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4/2009. (III. 17.) EüM on medical devices
CLIV of 1997 on health. on the basis of the authorization contained in Section 247 (2) (k) of Act no
161/2006 on the duties and powers of the Minister of Health (VII. 28.) Government Decree § 1 a)
Acting in the scope of duties specified in point 1, I order the following:
Scope of the Regulation
§ 1 (1) *
✖
The scope of this Regulation shall be as set out in paragraph 2
Medical devices manufactured, distributed and used in Hungary
devices and accessories.
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2. This Regulation shall not apply to:
(a) in vitro diagnostic devices;
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b) human blood, blood products, plasma or blood cells of human origin, or in accordance with Section 2 (1)
(e) a device containing human blood products, plasma or blood cells at the time of placing on the market;
c) *
except for the assets included in Section 2 (2) (d)
devices containing human tissue or cells, transplants of human origin,
tissues or cells or preparations thereof;
d) for devices containing tissues or cells of animal origin, with the exception of Section 2 (1) (b),
transplants, tissues or cells of animal origin;
e) *
with the exception of § 2 (2) c) and d) for human use
and other amendments to the laws governing the pharmaceutical market
XCV of 2005 (hereinafter: Gytv.) for a product that qualifies as a medicinal product, including the
medicinal products derived from human blood derivatives, where this is justified by the main mode of action of the product;
f) *
for devices in which the device and the drug are single
forms a single product intended exclusively for use in that combination and which
cannot be reused. For this single unit product, Gytv. shall apply. On this
products are subject to the essential requirements set out in Annex 1 in so far as they are concerned
the safety and performance characteristics of the device;
(g) a cosmetic product covered by specific legislation.
(3) This Regulation concerns the authorization of advanced therapy medicinal products and Regulation (EC) No 2001/83
European Parliament and of the Council of 13 November 2007 amending Directive 726/2004 / EC and Regulation (EC) No 726/2004
shall apply subject to a Regulation of the European Parliament and of the Council.
Interpretative provisions
§ 2 *
1. For the purposes of this Regulation, a medical device (hereinafter referred to as
CLIV of 1997 on health. § (hereinafter: Eütv.) § 3
(h) an instrument as defined in points (ha) to (d).
(2) To be considered as a medical device
(a) a device manufactured utilizing a tissue or cell of inanimate animal origin;
(b) a device for administering the medicinal product;
(c) a device of which an integral part is a substance which, when used alone, is a medicinal product,
which, in addition to the device, acts on the human body;
(d) a device of which an integral part is derived from human blood or human plasma alone
when used, a substance that is a medicinal component or a medicinal product that acts in addition to the device
the human body (hereinafter referred to as "human blood derivative"),
if its purpose complies with the provisions of the Eütv. § 3 h) point ha) -hd)
as set out in
(3) *
(4) In the case of devices referred to in clauses (2) c) -d), in addition to this Decree, the Gytv. provisions of this Regulation
apply to medicinal products.
(5) *
As to whether a given product qualifies as an asset, in case of doubt, the
The National Institute of Pharmacy and Food Health (hereinafter: OGYÉI) decides.
Section 3 (1) Annex 1 sets out the basic general and design and construction
requirements with which all devices placed on the market or put into service must comply.
2. Annex 2 sets out the requirements for classified and active implantable devices, a
the full quality assurance system that the manufacturer has chosen as the EC conformity assessment procedure
rules of procedure.
3. Annex 3 sets out the requirements for classified and active implantable devices, a
the rules for the EC type-examination procedure to be chosen by the manufacturer as the EC conformity assessment procedure.
(4) Annex 4 sets out the requirements for classified and active implantable devices, a
the rules for the EC product verification procedure to be chosen by the manufacturer as the EC conformity assessment procedure.
(5) Annex 5 sets out the requirements for classified and active implantable devices, a
the production quality assurance procedure that the manufacturer has chosen as the EC conformity assessment procedure
rules.
(6) Annex 6 sets out the EC conformity assessment of devices by the manufacturer
the rules for the product quality assurance procedure to be chosen as the procedure.
(7) Annex 7 sets out the EC declaration of conformity issued by the manufacturer
rules.
(8) *
Annex 8 specifies the manufacturer's custom-made
by issuing a declaration for devices or active implantable devices
rules.
(9) Annex 9 sets out the rules for classification.
(10) Annex 10 sets out the rules for clinical evaluation.
(11) Annex 11 sets out the mandatory format for the CE marking.
(12) Annex 12 contains the equipment incidents and the manufacturer's site
safety corrective action notification forms.
(13) Annex 13 sets out the rules for the periodic review.
! (14) *
Annex 14 contains Class IIa specifically
the National Public Health Center for the placing on the market in Hungary of devices intended for the disinfection of devices
necessary to notify it
sheet.
(15) *
The Eütv. 101 / C. § from the register in its entirety or only
the range of implants removed for certain data is defined in Annex 17.
Section 4 (1) For the purposes of this Decree
1. *
accessory: a product not covered by Section 2 (1) which
it is not a medical device in itself, but is intended to be used in conjunction with the device as expressly intended by the manufacturer
is intended for use in order to facilitate its original function (a
hereinafter the device shall be understood to mean the accessory);
2. Custom-made device: medical treatment by a suitably qualified doctor
ordered according to the needs of the patient for the exclusive, individual use, special design
device made with features. A custom - made device (eg a.
dental filling material, orthetic device) which is adapted to a specific requirement;
3. device intended for clinical investigation: any device which is approved by an appropriately qualified
made available to an authorized person for the purposes specified in the separate legislation
conduct a clinical trial to achieve this;
4. active device: any device whose operation - by the human body or by gravity
other than directly generated energy, depends on other external energy sources;
5. active implant: any active implantable device that has undergone surgical or other medical intervention
is partially or completely introduced into the human body or into a natural orifice thereof, and
it remains in place after the intervention;
6. Hip, knee and shoulder prosthesis: components of a complete joint implantable prosthesis, not including
including auxiliary components such as bolts, wedges, plates and tools, which
similar to a natural hip, knee, or shoulder joint;
Sub-category 7: a group of devices that share a common area of ​​use or technology;
8. generic device group: a group of devices that have the same or similar uses
their area or technology shows a similarity that allows for unique characteristics that do not reflect general characteristics
their classifications;
Device group 9: products of a generic device group from a manufacturer;
10. "specific instrument" means an instrument of a specified type number that has not been subject to conformity assessment
which could not be placed on the market but in a specified number in accordance with
may be used in accordance with this Regulation;
11. "single-use device" means a device intended by the manufacturer for a single patient and for single use;
12. *
manufacturer: the natural or legal person
(a) which devices are designed, manufactured, packaged and labeled under their own responsibility before being used on their own
marketing or conducting a clinical trial under his name, whether or not they are
operations are carried out by himself or on his behalf,
(b) which assembles, packs, processes, refurbishes a device for placing on the market under its own name,
label and mark them for the purpose of use, unless they are assembling devices already on the market,
or adaptive to a particular patient during their treatment according to their intended use
according to your individual needs;
13. *
authorized representative: resident in an EEA Member State, or
a natural or legal person established by the manufacturer
authorizes it to act on its behalf in relation to obligations under this Regulation; or
to whom the authorities and bodies may turn instead of the manufacturer;
14. *
distributor: the natural or legal person who places on the market
the device is provided free of charge until it is handed over to the end user after use
made available to it, in particular by the importer, distributor or reseller;
15. purpose of use: the use of the device by the manufacturer on the label in the instructions for use
or the purpose stated in the advertisement;
16. Intended use: by the manufacturer of the device in order to achieve the intended use
use in accordance with the specified indication and in the manner and under the conditions specified by the manufacturer;
17. EEA State: a Member State of the European Union and a party to the Agreement on the European Economic Area
another State and a State of which the European Community and its Member States are nationals, and
An international agreement concluded between a State not party to the Agreement on the European Economic Area
the same status as a national of a State party to the Agreement on the European Economic Area
enjoy;
18. *
placing on the market: custom-made, intended for clinical trials
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
In the European Economic Area (hereinafter referred to as the EEA) or with the European Community or the EEA
in a State having the same status as an EEA Member State in respect of assets under the Treaty (hereinafter
together: EEA Member State) for distribution or use, regardless of whether the device is new or
renovated;
19. putting into service: in the EEA Member State, the device can be used as intended as a product
making it available to the end user for the first time;
20. notified body: under the specific legislation, by assessing the conformity of the device and
designated to carry out certification tasks and the European Commission (hereinafter
Commission), as well as the body notified to the EEA Member States and other conformity
notified to the Commission for evaluation tasks
an organization with a specific identification number;
21. *
22. localized harmonized standard: adopted by the European standardization organizations and the European Union
Harmonized European standard published in the Official Journal of the European Union and published in accordance with Hungarian procedures
published as a national standard;
23. clinical data: derived from the use of a device, its
safety and performance information;
24. *
unexpected event, accident: occurred in connection with the asset
an event in which any malfunction, characteristics, or performance of the device occurs
malfunction or deterioration of the label and any deficiencies in the label or instructions for use, or
insufficiency for the death or serious deterioration of the health of the patient, the operator of the device or another person
led or could have led;
25. on-site safety corrective action (FSCA): on a device in circulation or in use
the action taken by the manufacturer to reduce the risk of an unexpected event;
26. *
responsible for the accident: the medical director of the health care provider or his
in the absence of an appropriate professional manager, who shall report the incident, accident,
performs tasks related to the investigation;
27. *
severe deterioration in health:
a) life-threatening illness,
b) permanent impairment of physiological function or health,
(c) a condition requiring medical or surgical intervention in accordance with (a);
and (b),
(d) diagnostic or in vitro diagnostic instructions used in accordance with the manufacturer 's instructions
damage caused by an erroneous result of a device test,
(e) fetal harm, fetal death or congenital or birth-related
disorder;
28. *
serious risk to public health: any unforeseen event or
an accident resulting in the death or serious health of several people
may lead to deterioration.
(2) *
In addition to the provisions of paragraph 1, for the purposes of this Decree, the Eütv. Third
Shall be taken into account.
Basic provisions
§ 5 (1) *
Device, other than custom-made, intended for clinical trials -
may be placed on the market or put into service if it complies with the requirements of paragraph 2
is marked.
A device may bear the CE marking if:
a) meets the essential requirements pursuant to Section 11, and
(b) the requirements of point (a) have been verified in accordance with Section 13 of the EC
conformity assessment procedure.
(3) *
The manufacturer or his authorized representative has already placed it on the market
at the time of production, have proof of compliance with paragraph 2 (a) and (b), e
documents with the content specified in this Regulation.
(4) *
By placing the device on the market or putting it into service
compliance with the provisions relating to the placing on the market or putting into service
You can check the fulfillment of the requirements for the device during the market surveillance procedure of OGYÉI.
§ 6 *
§ 7 (1) *
A device intended for clinical investigation in order to perform the investigation then
may be made available to an authorized person with the appropriate professional qualifications if he complies with the
The conditions set out in Section 11 (1).
(2) A custom-made device may be placed on the market and put into service if it is in accordance with Section 13 (5)
An EC conformity assessment procedure has been carried out and the device complies with Annex 8
regulations. A II.a,
II.b and III. In the case of devices in Class I, the statement provided for in Annex 8 shall be attached
should be made available to the patient identified by name, acronym or numerical code.
§ 8 If the risk incurred justifies it, it is also a device that qualifies as a machine according to special legislation
in addition to the provisions of this regulation, it must comply with the essential requirements of the specific legislation on machinery
health and safety requirements.
§ 9 If the device is subject to personal protective equipment requirements and compliance
18/2008 on the certification of (XII. 3.) SZMM decree, it is considered a personal protective equipment, then
it must also comply with the essential health and safety requirements contained therein.
§ 10 In addition to the provisions of this decree, the devices shall apply to the health of the population the ionizer
laying down basic safety standards for protection against the dangers arising from radiation,
and the dangers of ionizing radiation associated with medical exposure
specific legislation on the protection of human health against
Requirements for devices and examination of their conformity
§ 11. (1) All devices placed on the market or put into use must comply with their purpose
essential requirements for that device in accordance with Annex 1.
2. A device which satisfies the requirements of the national harmonized standard shall be presumed to conform
the part of the essential requirements set out in this Regulation for which it is
standard applies. The list of localized harmonized standards is issued by the Hungarian Standards Body
published in its Official Journal.
(3) For the purposes of this Regulation, a reference to national harmonized standards
in particular medicinal products and substances used in devices containing such medicinal products
European Pharmacopoeia articles on the interaction between Member States, as published in the Official Journal of the European Union
They were published.
Classification
Section 12 (1) The EC conformity assessment procedure for the selection of the device by the manufacturer - in Annex 9
I., II.a, II.b or III. class.
(2) The classification procedure shall not be performed for active implants and accessories. In those Article 13
The EC conformity assessment procedure referred to in paragraph 7 shall be carried out.
(3) *
In the case of a question arising from the application of the classification rules,
in case of doubt - decides in the OGYÉI decision.
(4) Breast implants and hip, knee and shoulder prostheses are included in Annex III. shall be classified in class
provided that the rules in Annex 9 do not apply.
(5) *
OGYÉI may address a request to the Commission if:
(a) the classification of a particular asset or category of assets in Annex 9
the application of the classification rules requires a Commission decision;
(b) by way of derogation from the provisions of Annex 9, a particular device or series of devices
should be listed;
c) *
a decision must be made as to whether a particular product or group of products
complies with Section 2 (1) and Section 4 (1) 1-4. definitions set out in point
one of; obsession
(d) the classification rules in Annex 9 need to be amended.
(6) *
In the case of application of paragraph 5, OGYÉI shall be taken by the Commission
act in accordance with this measure.
EC conformity assessment procedures
§ 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
manufacturers draw up an EC declaration of conformity.
2. In the case of a device in Class IIa, the manufacturer, if not in accordance with paragraph 3 (a)
the manufacturer’s EC declaration of conformity in accordance with Annex 7
must follow a procedure, linked
(a) a product inspection in accordance with Annex 4, or
(b) the production quality assurance referred to in Annex 5, or
(c) the product quality assurance procedure in accordance with Annex 6.
3. In the case of a device in Class IIb, the manufacturer may choose as the EC conformity assessment procedure:
(a) the full quality assurance system procedure in accordance with Annex 2, in such a way that:
that the test in accordance with paragraph 4 thereof is not applicable, or
(b) the type-examination procedure according to Annex 3, combined
(ba) a product inspection in accordance with Annex 4, or
(bb) production quality assurance in accordance with Annex 5, or
(bc) the product quality assurance procedure in accordance with Annex 6.
(4) A III. For devices classified in Class I, the manufacturer may choose as the EC conformity assessment procedure:
(a) the full quality assurance system procedure in accordance with Annex 2, or
(b) the type-examination procedure according to Annex 3, combined
(ba) a product inspection in accordance with Annex 4, or
(bb) the production quality assurance procedure in accordance with Annex 5.
(5) For custom-made devices and devices intended for clinical investigations,
and, in the case specified in Section 15, the EC conformity assessment procedures pursuant to paragraphs 1 to 4
they cannot be continued.
(6) *
(7) In the case of an active implant, custom-made devices and devices intended for clinical investigation
the manufacturer may choose as the EC conformity assessment procedure:
(a) the full quality assurance system procedure in accordance with Annex 2, or
(b) the type-examination procedure according to Annex 3, combined
(ba) a product inspection in accordance with Annex 4, or
(bb) production quality assurance in accordance with Annex 5
process.
(8) *
In the case of a custom-made device, the manufacturer shall act in accordance with Annex 8. The
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.
(e) and draw up a declaration in accordance with Annex 8, point A or B, point 3.1.
the documentation specified in The documentation must be kept for 5 years and it
shall be made available upon request to OGYÉI. These devices are not CE marked
may be indicated.
(9) During the EC conformity assessment procedure, the manufacturer or the notified body
take into account all the examinations and evaluations that will be carried out at an intermediate stage of manufacture e
carried out in accordance with this Regulation.
10. The procedures set out in Annexes 3, 4, 7 and 8 may also be initiated by the authorized representative of the manufacturer
behalf.
(11) *
If, according to OGYÉI, the manufacturer for a particular device or series of devices
did not select and proceed with the appropriate procedure, OGYÉI - the appropriate procedure
may request the Commission.
(12) *
In the case referred to in paragraph 11, after the decision of the Commission, the OGYÉI
act in accordance with the decision.
Designated organization and procedures
Section 14 (1) The notified body may, in justified cases, require any information or data which:
for the chosen procedure of conformity assessment, verification, certification and certification
necessary to maintain its validity. The documents required for the procedure pursuant to Section 13 (1) - (8)
in Hungarian or in an official language of another EEA Member State accepted by the notified body
shall be made available to the notified body.
(2) Annexes 2, 3, 5 and 6 may be actively implanted by the notified body
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.
Before the expiration of the certificate - on the date specified in the agreement between the parties
in the absence of a request submitted at least 3 months before the expiry date - a further maximum of 5 years
periods, the certificate may be extended.
3. The manufacturer or his authorized representative and the notified body must
The conditions for carrying out the evaluations and tests in accordance with Annex 6 in the contract
record.
(4) Where the notified body is involved in the EC conformity assessment procedure
necessary and several organizations have been designated to carry out the procedure, one of which is the manufacturer or
acting by an authorized representative.
5. Where a notified body finds that the manufacturer does not meet the requirements of this Regulation
requirements or the EC certificate of conformity could not have been issued,
the notified body shall, taking into account all the circumstances of the case, suspend or limit the
certificate of conformity issued by it.
(6) If, at the request of the notified body, the certificate is suspended or restricted,
within the appropriate time limit therein - the manufacturer has not taken the appropriate measures
ensure compliance with this Regulation and the issue of the EC certificate of conformity
necessary conditions, the notified body shall withdraw the certificate.
(7) *
The designated organization shall be notified by OGYÉI within 15 days of its decision
inform OGYÉI on a regular form of all issued, amended, supplemented,
suspended, revoked or refused certificate and shall inform the other notified bodies of all
suspended, revoked or refused certificate and, upon request,
issued
certificates. OGYÉI shall notify the Commission, the EEA, on the basis of the information of the notified body
States. The notified body shall make available to OGYÉI, at its request, everything related to its activities
other related information.
(8) *
If OGYÉI 's market surveillance procedure involves market surveillance
6/2013 on the detailed rules of activity (I. 18.) Government Decree 6 / A. § (1) or 6 / C. §
(1), the designated organization which conducted the decision pursuant to Section 13
review the procedure pursuant to § 13 in the light of the provisions of the decision.
Separate procedure for kits and multi-instrument systems and sterilization procedure
§ 15. (1) Unlike the procedures pursuant to § 13, the sets of devices and the systems consisting of several devices shall be
Paragraphs 2 to 6 shall apply.
(2) *
Any natural or legal person that is placing on the market
devices bearing the CE marking for their intended purpose and specified by their manufacturer
used as part of a set of uses, compiles it into a kit or set of tools, issues a statement,
certifying that
(a) checked the compatibility of the devices in accordance with the manufacturer 's instructions; and
the fitting was done accordingly;
(b) the packaging of the self - packaged kit or system and the accompanying instructions for use comply with
the manufacturer's relevant instructions;
(c) the activity was carried out under internal control and supervision.
