in Section 11 (1).
p.000003: (2) A custom-made device may be placed on the market and put into service if it is in accordance with Section 13 (5)
p.000003: An EC conformity assessment procedure has been carried out and the device complies with Annex 8
p.000003: regulations. A II.a,
p.000003: II.b and III. In the case of devices in Class I, the statement provided for in Annex 8 shall be attached
p.000003: should be made available to the patient identified by name, acronym or numerical code.
p.000003: § 8 If the risk incurred justifies it, it is also a device that qualifies as a machine according to special legislation
p.000003: in addition to the provisions of this regulation, it must comply with the essential requirements of the specific legislation on machinery
p.000003: health and safety requirements.
p.000003: § 9 If the device is subject to personal protective equipment requirements and compliance
p.000003: 18/2008 on the certification of (XII. 3.) SZMM decree, it is considered a personal protective equipment, then
p.000003: it must also comply with the essential health and safety requirements contained therein.
p.000003: § 10 In addition to the provisions of this decree, the devices shall apply to the health of the population the ionizer
p.000003: laying down basic safety standards for protection against the dangers arising from radiation,
p.000003: and the dangers of ionizing radiation associated with medical exposure
p.000003: specific legislation on the protection of human health against
p.000003: Requirements for devices and examination of their conformity
p.000003: § 11. (1) All devices placed on the market or put into use must comply with their purpose
p.000003: essential requirements for that device in accordance with Annex 1.
p.000003: 2. A device which satisfies the requirements of the national harmonized standard shall be presumed to conform
p.000003: the part of the essential requirements set out in this Regulation for which it is
p.000003: standard applies. The list of localized harmonized standards is issued by the Hungarian Standards Body
p.000003: published in its Official Journal.
p.000003: (3) For the purposes of this Regulation, a reference to national harmonized standards
p.000003: in particular medicinal products and substances used in devices containing such medicinal products ...

p.000003: (l) for active devices not covered by point (e), the year of manufacture, including the batch or serial number
p.000003: It may comprise;
p.000003: (m) where appropriate, the method of sterilization;
p.000003: n) in the case of assets falling under Section 2 (1) (e), an indication that the
p.000003: device contains a human blood derivative.
p.000003: 13.4. If the intended purpose of the device is not obvious to the user, to the manufacturer
p.000003: you must clearly indicate this on the label and in the instructions for use.
p.000003: 13.5. Where appropriate and feasible, assets should be identified and detachable
p.000003: components, in series if necessary, so that all necessary measures can be taken
p.000003: to identify any potential hazards posed by the devices and detachable parts
p.000003: order.
p.000003: 13.6. The instructions for use must contain the following information, as the case may be
p.000003: logically:
p.000003: (a) with the exception of points (d) and (e), 13.3. described in point;
p.000003: (b) the performance referred to in point 3 and any undesirable side effects;
p.000003: (c) if the device is used with other medical devices or equipment in order to ensure its intended use
p.000003: should be linked, the data needed to form a secure combination a
p.000003: to select appropriate tools or equipment;
p.000003: (d) all information necessary to verify that the device is correctly installed,
p.000003: is in a safe and ready condition. It must also be specified for accurate and safe operation of the device
p.000003: information on the nature and frequency of maintenance and calibration required;
p.000003: (e) where applicable, information to avoid certain risks associated with the implantation of the device;
p.000003: (f) reciprocity in connection with the device during special treatments or tests
p.000003: information on the risk of interference;
p.000003: (g) information on any damage to the sterile packaging, if necessary
p.000003: data on the method of re-sterilization;
p.000003: (h) in the case of a reusable device, information on the procedures for re-use,
p.000003: including cleaning, disinfection, packaging and, where appropriate, re - sterilization; and
p.000003: data limiting the number of re-uses. Devices to be sterilized before use
p.000003: the cleaning and sterilization instructions must be such that, when used properly, the device
p.000003: meet the requirements of Chapter I. If there is an indication on the device that the device is once
p.000003: used, information on the known characteristics and technical factors known to the manufacturer,
p.000003: which may pose a risk if the device is reused. If
p.000003: 13.1. no instructions for use are required, the information shall be made available to the user on request
p.000003: made;
p.000003: (i) if necessary, additional steps to be taken before the device is put into service (eg sterilization,
p.000003: final assembly, etc.);
p.000003: (j) in the case of devices emitting radiation for medical purposes, the nature, type, intensity and
p.000003: distribution.
p.000003: The instructions for use must also contain the information on the basis of which it is
p.000003: Contraindications and necessary precautions can be briefly informed by medical staff a
p.000003: patients. This information must include:
p.000003: (k) precautions to be taken in the event of a change in the performance of the device;
p.000003: (l) effects under reasonably foreseeable environmental conditions, such as magnetic fields, external
p.000003: electrical effects, electrostatic discharges, pressure and pressure changes, acceleration, self-ignition ...

