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
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
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Political / vulnerable
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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
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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
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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;
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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
...
Health / Mentally Disabled
Searching for indicator disabled:
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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
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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
Searching for indicator illness:
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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
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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:
(return to top)
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:
(return to top)
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
...
Social / Marital Status
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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:
(return to top)
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
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| children | Child |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| family | Motherhood/Family |
| gender | gender |
| hazard | Natural Hazards |
| illness | Physically Disabled |
| impairment | Cognitive Impairment |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| pregnant | Pregnant |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| terminal | Terminally Ill |
| threat | Threat of Stigma |
| union | Trade Union Membership |
| vulnerability | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| 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