(3) *
Any natural or legal person that is placing on the market
for the purposes of paragraph 2, a multi-device system or other CE
sterilizes labeled devices designed by their manufacturers to be sterilized before use
them, you can follow the
One of the procedures provided for in Annex 2 or 5. Application of those Annexes and
intervention by designated organizations until the sterile package is opened or damaged to ensure sterility
limited to procedural aspects. The person concerned shall make a declaration stating that:
sterilization was performed according to the manufacturer's instructions.
4. The device referred to in paragraphs 2 to 3 need not bear a new CE marking, but must be accompanied by the
The information provided for in Annex 1 (A) (13), including, where applicable, the
assembly instructions from the manufacturers of the devices included in the assembly.
(5) *
The declarations referred to in paragraphs 2 to 3 shall be kept for 5 years, and
they must be made available to OGYÉI upon request.
(6) If the kit or system contains a device that does not bear the CE marking or is not original
the kit or system should be a stand-alone device
shall be considered and inspected in accordance with its classification and certified in accordance with § 13.
Clinical evaluation *
§ 16 *
1. The clinical evaluation in accordance with Annex 10 shall be based on clinical data.
(2) Sources of clinical data:
(a) the clinical investigation (s) of the device,
(b) a similar device in the scientific literature that can be demonstrated to be equivalent to that device
reported clinical trials or other studies on this device, or
(c) other information about that asset or a similar asset that can be shown to be equivalent to that asset
published or unpublished reports of clinical experience.
(3) The authorization of a clinical trial and the manner in which it is carried out shall be carried out in human medical research,
clinical trials of investigational medicinal products for human use; and
medical devices for clinical trials for human use
Government Decree on the Rules of the Authorization Procedure for the Examination of
contained in the Ministerial Decree on the Clinical Trials of Medical Devices.
Registration
§ 17. (1) *
A manufacturer established in Hungary which:
Following the procedure pursuant to Section 13 (1) and (8), it manufactures devices under its own law, which is Hungary
a person established in the territory of the Republic of Lithuania who carries out an activity pursuant to Section 15 (2) - (3),
name, registered office and place of business, a description of the assets concerned at the latest first
and any change in this information
without delay, for registration in accordance with Annex 16
notify OGYÉI on the form or in its electronic version.
(2) *
If it is not established in the EEA, in paragraph 1
the registered office of the manufacturer's authorized representative who markets such devices under his own name
is not in another EEA state but in the territory of Hungary, its name, registered office and the assets concerned
description at the latest at the time of first placing on the market and any changes to that information
on the form set out in Annex 16 for registration
or notifies OGYÉI via its electronic version.
(3) *
The manufacturer or his authorized representative referred to in paragraphs 1 to 2
At the request of OGYÉI, OGYÉI informs the partner authorities and the
Commission.
Who.
(4) *
OGYÉI shall issue a certificate of registration pursuant to paragraphs (1) - (2)
(5) The name, address or registered place of business of the manufacturer or of his authorized representative
on the packaging or collective packaging and on the instructions for use - Annex 1, paragraph 13.1. in accordance with
- need to indicate.
(6) *
All II.a, II.b and III. classified device and can be actively implanted
When using the device in Hungary, OGYÉI may request information from
information on the distributor and the identity of the device, as well as the label and instructions for use
This Guide.
Registration fee
§ 18. For the registration procedure of the initiator of the proceedings pursuant to § 17 -
regardless of its outcome - for each group of assets as defined in a separate legal act
you have to pay a service fee.
Provisions related to data management
§ 19. (1) *
(2) *
If required by this Decree, OGYÉI with the following information
you can provide information about: *
the)   *
relating to the register of manufacturers and authorized representatives
informations,
b) *
by the manufacturer or his authorized representative or by carrying out the procedure
by an authorized person in accordance with 21 / A. § (4) in the case specified by OGYÉI
informations,
(c) certificates accepted, modified, supplemented, suspended or withdrawn
information found,
(d) details of contacts with the Commission, EU partner authorities and designated organizations
and information.
Conformity marking
§ 20. (1) The CE conformity marking determined in accordance with Annex 11 on the device may only be made by the manufacturer or
may be placed by its authorized representative. The manufacturer or his authorized representative must affix the mark
it must be visibly, legibly and indelibly marked on the device and its commercial
packaging and instructions for use.
2. By way of derogation from paragraph 1, in the case of devices placed on the market in a sterile state, the CE marking shall be affixed:
should only be placed on sterile packaging and commercial packaging.
3. Any marking which is likely to deceive or confuse the CE marking shall be prohibited
marking or limits its visibility and legibility. Any other markings may be placed on
on the device, on the packaging or in the instructions accompanying the device, provided that this does not reduce the CE marking
visibility and legibility of the marking.
(4) *
While retaining the original purpose of use, the device is as follows
in the event of a change which affects the safe use of the device, the CE marking shall only be in accordance with § 13
may be indicated after the procedures have been repeated.
The notified body carrying out the EC conformity assessment shall decide whether the modification of the instrument will affect the
safe use of the device. In the event of a dispute, OGYÉI will decide on this issue.
5. In addition to the CE marking, if the conformity assessment procedure 2, 4,
Any of the procedures set out in Annex 5 or 6 - the notified body carrying out the procedure must be indicated
identification mark.
(6) It does not comply with the requirements of this Regulation at a trade fair, exhibition or demonstration
a product may be displayed if this is indicated by a clearly visible sign indicating it
that the required conformity assessment has not been carried out.
(7) Where the device is subject to requirements other than those laid down in this Regulation
provides for the use of the CE marking on the basis of different aspects, separate legislation is different
In the absence of a provision, the CE conformity marking shall also indicate that the device conforms to the
other relevant requirements.
Reporting of unexpected events and accidents after the placing on the market
§ 21. *
(1) *
The manufacturer or his authorized representative and the
distributor and the health care provider through the accident officer
after the entry into force of Annexes I, II.a, II.b and III. unexpected occurrence in connection with a class I asset
event, accident, if the unexpected event or accident
(a) involves a serious risk to public health, immediately but not later than 2 days,
(b) resulted in death or serious deterioration of health, immediately but no later than 10 days after detection,
c) *
not covered by points (a) or (b), without delay, but not later than
must notify OGYÉI within 30 days of detection.
(1a) *
The user in connection with the medical device
you can report an unexpected event or accident to OGYÉI.
(2) The notification
(a) by the distributor and the healthcare provider on the form set out in Part A of Annex 12,
(b) by the manufacturer or his authorized representative on the form set out in Annex 12, Part B,
(c) by the user on the form set out in Part A of Annex 12.
(3) *
The notification pursuant to paragraphs (1) - (1a) shall be notified to OGYÉI, if not the
the manufacturer or his authorized representative has lodged the notification - the manufacturer or his authorized representative
shall inform its representative immediately, but no later than 8 days after becoming aware of it.
(4) *
The manufacturer or his authorized representative must be informed
event within 60 days and the results of the investigation to OGYÉI in the final report
to report.
(5) *
Where the manufacturer or his authorized representative
on the basis of the investigation pursuant to paragraph 1, it considers it justified to prevent the unexpected event, on-site security
take corrective action. It shall notify OGYÉI of the ordering of the measure in accordance with Annex 12 C).
on the bilingual form set out in
(6) *
The manufacturer must verify the on-site safety corrective action
and to inform OGYÉI thereof.
21 / A. § *
(1) *
OGYÉI is sent by notifiers pursuant to Section 21 (2)
records and confirms notifications.
(2) *
If the manufacturer becomes aware of the event in accordance with Annex 12, Part B, paragraph 10.
does not or will not fully investigate the investigation by the expected date announced in accordance with
and at the same time, if it finds, on the basis of the
that the device does not comply with the requirements of this Regulation
suspension or restriction of the marketing or use of
(3) *
The manufacturer or his authorized representative shall notify OGYÉI,
if the manufacturer has recalled the device completely from the market due to an unexpected event or accident. The device is complete
should be treated as an on-site security corrective action.
(4) *
OGYÉI - if possible with the manufacturer or his authorized representative
in cooperation with its representative - investigates the unexpected event, accident, and after the investigation is completed
notify the Commission and the partner authorities without delay in accordance with Article 22
and to reduce the risk of the cases specified in Section 21 (1)
measures taken or planned.
(5) *
If the unexpected event or corrective action a
certification, the manufacturer shall inform the authorized person of the reports sent to OGYÉI
representative, the dealer authorized to distribute the device and the notified body.
(6) The preliminary incident report shall not be construed as acknowledging by the notifier that the device is
was the cause of an unexpected event, an accident.
(7) The manufacturer or his authorized representative shall be obliged to cover events related to the device
record and make changes necessary for the safe use of the device.
21 / B. § *
The name of the head of the health care provider responsible for the accident,
position, contact details, name of the health care provider, occurred in the data
changes must be notified to OGYÉI in writing or electronically within 30 days.
22-23 / A. § *
Specific public health measures
§ 24. (1) *
If OGYÉI in connection with a product or a group of products
finds that the protection of health and safety or compliance with public health regulations
such products should be withdrawn from the market or placed on the market and used
be prohibited, restricted or subject to special requirements necessary and appropriate
take a reasonable transitional measure within its competence.
(2) *
OGYÉI on the measure taken pursuant to paragraph (1) - its
shall inform the partner authorities and the Commission.
§ 25 *
If not with the other device in circulation, the individual device is not
substitutable for public health purposes, at the medically justified request, by the Ethics Committee
after receiving its opinion on the effectiveness and substitutability of
for a maximum period of 1 year for use by a specific healthcare provider,
or, in the case of an implant, OGYÉI may exceptionally authorize it for use on a specific person
the occasional putting into service and use of a specific device, provided that the device is safe
which has not been subject to the procedures under Section 13 (1) - (8).
Cooperation with EU partner authorities and the Commission
§ 26 (1) *
OGYÉI for assets in the member states of the European Union
Member States shall cooperate in order to maintain the uniform application of harmonized legislation
competent authorities (partner authorities) and the Commission.
2. The essential purpose of the exchange of information and data in the course of cooperation shall be to ensure the security of assets.
(3) *
In its decisions, OGYÉI takes into account the information provided by the Commission
data, information and resolution provided.
(4) *
OGYÉI public data provided by the Commission,
publishes information, resolutions and recommendations on its website in Hungarian.
(5) *
OGYÉI in the provision of information and data to the recommendations
follow an appropriate procedure.
European Databank *
26 / A. § *
OGYÉI by the designated organization pursuant to Section 14 (7)
data sent in accordance with Section 17, Paragraphs (1) - (2), 21 / A. §
It shall transmit the notifications referred to in paragraph 4 and the results of the investigations to the European Databank.
Periodic review
§ 27. (1) The health care provider using the devices according to Annex 13 shall be regular
shall be subject to periodic review in order to obtain adequate information
available during use
deterioration, possible changes in the specifications given in the documentation of the device,
and the existence of proper and safe performance.
(2) The frequency of the review and other requirements related to the review are set out in Annex 13
Define.
(3) *
The review is a body authorized by OGYÉI to do so by OGYÉI
based on a defined and published set of requirements.
Inspection of healthcare providers
§ 28. (1) *
To issue a health care provider's operating license
competent public health function of the capital and county government office district
(Capital District) Office, or the National Chief Medical Officer (hereinafter together referred to as the Health Officer)
administrative body) the operating authorization procedure as well as the health
During the regular inspection of the service provider, the available documents and protocols
by checking that the user meets each device's intended and
requirements for its safe performance and whether it exists
accident officer designated.
(2) *
If the public health administration determines that the
the healthcare provider using the device complies with his obligations under this Regulation,
in particular its obligation under Section 27 - has not been complied with, the user has a reasonable period of time
calls for the documentation of the device to be replaced accordingly,
to restore its performance. If the user does not fulfill the obligation contained in the call
meet the state health administration body - the general exercise of health services
96/2003 on the conditions of operation and the operating license procedure. (VII. 15.) Gov. Decree
as provided for in
suspending the provision of healthcare intended for or in connection with the use of a given device,
or initiates the decommissioning of the given device at OGYÉI.
(3) *
If during the inspection there is a reasonable suspicion that the device is not
meets the requirements of § 11 or has not or has not been properly carried out in accordance with § 13
the EC conformity assessment procedure for the device in question
public administration body shall notify it at the same time as ordering the suspension of the use of the given device
OGYÉI and the National Health Insurance Fund Manager.
(4) *
The state health administration body shall comply with paragraphs 2 to 3
decisions under the General Administrative Procedure Act
there is a remedy.
! (5) *
Manufacturer, distributor or authorized representative
for the disinfection of devices in Class IIa specifically placed on the market during the previous calendar year
by the first day of March of the year in question.
shall inform the national chief medical officer by sending a form in accordance with Annex.
Entry into force, transitional provisions
Section 29 (1) This Decree shall enter into force on 21 March 2010.
(2) The provisions of Section 12 (6) and Section 13 (12) after the entry into force of this Decree
shall apply to proceedings initiated.
(3) - (6) *
(7) *
(8) *
§ 30. *
§ 31 *
This Regulation
(a) the approximation of the laws of the Member States relating to active implantable medical devices
Council Directive 90/385 / EEC of 20 June 1990 on the
(b) Directives 87/404 / EEC (simple pressure vessels), 88/378 / EEC (safety of toys), 89/106 / EEC
(construction products), 89/336 / EEC (electromagnetic compatibility), 89/392 / EEC (machinery), 89/686 / EEC
(personal protective equipment), 90/384 / EEC (non-automatic weighing instruments), 90/385 / EEC (active
implantable medical devices), 90/396 / EEC (gas appliances), 91/263 / EEC (telecommunications equipment),
terminal equipment), 92/42 / EEC (new hot-water boilers fired with liquid or gaseous fuels) and
73/23 / EEC (electrical equipment designed for use within certain voltage limits)
Council Directive 93/68 / EEC of 22 July 1993 amending Directive
(c) Directive 93/42 / EEC of the European Parliament and of the Council of 14 June 1993 concerning medical devices
Directive
(d) Directive 98/79 / EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices;
Council Directive
(e) Council Directive 93/42 / EEC concerning medical devices incorporating stable preparations of human blood or plasma
2000/70 / EC of the European Parliament and of the Council of 16 November 2000 amending
Directive
(f) amending Council Directive 93/42 / EEC concerning medical devices
Directive 2001/104 / EC of the European Parliament and of the Council of 7 December 2001
(g) Directive 93/42 / EEC concerning medical devices and the reclassification of hip, knee and shoulder prostheses
Commission Directive 2005/50 / EC of 11 August 2005 within the framework of Council Directive
(h) Council Directive 93/42 / EEC concerning medical devices and the placing on the market of biocidal products
2007/47 / EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 98/8 / EC
Directive of the European Parliament and of the Council
for compliance.
(2) This Regulation
(a) the authorization of advanced therapy medicinal products and Directive 2001/83 / EC and
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 1 November 2007 amending Regulation (EC) No 726/2004
Regulation and
(b) Commission Decision 2010/227 / EU of 19 April 2010 on the European Databank for Medical Devices (EUDAMED)
Decision
c) *
as regards Council Directive 90/385 / EEC, animal tissues
for active implantable medical devices manufactured using
As regards Council Directive 93/42 / EEC, medical devices manufactured utilizing tissues of animal origin
on specific requirements for equipment
Commission Regulation (EU) No 722/2012 of 8 August 2012
lays down the provisions necessary for its implementation.
Annex 1 to Regulation 4/2009 (III. 17.) EüM
Essential requirements
A. For class assets
I. General requirements
1. The device must be designed and manufactured in such a way as to be specified by the manufacturer
when used as intended, do not endanger the health of patients
the safety or security of users and, where appropriate, other persons, and
provided that all risks associated with its intended use
acceptable in relation to the benefits to the patient and compatible
with a high level of health and safety requirements. This includes:
(a) minimizing the risk of operational error that is
arises from the ergonomic features of the device and the environment in which the device is intended to be used
(patient safety design), and
(b) the technical knowledge, experience, education and training of the target users and appropriate
taking into account, where appropriate, his medical and physical condition (lay, professional, disabled or disabled)
design that takes other users into account).
2. The design and manufacturing solutions applied by the manufacturer must comply with the safety principles,
taking into account generally accepted technical standards. The most suitable solutions
the manufacturer must apply the following principles in the order in which they are listed:
(a) elimination or reduction of risk (safe design and construction per se);
(b) the application of adequate protection measures in respect of unavoidable risks,
including an alarm if necessary;
(c) informing users of any deficiencies in the security measures adopted is maintained
risk.
3. The device must have the performance intended by the manufacturer and be designed and manufactured
and packaged to suit one or more of the specifications referred to in Section 2 (1) specified by the manufacturer
function.
4. Device characteristics and performance referred to in points 1, 2 and 3 - specified by the manufacturer
during life and under normal conditions of use - do not change
adversely affect the health status of patients and, where appropriate, other persons
and endanger your safety.
5. The device must be designed, manufactured and packaged in such a way that it is suitable for its intended purpose
provided during use of the characteristics and performance of transport and storage conditions do not
taking into account the instructions and information provided by the manufacturer.
6. Any undesirable side effect must present an acceptable level of risk as claimed by the manufacturer
compared to performance.
6a. Demonstration of compliance with the essential requirements shall be in accordance with Annex 10
clinical evaluation.
II. Design and construction requirements
7. Chemical, physical and biological properties
7.1. The device must be designed and constructed in such a way as to ensure compliance with the general requirements.
features and services in accordance with Particular attention should be paid
(a) the choice of materials used, in particular toxicity, and where necessary flammability
point of view;
(b) the compatibility of the materials used with biological tissues, cells and body fluids, taking into account
taking into account the purpose for which the device is used;
(c) the results of biophysical or modeling research which has previously been validated
proved if it can be interpreted for the device.
7.2. The device must be designed, manufactured and packaged in such a way that harmful substances and
their residues present the lowest possible risk during transport, storage and disposal of the asset
persons involved in its use, as well as patients, taking into account the purpose for which the device is used. Strange
attention should be paid to the human tissues involved and to the duration and frequency of use.
7.3. The device must be designed and manufactured in such a way that it can be used safely with
substances, media and gases with which it is used during normal use or during routine procedures
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:
to be compatible with the medicinal product in question, subject to the provisions relating to the medicinal product, and
restrictions as well as its performance according to the intended use.
7.4. *
If an integral part of the device is a substance that is on its own
used - Gytv. as a medicinal product and suitable for the device
have an additional effect on the human body compared to its effect, the quality and safety of the substance
and its usefulness in Regulation 52/2005 on the placing on the market of medicinal products for human use. (XI. 18.)
It must be certified on the basis of the methods specified in Annex 1 of the EüM Decree.
For the substances referred to in the first paragraph, the notified body shall be satisfied that:
the usefulness of the substance as part of the device, taking into account the purpose of the device,
seek a scientific opinion from one of the competent authorities designated by the Member States or
primarily from the European Medicines Agency (EMA) under Regulation (EC) No 726/2004
quality and safety - including the clinical benefit / risk of incorporation of the substance into the device
proportion. When issuing its opinion
the competent authority or the EMA has the manufacturing process and the substance has been placed in the device
data established by the notified body on the usefulness of its incorporation.
If the device also includes human blood products as an integral part, the designated body after
convinced of the usefulness of the substance as part of the tool and considering the tool
scientific opinion from the EMA on the quality and safety of the substance, including human
clinical benefit / risk of incorporation of a blood product into a device. When commenting on the
EMA for the manufacturing process and the incorporation of the substance into the device by the notified body
take into account the data established.