p.000003: it must not be reported to the implanter or any other person.
p.000003: 2. The device must be as intended by the manufacturer
p.000003: performance, that is to say, it must be designed and manufactured in such a way as to be suitable for the
p.000003: § (1).
p.000003: 3. The characteristics and performances of the device referred to in points 1 and 2, as specified by the manufacturer
p.000003: during life and under normal conditions of use - do not change
p.000003: adversely affect the health status of patients and, where appropriate, other persons
p.000003: and endanger your safety.
p.000003: 4. The device must be designed, manufactured and packaged in such a way that its characteristics and
p.000003: storage and transport conditions (temperature,
p.000003: moisture content, etc.).
p.000003: 5. Possible undesirable side effects, in comparison with the intended performance, are acceptable
p.000003: risk.
p.000003: 5a. Demonstration of compliance with the essential requirements shall be in accordance with Annex 10
p.000003: clinical evaluation.
p.000003: II. Design and construction requirements
p.000003: 6. The design and manufacturing solutions applied by the manufacturer must comply with the safety principles,
p.000003: taking into account generally accepted technical standards.
p.000003: 7. An implantable device shall be designed, constructed and packaged in non-reusable packaging that:
p.000003: to be sterile at the time of placing on the market and to be stored and transported as specified by the manufacturer
p.000003: conditions remain sterile until the package is opened before implantation of the device.
p.000003: 8. The device shall be so designed and constructed that it can be removed as far as possible, and a
p.000003: minimize it
p.000003: (a) the risk of injury due to its physical characteristics, including dimensional characteristics;
p.000003: (b) the risks associated with the use of energy sources, in particular electricity
p.000003: in the case of energy use - insulation, fault currents and overheating of the device;
p.000003: (c) with reasonably foreseeable environmental effects (eg magnetic fields, external electricity
p.000003: influences, electrostatic discharge, pressure, temperature, or pressure and
p.000003: acceleration changes);
p.000003: (d) medical interventions, especially defibrillators or high-frequency
p.000003: risks associated with the use of surgical instruments;
p.000003: (e) basic safety requirements for protection against the dangers arising from ionizing radiation
p.000003: ionizing radiation related to medical exposure
p.000003: safety requirements in specific legislation on the protection of human health against
p.000003: ionizing radiation from radioactive materials in the device
p.000003: emerging risks;
p.000003: (f) the risks that may arise if maintenance and calibration are impossible,
p.000003: including
p.000003: fa) excessive increase of fault currents,
p.000003: (fb) the aging of the materials used,
p.000003: fc) excessive heating of the device,
p.000003: (fd) a decrease in the accuracy of any measuring or control mechanism.
p.000003: 9. Devices must be designed and manufactured in such a way as to guarantee compliance with the 'I. general
p.000003: requirements and performance referred to in the section "requirements", in particular:
p.000003: (a) the choice of substances used, in particular as regards toxicity;
p.000003: (b) interactions between the materials used and biological tissues, cells and body fluids
p.000003: compatibility with regard to the intended use of the device;
p.000003: (c) the compatibility of the devices with the materials to be administered;
p.000003: (d) quality of contacts, in particular safety;
p.000003: (e) reliability of the energy source;
p.000003: (f) where applicable, adequate tightness;
p.000003: (g) programming, control and monitoring systems, including software;
p.000003: proper functioning.
p.000003: In the case of a device that contains software or a device that is medical software in its own right, the software is a
p.000003: be validated by methods appropriate to the state of the art, taking into account developments
p.000003: principles of lifetime, risk management, validation and control.
p.000003: 10. * ...