When it is done in an additional material that is part of the device - especially related to the manufacturing process
change, the notified body must be informed and the competent authority must be consulted (ie the first
consultation) with the pharmaceutical authority to confirm that the supplement
material quality is unchanged and remains safe. The competent authority shall take this into account
the usefulness of incorporating the substance into the device by the notified body
specified data to ensure that the changes are not adversely affected
the benefit / risk balance of adding the substance to the device.
If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
information that the additive has been incorporated into the device
may influence the benefit / risk balance associated with its incorporation, inform the notified body
that this information is existing in connection with the incorporation of the additional substance into the device
benefit / risk ratio. The notified body shall take the updated scientific opinion into account
and review its assessment in the conformity assessment procedure accordingly.
7.5. Devices must be designed and manufactured in such a way as to minimize them from the device
risk due to leaking materials. Particular attention must be paid in the European Union
3/2006 on the list of classified dangerous substances (I. 26.) EüM Decree No. 1
carcinogenic, mutagenic or teratogenic substances in accordance with Annex
Where parts of a device (or the device itself) intended for medicinal products,
the introduction and / or removal of body fluids or other substances from the body, or
if they are intended for the transport of such body fluids or substances in accordance with Regulation 3/2006.
(I. 26.) EüM Decree No. 1 or 2 carcinogen, mutagen or
contain phthalates classified as teratogenic, on the device itself and / or on each unit
The label on the sales package and, where appropriate, on the sales packaging shall indicate that:
the device contains phthalates.
Where such devices are intended for children or pregnant or breastfeeding mothers
the manufacturer’s technical documentation and instructions for use
explicitly justify the use of these substances, in particular this paragraph
compliance with its essential requirements and provide information to these user groups
the residual risks and, if necessary, the appropriate precautions.
7.6. The device must be designed and manufactured in such a way that the materials which may enter the device from the environment
the risk posed by the device and its environment should be kept to a minimum.
8. Infection and microbial contamination
8.1. The device and its manufacturing process should be designed to be as small as possible
reduce the risk of infection for patients, users and third parties. The design
allow easy handling of the device and minimize use during use where necessary
reduce device contamination by patients or the patient device.
8.2. Tissues of animal origin are derived from animals that have previously been the tissues
have been subjected to veterinary inspection and supervision approved in accordance with their intended use. The selected
the organization must keep records of the geographical origin of the animals. Of animal origin
the processing, preservation, testing and handling of tissues, cells and materials shall be carried out in such a way that:
be optimally secure. Particular care should be taken to ensure that viruses are tested by validated procedures
with viruses and other infectious pathogens during production
protection against.
8.3. A device shipped in a sterile condition must be designed, manufactured and not reused
may be packaged using appropriate packaging or using an appropriate procedure to ensure sterility a
sterile packaging under the conditions of storage and transport specified by the manufacturer at the time of placing on the market
until damaged or opened.
8.4. A device shipped in a sterile state must be manufactured and sterilized by an appropriate, validated method.
8.5. The device to be sterilized must be kept in a properly controlled environment, etc. circumstances
produce.
8.6. The packaging system used to package the non-sterile device should provide the required
purity and, if the device needs to be sterilized before use, by microbes
reduce the risk of contamination to a minimum and the packaging must be suitable for the manufacturer's instructions
sterilization method.
8.7. The packaging or label of the device should allow it to be available in sterile and non-sterile condition
discrimination between identical or similar products.
9. Structural and environmental properties
9.1. If the device is intended to be used in conjunction with other devices or equipment, it is complete
assembly, including connections, be secure and do not damage the devices specified
performance. Any restrictions on use shall be indicated on the label or on the label
instructions for use.
9.2. The device must be so designed and constructed that it can be removed as far as possible, and
minimize it
(a) its physical characteristics, including volume / pressure ratio, dimensional characteristics and, where
justified - the risk of injuries related to ergonomic features;
(b) with reasonably foreseeable environmental effects (eg magnetic fields, external electricity
influences, electrostatic discharge, pressure, temperature or pressure and
acceleration changes);
(c) interference with other means normally used for certain examinations or treatments
risk;
(d) the aging of the materials used or the measuring or checking equipment
risks due to the lack of maintenance and calibration
(eg for implants).
9.3. The device must be designed and constructed in such a way that it is used as intended
in the event of a single fault condition, the risk of fire and explosion must be kept to a minimum.
This is especially true for devices that are flammable or inflammatory
exposed.
10. Devices with a measuring function
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
satisfactory accuracy and stability of the measured values ​​are ensured within appropriate accuracy limits
be. The accuracy limits must be indicated by the manufacturer.
10.2. Measuring, operating and display units must comply with ergonomic principles
designed taking into account the purpose of the device.
10.3. The results of measurements made with a device with a measuring function are defined in Act XLV of 1991 on Measurement.
be expressed in legal units of law.
11. Radiation protection
11.1. General requirement
11.1.1. The device must be designed and constructed in such a way that patients, users and
exposure of other persons is compatible with the intended use
be kept to a minimum without limiting the dose level prescribed for therapeutic or diagnostic purposes.
11.2. Intended radiation
11.2.1. If the device is designed to be of a hazardous level for a specific medical purpose
emits radiation the benefits of which outweigh the risks inherent in the emission, the user must
be able to control emissions. The design and construction of such devices must be such as to
to ensure repeatability and tolerance of relevant variable parameters.
11.2.2. Devices that emit potentially hazardous, visible or invisible radiation - if required
mode - the radiation must be indicated by an acoustic or light signal.
11.3. Unintended radiation
11.3.1. The device should be designed and constructed to meet the needs of patients, users and others
the exposure of persons to accidental, diffuse or accidental radiation is kept to a minimum.
be.
11.4. User's Guide
11.4.1. The instructions for use of the device emitting the radiation shall provide detailed information a
the nature of the radiation emitted, the way in which patients and users are protected, misuse
and the elimination of hazards associated with the equipment.
11.5. Ionizing radiation
11.5.1. The device emitting ionizing radiation must be so designed and constructed that:
ensure, if feasible, the amount and geometry of the emitted radiation
and its variability in relation to the intended use, and
controllability.
11.5.2. A device for emitting ionizing radiation for radiological diagnostic purposes shall be designed and constructed
be designed to provide a medical image and / or output quality such that a
patient and user radiation exposure should be kept to a minimum.
11.5.3. A device intended to emit ionizing radiation for radiological therapeutic purposes shall be designed and constructed
to allow for dose, beam type, energy and, where appropriate, radiation quality.
reliable control and regulation.
12. Requirements for devices connected to or equipped with an energy source
12.1.1. Devices incorporating programmable electronic systems shall be designed to:
ensure the repeatability, reliability and reliability of these systems in accordance with their intended use
performance. THE
In the event of an individual error in the system, solutions shall be applied which:
eliminate or reduce potential risks as far as possible.
12.1.2. A device that contains software or a device that is medical software in itself
software must be validated by modern methods, taking into account the development
principles of lifetime, risk management, validation and control.
12.2. A device in which the safety of the patient depends on the internal power supply must be provided with
means for determining the state of the energy source.
12.3. A device in which the safety of the patient depends on an external power supply shall have an alarm system
indicating any failure of the power supply.
12.4. A device designed to monitor one or more clinical parameters of a patient
it must have an appropriate alarm system to alert the user in the event of the death of the patient, or
in situations threatening a serious deterioration in his health.
12.5. The design and construction of the device must be such as to minimize such
the risk of electromagnetic fields being generated by other devices in the normal environment
or may adversely affect the operation of equipment.
12.6. Protection against electrical hazards
The device must be designed and constructed in such a way as to be avoidable as far as possible
there is a risk of accidental electric shock when used and installed properly, and
in a single fault condition.
12.7. Protection against mechanical and thermal risks
12.7.1. The device should be designed and constructed to meet the needs of patients and users
be protected against mechanical hazards such as inadequate strength
and stability and hazards associated with moving parts.
12.7.2. The device must be so designed and constructed that, taking account of technical progress:
to the lowest possible level of vibrations caused by non-intended operation
danger from. To this end, vibration reduction methods, especially vibrations, should be applied
place of origin.
12.7.3. The device must be designed and constructed to be as low as possible
emissions from the device that are not intended to function properly
noise hazards, taking into account technical progress and available - in particular
noise abatement solutions.
12.7.4. It is connected to the supply of electrical, gas, hydraulic or pneumatic energy
connectors and fittings that must be handled by the user are designed and constructed
so that all risks are kept to a minimum.
12.7.5. Accessible parts of the device and their surroundings (except those parts which:
intended to supply heat or reach a certain temperature) do not reach dangerous temperatures during normal use.
12.8. Protection against the risks arising from the transfer of substances or energy to patients
12.8.1. The device for delivering energy or substances to patients should be designed so that the amount delivered is a
be set with sufficient precision for patient and user safety and that this setting is not changed.
12.8.2. The device must be suitable for any disturbance of quantity control
to prevent or signal The device should be suitable for energy or material random
to prevent dangerous overdose.
12.9. The purpose of the controls and indicators must be clearly indicated on the device. If it's you
the device has the information necessary for its operation, or the device visually indicates the operating or
setting parameters, this information is provided to the user and, where applicable, to the patient
be understandable.
13. Information to be provided by the manufacturer
13.1. All devices must be equipped with the equipment necessary for safe use and identification of the manufacturer,
information taking into account the qualifications and level of knowledge of potential users.
This information consists of the information on the label and the instructions for use. To use the device safely
necessary information primarily on the device itself or on an individual, where appropriate commercial basis
should also be indicated on the packaging if practicable. If individual packaging is not possible, the
information shall be provided in the prospectus supplied with the devices (one or more devices). All
each device must include instructions for use in the packaging. Indispensable for use
guidance for Class I or Class IIa devices, if complete without such guidance
can be used safely.
13.2. The information on the label should preferably be given in symbols. All symbols and
identification color in accordance with harmonized standards. In areas where there are no standards,
the symbols and colors must be described in the documentation supplied with the device.
13.3. The label must contain the following information:
(a) the name or trade name and address of the manufacturer. For the purpose of distribution in the Community
In the case of a device imported into the Community, if the manufacturer does not have a registered office a
Community, on the label or on the outer packaging or in the instructions for use
the name and address of the authorized representative must be indicated;
(b) to identify the device and the contents of the packaging, in particular for the user
essential details that are essential;
(c) where appropriate, the word "STERILE";
(d) where appropriate, the batch number preceded by the word "LOT" or the serial number;
(e) where appropriate, the expiry date of the safe use of the device, expressed in years and months;
(f) where applicable, an indication that the device is intended for single use. The manufacturer is one-time
its indication of use should be uniform throughout the Community;
(g) in the case of custom-made devices, the words "custom-made device";
(h) in the case of devices intended for clinical investigations, the words "for clinical investigations only";
(i) any special storage conditions or handling requirements;
(j) any special operating instructions;
(k) all necessary warnings and instructions for precautions to be taken;
(l) for active devices not covered by point (e), the year of manufacture, including the batch or serial number
It may comprise;
(m) where appropriate, the method of sterilization;
n) in the case of assets falling under Section 2 (1) (e), an indication that the
device contains a human blood derivative.
13.4. If the intended purpose of the device is not obvious to the user, to the manufacturer
you must clearly indicate this on the label and in the instructions for use.
13.5. Where appropriate and feasible, assets should be identified and detachable
components, in series if necessary, so that all necessary measures can be taken
to identify any potential hazards posed by the devices and detachable parts
order.
13.6. The instructions for use must contain the following information, as the case may be
logically:
(a) with the exception of points (d) and (e), 13.3. described in point;
(b) the performance referred to in point 3 and any undesirable side effects;
(c) if the device is used with other medical devices or equipment in order to ensure its intended use
should be linked, the data needed to form a secure combination a
to select appropriate tools or equipment;
(d) all information necessary to verify that the device is correctly installed,
is in a safe and ready condition. It must also be specified for accurate and safe operation of the device
information on the nature and frequency of maintenance and calibration required;
(e) where applicable, information to avoid certain risks associated with the implantation of the device;
(f) reciprocity in connection with the device during special treatments or tests
information on the risk of interference;
(g) information on any damage to the sterile packaging, if necessary
data on the method of re-sterilization;
(h) in the case of a reusable device, information on the procedures for re-use,
including cleaning, disinfection, packaging and, where appropriate, re - sterilization; and
data limiting the number of re-uses. Devices to be sterilized before use
the cleaning and sterilization instructions must be such that, when used properly, the device
meet the requirements of Chapter I. If there is an indication on the device that the device is once
used, information on the known characteristics and technical factors known to the manufacturer,
which may pose a risk if the device is reused. If
13.1. no instructions for use are required, the information shall be made available to the user on request
made;
(i) if necessary, additional steps to be taken before the device is put into service (eg sterilization,
final assembly, etc.);
(j) in the case of devices emitting radiation for medical purposes, the nature, type, intensity and
distribution.
The instructions for use must also contain the information on the basis of which it is
Contraindications and necessary precautions can be briefly informed by medical staff a
patients. This information must include:
(k) precautions to be taken in the event of a change in the performance of the device;
(l) effects under reasonably foreseeable environmental conditions, such as magnetic fields, external
electrical effects, electrostatic discharges, pressure and pressure changes, acceleration, self-ignition
risk of warming, etc. precautionary measures in the event of
(m) information on the medicinal products or medicinal products for which administration is sought
intended, including any restrictions on such substances;
(n) precautions against any special, unusual hazards associated with the waste of the device;
(o) the information contained in paragraph 7.4. Therapeutic substance or human substance present as an integral part of the device in accordance with
to mark a blood product;
(p) in the case of devices with a measuring function, the accuracy required of the device;
(q) the date of issue or the latest revision of the instructions for use.
13.7. A 13.1-13.6. The end user of the device must be listed in Hungarian
available to them. For controls, located directly next to them
foreign language labels are considered symbols if they have the meaning of use
guide explains in detail.
B. For active implantable devices
I. General requirements
1. The device must be designed and manufactured in such a way as to be suitable for the purpose and conditions of use
implantation should not endanger the health or safety of patients. The device poses no danger
it must not be reported to the implanter or any other person.
2. The device must be as intended by the manufacturer
performance, that is to say, it must be designed and manufactured in such a way as to be suitable for the
§ (1).
3. The characteristics and performances of the device referred to in points 1 and 2, as specified by the manufacturer
during life and under normal conditions of use - do not change
adversely affect the health status of patients and, where appropriate, other persons
and endanger your safety.
4. The device must be designed, manufactured and packaged in such a way that its characteristics and
storage and transport conditions (temperature,
moisture content, etc.).
5. Possible undesirable side effects, in comparison with the intended performance, are acceptable
risk.
5a. Demonstration of compliance with the essential requirements shall be in accordance with Annex 10
clinical evaluation.
II. Design and construction requirements
6. The design and manufacturing solutions applied by the manufacturer must comply with the safety principles,
taking into account generally accepted technical standards.
7. An implantable device shall be designed, constructed and packaged in non-reusable packaging that:
to be sterile at the time of placing on the market and to be stored and transported as specified by the manufacturer
conditions remain sterile until the package is opened before implantation of the device.
8. The device shall be so designed and constructed that it can be removed as far as possible, and a
minimize it
(a) the risk of injury due to its physical characteristics, including dimensional characteristics;
(b) the risks associated with the use of energy sources, in particular electricity
in the case of energy use - insulation, fault currents and overheating of the device;
(c) with reasonably foreseeable environmental effects (eg magnetic fields, external electricity
influences, electrostatic discharge, pressure, temperature, or pressure and
acceleration changes);
(d) medical interventions, especially defibrillators or high-frequency
risks associated with the use of surgical instruments;
(e) basic safety requirements for protection against the dangers arising from ionizing radiation
ionizing radiation related to medical exposure
safety requirements in specific legislation on the protection of human health against
ionizing radiation from radioactive materials in the device
emerging risks;
(f) the risks that may arise if maintenance and calibration are impossible,
including
fa) excessive increase of fault currents,
(fb) the aging of the materials used,
fc) excessive heating of the device,
(fd) a decrease in the accuracy of any measuring or control mechanism.
9. Devices must be designed and manufactured in such a way as to guarantee compliance with the 'I. general
requirements and performance referred to in the section "requirements", in particular:
(a) the choice of substances used, in particular as regards toxicity;
(b) interactions between the materials used and biological tissues, cells and body fluids
compatibility with regard to the intended use of the device;
(c) the compatibility of the devices with the materials to be administered;
(d) quality of contacts, in particular safety;
(e) reliability of the energy source;
(f) where applicable, adequate tightness;
(g) programming, control and monitoring systems, including software;
proper functioning.
In the case of a device that contains software or a device that is medical software in its own right, the software is a
be validated by methods appropriate to the state of the art, taking into account developments
principles of lifetime, risk management, validation and control.
10. *
If the device is an integral part of a substance which, if by itself
used - the Gytv. which is considered to be a medicinal product and which is suitable for
have an additional effect on the human body compared to the effect of the device, the quality, safety and safety of the substance
52/2005 on the placing on the market of medicinal products for human use. (XI. 18.) EüM
shall be certified in accordance with the methods set out in Annex 1 to this Regulation.
With regard to the substances referred to in the first paragraph, the notified body shall, after having ascertained the substance as
request a scientific opinion on the usefulness of the part of the device, taking into account its purpose
from one of the competent authorities designated by the Member State or from the ERF in accordance with Regulation (EC) No 726/2004
regarding the quality and safety of the material, including when the material is incorporated into the device
clinical benefit / risk. When giving an opinion, the competent authority or the EMA shall
process and the usefulness of the incorporation of the substance into the device by the notified body
takes into account the data specified by the
If a device contains human blood products as an integral part, the designated body after
convinced of the usefulness of the substance as part of the device, taking into account the device
request a scientific opinion from the EMA on the quality and safety of the substance,
including the clinical benefit / risk of incorporating the human blood product into the device
money. When commenting on the EMA, the manufacturing process and the material took place in the device
data specified by the notified body on the usefulness of its incorporation.
When it is done in an additional material that is part of the device - especially related to the manufacturing process
change, the notified body must be informed and the competent authority must be consulted (ie the first
consultation) with the pharmaceutical authority to confirm that the supplement
material quality is unchanged and remains safe. The competent authority shall take this into account
the usefulness of incorporating the substance into the device by the notified body
specified data to ensure that the changes are not adversely affected
the benefit / risk balance of adding the substance to the device.
If the competent pharmaceutical authority of the person concerned (ie involved in the first consultation) is an additional substance
information that the additive has been incorporated into the device
may influence the benefit / risk balance associated with its incorporation, inform the notified body
that the benefit / risk balance associated with the incorporation of the additional substance into the device
It can affect. The notified body shall take the updated scientific opinion into account and the EC
review its assessment in the conformity assessment procedure on that basis.
11. Devices and, where appropriate, their components must be identifiable in such a way as to:
that any potential risk associated with the device and its components is discovered
allow all necessary measures to be taken.
12. Devices must bear a code by which the devices (in particular the type of device and
year of manufacture) and their manufacturer can be clearly identified. This code is surgical if necessary
can be read without intervention.
13. If a device or accessory has instructions that
display of operating or control parameters required for the operation of the device
such information must be easy for the user and
where appropriate, for the patient.
14. Each device must bear the following particulars, in letters grouped on the same side, legibly and indelibly marked
data, where appropriate in the form of commonly known symbols:
14.1. On the sterile package:
(a) the method of sterilization;
(b) a mark enabling the packaging in question to be identified by
sterility;
(c) the name and address of the manufacturer;
(d) the name of the asset;
(e) on a device intended for clinical investigations, the words "for clinical investigations only";
(f) in the case of a custom-made device, the words "custom-made device";
(g) an indication that the implantable device is in a sterile state;
(h) month and year of manufacture;
(i) the expiry date of the safe implantation of the device.
14.2. On the commercial packaging:
(a) the name and address of the manufacturer and, if the manufacturer is authorized, the name and address of the authorized representative
has no registered office within the Community;
(b) the name of the asset;
(c) the purpose for which the device is to be used;
(d) characteristics relevant to use;
(e) in the case of a device intended for clinical investigations, the words “clinical trials only
for the purpose of
(f) in the case of a custom-made device, the words "custom-made device";
(g) an indication that the implantable device is in a sterile state;
(h) year and month of manufacture;
(i) the expiry date of the safe implantation of the device;
(j) conditions for transport and storage of the device;
k) in the case of devices pursuant to Section 2 (1) (d) - (e), an indication that the device is human
contains a blood product.
15. When placed on the market, all devices must be accompanied by instructions for use which:
contains the following information:
(a) the year in which the right to affix the CE marking arose;
b) a 14.1. and 14.2. with the exception of those referred to in points (h) to (i);
(c) details of the services referred to in point 2, as well as any undesirable side effects;
(d) information enabling the doctor to use the appropriate equipment and software or accessories
selection;
(e) information enabling the doctor and, where appropriate, the patient to use the device,
the intended use of its accessories and software, and contains information on
the scope and timing of the performance review and inspections, given
and, where appropriate, for maintenance activities;
(f) information enabling, where appropriate, the implantation of the device
avoiding certain risks;
(g) information on the presence of the device during certain special examinations or treatments
the risk of interactions that occur. Interaction should be understood as adverse effects
applied to the device by the instrument used during the test or treatment, or vice versa;
(h) instructions in the event of damage to the sterile packaging and, where appropriate, re-sterilization
a description of the appropriate manner;
(i) where applicable, a warning that the device may be re - used only if:
under the responsible management of the manufacturer, has been refurbished to meet the essential requirements again.
The instructions for use must also contain the particulars necessary to enable the
doctor to inform the patient about contraindications and what to do
precautions. This information must cover in particular:
(j) information enabling the life of the energy source to be determined;
(k) the precautions to be taken in the event of a performance of the device
change occurs;
(l) precautions to be taken under reasonably foreseeable environmental conditions
magnetic fields, external electrical influences, electrostatic discharge, pressure or
in the case of exposure to pressure changes, acceleration;
(m) adequate information on the medicinal products to be administered by the device in question
responsibility;
(n) the date of issue or the latest revision of the instructions for use.
A 13-15. The end user of the device must be in Hungarian
available to them.
16. Confirmation that the device, under the intended conditions of use, a
in terms of characteristics and performance. General Requirements ”
requirements and an assessment of side effects or adverse reactions is provided in Annex 10
should be based on clinical data determined in accordance with
Annex 2 to Regulation 4/2009 (III. 17.) EüM
EC declaration of conformity
(Full quality assurance system)
A. For class assets
1. The manufacturer must, for the purposes of the manufacture and final inspection of the products concerned,
apply the quality system as specified in point 3 and undertake the quality system as specified in point 3.3. and the
The examination (audit) provided for in point 4 and the review provided for in point 5.
2. The obligations laid down in point 1 of the EC declaration of conformity procedure
manufacturer shall ensure that the products in question comply with the provisions of this Regulation that apply to them
requirements and make a statement to that effect.
The manufacturer must affix the CE marking and written conformity in accordance with § 5
must make a declaration. This statement must relate to one or more specific instruments, clearly
identifying the product (s) by the name, type designation or other unambiguous identifier of the product and
must be retained by the manufacturer.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body. The application shall:
must include:
(a) the name and address of the manufacturer and the address of each premises of the quality system concerned;
(b) any information relating to the product or family of products covered by the procedure;
(c) a written declaration of compliance with the quality system for the same products
has not yet applied to another designated body;
(d) the quality system documentation;
(e) an undertaking by the manufacturer to fulfill the obligations arising out of the quality system as approved
the following obligations;
(f) an undertaking by the manufacturer to operate an approved quality system
maintains it with sufficient efficiency;
(g) an undertaking by the manufacturer to institute and maintain a systematic procedure
up - to - date to review post - production experience with the device, including
Provisions of Annex 10 - and shall make the necessary adjustments. This undertaking must also oblige the manufacturer to:
to report without delay the events detailed therein in accordance with Section 21.
3.2. The application of the quality system must ensure that the product is designed from
comply with the relevant requirements of this Regulation at all stages until the final inspection.
All the elements, requirements and provisions adopted by the manufacturer for his quality system
systematically and orderly, in the form of written policies and procedures such as quality programs,
quality plans, quality manuals and quality records must be documented. They must include
in particular the relevant documentation, data and records resulting from the procedures referred to in point (c).
The documentation must contain in particular:
(a) the manufacturer 's quality objectives;
(b) the organization of the undertaking, in particular:
(ba) the organizational structure, responsibilities and powers of the management with regard to product design and implementation;
production quality,
(bb) the effectiveness of the quality system, in particular the design and manufacturing quality which it intends to achieve
means of verifying the suitability of non-compliant products
also,
(bc) the means of monitoring the effective operation of the quality system where:
the design, manufacture and / or acceptance inspection and testing of the product or of any of its components
carried out by the organization, highlighting the method used to audit the external organization and its level of detail;
(c) the procedures for directing and controlling the design of the product, including the appropriate
documentation, in particular:
(ca) a general description of the product, including any variants planned and its intended use,
(cb) the design documentation, including applicable standards and risk analysis
and to meet the essential requirements of the product
a description of the solutions, if applicable
nationalized harmonized standards are not fully implemented,
(cc) the design examination and checking techniques, processes and procedures that will be used when designing the product; and
systematic measures,
(cd) if the device must be connected to other device (s) in order to function properly for its intended purpose,
proof that it has the characteristics specified by the manufacturer for any device (s)
meets the essential requirements
(ce) a statement as to whether the device incorporates, as an integral part, Annex 1, Part A.II. point
7.4. substance or human blood derivative referred to in
to evaluate the safety, quality and usefulness of the substance or human blood derivative
data from tests carried out taking into account the purpose for which the device is used,
cf) *
a statement that the device is in accordance with Council Directive 90/385 / EEC
active implantable medical devices manufactured utilizing tissues of animals
animal tissues and Council Directive 93/42 / EEC
requirements for medical devices manufactured using
Commission Regulation (EU) No 722/2012 laying down specific requirements
hereinafter referred to as Commission Regulation (EU) No 722/2012) using tissue of animal origin,
(cg) Annex 1, A.I. solutions applied in accordance with point 2 of
ch) assessment of suitability for clinical trial,
(ci) a clinical evaluation in accordance with Annex 10,
(cj) the draft label and, if any, the instructions for use;
(d) the inspection and quality assurance techniques at the manufacturing stage, in particular:
the methods and procedures used, in particular as regards sterilization, procurement and relevant
documentation,
- the product identification procedures at all stages of manufacture, from drawings, descriptions or other relevant documents
compiled from documents and kept up to date;
(e) the examinations and tests that will be carried out before, during and after manufacture, the frequency with which they will be carried out,
used test equipment. The verification of test equipment must be duly substantiated
be.
3.3. The notified body must examine the quality system to determine whether:
does it comply with 3.2. requirements referred to in The relevant
quality systems complying with harmonized standards meet these requirements.
At least one member of the assessment team must have experience of the technology concerned
evaluation. The evaluation procedure must include - representative
the assessment of the design documentation of the product (s) in question, and
processes - the manufacturer 's premises and, where appropriate, suppliers and / or
inspection of the premises of subcontractors. The decision of the notified body must be notified to the manufacturer.
This should include the conclusions of the audit and the evaluation
justification.
3.4. The manufacturer must keep the notified body that has approved the quality system informed of any intended updating of the quality system
planned significant change to the quality system and its scope
changes in the product types covered. The notified body must examine the proposed changes, and
verify that the requirements of paragraph 3.2 are still met. requirements referred to in point. THE
the decision must be communicated to the manufacturer. This decision should include an audit
conclusions drawn and the reasons for the assessment.
4. Examination of the product design
4.1. In addition to the obligations imposed by point 3, the manufacturer must lodge an application with a notified body
intended for manufacture and 3.1. for a product belonging to the product group referred to in point
examination of the relevant design documentation.
4.2. The application must include the plans, manufacture and services of the product in question. contain
3.2. the documents listed in point (c) which are necessary to establish that:
whether the product satisfies the requirements of this Regulation.
4.3. *
The notified body must examine the application and where:
product complies with the relevant requirements of this Regulation, it shall issue a design examination certificate to the applicant. The selected
may request that the application be supplemented by further tests or trials in order to:
compliance with the requirements of this Regulation. The certificate must include the test
conclusions, conditions for validity, data necessary to identify the approved plan
and, where appropriate, a description of the intended use of the product. Annex 1, Part A, Section 7
point 7.4. in the case of the devices referred to in the second subparagraph of
before taking a decision, request Annex 1, Part A, point 7, point 7.4. in the first paragraph of
the competent body authorized to register medicinal products or the EMA
provided that the registrant has the appropriate documentation
deliver its opinion within 210 days of receipt. For device documentation
it must contain the scientific opinion of the registrant or the EMA. To the notified body
make its decision taking into account the opinion of the registrant,
and shall inform the registrant thereof.
Annex 1, Part A, section 7 7.4. in the case of the devices referred to in the third subparagraph of
The EMA shall include the scientific opinion of the EMA on the device. THE
the notified body shall give due consideration to the expertise of the EMA when making its decision. The selected
an organization may not issue a certificate if the EMA's opinion is unfavorable. The designated organization is the final one
notify the EMA of its decision. In the case of devices manufactured utilizing tissues of animal origin:
the notified body must follow the procedures provided for in Commission Regulation (EU) No 722/2012.
4.4. Any changes to the approved plan must be additionally approved by the designated certificate issuer
these changes may affect compliance with the essential requirements of this Regulation
compliance or conditions of use of the product. The applicant shall inform the
The notified body which has issued the EC design examination certificate in respect of each design which it has approved
change. The additional approval must be given in the form of an addition to the original EC design examination certificate.
5. Review
5.1. The review ensures that the manufacturer is in charge of the approved quality system
fulfill its obligations properly.
5.2. The manufacturer must authorize the notified body for all necessary
and provide it with all the necessary documents, in particular
following:
(a) the quality system documentation;
(b) the data taken into account in the design part of the quality system, such as the
with the results of analyzes, calculations, tests, Annex 1
With the solutions applied as specified in point 2 of Part A, a
clinical trial evaluation and clinical evaluation, placing on the market
the clinical product follow-up plan and, where appropriate, the results thereof;
(c) the data taken into account in the production part of the quality system, such as
inspection reports, test data, calibration data, qualification of personnel
reports.
5.3. The notified body must periodically carry out audits and assessments to make sure that:
ensure that the manufacturer operates the approved quality system and provide the manufacturer with an assessment
you must report.
5.4. In addition, the designated organization visits without prior notice
you can do at the manufacturer. At the time of such visits, the notified body shall, if necessary,
may carry out tests or have them carried out in order to check the proper functioning of the quality system. To the manufacturer
the inspection report and, if tests have been carried out, the inspection report must be sent.
6. Administrative requirements
6.1. The manufacturer or his authorized representative shall, for a period ending at least 5 years after the last product has been manufactured,
in the case of implantable devices, for at least 15 years, make available to the authorities on request:
(a) the declaration of conformity;
b) a 3.1. the documentation referred to in point (d);
c) 3.2. the documentation, data and records specified in point (b);
d) and 3.4. the changes referred to in point;
e) a 4.2. the documentation referred to in point.
(f) the notified body in accordance with points 3.3, 4.3, 4.4, 5.3. and 5.4. and
reports.
7. Application to devices in Classes IIa and IIb
7.1. In accordance with Section 13, Paragraphs (2) - (3), this Annex, with the exception of the provisions of Section 4,
may also be applied to products in Classes IIa and IIb.
7.2. In the case of Class IIa devices, the notified body must:. described in point
as part of the assessment (c), each asset class shall have at least one
assess the conformity of the technical documentation with this Regulation for a representative sample.
7.3. The notified body must, in the case of devices in Class IIb: described in point
as part of the assessment (c), all generic asset groups
for at least one representative sample, the technical documentation shall assess the e
compliance with this Regulation.
7.4. In selecting the representative sample, the notified body shall take into account the novelty of the technology,
the similarity of the design, technological, manufacturing and sterilization procedures, the intended use,
and previous (eg physical, chemical or biological) tests performed in accordance with this Regulation
the results of evaluations). The notified body shall document the sampling
and make them available to the authority.
7.5. Additional samples to be taken by the notified body as part of the surveillance assessment as specified in point 5
assess.
8. Application to devices falling under Section 2 (1) (e)
The production of all batches of devices falling under Section 2 (1) (e)
upon completion, the manufacturer shall notify the notified body of the release of that batch, and
send it the information set out in Annex 1, Part A, point 7.4 by the laboratory referred to in the third paragraph of
issued an official certificate for the batch of human blood derivative used in the device
the issue of.
B. For active implantable devices
1. The manufacturer must be responsible for the design, manufacture and final inspection of the products concerned
the quality system approved in accordance with points 3 and 4
shall be subject to the review provided for in point 5.
2. The obligations laid down in point 1 for the EC declaration of conformity procedure
manufacturer shall ensure that the products in question comply with the provisions of this Regulation that apply to them
and make a statement to that effect.
The manufacturer or his authorized representative must affix the CE marking in accordance with Article 5, and
issue a written declaration of conformity. One or more specifics of this statement
clearly identifying the device (s) by product name, type designation or other
with a clear identifier and must be kept by the manufacturer.
The CE marking must be supplemented by the identification mark of the competent notified body.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body. The application shall:
must include:
(a) all relevant information for the product category envisaged;
(b) the quality system documentation;
(c) an undertaking by the manufacturer to fulfill the obligations arising out of the quality system as approved
the following obligations;
(d) an undertaking by the manufacturer to operate an approved quality system
maintains it with sufficient efficiency;
(e) an undertaking by the manufacturer to comply with the provisions referred to in Annex 10
introduces and maintains an after-sales monitoring system that includes That's the commitment
also obliges the manufacturer to report the events detailed therein in accordance with Section 21 without delay.
3.2. The application of the quality system must ensure that the product is designed from
comply with the relevant requirements of this Regulation at all stages until the final inspection.
All the elements, requirements and provisions adopted by the manufacturer for his quality system
be documented in a systematic and orderly manner in the form of written policies and procedures. Of this
the quality documentation must enable the policies and procedures to be codified,
such as quality programs, quality plans, quality manuals and quality records.
They shall contain in particular the appropriate documentation, data and data from the procedures referred to in point (c)
records.
The documentation must contain in particular:
(a) the manufacturer 's quality objectives;
(b) the organization of the undertaking, in particular:
(ba) the organizational structure, responsibilities of the management staff,
and its organizational responsibilities for the quality of the design and manufacture of the products,
(bb) the effectiveness of the quality system, in particular the design and manufacturing quality which it intends to achieve
means of verifying the suitability of non-compliant products
also,
(bc) the means of monitoring the effective operation of the quality system where:
the design, manufacture and / or acceptance inspection and testing of the product or of any of its components
carried out by the organization, highlighting the method used to audit the external organization and its level of detail;
(c) the procedures for the management and control of the design of the products, in particular:
(ca) the design specifications, including applicable standards, and solutions
used to meet the essential requirements for the product,
if the standards referred to in Article 4 are not applied or are not applied in full,
(cb) the design examination and verification techniques, processes and product design procedures used; and
systematic measures,
(cc) a statement as to whether the device incorporates, as an integral part, Annex 1, Part A.II. point
7.4. substance or human blood derivative referred to in
to evaluate the safety, quality and usefulness of the substance or human blood derivative
data from tests carried out taking into account the purpose for which the device is used,
cd) assessment of suitability for clinical trial,
(ce) the clinical evaluation in accordance with Annex 10;
(d) the inspection and quality assurance techniques at the manufacturing stage, in particular:
(da) the methods and procedures used, in particular sterilization, procurement of materials and
in connection with the relevant documentation,
(db) the product identification procedures at all stages of manufacture, from drawings, descriptions or other relevant
compiled from documents and kept up to date;
(e) the examinations and tests that will be carried out before, during and after manufacture, the frequency with which they will be carried out,
used test equipment.
3.3. The notified body must examine the quality system to determine whether:
does it comply with 3.2. requirements referred to in The relevant
quality systems complying with harmonized standards meet these requirements.
At least one member of the assessment team must have experience of assessment in the technology concerned
on. The assessment procedure must include the manufacturer 's premises and, in duly substantiated cases
- inspection of the premises of suppliers and / or subcontractors, inspection of production processes
order.
The decision must be notified to the manufacturer after the last inspection. This should include what was deducted from the audit
conclusions and justification for the evaluation
3.4. The manufacturer must keep the notified body that has approved the quality system informed of any intended updating of the quality system
planned change in the quality system. The notified body must examine the proposed
changes and verify that the requirements of paragraph 3.2 are still met. requirements referred to in point. The decision
communicated to the manufacturer. This decision must include the information deducted from the audit
conclusions and justification for the evaluation.
4. Examination of the product design
4.1. In addition to the obligations imposed by point 3, the manufacturer must lodge an application with a notified body
intended for manufacture and 3.1. for a product belonging to the product group referred to in point
examination of the relevant design documentation.
4.2. The application must cover the design, manufacture and services of the product in question, and
it must contain all the documents necessary to establish that the product satisfies the requirements of
the requirements of this Regulation, in particular 3.2. the requirements of subparagraphs (c) and (d).
The application must include, inter alia:
(a) the design specifications, including standards, that have been applied; these standards
necessary proof of its applicability, in particular in the case referred to in Article 4
standards have not been applied in full
degree. This certificate must contain the information required by the manufacturer or under his responsibility
the results of appropriate tests;
(b) information on whether the product contains as an integral part of the product
The substance referred to in Annex 1, Part B, point 10, which interacts with the device in question
may result in the entry of the substance into physiological processes, the relevant experiments performed
together with data;
(c) the clinical evaluation in accordance with Annex 10;
(d) the draft instructions for use.
4.3. *
The notified body shall examine the application and the product concerned
meets the relevant requirements of this Regulation, shall issue an EC design examination certificate to the applicant. THE
the notified body may request further tests or trials to supplement the application,
to assess compliance with the requirements of this Regulation. The certificate must include the
the conclusions of the examination, conditions for its validity, to identify the approved plan
the necessary particulars and, where appropriate, a description of the intended use of the product. Annex 1, Part B.
In the case of devices referred to in the second paragraph of point 10, the notified body must take decisions
referred to in the first paragraph of point 10 of Part B of Annex 1
the opinion of the competent body authorized to register medicinal products or the EMA,
that the registrant has received the relevant documentation from the date of receipt
You must provide an opinion within 210 days. The documentation concerning the device must include:
the scientific opinion of the registrant or the EMA. The notified body must:
it must take its decision after considering the opinion of the registrant, and
you must also inform the registrant.