p.000003: (b) the name of the asset;
p.000003: (c) the purpose for which the device is to be used;
p.000003: (d) characteristics relevant to use;
p.000003: (e) in the case of a device intended for clinical investigations, the words “clinical trials only
p.000003: for the purpose of
p.000003: (f) in the case of a custom-made device, the words "custom-made device";
p.000003: (g) an indication that the implantable device is in a sterile state;
p.000003: (h) year and month of manufacture;
p.000003: (i) the expiry date of the safe implantation of the device;
p.000003: (j) conditions for transport and storage of the device;
p.000003: k) in the case of devices pursuant to Section 2 (1) (d) - (e), an indication that the device is human
p.000003: contains a blood product.
p.000003: 15. When placed on the market, all devices must be accompanied by instructions for use which:
p.000003: contains the following information:
p.000003: (a) the year in which the right to affix the CE marking arose;
p.000003: b) a 14.1. and 14.2. with the exception of those referred to in points (h) to (i);
p.000003: (c) details of the services referred to in point 2, as well as any undesirable side effects;
p.000003: (d) information enabling the doctor to use the appropriate equipment and software or accessories
p.000003: selection;
p.000003: (e) information enabling the doctor and, where appropriate, the patient to use the device,
p.000003: the intended use of its accessories and software, and contains information on
p.000003: the scope and timing of the performance review and inspections, given
p.000003: and, where appropriate, for maintenance activities;
p.000003: (f) information enabling, where appropriate, the implantation of the device
p.000003: avoiding certain risks;
p.000003: (g) information on the presence of the device during certain special examinations or treatments
p.000003: the risk of interactions that occur. Interaction should be understood as adverse effects
p.000003: applied to the device by the instrument used during the test or treatment, or vice versa;
p.000003: (h) instructions in the event of damage to the sterile packaging and, where appropriate, re-sterilization
p.000003: a description of the appropriate manner;
p.000003: (i) where applicable, a warning that the device may be re - used only if:
p.000003: under the responsible management of the manufacturer, has been refurbished to meet the essential requirements again.
p.000003: The instructions for use must also contain the particulars necessary to enable the
p.000003: doctor to inform the patient about contraindications and what to do
p.000003: precautions. This information must cover in particular:
p.000003: (j) information enabling the life of the energy source to be determined;
p.000003: (k) the precautions to be taken in the event of a performance of the device
p.000003: change occurs;
p.000003: (l) precautions to be taken under reasonably foreseeable environmental conditions
p.000003: magnetic fields, external electrical influences, electrostatic discharge, pressure or
p.000003: in the case of exposure to pressure changes, acceleration;
p.000003: (m) adequate information on the medicinal products to be administered by the device in question
p.000003: responsibility;
p.000003: (n) the date of issue or the latest revision of the instructions for use.
p.000003: A 13-15. The end user of the device must be in Hungarian
p.000003: available to them.
p.000003: 16. Confirmation that the device, under the intended conditions of use, a
p.000003: in terms of characteristics and performance. General Requirements ”
p.000003: requirements and an assessment of side effects or adverse reactions is provided in Annex 10
p.000003: should be based on clinical data determined in accordance with ...