In the case of devices referred to in the third paragraph of point 10 of Part B of Annex 1, the
the dossier shall include the EMA's scientific opinion on the device. The selected
the organization shall give due consideration to the opinion of the EMA when making its decision. The notified body does not
may issue the certificate if the EMA's opinion is unfavorable. The notified body shall make the final decision
notify the EMA. In the case of a device made using tissues of animal origin, the designated
organization shall follow the procedures provided for in Commission Regulation (EU) No 722/2012.
4.4. The manufacturer or the applicant must inform the issuer of the EC design examination certificate
the notified body of any changes to the approved plan. These
Changes must be approved in addition by the notified body which issued the certificate if these:
changes may affect compliance with the requirements of this Regulation or the use of the product
conditions. Additional acceptance shall take the form of an addition to the EC design-examination certificate
taken.
5. Review
5.1. The review ensures that the manufacturer is in charge of the approved quality system
fulfill its obligations properly.
5.2. The manufacturer must authorize the notified body for all necessary
and provide it with all the necessary documents, in particular
following:
(a) the quality system documentation;
(b) the data taken into account in the design part of the quality system, such as
results of analyzes, calculations, tests, evaluation of admissibility for clinical trials and clinical
post-marketing clinical product follow-up plan and, where appropriate
with the results;
(c) the data taken into account in the production part of the quality system, such as
inspection reports, test data, calibration data, qualification of personnel
reports.
5.3. The notified body must periodically carry out audits and assessments to make sure that:
ensure that the manufacturer operates the approved quality system and provide the manufacturer with an assessment
you must report.
5.4. In addition, the notified body may pay unannounced visits to
manufacturer for which the manufacturer receives a test report.
6. Administrative requirements
6.1. The manufacturer or his authorized representative shall, on request for a period ending at least 15 years after the last product has been manufactured
shall make available to the authorities:
(a) the declaration of conformity;
b) a 3.1. the documentation referred to in point (d);
c) a 3.2. the documentation, data and records specified in point (b);
d) and 3.4. the changes referred to in point;
e) a 4.2. the documentation referred to in point.
(f) the notified body in accordance with points 3.3, 4.3, 4.4, 5.3. and 5.4. and
reports.
7. Application to devices referred to in Section 2 (1) (e):
The production of all batches of devices falling under Section 2 (1) (e)
upon completion, the manufacturer shall notify the notified body of the release of that batch, and
an official certificate issued by the laboratory referred to in Annex 1, Part B, point 10
a certificate of batch production of the human blood derivative used in the device.
Annex 3 to Regulation 4/2009 (III. 17.) EüM
EC type - examination procedure
A. For class assets
1. EC type-examination is the procedure whereby a notified body ascertains and
certify that a representative sample of the production envisaged meets the relevant requirements of this Regulation. The
The application for EC type-examination shall be lodged by the manufacturer or by his authorized representative with a notified body.
2. The application shall include:
(a) the name and address of the manufacturer and, if the application is lodged by the authorized representative,
application;
(b) the documentation described in point 3, representative of the production envisaged and hereinafter called
type) to assess compliance with the requirements of this Regulation. THE
the applicant must place the type at the disposal of the notified body. The designated organization
may request additional samples if necessary;
(c) a written declaration that no other notified body has been notified for the same type
have submitted an application.
3. The documentation must enable the design, manufacture and product services to be carried out
and should include:
(a) the type, including any variants planned, and its intended use
a general description of its application (s);
(b) design drawings, methods of manufacture envisaged, in particular as regards sterilization; the
parts, components, circuits, etc. drawings;
(c) descriptions necessary for an understanding of the said drawings and diagrams and the operation of the product; and
explanations;
(d) a list of the national harmonized standards applied in full or in part; and
a description of the solutions adopted to meet the essential requirements,
if the localized standards referred to are not fully implemented;
(e) design calculations, risk analyzes, technical examinations, etc. results;
(f) a statement as to whether the device incorporates, as an integral part, Annex 1, Part A.II. point 7.4.
or a human blood derivative and the substance or
the tool for evaluating the safety, quality and usefulness of a human blood derivative
data from tests performed taking into account its intended use;
g) *
a statement that the instrument is covered by Commission Regulation (EU) No 722/2012
has been made using the tissue of animal origin referred to;
(h) Annex 1, A.I. the solutions adopted as referred to in point 2;
(i) pre-clinical evaluation;
(j) clinical data in accordance with Annex 10;
(k) the design of the label and, if necessary, the instructions for use.
4. The notified body must:
4.1. examine and evaluate the documentation and verify that the type:
manufactured in accordance with the documentation; keep records of the items that the
designed in accordance with the relevant requirements of national harmonized standards and those which are not;
4.2. perform or have performed the appropriate examinations and necessary tests
necessary to verify that the solutions adopted by the manufacturer satisfy the requirements set out in Annex 1
essential requirements if the nationalized harmonized standards are not fully applied. If the
the product must be connected to other devices in order to function properly as intended
make sure that this is done with another device having the characteristics specified by the manufacturer
when combined, it meets the essential requirements;
4.3. perform or have performed the appropriate examinations and necessary tests which:
they are necessary to verify that, if the manufacturer has chosen the appropriate standards to be used, they have been applied
actually applied it;
4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out.
5. *
If the type meets the requirements of this Regulation, the notified body
It shall issue an EC type - examination certificate to the applicant. The certificate must include the
the name and address of the manufacturer, conclusions of the examination, conditions for its validity and the
data necessary to identify the approved type. The relevant parts of the documentation
it must be attached to the certificate and a copy kept by the notified body. The 1.
Annex I, Part A, point 7 7.4. in the case of the devices referred to in the second subparagraph of
Before taking a decision, the organization shall request the information specified in Annex 1, Part A, point 7, paragraph 7.4. first subparagraph
The competent body for the registration of medicinal products for the purposes of paragraph 1
or the opinion of the EMA, provided that the registration body has the appropriate documentation
deliver its opinion within 210 days of receipt. For device documentation
it must contain the scientific opinion of the registrant or the EMA. The selected
the registration body shall take its decision, taking into account the opinion of the registrant, and shall inform the
it must also inform the registrant. Annex 1, Part A, section 7 7.4.
in the case of devices referred to in the third subparagraph of point (a), the documentation concerning the device
the EMA’s scientific opinion on the instrument. The notified body must:
take due account of the opinion of the EMA when making its decision. The notified body does not
may issue the certificate if the EMA's opinion is unfavorable. The notified body shall make the final decision
notify the EMA. In the case of a device made using tissues of animal origin, the designated
organization shall follow the procedures provided for in Commission Regulation (EU) No 722/2012.
6. The applicant must keep the notified body that has issued the EC type-examination certificate informed of:
any substantial modification to an approved product. Modifications to the approved product are subject to type examination
the notified body issuing the certificate must re - accept or supplement it if the
Modifications may affect compliance with the essential requirements or the use of the product
conditions. The new or additional approval, if any, shall be the original EC type-examination certificate
as a supplement.
7. Administrative requirements
7.1. A copy of the EC type - examination certificates and their additions may be obtained from another notified body.
The annexes to the certificates shall, upon reasoned request and after informing the manufacturer, be amended
shall also be made available to a designated body.
7.2. The manufacturer or his authorized representative must, with the technical documentation,
Copies of the EC type - examination certificates and their additions from the last production of the device at least
for a period of five years. For implantable devices, this period is the last product
at least fifteen years from the date of manufacture.
B. For active implantable devices
1. EC type-examination is the procedure whereby a notified body ascertains and
certify that a representative sample of the production envisaged meets the relevant requirements of this Regulation.
2. The application for EC type-examination shall be lodged by the manufacturer or by his authorized representative with a notified body.
The application must include:
(a) the name and address of the manufacturer and, if the application is lodged by the authorized representative,
application;
(b) a written declaration that no other notified body has been notified for the same type
an application has been submitted;
(c) the documentation described in point 3, representative of the production envisaged (hereinafter referred to as
type) to assess compliance with the requirements of this Regulation.
The applicant must place the type at the disposal of the notified body. A designated organization is required
You may request additional samples.
3. The documentation must enable the design, manufacture and services of the device to be obtained
and should include:
(a) a general description of the type, all variants planned and its intended use (s)
a description;
(b) design drawings, methods of manufacture envisaged, in particular as regards sterilization, and
parts, components, circuits, etc. drawings;
(c) descriptions and explanations necessary for the understanding of said drawings and diagrams and the operation of the product;
(d) a list of the national harmonized standards applied in full or in part; and
a description of the solutions adopted to meet the essential requirements,
if the nationalized harmonized standards are not fully implemented;
(e) design calculations, risk analyzes, technical examinations, etc. results;
(f) a statement as to whether the device incorporates, as an integral part, Annex 1, point B.II 10.
or a human blood derivative and the substance prescribed in this connection
or the tool for evaluating the safety, quality and usefulness of a human blood derivative
data from tests performed taking into account its intended use;
(g) pre-clinical evaluation;
(h) clinical data in accordance with Annex 10;
(i) the draft instructions for use.
4. The notified body must, during the EC type-examination procedure:
4.1. examine and evaluate the documentation and verify that the type conforms to the documentation
They manufactured; lays down the items covered by the nationalized harmonized standards
designed in accordance with the relevant requirements of this Regulation and those that are not;
4.2. perform or have performed the appropriate examinations and necessary tests to check that:
the solutions adopted by the manufacturer meet the essential requirements of Annex 1 if a
nationalized harmonized standards are not fully implemented;
4.3. perform or have performed the appropriate examinations and necessary tests to check that,
that if the manufacturer has chosen the appropriate standards to be used, he has actually applied them;
4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out.
5. *
If the type meets the requirements of this Regulation, the notified body
It shall issue an EC type - examination certificate to the applicant. The certificate must include the
the name and address of the manufacturer, the conclusions of the examination,
the conditions of validity and the particulars necessary for identification of the approved type
required. The relevant parts of the documentation must be attached to the certificate and a copy designated
organization must retain.
For devices referred to in Annex 1, Part B, point 10, second paragraph, the notified body is Annex 1
With regard to the aspects referred to in point 10 of Part B - consult the Medicines Agency before taking a decision
with the competent body authorized to register or with the EMA,
the organization must issue an opinion within 210 days of receipt of the valid documentation. THE
the scientific opinion of the registrant or the EMA in the dossier for the device
must contain. The notified body shall give due consideration to the consultation when making its decision
views expressed during the It shall communicate its final decision to the registrant concerned
organizations.
For the instruments referred to in the third paragraph of point 10 of Part B of Annex 1, the ERF is scientific
Your opinion should be included in the documentation for the device. It is sufficient when the decision of the notified body is made
carefully consider the opinion of the EMA. The notified body will not issue the certificate if the EMA
its scientific opinion is unfavorable. The notified body shall communicate its final decision to the EMA.
6. The applicant must keep the notified body that has issued the EC type-examination certificate informed of:
any modification to the approved product.
These modifications shall be re-submitted to the notified body that issued the EC type-examination certificate
if the amendments are likely to affect compliance with the essential requirements or
the conditions prescribed for the use of the product. New acceptance, if warranted, of the original type examination
certificate.
7. Administrative requirements
7.1. A copy of the EC type - examination certificates and their additions may be obtained from another notified body.
The annexes to the certificates shall, upon reasoned request and after informing the manufacturer, be amended
shall also be made available to a designated body.
7.2. The manufacturer or his authorized representative shall keep the EC type - examination certificates
copies of its documentation and additions for a period ending at least fifteen years after the last device has been manufactured
you have to keep it.
7.3. If the manufacturer does not have a registered office in an EEA Member State, the technical documentation is available
the obligation of an authorized representative pursuant to Section 4 (1) (13).
Annex 4 to Regulation 4/2009 (III. 17.) EüM *
EC Product Inspection
A. For class assets
1. EC product verification is the procedure whereby the manufacturer or his authorized representative certifies - and
declares that the products subject to the procedure set out in point 4 conform to the EC type-examination certificate
type as described in the certificate and meet the requirements of this Regulation which apply to them.
2. The manufacturer must take all measures necessary to ensure that:
manufacture products which conform to the EC type-examination certificate
described in this Regulation and the requirements of this Regulation that apply to them. Before the start of production, the manufacturer must
draw up documentation setting out the manufacturing processes, in particular if
necessary for sterilization - as well as all the pre-existing requirements that apply to it
serve to ensure production
homogeneity and, where necessary, the conformity of the products in the EC type-examination certificate
with the model described in this Regulation and with the relevant provisions of this Regulation. The manufacturer must indicate in accordance with § 5
You must issue a CE mark and a declaration of conformity. Products marketed aseptically
In addition, in the case of also provided for in
which, however, apply only to those stages of manufacture which are sterilization and sterility
serve to maintain.
3. The manufacturer must undertake to set up and keep up to date a system with which
evaluate the experience gained with the device in the post-production phase, including Annex 10
and shall arrange for the necessary amendments to be made. This undertaking must also oblige the manufacturer to:
Report the events detailed therein in accordance with Section 21 without delay.
4. The notified body must carry out the appropriate examinations in order to verify the conformity of the product with this Regulation
compliance with the requirements of this Regulation by examination of each product at the choice of the manufacturer.
or by examining the products on a statistical basis in accordance with point 6. The
the checks mentioned above do not apply to ensuring the sterility of the manufacturing process
steps.
5. Inspection and testing of each product (piece test)
5.1. Each product shall be individually examined in accordance with the relevant national harmonized standards or
with these equivalent tests to determine whether they are equivalent to EC type-examination
with the model described in the certificate and complies with the relevant requirements of this Regulation.
5.2. The notified body must affix, or cause to be affixed, its identification mark on each approved product
and issue a written certificate of the tests performed.
6. Statistical verification
6.1. The manufacturer must produce and present the products as a single lot.
6.2. A random sample shall be taken from each lot. The sample products are individually
shall be examined in accordance with or with the relevant national harmonized standards
equivalent tests to determine whether they correspond to EC type-examination
with the model described in the certificate. Whether the lot is acceptable or should be returned depends on the outcome of the test
to instruct.
6.3. Statistical control of assets is based on characteristics and / or variables that are high
operating to ensure safety and state-of-the-art performance
shall be determined by sampling from systems with From the systems
sampling shall be determined by nationalized harmonized standards, taking into account orally
the specific nature of the rotating product categories.
6.4. If the lot is accepted, the notified body shall indicate on each product or
indicate its identification number and issue a written certificate of conformity
tests. All products in the lot may be put on the market except those in the sample
proven products.
If a lot is rejected, the notified body must take appropriate measures
to prevent the product from being placed on the market. For frequent item rejections a
the notified body may suspend the statistical verification.
The manufacturer may, under the responsibility of the notified body, affix the notified body during the manufacturing process
identification number.
7. *
Administrative requirements
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
in the case of assets, you must be able to provide OGYÉI with at least fifteen years:
(a) the EC declaration of conformity;
(b) the documentation referred to in point 2;
(c) in section 5.2. and 6.4. the certificates referred to in point.
(d) where appropriate, the EC type-examination certificate referred to in Annex 3.
8. Application to devices in Class IIa
In accordance with Section 13 (2), this Annex also applies to Class IIa devices
applicable under the following conditions:
8.1. 1-2. By way of derogation from point 1, the manufacturer shall certify and
declares that the products of Class IIa are subject to the technical specifications referred to in point 3 of Annex 7
have been manufactured in accordance with the documentation and meet the relevant requirements of this Regulation;
8.2. 1-2, 5-6. By way of derogation from point 1, the examination carried out by the notified body shall be aimed at confirming the
For Class IIa products, the technical documentation referred to in point 3 of Annex 7
its compliance.
9. Application to devices falling under Section 2 (1) (e)
In the case of point 5, all production batches of devices falling under Section 2 (1) (e)
after completion of its production and, in the case of the inspection referred to in point 6, by the manufacturer
the notified body of the issue of the production batch and send it to the notified body
organization has the official certificate of the human batch used in the finished batch
blood product obtained by a public laboratory or a Member State in accordance with Article 114 of Directive 2001/83 / EC
Issued by a laboratory designated for that purpose in accordance with paragraph 2.
B. For active implantable devices
1. EC product verification is the procedure whereby the manufacturer or his authorized representative certifies - and
declares that the products examined in accordance with the procedure set out in point 3 are in conformity with the EC requirements
described in the type-examination certificate and meet the requirements of this Regulation that apply to them.
2. The manufacturer or his authorized representative must take all measures necessary
to ensure that the manufacturing process produces a product which complies with EC
the type as described in the type-examination certificate and the relevant requirements of this Regulation. THE
the manufacturer or his authorized representative must affix the CE marking in accordance with § 5 to all devices
and issue a declaration of conformity.
3. The manufacturer must, before production begins, draw up documentation which:
records the manufacturing processes, in particular sterilization, as well as all, already
previously formulated specification, which serves to ensure the manufacture
the conformity of the products with the type as described in the EC type-examination certificate and e
with the relevant provisions of this Regulation.
4. The manufacturer must undertake to comply with the provisions referred to in Annex 10
establishes and maintains an up - to - date system for evaluating
experience gained in the post-production phase and arrange for any necessary modifications
implementation. This undertaking also obliges the manufacturer to comply with Article 21 without delay
report the events detailed there.
5. The notified body shall certify the conformity of the device with the requirements of this Regulation
perform the appropriate examinations by statistical verification of the device in accordance with point 6
and rehearsals. The manufacturer must authorize the notified body to take the measures referred to in point 2
evaluate the effectiveness of the measures by means of an actual product inspection (product audit).
6. Statistical verification
6.1. The manufacturer must produce and present the products as a single batch and must do everything in his power to do so
necessary measures to ensure that the manufacturing process ensures all batches produced
uniformity.
6.2. A random sample shall be taken from each lot. The products in the sample must be examined individually,
and the appropriate tests as provided for in the relevant national harmonized standards, or
equivalent tests must be carried out to determine whether the devices
correspond to the model described in the EC type-examination certificate. It depends on the result of the test that a
is acceptable or should be rejected.
6.3. The statistical control of an asset is based on characteristics and / or variables that are of a high degree
operating to ensure safety and state-of-the-art performance
shall be determined by sampling from systems with The sampling procedure is localized
shall be determined on the basis of harmonized standards, taking into account the
the specific nature of product categories.
6.4. If the lot is accepted, the notified body shall indicate on each product or
indicate its identification number and issue a written certificate of conformity
tests. All products in the lot may be put on the market except those in the sample
proven products.
If the lot is rejected, the notified body must take appropriate measures
to prevent the product from being placed on the market. For frequent item rejections a
a designated body may suspend the statistical verification.
The manufacturer may, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.
6.5. The manufacturer or his authorized representative must ensure compliance with the notified body's requirements on request
certificate.
7. When a series of devices referred to in Section 2 (1) (e) is completed, the manufacturer
inform the notified body that the series has been completed and send it to the notified body
the official certificate of the human blood product used in the completed device series, issued by the State
designated for that purpose by a laboratory or a Member State in accordance with Article 114 (2) of Directive 2001/83 / EC
issued by a laboratory.
Annex 5 to Regulation 4/2009 (III. 17.) EüM
EC declaration of conformity (production quality assurance)
A. For class assets
1. The manufacturer must, for the purposes of the manufacture and final inspection of the products concerned,
apply the quality system as specified in point 3 and undertake the quality system as specified in point 4
review.
2. The EC declaration of conformity shall form part of the procedure whereby the manufacturer who satisfies the obligations of section 1.
ensure and declare that the products concerned satisfy the obligations set out in
Described in the EC type-examination certificate and satisfy the requirements of this Regulation that apply to them.
The manufacturer or his authorized representative must affix the CE marking in accordance with Article 5, and
issue a written declaration of conformity. One or more specifics of this statement
clearly identifying the device (s) by product name, type designation or other
with a clear identifier. The declaration must be kept by the manufacturer.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body. The application shall:
must include:
(a) the name and address of the manufacturer,
(b) all relevant information for the products or product categories covered by the procedure,
(c) a written declaration that no other designated person has been contacted in respect of the same products
organization,
d) the quality system documentation,
e) to undertake the obligations arising out of the quality system as approved,
(f) an undertaking to maintain the quality system as approved and
effectiveness,
(g) where appropriate, the technical documentation of the approved types and the EC type - examination certificates
a copy,
(h) an undertaking by the manufacturer to institute and maintain a systematic procedure
up - to - date to review post - production experience with the device, including
Provisions of Annex 10
and make the necessary corrections. This undertaking also requires the manufacturer to comply with Article 21
report the events detailed therein without delay.
3.2. The quality system must ensure compliance of the products with
described in the type-examination certificate. Approved by the manufacturer for the quality system
all elements, requirements and specifications in a systematic and orderly manner in the form of written policies and procedures
documented in the form of. This quality documentation should allow for policies and procedures
such as quality programs, quality plans, quality manuals and
quality records. The documentation must include a description of:
(a) the manufacturer's quality objectives;
(b) the organization of the undertaking, in particular:
(ba) the organizational structure, responsibilities and powers of the management with regard to the manufacture of the products
in respect of
(bb) the methods used to monitor the effective operation of the quality system, in particular:
with a view to ensuring the quality to be achieved, including products which do not comply with this Regulation
regulations,
(bc) the means of monitoring the effective operation of the quality system where:
manufacture and / or acceptance inspection and testing of the product or component of the product
carried out by the organization, highlighting the method used to audit the external organization and its level of detail;
(c) the inspection and quality assurance techniques used during the manufacturing phase, in particular:
(ca) sterilization, procurement and documentation processes and procedures,
(cb) based on drawings, specifications or other relevant documents, at all stages of the manufacturing process
product identification procedures applied and kept up to date;
(d) the examinations and tests that will be carried out before, during and after manufacture, the frequency with which they will take place,
test equipment; the verification of the test equipment must be duly substantiated.
3.3. The notified body must examine the quality system to determine whether it satisfies the
whether it complies with 3.2. requirements referred to in The relevant
quality systems complying with harmonized standards meet these requirements. The
at least one member of the assessment team must have previous assessment experience on the technology concerned
on. In order to control the manufacturing processes, the assessment procedure should be included
inspections at the manufacturer's premises and, where appropriate, at the premises of the manufacturer's suppliers. The decision
which must contain the conclusions of the examination and the reasoned assessment decision,
it must be notified to the manufacturer after the last inspection.
3.4. The manufacturer must keep the notified body that has approved the quality system informed of any intended updating of the quality system
planned significant change to the quality system. The notified body must
examine the proposed changes and verify that the requirements of paragraph 3.2 are still met.
requirements referred to in point. The decision to accept the notification, which
it must contain the conclusions of the examination and the reasoned assessment decision,
manufacturer.
4. Review
4.1. The purpose of the review is to make sure that the manufacturer maintains the approved quality system
fulfill its obligations properly.
4.2. The manufacturer must authorize the notified body to carry out all necessary inspections,
for which you must provide all the necessary information, in particular:
a) the quality system documentation,
b) the technical documentation,
(c) the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports
and test data, calibration data, personnel qualification reports.
4.3. The notified body must periodically carry out audits and assessments to make sure that:
ensure that the manufacturer operates the approved quality system and the manufacturer
provide an evaluation report.
4.4. The notified body may pay unexpected visits to the manufacturer. Such visits
the notified body may, if necessary, carry out tests or have them carried out by the quality system
to verify its proper functioning. It was made about the inspection - and if it happened - about the tests
the report shall be made available to the manufacturer.
5. Administrative requirements
5.1. The manufacturer or his authorized representative shall, for a period ending at least 5 years after the last product has been manufactured,
in the case of implantable devices, for at least 15 years, make available to the authorities on request:
(a) the declaration of conformity;
b) a 3.1. the documentation referred to in point (d);
c) a 3.1. the documentation referred to in point (g);
d) and 3.4. the changes referred to in point;
(e) the notified body must comply with points 4.3 to 4.4. its decisions and reports referred to in
(f) where appropriate, the EC type-examination certificate referred to in Annex 3.
6. Application to devices in Class IIa
In accordance with Section 13 (2), this Annex applies to Class IIa devices
with the following exceptions:
6.1. Unlike Figures 2, 3.1-3.2. the manufacturer shall ensure and declare, by means of the declaration of conformity,
that the products in Class IIa conform to the technical documentation referred to in point 3 of Annex 7
and comply with the requirements of this Regulation that apply to them.
6.2. In the case of Class IIa devices, the notified body must:. described in point
as part of the assessment, examine whether for each asset category in Annex 7, point 3
at least one representative sample of the technical documentation specified in this Regulation complies with this Regulation.
6.3. In selecting the representative sample, the notified body shall take into account the novelty of the technology,
the similarity of the design, technological, manufacturing and sterilization procedures, the intended use,
and previous (eg physical, chemical or biological) tests performed in accordance with this Regulation
the results of evaluations). The notified body shall document the sampling
and make them available to the authority.
6.4. A 4.3. Additional samples shall be taken by the notified body as part of the surveillance assessment referred to in point
assess.
7. Application to devices falling under Section 2 (1) (e)
The production of all batches of devices falling under Section 2 (1) (e)
upon completion, the manufacturer shall notify the notified body of the release of that batch, and
send it the information listed in Annex 1, A.II. point
7.4. an official certificate issued by a laboratory in accordance with the third subparagraph of point
on the release of a batch of a human blood derivative used in a device.
B. For active implantable devices
1. The manufacturer must, for the purposes of the manufacture and final inspection of the products concerned,
apply the quality system as specified in point 3 and undertake the quality system as specified in point 4
review.
2. The EC declaration of conformity shall form part of the procedure whereby the manufacturer who satisfies the obligations of section 1.
ensure and declare that the products concerned satisfy the obligations set out in
Described in the EC type-examination certificate and satisfy the requirements of this Regulation that apply to them.
The manufacturer or his authorized representative must affix the CE marking in accordance with Article 5, and
issue a written declaration of conformity. One or more specifics of this statement
clearly identifying the device (s) by product name, type designation or other
with a clear identifier. The declaration must be kept by the manufacturer.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body. The application shall:
must include:
(a) all relevant information for the product category envisaged,
b) the quality system documentation,
(c) a declaration that the manufacturer must undertake to supply the approved quality system
liabilities,
(d) a declaration that the manufacturer maintains the approved quality system with sufficient efficiency,
(e) where appropriate, the technical documentation of the approved types and the EC type - examination certificates
a copy,
(f) an undertaking by the manufacturer to comply with the provisions referred to in Annex 10
introduces and maintains an after-sales monitoring system. That's the commitment, too
obliges the manufacturer to report the events detailed therein in accordance with Section 21 without delay.
3.2. The quality system must ensure compliance of the products with the EC requirements
described in the type-examination certificate. Approved by the manufacturer for the quality system
all elements, requirements and specifications in a systematic and orderly manner, in writing policies and procedures
documented in the form of. This quality documentation should allow for policies and procedures
such as quality programs, quality plans, quality manuals and
quality records. The documentation must include a description of:
(a) the manufacturer 's quality objectives;
(b) the organization of the undertaking, in particular:
(ba) the organizational structure, responsibilities and powers of the management with regard to the manufacture of the products
in respect of
(bb) the methods used to monitor the effective operation of the quality system, in particular:
with a view to ensuring the quality to be achieved, including for products which do not comply with this Regulation
regulation,
(bc) the means of monitoring the effective operation of the quality system where:
manufacture and / or acceptance inspection and testing of the product or component of the product
carried out by the organization, highlighting the method used to audit the external organization and its level of detail;
(c) the inspection and quality assurance techniques used during the manufacturing phase, in particular:
(ca) sterilization, procurement and documentation processes and procedures,
(cb) based on drawings, specifications or other relevant documents, at all stages of the manufacturing process
product identification procedures applied and kept up to date;
(d) the examinations and tests that will be carried out before, during and after manufacture, the frequency with which they will take place, and the frequency with which they will be carried out
test equipment.
3.3. The notified body must examine the quality system to determine whether:
does it comply with 3.2. requirements referred to in The relevant
quality systems complying with harmonized standards meet these requirements. The
at least one member of the assessment team must have assessment experience on the technology concerned.
The assessment procedure must include an inspection to verify the manufacturing process
at the premises of the manufacturer and, where appropriate, at the premises of the manufacturer's suppliers.
The decision must be notified to the manufacturer after the last inspection. This should include what was deducted from the audit
conclusions and justification for the evaluation.
3.4. The manufacturer must keep the notified body that has approved the quality system informed of any intended updating of the quality system
planned change in the quality system. The notified body must examine the proposed
changes and verify that the requirements of paragraph 3.2 are still met. requirements referred to in point. THE
the notified body must communicate its decision to the manufacturer. The decision shall include the findings of the audit
conclusions and justification for the evaluation.
4. Review
4.1. The purpose of the review is to make sure that the manufacturer maintains the approved quality system
fulfill its obligations properly.
4.2. The manufacturer shall authorize the notified body to carry out all necessary inspections for which it is responsible
you must provide all the necessary information, in particular:
a) the quality system documentation,
b) the technical documentation,
(c) the manufacturing records as specified in the quality system, such as inspection reports
reports and test data, calibration data, personnel qualification reports.
4.3. The notified body must periodically carry out audits and assessments to make sure that:
ensure that the manufacturer operates the approved quality system and that the manufacturer
provide an evaluation report.
4.4. The notified body may pay unexpected visits to the manufacturer. A report on these is made by the manufacturer
shall be made available to the
5. The notified body must communicate the quality systems to the other notified bodies
information on the acceptance, rejection or revocation of
6. Application to devices referred to in Section 2 (1) (e):
The production of all batches of devices falling under Section 2 (1) (e)
upon completion, the manufacturer shall notify the notified body of the release of that batch, and
an official certificate issued by the laboratory referred to in Annex 1, Part B, point 10
a certificate of batch production of the human blood derivative used in the device.
Annex 6 to Regulation 4/2009 (III. 17.) EüM
Product quality assurance
1. The manufacturer must lodge an application for final inspection of the products concerned with a notified body
apply the quality system as approved in point 3 and
the review provided for in In addition, in the case of products marketed as sterile, the manufacturer must use
Annex 5, point A, paragraphs 3-4. which, however, apply only to those stages of production
which serve to sterilize and maintain sterility.
2. The EC declaration of conformity shall form part of the procedure whereby the manufacturer who satisfies the obligations of section 1.
ensure and declare that the products concerned satisfy the obligations set out in
Described in the EC type-examination certificate and satisfy the requirements of this Regulation that apply to them. To the manufacturer
the
In accordance with § 5, you must affix the CE marking and a written declaration of conformity
issued. This statement must relate to one or more specific instruments, clearly
identifying the product (s) by the name, type designation or other unambiguous identifier of the product. The statement
must be retained by the manufacturer. The CE marking together with the identification number of that notified body
which performs the tasks referred to in this Annex.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body.
The application must include:
(a) the name and address of the manufacturer;
(b) all relevant information for the products or product categories placed under the procedure;
(c) a written declaration that no other designated person has been contacted in respect of the same products
organization;
(d) the quality system documentation;
(e) the obligations arising from the quality system as approved;
(f) an undertaking to maintain the quality system as approved and
effectiveness;
(g) where appropriate, the technical documentation of the approved types and the EC type - examination certificates
a copy;
(h) an undertaking by the manufacturer to institute and maintain a systematic procedure
up - to - date to review post - production experience with the device, including
Provisions of Annex 10 - and shall make the necessary adjustments. This undertaking must also oblige the manufacturer to:
to report without delay the events detailed therein in accordance with Section 21.
3.2. In the quality system, a representative sample of each product or each series
shall be examined and specified in the relevant national harmonized standard (s), or
equivalent tests must be carried out to ensure that the products conform
of the type as described in the type-examination certificate and satisfy the requirements of this Regulation that apply to them
requirements. All the elements and requirements introduced by the manufacturer into his quality system
and prescription in a systematic and systematic manner, in the form of written policies and procedures
documented. This quality documentation should allow for policies and procedures
codification such as quality programs, quality plans, quality manuals
and quality records. The documentation must include a description of:
(a) the quality objectives and the organizational structure, management with product quality
responsibilities and powers in relation to
(b) the examinations and tests that will be carried out after manufacture; the test equipment
its authentication must be duly substantiated;
(c) the methods of monitoring the efficient operation of the quality system;
(d) the quality records, such as inspections, tests and verifications,
staff qualification reports;
(e) the methods of monitoring the efficient operation of the quality system where the product is intended
or acceptance inspection and testing of a component of the product is carried out by an external body, highlighting:
the method used to audit the external organization and its level of detail.
The above tests do not apply to the manufacturing phases to ensure sterility.
3.3. The notified body must examine the quality system to determine whether it satisfies the
whether it complies with 3.2. requirements referred to in The relevant
quality systems complying with harmonized standards meet these requirements. The
at least one member of the assessment team must have previous assessment experience on the technology concerned
on. In order to control the manufacturing processes, the assessment procedure should be included
inspections at the manufacturer's premises and, where appropriate, at the premises of the manufacturer's suppliers. The decision
which must contain the conclusions of the examination and the reasoned assessment decision,
it must be notified to the manufacturer after the last inspection.
3.4. The manufacturer must keep the notified body that has approved the quality system informed of any intended updating of the quality system
planned significant change to the quality system. The notified body must
examine the proposed changes and verify that the requirements of paragraph 3.2 are still met.
referred to in point
requirements. The decision to accept the notification, which shall include the
the conclusions of the examination and the justification for the assessment must be communicated to the manufacturer.
4. Review
4.1. The purpose of the review is to make sure that the manufacturer maintains the approved quality system
fulfill its obligations properly.
4.2. The manufacturer must allow the notified body entrance for inspection purposes
have access to the premises used for inspection, testing and storage, and
provide it with the necessary documents, in particular:
(a) the quality system documentation;
(b) the technical documentation;
(c) the quality records, such as inspection reports and test data,
calibration data, personnel qualification reports.
4.3. The notified body must periodically carry out audits and evaluations to ensure that:
ensure that the manufacturer operates an approved quality system. Evaluator for the manufacturer
you must report.
4.4. The notified body may pay unexpected visits to the manufacturer. Such visits
may, if necessary, carry out tests or have them carried out on the correct operation of the quality system
and to verify that production complies with the requirements of this Regulation
requirements. For this purpose, a sufficient number of the final product shall be taken on site by the notified body
sample shall be tested and the relevant localized harmonized
tests specified in the standard (s) or equivalent. If one or more samples do not
the notified body
take the necessary measures. The manufacturer must be provided with the visit
report or, if tests have been performed, the test report.
5. Administrative requirements
5.1. The manufacturer or his authorized representative shall, for a period ending at least 5 years after the last product has been manufactured,
in the case of implantable devices, for at least 15 years, make available to the authorities on request:
(a) the declaration of conformity;
b) a 3.1. the documentation referred to in point (g);
c) a 3.4. the changes referred to in point;
(d) 4.3.4.4 of the notified body. its decisions and reports referred to in
(e) where appropriate, the EC type-examination certificate referred to in Annex 3.
6. Application to devices in Class IIa
In accordance with Section 13 (2), this Annex applies to Class IIa devices
with the following exceptions:
6.1. Unlike Figures 2, 3.1-3.2. the manufacturer shall ensure and declare, by means of the declaration of conformity,
that the products in Class IIa conform to the technical documentation referred to in point 3 of Annex 7
and comply with the requirements of this Regulation that apply to them.
6.2. In the case of Class IIa devices, the notified body must:. described in point
as part of the assessment, examine whether for each asset category in Annex 7, point 3
at least one representative sample of the technical documentation specified in this Regulation complies with this Regulation.
6.3. In selecting the representative sample, the notified body shall take into account the novelty of the technology,
the similarity of the design, technological, manufacturing and sterilization procedures, the intended use,
and this Regulation
previous assessments (eg physical, chemical or biological) that have been properly performed
results. The notified body shall document the sampling aspects and make them available
for the authority.
6.4. A 4.3. Additional samples shall be taken by the notified body as part of the surveillance assessment referred to in point
assess.
Annex 7 to Regulation 4/2009 (III. 17.) EüM *
Manufacturer 's EC declaration of conformity
1. The manufacturer's EC declaration of conformity is the procedure whereby the manufacturer or his authorized representative
who fulfills the obligations referred to in point 2 and in a sterile condition or with a measuring function
fulfills the obligations laid down in point 5 in respect of the placing on the market of
ensure and declare that the products concerned satisfy the requirements of this Regulation that apply to them.
2. *
The manufacturer must draw up the specifications listed in point 3
documentation. The manufacturer or his authorized representative shall keep the documentation, which shall include the EC
declaration of conformity, - upon request - made available to OGYÉI for inspection
for at least 5 years after the last product has been manufactured and, in the case of implantable devices, the last product
for at least 15 years from the date of manufacture. If neither the manufacturer nor his authorized representative is in Hungary
the obligation to keep the above documentation rests with the distributor of the product.
3. The technical documentation must enable the conformity of the product with the requirements of this Regulation to be assessed
It meets. The technical documentation must include:
(a) a general description of the product, including any variants planned and its intended use
application (s);
b) design drawings, methods of manufacture envisaged, drawings of components, fittings and circuits;
(c) descriptions necessary for an understanding of the said drawings and diagrams and the operation of the product
and explanations;
(d) the results of the risk analysis and the fully or partially applied nationalized harmonized
a list of standards and a description of the solutions adopted to meet the essential requirements
nationalized harmonized standards are not fully adopted
prevail;
(e) in the case of products placed on the market in a sterile state, a description of the methods used; and
validation report;
(f) results of design calculations made and examinations carried out;
(g) the solutions adopted pursuant to Annex 1, Part A, point 2;
(h) pre-clinical evaluation;
(i) the clinical evaluation in accordance with Annex 10;
(j) the label and instructions for use.
4. *
The manufacturer must undertake to establish and maintain a systematic procedure
up to date to review the device after manufacture and in accordance with the requirements of annex 10
experience gained and shall make the necessary adjustments to make the necessary adjustments,
taking into account the nature of the instrument and the risks involved in its use. This undertaking must also oblige the manufacturer to:
to immediately report the events detailed therein to OGYÉI in accordance with the provisions of Section 21.
5. Class I devices placed on the market in a sterile state or with a measuring function
the manufacturer need not only comply with the requirements set out in this Annex
but also one of the procedures referred to in Annexes 2, 4, 5 or 6. These a
The application of Annexes I and II and the involvement of the notified body shall be limited to:
(a) in the case of products placed on the market in a sterile state, only to ensure a sterile state; and
production processes to maintain
(b) in the case of devices with a measuring function, only the measurement technology of the products
manufacturing processes for compliance with the requirements.
Section 6.1 of this Annex. shall apply.