p.000003: assess.
p.000003: Annex 7 to Regulation 4/2009 (III. 17.) EüM *
p.000003: Manufacturer 's EC declaration of conformity
p.000003: 1. The manufacturer's EC declaration of conformity is the procedure whereby the manufacturer or his authorized representative
p.000003: who fulfills the obligations referred to in point 2 and in a sterile condition or with a measuring function
p.000003: fulfills the obligations laid down in point 5 in respect of the placing on the market of
p.000003: ensure and declare that the products concerned satisfy the requirements of this Regulation that apply to them.
p.000003: 2. *
p.000003: The manufacturer must draw up the specifications listed in point 3
p.000003: documentation. The manufacturer or his authorized representative shall keep the documentation, which shall include the EC
p.000003: declaration of conformity, - upon request - made available to OGYÉI for inspection
p.000003: for at least 5 years after the last product has been manufactured and, in the case of implantable devices, the last product
p.000003: for at least 15 years from the date of manufacture. If neither the manufacturer nor his authorized representative is in Hungary
p.000003: the obligation to keep the above documentation rests with the distributor of the product.
p.000003: 3. The technical documentation must enable the conformity of the product with the requirements of this Regulation to be assessed
p.000003: It meets. The technical documentation must include:
p.000003: (a) a general description of the product, including any variants planned and its intended use
p.000003: application (s);
p.000003: b) design drawings, methods of manufacture envisaged, drawings of components, fittings and circuits;
p.000003: (c) descriptions necessary for an understanding of the said drawings and diagrams and the operation of the product
p.000003: and explanations;
p.000003: (d) the results of the risk analysis and the fully or partially applied nationalized harmonized
p.000003: a list of standards and a description of the solutions adopted to meet the essential requirements
p.000003: nationalized harmonized standards are not fully adopted
p.000003: prevail;
p.000003: (e) in the case of products placed on the market in a sterile state, a description of the methods used; and
p.000003: validation report;
p.000003: (f) results of design calculations made and examinations carried out;
p.000003: (g) the solutions adopted pursuant to Annex 1, Part A, point 2;
p.000003: (h) pre-clinical evaluation;
p.000003: (i) the clinical evaluation in accordance with Annex 10;
p.000003: (j) the label and instructions for use.
p.000003: 4. *
p.000003: The manufacturer must undertake to establish and maintain a systematic procedure
p.000003: up to date to review the device after manufacture and in accordance with the requirements of annex 10
p.000003: experience gained and shall make the necessary adjustments to make the necessary adjustments,
p.000003: taking into account the nature of the instrument and the risks involved in its use. This undertaking must also oblige the manufacturer to:
p.000003: to immediately report the events detailed therein to OGYÉI in accordance with the provisions of Section 21.
p.000003: 5. Class I devices placed on the market in a sterile state or with a measuring function
p.000003: the manufacturer need not only comply with the requirements set out in this Annex
p.000003: but also one of the procedures referred to in Annexes 2, 4, 5 or 6. These a
p.000003: The application of Annexes I and II and the involvement of the notified body shall be limited to:
p.000003: (a) in the case of products placed on the market in a sterile state, only to ensure a sterile state; and
p.000003: production processes to maintain ...