6. Application to Group IIa assets
In accordance with Section 13 (2), this Annex may apply to Group II.a.
products with the following derogation:
6.1. Where this Annex is used in conjunction with the procedure referred to in Annex 4, 5 or 6
the declarations of conformity referred to in them and in this Annex
shall be issued in the form of a single declaration. If this statement is based on this Annex, the
the manufacturer must ensure and declare that the products are designed to comply with this Regulation
relevant requirements.
Annex 8 to Regulation 4/2009 (III. 17.) EüM *
A. Ordered Equipment Statement *
1. In the case of custom-made devices or devices intended for clinical investigations, the manufacturer or his authorized representative
shall draw up a declaration containing the information specified in point 2.
2. The declaration (certificate of workmanship) must contain the following information:
2.1. For custom-made devices:
(a) the name and address of the manufacturer;
(b) data enabling the device to be identified;
(c) a statement that the device is intended for the exclusive use of a specific named patient;
(d) the name of the specialist or other authorized person who ordered the device and, where applicable, the
the name of the healthcare provider;
(e) the specific characteristics of the device in accordance with the specifications set out in the order;
(f) a statement that the device meets the essential requirements set out in Annex 1,
indicating those, if any, which have not been fully complied with, together with the reasons therefor.
2.2. *
3. *
The manufacturer must undertake to make available to OGYÉI:
3.1. In the case of custom-made devices, documentation indicating the place of manufacture
(locations) and enables the design, manufacture and performances of the device to be understood,
including the required performance to enable compliance with the requirements of this Regulation
to assess compliance.
The manufacturer shall take all measures necessary so that the manufacturing process produces such materials
ensure that the devices comply with the documentation referred to in the previous paragraph.
3.2. *
4. The data listed in the declarations relating to this Annex shall be kept for at least 5 years, implantable
and for at least 15 years.
5. In the case of custom-made devices, the manufacturer's undertaking to:
establish and maintain a systematic process to review and document
the experience gained from the device after manufacture, including the provisions of Annex 10,
and arrange for the necessary corrections. This undertaking also requires the manufacturer to comply with Article 21
report the events detailed therein without delay.
B. Ordered Equipment Statement *
1. In the case of custom-made devices or devices intended for clinical investigations, the manufacturer or his authorized representative
shall draw up a declaration containing the information specified in point 2.
2. The declaration (certificate of workmanship) must contain the following information:
2.1. For custom-made devices:
(a) the name and address of the manufacturer;
(b) information necessary to identify the asset;
(c) a statement that the device is intended for the exclusive use of a particular patient, in the name of the patient
together;
(d) the name of the specialist who prescribed the device and, where applicable, the name of the healthcare provider;
(e) the specific characteristics of the device in accordance with the specifications set out in the order;
(f) a statement that the device meets the essential requirements set out in Annex 1,
indicating those, if any, which have not been fully complied with, together with the reasons therefor.
2.2. *
3. *
The manufacturer must undertake to make available to OGYÉI:
3.1. In the case of custom-made devices, documentation indicating the place of manufacture
(locations) and enables the design, manufacture and performances of the device to be understood,
including the planned performance to enable compliance with the requirements of this Regulation
to assess compliance. The manufacturer shall take all measures necessary in order that the:
ensure that the devices manufactured during manufacture are in conformity with the documentation.
3.2. *
4. The particulars listed in the declarations relating to this Annex have been calculated since the last product was manufactured
it must be kept for at least fifteen years.
5. In the case of custom-made devices, the manufacturer's undertaking to:
establish and maintain a systematic process to review and document
the experience gained from the device after manufacture, including the provisions of Annex 10,
and arrange for the necessary corrections. This undertaking also requires the manufacturer to comply with Article 21
report the events detailed therein without delay.
Annex 9 to Regulation 4/2009 (III. 17.) EüM
Rules for classification
I. Definitions
1. Definitions for classification rules
1.1. periods
Transient: Designed for continuous use for less than 60 minutes under normal conditions.
Short-term: normally designed for continuous use for less than 30 days.
Long-term: Designed for continuous use for more than 30 days under normal conditions.
1.2. Invasive devices
Invasive devices: A device that is partially or through a body orifice or body surface
it penetrates the body completely.
Body orifice: a natural orifice on the skin, including the outer surface of the eyeball, or by any surgical procedure
created a permanent opening, such as a stoma.
Surgical invasive device: An invasive device that travels through the surface of the body through surgery
or enters the body in connection therewith.
Implantable device (implant): any device that is used to perform a surgical procedure
fully introduced into the body, or
- replace the epidermis or eye surface and remain in place after the procedure.
The means by which they are partially introduced by surgery are
into the human body and which remain in place for at least 30 days after the intervention shall be an implantable device
to view.
1.3. Reusable surgical instrument: an instrument that can be used for cutting during surgical procedures,
for drilling, sawing, scraping, coupling, clamping, spreading, etc. serve without
that it is connected to any active device and that can be reused after proper procedures have been performed.
1.4. Active device: a device whose operation depends on electricity or other energy, here
not including energy directly from the human body or gravity.
Devices that are intended to be energy and matter between the patient and the active device are not considered to be active devices
or transmitting other parameters without undergoing a substantial change. Standalone software is active
considered as an asset.
1.5. Active therapeutic device: an active device used alone or in combination with other devices that is a disease,
to maintain biological functions and structures in connection with the treatment or alleviation of injury or disability,
to change, replace or restore.
1.6. Active diagnostic tool: An active tool used alone or in combination with another device to provide information
to diagnose a physiological condition, disease or congenital anomaly,
to monitor or manage.
1.7. Central circulatory system:
For the purposes of this Annex, the central circulatory system means the following vessels:
arteriae pulmonales, aortic aorta, arcus aortae, descending aorta bifurcatio aortae, arteriae
coronariae, common carotid artery, external carotid artery, internal carotid artery,
arteriae cerebrales, truncus brachiocephalicus, cord vein, pulmonary vein, superior vena cava,
inferior vein.
1.8. Central nervous system: for the purposes of this Annex, the brain, meninges and spinal cord.
II. Implementing rules
2. Implementing rules
2.1. The application of the classification rules is determined by the intended purpose of the asset.
2.2. If the asset is intended to be used in combination with another asset, the classification rules apply to the asset
shall be applied to each of them separately. Accessories must be classified in their own right, regardless of
the means by which they are used.
2.3. The software that controls the device or affects the use of the device is in the same
belongs to the class as the device.
2.4. If the device is not exclusively or primarily not in a specific part of the body
shall be judged and classified on the basis of the highest use
contains a level of vulnerability.
2.5. If there are multiple rules for the same device based on the performance specified by the manufacturer
the strictest rule resulting in a higher classification shall apply.
2.6. Chapter I, Section 1.1. in calculating the period referred to in point
use means the uninterrupted actual use of the device for its intended purpose. When
the device is discontinued in order to be immediately replaced by the same device or replaced by the same device,
then this should be considered as an extension of the continuous use of the tool.
III. Classification
1. Non-invasive devices
1.1. Rule 1
All non-invasive devices are in Class I, unless otherwise specified below
rule applies to it.
1.2. Rule 2
Any non-invasive device intended to contain blood, body fluids or body tissues, liquids or gases
for the purpose of final injection, administration or introduction into the body, in accordance with Annex II.a.
belongs to class if
(a) can be connected to an active device in Class IIa or higher, or
b) its purpose is to store or conduct blood or other body fluids, or organs, parts of organs
or storage of body tissues. In all other cases, it is in Class I.
1.3. Rule 3
Any non-invasive device intended for blood, other body fluids as well
modification of the biological or chemical composition of other fluids entering the body by infusion, II.b
unless the treatment involves filtration, centrifugation or gas or heat exchange.
because in these cases it belongs to class II.a.
1.4. Rule 4
Non-invasive devices that come in contact with a damaged skin surface
(a) are in Class I if they are intended to form a mechanical barrier or compression,
swallow secretions,
(b) are in Class II.b if they are intended primarily for lack of continuity of leather cover
used for associated wounds that can only heal as a secondary effect,
(c) in all other cases, be in Class IIa, including devices which are wounds
provide a microenvironment.
2. Invasive devices
2.1. Rule 5
All orifice - related invasive devices other than surgically invasive devices, and
which is not intended to be connected to an active medical device or which is
designed to be connected to a Class I active device
(a) in Class I, if intended for temporary use,
(b) in Class IIa, if intended for short-term use, unless in the oral cavity,
used in the throat, nasal cavity or ear canal up to the eardrum, in which case it is in Class I,
(c) is in Class IIb if intended for long-term use, except in the case of the oral cavity, throat,
used in the nasal cavity or ear canal up to the eardrum and need not be absorbed through the mucosa;
in these cases it is in Class IIa.
All orifice - related invasive devices that are not surgically invasive devices and that
Intended for connection to an active device in Class IIa or higher, in Class IIa.
2.2. Rule 6
All surgically invasive devices intended for temporary use are in Class IIa, unless:
(a) specifically for the control of disorders of the heart or the central circulatory system,
intended to diagnose, monitor or correct by direct contact with these parts of the body;
in this case, Annex III. belongs to class
(b) reusable surgical instruments, in which case they are in Class I,
(c) intended for direct contact with the central nervous system; in this case III. belongs to class
(d) intended to supply energy in the form of ionizing radiation; in this case to Class II.b.
belongs to,
(e) it is intended to have a biological effect, in whole or in part
absorbed; in this case it is in Class II.b,
(f) the purpose for which the medicinal product is to be administered by means of a dosing system and taking into account that route of administration
potentially dangerous; in this case it is in Class II.b.
2.3. Rule 7
All surgically invasive devices intended for short-term use are in Class IIa, except
if
(a) specifically for the control of disorders of the heart or the central circulatory system,
intended to diagnose, monitor or correct by direct contact with these parts of the body;
in this case, Annex III. belongs to class
(b) specifically intended for use in direct contact with the central nervous system; in this
in that case, Annex III. belongs to class
(c) intended to supply energy in the form of ionizing radiation; in this case it is in Class II.b,
(d) it is intended to have a biological effect or to be completely or largely absorbed; in this case, Annex III.
belongs to class
(e) it is intended to undergo a chemical change in the body (unless the device is intended to
tooth) or give medicine; in this case the
It belongs to class II.b.
2.4. Rule 8
All implantable devices and long - term surgically invasive devices a
It is in Class II.b, unless intended
(a) gets into the tooth; in this case it is in Class IIa,
(b) in direct contact with the heart, the central circulatory system or the central nervous system
use; in this case, Annex III. belongs to class
(c) has a biological effect or is partially or completely absorbed; in this case, Annex III. classes
belongs to,
d) undergoes a chemical change in the body (unless it gets into the tooth) or for the administration of a medicine
It serves; in this case, Annex III. belongs to class.
3. Additional rules for active assets
3.1. Rule 9
All active therapeutic devices intended to transmit or exchange energy are in Class IIa.
unless it has the characteristics of transmitting energy to the human body, or
energy exchange with the human body, the nature, density and
potentially hazardous given its application environment; in this case the
It belongs to class II.b.
Any active device intended to be active therapeutic in Class IIb
monitor or control the operation of such devices or are intended to operate such devices
class II.b.
3.2. Rule 10
All active diagnostic tools are in Class IIa that are intended to:
(a) release the energy absorbed by the human body, except for the patient's body in the visible spectrum
means used to illuminate the
b) represents the distribution of radiological preparations in vivo,
(c) allow the direct diagnosis and monitoring of vital physiological processes, unless:
was specifically designed to monitor vital physiological parameters that
may result in an immediate hazard to the patient (eg cardiac function, respiration,
changes in central nervous system activity); in this case it is in Class II.b.
Active devices intended to emit ionizing radiation and for radiological diagnosis or therapy,
including devices which control or monitor them and which directly affect their operation, in accordance with Annex II.b.
belong to class.
3.3. Rule 11
Any active device that is used to inject drugs, body fluids, or other substances into the body
intended for administration or removal from the body is in Class IIa, unless the substance so requires
potentially hazardous in nature, the part of the body concerned or the route of administration
performs; in this case it is in Class II.b.
3.4. Rule 12
All other active devices are in Class I.
4. Special rules
4.1. Rule 13
Any device which, as an integral part, contains a material which, when used separately, is
52/2005 on the placing on the market of medicinal products for human use (XI. 18.) EüM decree
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
belongs to.
Any device that contains a human blood derivative as an integral part is listed in Annex III. belongs to class.
4.2. Rule 14
Any device used for contraception or the prevention of the sexual transmission of diseases shall be
unless it is an implantable or long-term invasive device; in such cases a
III. belongs to class.
4.3. Rule 15
Specially for disinfecting, cleaning, rinsing and, if necessary, moistening contact lenses
intended for use are in Class II.b.
Devices specifically intended for the disinfection of devices are in Class II.a. Except
if used for specifically invasive device disinfection, in which case Class IIb
belongs to.
This rule does not apply to products other than contact lenses
intended for the physical cleaning of equipment.
4.4. Rule 16
Devices specifically intended for the recording of X-ray diagnostic images are in Class II.a.
4.5. Rule 17
Any device manufactured utilizing non-viable animal tissues or derivatives shall be as set out in Annex III. classes
unless such device is intended to come into contact with intact skin only.
5. Rule 18
As an exception to the other rules, blood bags are in Class II.b.
Annex 10 to Regulation 4/2009 (III. 17.) EüM *
Clinical evaluation
A. For class assets
1. General requirements
1.1. When the device is used as intended, in accordance with Annex 1, Part A, points 1 and 3
demonstration of compliance with performance and performance requirements, adverse reactions and
Evaluation of the acceptability of the benefit / risk balance according to Annex 1, Part A, point 6 on clinical data
should be based on. The evaluation of these data (hereinafter referred to as “clinical evaluation”) - where
taking into account all relevant harmonized standards - defined and methodologically sound procedures
based on:
1.1.1. the safety, performance, design characteristics and intended purpose of the device,
a critical evaluation of the currently available scientific literature, where
(a) the equivalence of the asset with the asset to which the data relate,
provable, and
(b) the data adequately demonstrate compliance with the essential requirements;
1.1.2. or a critical evaluation of the results of all clinical trials performed;
1.1.3. or 1.1.1. and 1.1.2. critical evaluation of the combined data according to
1.2. Implantable or III. In the case of a device in this class, clinical investigations must be performed unless
if existing clinical data can be relied upon with due justification.
1.3. The clinical evaluation and its outcome should be documented. This documentation is for the tool
shall be included in the technical documentation and / or be fully referenced in the technical documentation.
1.4. The clinical evaluation and its documentation shall be kept up - to - date on the device
post-marketing data. If the manufacturer considers that there is no need for placing on the market
post-marketing clinical follow-up as part of the market surveillance plan
and should be documented.
1.5. *
If OGYÉI deems it essential
Demonstration of compliance with the requirements based on clinical data is not appropriate, the sanction
duly substantiated, in particular
the outcome of risk management and the specifics of the asset-body interaction, a
intended clinical performance and the manufacturer's claim. If the
Demonstration of compliance with the essential requirements is based solely on the performance evaluation of the product range
examination and evaluation prior to medical use, it shall be duly substantiated.
B. For active implantable devices
1. General requirements
1.1. During the intended use of the device, in accordance with Annex 1, Part B, points 1 and 2
demonstration of compliance with performance and performance requirements, adverse reactions and
The assessment of the acceptability of the benefit / risk balance according to Annex 1, Part B, point 5 shall be based on clinical data
based. Evaluation of these data (hereinafter referred to as clinical evaluation) - where applicable, into account
taking into account all relevant harmonized standards, a defined and methodologically sound procedure
based on:
1.1.1. the safety, performance, design characteristics and intended purpose of the device,
a critical evaluation of the currently available scientific literature, where
(a) the equivalence of the asset with the asset to which the data relate,
provable, and
(b) the data adequately demonstrate compliance with the essential requirements;
1.1.2. or a critical evaluation of the results of all clinical trials performed;
1.1.3. or 1.1.1. and 1.1.2. critical evaluation of the combined data according to
1.2. Clinical investigations must be performed unless duly substantiated
can rely on existing clinical data.
1.3. The clinical evaluation and its outcome should be documented. This documentation is for the tool
shall be included in the technical documentation and / or be fully referenced in the technical documentation.
1.4. The clinical evaluation and its documentation shall be kept up - to - date on the device
post-marketing data. If the manufacturer considers that there is no need for placing on the market
post-marketing clinical follow-up as part of the market surveillance plan
and should be documented.
1.5. *
If OGYÉI deems it essential
Demonstration of compliance with the requirements based on clinical data is not appropriate, the sanction
duly substantiated, in particular as regards the outcome of the risk management, and
the characteristics of the device-body interaction, the intended clinical performance, and a
taking into account the manufacturer's claim. Where proof of compliance with the essential requirements is provided only
based on performance evaluation, batch testing and pre-medical evaluation
occurs, it must be duly substantiated.
1.6. *
During the clinical evaluation, the data are provided by OGYÉI in accordance with the data protection regulations
treated in accordance with
Annex 11 to Regulation 4/2009 (III. 17.) EüM
"CE" conformity marking
The CE marking shall consist of the initials "CE" taking the following form:
The above proportions must also be observed when using a reduced or enlarged signal.
The two letters of the CE marking must have the same vertical dimension and may not be less than 5 mm.
In the case of small devices, the minimum size requirement may be waived.
Annex 12 to Regulation 4/2009 (III. 17.) EüM
Medical device incidents and manufacturer's on-site safety corrective actions
notification form
A) * The healthcare provider, distributor, user
notification form for an unforeseen event or accident involving a medical device
Applicant details:
Name of notifier:
□ Distributor □ Distributor
□ Importer □ User
Street, house number or mailbox
Postal code City Contact name
Telephone Fax
E-mail
Name and contact details of the person responsible for the accident
Device information:
Trade name of the asset The risk class of the asset
Device type or catalog number
Serial number and / or serial number
Device accessories
Software version (if applicable)
Manufacturer information:
Manufacturer's name Street, house number
Postcode City Country
Telephone Fax
E-mail
Details of the manufacturer's authorized representative Other representation in Hungary
Event Details: The date of the event
Location of the event
Description of the event
Consequences (eg death, damage to health, illness BNO-10 code
Measures taken in connection with the incident
Operating data:
Service construction (service contract: own service, brand service, eg Name and address of the service
Date of last periodic review, details of medical technology
Based on Annex 13
Date of last logged service intervention Date of last logged overhaul
Comment:
This notification does not imply that the manufacturer, the authorized representative confirms or acknowledges that it is notified
means of death or damage to the health of a person in any way, or indirectly
I hereby declare that the above data are to the best of my knowledge
Location: ................................................ Date: .............................................
.................................................. .................................................. ....................
..........