p.000003: belongs to.
p.000003: Any device that contains a human blood derivative as an integral part is listed in Annex III. belongs to class.
p.000003: 4.2. Rule 14
p.000003: Any device used for contraception or the prevention of the sexual transmission of diseases shall be
p.000003: unless it is an implantable or long-term invasive device; in such cases a
p.000003: III. belongs to class.
p.000003: 4.3. Rule 15
p.000003: Specially for disinfecting, cleaning, rinsing and, if necessary, moistening contact lenses
p.000003: intended for use are in Class II.b.
p.000003: Devices specifically intended for the disinfection of devices are in Class II.a. Except
p.000003: if used for specifically invasive device disinfection, in which case Class IIb
p.000003: belongs to.
p.000003: This rule does not apply to products other than contact lenses
p.000003: intended for the physical cleaning of equipment.
p.000003: 4.4. Rule 16
p.000003: Devices specifically intended for the recording of X-ray diagnostic images are in Class II.a.
p.000003: 4.5. Rule 17
p.000003: Any device manufactured utilizing non-viable animal tissues or derivatives shall be as set out in Annex III. classes
p.000003: unless such device is intended to come into contact with intact skin only.
p.000003: 5. Rule 18
p.000003: As an exception to the other rules, blood bags are in Class II.b.
p.000003: Annex 10 to Regulation 4/2009 (III. 17.) EüM *
p.000003: Clinical evaluation
p.000003: A. For class assets
p.000003: 1. General requirements
p.000003: 1.1. When the device is used as intended, in accordance with Annex 1, Part A, points 1 and 3
p.000003: demonstration of compliance with performance and performance requirements, adverse reactions and
p.000003: Evaluation of the acceptability of the benefit / risk balance according to Annex 1, Part A, point 6 on clinical data
p.000003: should be based on. The evaluation of these data (hereinafter referred to as “clinical evaluation”) - where
p.000003: taking into account all relevant harmonized standards - defined and methodologically sound procedures
p.000003: based on:
p.000003: 1.1.1. the safety, performance, design characteristics and intended purpose of the device,
p.000003: a critical evaluation of the currently available scientific literature, where
p.000003: (a) the equivalence of the asset with the asset to which the data relate,
p.000003: provable, and
p.000003: (b) the data adequately demonstrate compliance with the essential requirements;
p.000003: 1.1.2. or a critical evaluation of the results of all clinical trials performed;
p.000003: 1.1.3. or 1.1.1. and 1.1.2. critical evaluation of the combined data according to
p.000003: 1.2. Implantable or III. In the case of a device in this class, clinical investigations must be performed unless
p.000003: if existing clinical data can be relied upon with due justification.
p.000003: 1.3. The clinical evaluation and its outcome should be documented. This documentation is for the tool
p.000003: shall be included in the technical documentation and / or be fully referenced in the technical documentation.
p.000003: 1.4. The clinical evaluation and its documentation shall be kept up - to - date on the device
p.000003: post-marketing data. If the manufacturer considers that there is no need for placing on the market
p.000003: post-marketing clinical follow-up as part of the market surveillance plan
p.000003: and should be documented.
p.000003: 1.5. *
p.000003: If OGYÉI deems it essential
p.000003: Demonstration of compliance with the requirements based on clinical data is not appropriate, the sanction
p.000003: duly substantiated, in particular
p.000003: the outcome of risk management and the specifics of the asset-body interaction, a
p.000003: intended clinical performance and the manufacturer's claim. If the
p.000003: Demonstration of compliance with the essential requirements is based solely on the performance evaluation of the product range
p.000003: examination and evaluation prior to medical use, it shall be duly substantiated.
p.000003: B. For active implantable devices
p.000003: 1. General requirements
p.000003: 1.1. During the intended use of the device, in accordance with Annex 1, Part B, points 1 and 2
p.000003: demonstration of compliance with performance and performance requirements, adverse reactions and
p.000003: The assessment of the acceptability of the benefit / risk balance according to Annex 1, Part B, point 5 shall be based on clinical data
p.000003: based. Evaluation of these data (hereinafter referred to as clinical evaluation) - where applicable, into account
p.000003: taking into account all relevant harmonized standards, a defined and methodologically sound procedure
p.000003: based on:
p.000003: 1.1.1. the safety, performance, design characteristics and intended purpose of the device,
p.000003: a critical evaluation of the currently available scientific literature, where
p.000003: (a) the equivalence of the asset with the asset to which the data relate,
p.000003: provable, and
p.000003: (b) the data adequately demonstrate compliance with the essential requirements;
p.000003: 1.1.2. or a critical evaluation of the results of all clinical trials performed;
p.000003: 1.1.3. or 1.1.1. and 1.1.2. critical evaluation of the combined data according to
p.000003: 1.2. Clinical investigations must be performed unless duly substantiated
p.000003: can rely on existing clinical data.
p.000003: 1.3. The clinical evaluation and its outcome should be documented. This documentation is for the tool
p.000003: shall be included in the technical documentation and / or be fully referenced in the technical documentation.
p.000003: 1.4. The clinical evaluation and its documentation shall be kept up - to - date on the device
p.000003: post-marketing data. If the manufacturer considers that there is no need for placing on the market
p.000003: post-marketing clinical follow-up as part of the market surveillance plan
p.000003: and should be documented.
p.000003: 1.5. *
p.000003: If OGYÉI deems it essential
p.000003: Demonstration of compliance with the requirements based on clinical data is not appropriate, the sanction
p.000003: duly substantiated, in particular as regards the outcome of the risk management, and
p.000003: the characteristics of the device-body interaction, the intended clinical performance, and a
p.000003: taking into account the manufacturer's claim. Where proof of compliance with the essential requirements is provided only
p.000003: based on performance evaluation, batch testing and pre-medical evaluation
p.000003: occurs, it must be duly substantiated.
p.000003: 1.6. *
p.000003: During the clinical evaluation, the data are provided by OGYÉI in accordance with the data protection regulations
p.000003: treated in accordance with
p.000003: Annex 11 to Regulation 4/2009 (III. 17.) EüM
p.000003: "CE" conformity marking
p.000003: The CE marking shall consist of the initials "CE" taking the following form:
p.000003: The above proportions must also be observed when using a reduced or enlarged signal.
p.000003: The two letters of the CE marking must have the same vertical dimension and may not be less than 5 mm.
p.000003: In the case of small devices, the minimum size requirement may be waived.
p.000003: Annex 12 to Regulation 4/2009 (III. 17.) EüM
p.000003: Medical device incidents and manufacturer's on-site safety corrective actions
p.000003: notification form
p.000003: A) * The healthcare provider, distributor, user
p.000003: notification form for an unforeseen event or accident involving a medical device
p.000003: Applicant details:
p.000003: Name of notifier:
p.000003: □ Distributor □ Distributor
p.000003: □ Importer □ User
p.000003: Street, house number or mailbox
p.000003: Postal code City Contact name
p.000003: Telephone Fax
p.000003: E-mail
p.000003: Name and contact details of the person responsible for the accident
p.000003: Device information:
p.000003: Trade name of the asset The risk class of the asset
p.000003: Device type or catalog number ...

Appendix

Indicator List

IndicatorVulnerability
accessAccess to Social Goods
ageAge
authorityRelationship to Authority
breastfeedingbreastfeeding
childrenChild
disabilityMentally Disabled
disabledMentally Disabled
drugDrug Usage
educationeducation
familyMotherhood/Family
gendergender
hazardNatural Hazards
illnessPhysically Disabled
impairmentCognitive Impairment
influenceDrug Usage
languageLinguistic Proficiency
officerPolice Officer
opinionphilosophical differences/differences of opinion
partypolitical affiliation
pregnantPregnant
propertyProperty Ownership
restrictedIncarcerated
singleMarital Status
substanceDrug Usage
terminalTerminally Ill
threatThreat of Stigma
unionTrade Union Membership
vulnerabilityvulnerable

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers
disability['disabled']
disabled['disability']
drug['influence', 'substance']
influence['drug', 'substance']
substance['drug', 'influence']

Trigger Words

ethics

harm

protection

risk


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalpolitical affiliationparty3
Politicalvulnerablevulnerability1
HealthCognitive Impairmentimpairment1
HealthDrug Usagedrug1
HealthDrug Usageinfluence2
HealthDrug Usagesubstance37
HealthMentally Disableddisabled4
HealthMentally Disableddisability1
HealthMotherhood/Familyfamily1
HealthPhysically Disabledillness2
HealthPregnantpregnant1
HealthTerminally Illterminal1
Healthbreastfeedingbreastfeeding1
SocialAccess to Social Goodsaccess1
SocialAgeage2
SocialChildchildren1
SocialIncarceratedrestricted2
SocialLinguistic Proficiencylanguage3
SocialMarital Statussingle13
SocialPolice Officerofficer5
SocialProperty Ownershipproperty1
SocialThreat of Stigmathreat1
SocialTrade Union Membershipunion6
Socialeducationeducation1
Socialgendergender2
Socialphilosophical differences/differences of opinionopinion33
General/OtherNatural Hazardshazard1
General/OtherRelationship to Authorityauthority30