B) * Manufacturer's (authorized representative's) notification form
- unforeseen events and accidents of which he becomes aware
Report Form Manufacturer’s Incident Report
Recipient
Name of national competent authority (NCA)
Address of national competent authority (NCA)
Date of this report
Reference number assigned by the manufacturer
Reference number assigned by the national authority (if known) / Reference number assigned by NCA to whom sent (if
Known)
Type of report
□ Initial report
□ Follow-up report
□ Combined initial and final report
□ Final report
Unexpected event classification
Event causing death
□ Unanticipated serious deterioration in state of
health
□ Serious public health threat
□ Other reportable incidents
Name of other national authority (ies) that received the notification / Identify to what other NCAs this
report was also sent
2 Information on submitter of the report
Type of submitter
□ Manufacturer
□ Authorized representative in accordance with Section 4 (1) (13) of the EüM Decree on Medical Devices /
Authorized representative within EEA and Switzerland
3 Manufacturer information / Manufacturer information Manufacturer name / Manufacturer name
Manufacturer's Contact person
Address
Postal code
E - mail address / E - mail
City / City
Fax / Fax Country / Country
Authorized Representative information
Name of the authorized representative
The authorized representative’s Contact person
Address
Postal code
E - mail address / E - mail
City / City
Fax / Fax Country / Country
5 Data related to the notified medical device
Class
□ Active implants / AIMD Active implants
□ III. Class III device / MDD Class III
□ Class II.b device / MDD Class IIb
□ Class II.a device / MDD Class IIa
□ Class I device / MDD Class I
Nomenclature system (preferably GMDN)
Code / Nomenclature code
Code text name / Nomenclature text
Commercial name, brand name / Commercial name / brand name / make
Model and / or catalog number
Serial number and / or batch number (s) and / or lot / batch number (s)
Software version number (if applicable) / Software version number (if applicable)
Date of manufacture / expiry date (if applicable) / Manufacturinq date / expiry date (if applicable)
Accessory / associated device (if any)
device (if applicable)
Notified body ID number
6 Incident information
Registration number of the application at the place of application (if applicable) / User facility report reference
number, if applicable
Manufacturer's awareness date
Date of incident occurred
Incident description narrative
Number of persons involved (if known)
Number of medical devices involved (if known)
Medical device current location / disposition (if known)
Operator of the medical device at the time of the incident
□ Health care professional
□ Patient / patient
□ Other
Usage of the medical device
□ Initial use
□ Reuse of a reusable medical device
□ Other (please specify):
□ Refurbished device / re-serviced / refurbished
□ Before use
problem noted prior use
7 Information on the persons involved
Conditions of use of the device
Care provided by the healthcare provider to the person concerned / Remediai action taken by the healthcare
facility relevant to the care of the person involved
Age of the person at the time of the incident (if known) / Age of the person at the time of the incident, if applicable
Gender concerned (if known) / Gender (if applicable)
□ Woman
□ Male / Male
Weight in kilograms (if applicable)
8 Healthcare facility information (where the event occurred) / Healthcare facility information
Name of the healthcare facility Incident Contact person within the
facility Address
Postal code
Phone number / Phone E-mail / E-mail
City / City
Fax / Fax Country / Country
9 Manufacturer's preliminary remarks (in case of prior and follow-up notification) / Manufacturer's
preliminary comments (Initial / Follow-up report)
Manufacturer's preliminary analysis
Preliminary corrective actions / preventive actions by the manufacturer
implemented by the manufacturer
Expected date of next report
10 Results of manufacturers final investigation (Final report)
The manufacturer’s device analysis results
Corrective action / remedial action / preventive action / on-site safety corrective action /
Remedies action / corrective action / preventive action / Field Safety Corrective Action
Note: to be completed from medical devices in case of on-site safety corrective action
C: Annex C of the Decree on the submission of the FSCA
to fill in the FSCA report form of this annex
Time Schedule for the implementation of the identified
action
Manufacturer's comments on the measures / Final comments from the manufacturer
Further investigations
Is the manufacturer aware of events related to the device for similar reasons?
aware of similar incidents with this type of medical device with a similar root cause?
□ Yes
□ No
If yes, in which countries and the report number?
reference numbers of the incidents
To be completed only for final notification. The device is marketed in the following countries:
report only. The medical device has been distributed to the following countries:
11 Comments
I declare that I have provided the above information to the best of my knowledge./ I affirm that the
The information given above is correct to the best of my knowledge.
..............................................
Signature
Name / Name
City / City
Date
Submission of this notification does not in itself mean that the manufacturer and / or his authorized representative are either
the competent national authority acknowledges that the submission of the notification is a complete solution and that:
the notified device would have contributed in any way to the death of the person involved in the incident, or
damage to health or would have been the direct cause of it.
Submission of this report does not, in itself, represent a conclusion by the manufacturer and / or
authorized representative or the national competent authority that the content of this report is complete or
accurate, that the medical device (s) listed failed in any continent and / or that the medical device (s) caused or
contributed to the alleged death ordeterioration in the state of health of any person.
(C) Manufacturer's authorized representative's form for on-site corrective action
Report Form
Field Safety Corrective Action
1 Administrative information
Name of national competent authority (NCA)
Address of national competent authority (NCA)
Date of this report
Reference number assigned by the manufacturer
For the unexpected event, accident reference number at the competent authority where the prior notification
authority name (if known) / Incidence reference number and name of the co-ordinating national
competent authority (if applicable)
Name of other national authority (ies) that received the notification
other national competent authorities this report was also sent
2 Information on submitter of the report
Type of submitter
□ Manufacturer
□ Authorized representative within EEA
□ Others (identify the role):
3 Manufacturer information
Manufacturer name
Name of contact person at the manufacturer
Address
Postal code
E - mail address / E - mail
City / City
Fax / Fax Country / Country
4 Authorized representative information
Name of the authorized representative
The authorized representative’s contact person
Address
Postal code
E - mail address / E - mail
City / City
Fax / Fax Country / Country
5 National contact point information
National contact point name
Name of the contact person
Postal code
E - mail address / E - mail
City / City
Fax / Fax Country / Country
6 Medical device information
Class
□ Active implantable medical device / AIMD Active implants
□ III. Class III device / MDD Class III
□ Class II.b device / MDD Class IIb
□ Class II.a device / MDD Class IIa
□ Class I device / MDD Class I
Nomenclature system (preferable GMDN) Code / Nomenclature code
Text name of the code / Nomenclature text Commercial, brand name / Commercial name / brand name / make Model- and
catalog number / Model and / or catalog number
Serial number and / or lot or batch number (s) and / or lot / batch number (s)
Software version number (if applicable) / Software version number (if applicable)
Manufacturing date / expiry date (if known)
applicable)
Accessories / associated device (if any)
(if applicable)
Notified body ID number
7 Description of the on - site safety corrective action (FSCA)
Reason and background information of on - site security corrective actions
for the FSCA
Description and justification of the procedure (corrective / preventive)
action (corrective / preventive)
Propose the necessary measures to the distributor and the user
to be taken by the distributor and the user
Attachments please find
□ Field Safety Notice (FSN) in English
□ FSN in national language
□ Others (please specify):
Time schedule for the implementation of the different
actions
States concerned by on - site security corrective actions (Member States, EEA States)
within the EEA are affected by this FSCA
These countries outside the EEA and Switzerland are affected by this FSCA
8 Comments
I declare that I have provided the above information to the best of my knowledge./ I affirm that the
The information given above is correct to the best of my knowledge.
.................................................. ..............
Signature
Name / Name City / City Date / Date
Submission of this notification does not in itself mean that the manufacturer and / or his authorized representative are either
the competent national authority acknowledges that the submission of the notification is a complete solution or that
the notified device would have contributed in any way to the death of the person involved in the incident,
or would have been the direct cause of the damage.
Submission of this report does not, in itself, represent a conclusion by the manufacturer and / or
authorized representative or the national competent authority that the content of this report is
complete or accurate that the medical device (s) listed failed in any continent and / or that the medical
device (s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
Annex 13 to Regulation 4/2009 (III. 17.) EüM *
Periodic review
I. Scope of products subject to periodic review, frequency of review
1. Defibrillator 1
annually
2. High Frequency Surgical Cutter 1
annually
3. Incubator 1
annually
4. Anesthetic breathing apparatus 1
annually
5. Operating light 1
annually
6. Dialysis equipment 1
annually
7. Invasive and interventional X-rays. equipment 1
annually
8. Operating table 2
annually
9. Tonometer 2
annually
10. X-ray examination and recording workplace 2
annually
11. Surgical image intensifier 2
annually
12. Surgical and surveillance monitor, ECG 2
annually
13. Laser 2
annually
14. Invasive Blood Pressure Monitor and Blood Flow Meter 2
annually
15. Machine infusion device 3
annually
16. Blood warming device 3
annually
17. Sterilization equipment 3
annually
18. Mains-operated electrotherapy device (stimulator, high-frequency device, etc.)
3
annually
19. Medical gas supply equipment and complete system 3
annually
20. Imaging Ultrasound Diagnostic Device 3
annually
II. Other specifications
1. *
The result of the test must be recorded. The documentation of the institution
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
to the state health administration body and OGYÉI. In addition to the test results
the method of control must also be indicated.
2. In the case of equipment which is difficult or difficult to transport, or in the case of equipment which is temporary
nor is it indispensable in the institution, a local control method must be provided.
3. The periodic inspection shall be performed after the service intervention following the failure
also if the intervention extended to the property to be tested.
4. The periodic review shall not affect the competence of the other certification body
referred to mandatory tests (eg scale verification).
5. The first periodic inspection after commissioning, depending on the required frequency 1, 2
or after 3 years. The further review shall take effect from the date of the previous review.
! Annex 14 to Regulation 4/2009 (III. 17.) EüM *
! NOTIFICATION FORM
For the National Center for Public Health
devices in Class IIa specifically intended for the disinfection of medical devices
on the placing on the market in Hungary
Details of the manufacturer, distributor, authorized representative Notifier (company)
name:
.................................................. .................................................. ....................
..............................
Headquarter:                                  _                                  _                                  _
_
.................................................. .................................................. ....................
..........
Site address: _ _ _ _ ........................................... .............
County:
.................................................. .
Phone: .................................... Fax:
................................... E-mail:
.................................................. ..
Contact person
name:
.................................................. .................................................. ............
Contact address: _ _ _
_
.................................................. .................................................. ..................
Phone: ..................................... Fax:
................................... E-mail:
.................................................. .
Data on the marketed medical device (disinfectant)
Name of Product
Name of the biocidal active substance (s)
Stripping
Active substance content
Current year:
Notes:
Company signature, company stamp, date:
Annex 15 to Regulation 4/2009 (III. 17.) EüM *
Annex 16 to Regulation 4/2009 (III. 17.) EüM *
4/2009 on medical devices. (III. 17.) EüM Decree, manufacturer and equipment declaration
Form
1. Details of the Office
Competent Authority code HU / CA / 01
Competent Authority name
Medical Registration and Training Center Medical Technology Department
Country code HU
Postal code 1051
Street, number Zrínyi.
e-mail amd@eekh.hu
City / City Budapest
Mailbox / P.O.B. 1380 P.O.Box 1188
Fax / Fax number
+36 1 269 1255
2. Identification of the registration
Date of registration
Registration number
Reason of the registration
□ first
first registration
□ tool for performance evaluation
Change of address and / or name of the manufacturer or his authorized representative
address and / or name of the manufacturer or the authorized representative
□ distribution
discontinuation by manufacturer
□ withdrawal of the product from the market
Competent Authority
In case of change, suspension or revocation number of the previous notification
discontinuation or withdrawal, provide number of the previous registration
Status of the organization making this registration application
□ Manufacturer / Authorized Representative /
Authorized representative
3. Identification of the manufacturer Full name of the manufacturer
The manufacturer
short name
The manufacturer
tax number
The manufacturer
Headquarters
Country / Country
Postal code
Street, house number / Street, number
Contact details
Name / Name
Fax / Fax number
City / City
Mailbox / P.O.B.
Telephone number
e-mail
4. Identification of the authorized representative
Full name of the authorized representative
Short name of the authorized representative
Authorized representative 's registered office. Registered office of the authorized representative
Postal code City / City Street, house number / Street, number Mailbox / P.O.B. THE
contact details
Name Telephone name
Fax / Fax number e-mail
5. Identification of the device concerned Code and name of the device category
code Name
□ 01 Active implantable devices
□ 02 Anesthetic and respiratory equipment
Anesthetic and respiratory devices
□ 03 Dental devices
□ 04 Electromechanical devices Electro-medical
mechanical devices
□ 05 Hospital equipment and devices qualifying as medical devices
□ 06 In vitro diagnostic medical devices
□ 07 Inactive implantable devices
Hospital hardware
In vitro diagnostic medical devices
Non-active implanatble devices
□ 08 Ophthalmic and optical
devices
□ 09 Reusable instruments Reusable instruments
□ 10 Disposable devices Single use devices
□ 11 Technical aids for the disabled
□ 12 Radiodiagnostic and therapeutic devices
Technical aids for disabled persons
Diagnostic and therapeutic radiation devices
CE marking □ yes □ no
GMDN code (if it's available)
Description of the device in Hungarian and in English
Classification of the device (s)
□ Class I device (non-sterile, without measuring function)
sterile device and that with measuring function
□ Class IIa device
□ Class IIb device
□ III. Class III device
□ Active implant / Active implant
□ Class I device with measuring function
□ Class I device, sterile
□ In vitro diagnostic medical device other than in vitro diagnostic medical device
8/2003 on instruments (III. 13.) ESzCsM Decree No. 2 and the
In vitro diagnostic medical device except devices listed in IVDD Annex II
and those intended for self testing
□ 8/2003 on in vitro diagnostic medical devices. (III. 13.) ESzCsM decree
Devices according to list “A” in Annex 2, point 1 under
list A of IVDD Annex II
□ 8/2003 on in vitro diagnostic medical devices. (III. 13.) ESzCsM decree
Devices under list B of IVDD Annex II
□ 8/2003 on in vitro diagnostic medical devices. (III. 13.) ESzCsM Decree No. 2
Self-monitoring devices not listed in Annex IV and intended
for self testing
Trade name of the device
Alternative make of the device (if the device may be marketed under another name)
Device type
The device complies with Regulation 4/2009 on medical devices. (III. 17.) EüM Decree § 4 (1)
Custom made device, MDD Article 6
The device complies with Regulation 4/2009 on medical devices. (III. 17.) EüM decree
Placed on the market as a system or procedure pack, MDD Article 12
The device is marketed as sterile
Device with measuring function
8/2003 on in vitro diagnostic medical devices. (III.
13.) ESzCsM Decree § 7
□ yes □ no
□ yes □ no
□ yes □ no
□ yes □ no
□ “new” product
/
"New"
Notification according to IVDD Article 10 (4)
product
The device is available in the following countries / Known to be in the market in
6. Data of the certificate
The conformity of the device has been assessed by a designated organization
Notified Body
Identification number of the notified body carrying out the assessment
Notified Body
Reference number of the certificate
Certificate Issuer
Certificate type
□ full quality assurance system (4. (III. 17.) on medical devices)
According to Annex 2 of the EüM Decree) / full quality assurance system approval certificate (MDD Annex II)
□ type examination procedure (Decree 4/2009 (III. 17.) EüM on medical devices
According to Annex 3) / type examination certificate (MDD Annex III)
□ product inspection (Annex 4 to Decree 4/2009 (III. 17.) EüM on medical devices
verification certificate (MDD Annex IV)
□ production quality assurance (Article 5 of Decree 4/2009 (III. 17.) EüM on medical devices).
production quality assurance system approval certificate (MDD Annex V)
□ product quality assurance (Article 6 of Decree 4/2009 (III. 17.) EüM on medical devices).
/ product quality assurance system approval certificate (MDD Annex VI)
Date of the certificate
Certificate validity
7. List of tools (where appropriate) in Hungarian and English / Where appropriate, detailed
list of devices in Hungarian and in English
Generic Device Group Code
Generic Device Name
Group Term
8. I declare that the above information is true./ I affirm that the information given above
is correct to the best of my knowledge.
.................................................. ........
Name / Name
.....................................
City / City
.................................................. .
Signature
.....................................
Date
Annex 17 to Decree 4/2009 (III. 17.) EüM *
A) The Eütv. 101 / C. § (1) of the Act exempt from the obligation to keep records:
1. sutures (absorbent and non-absorbable)
2. dental fillings
3. Intrauterine contraceptives
4. Grommet (insertional)
5. HALO frame
6. tracheal cannula
7. tracheal T tube
8. tampons
9. Ruthenium applicator
10. 106Ru plaque
11. works
12. magazines and staples used for sewing machines
13. central venous cannula
14. liquid implants used in ophthalmology
B) The Eütv. 101 / C. § (1) of the Eütv. 101 / C. §
In the case of paragraph 1 (d) (da), registration of the batch number and serial number
range of instruments withdrawn in respect of:
1. screws
2. plates
3. cerclages
4. staple wires
5. medullary wires
6. fracture fixing wires
7. medullary splints
8. chest wall nets
9. Abdominal hernia implants
10. fracture fixing wire
11. implantable rail
Amended by 3/2012. (I. 3.) NEFMI Decree § 8 (9). Amended by 3/2015. (I. 14.) EMMI Decree § 31 a).
Amended by 10/2012. (VII. 19.) EMMI Decree § 26 a), 3/2015. (I. 14.) EMMI
Decree § 31 b).
Amended by: 29/2011. (VI. 7.) NEFMI Decree § 30 d), 10/2012. (VII. 19.) EMMI Decree § 26 b).
Found: 10/2012. (VII. 19.) EMMI Decree § 25. Valid: 2012. VII. From 20.
Repealed by 56/2013. (VII. 31.) EMMI Decree § 43 a). Repealed: 2013. VIII. 29 onwards.
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 a), 54/2016. (XII. 30.) EMMI Decree § 63 (1) a).
A 33/2009. (X. 20.) EüM enters into force with an amended text pursuant to Section 26 (6) a).
A 33/2009. (X. 20.) EüM enters into force with an amended text in accordance with Section 26 (5) a). Amended by 23/2015. (ARC.
28.) EMMI Decree § 105 b), 54/2016. (XII. 30.) EMMI Decree § 63 (1) b), 38/2018. (X. 31.) EMMI Decree § 14 a).
Found: 3/2015. (I. 14.) EMMI Decree § 29. Valid: 2015. II. 1st. Amended by 10/2012. (VII. 19.) EMMI
Decree 26 § c).
Modified: 16/2014. (III. 12.) EMMI Decree § 19 a). Modified: 16/2014. (III. 12.) EMMI Decree § 19 a).
Modified: 16/2014. (III. 12.) EMMI Decree § 19 a). Amended by: 29/2011. (VI. 7.) NEFMI Decree § 31 c).
Repealed by: 29/2011. (VI. 7.) NEFMI Decree § 31 d). Repealed: 2011. VI. 12 onwards.
Established: 29/2011. (VI. 7.) NEFMI Decree § 10 (1). Effective: 2011. VI. From 12.
Filed: 29/2011. (VI. 7.) NEFMI Decree § 10 (2). Effective: 2011. VI. 12 onwards.
Filed: 29/2011. (VI. 7.) NEFMI Decree § 10 (2). Effective: 2011. VI. 12 onwards.
Filed: 29/2011. (VI. 7.) NEFMI Decree § 10 (2). Effective: 2011. VI. 12 onwards. Amended by 10/2012. (VII. 19.)
Article 26 d) of the EMMI Decree.
Amended by: 29/2011. (VI. 7.) NEFMI Decree § 31 e), 3/2014. (I. 16.) EMMI
§ 35 of the Decree.
Found: 33/2012. (X. 11.) EMMI Decree § 4 (1). Effective: 12/12/2012.
Filed: 33/2012. (X. 11.) EMMI Decree § 4 (2). Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016.
(XII. 30.) EMMI Decree § 63 (1) c).
Repealed by: 29/2011. (VI. 7.) NEFMI Decree § 31 f). Repealed: 2011. VI. 12 onwards.
Found: 33/2012. (X. 11.) EMMI Decree § 5. Effective: 12/12/2012. Amended by 23/2015. (IV. 28.) EMMI
Decree 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Established: 29/2011. (VI. 7.) NEFMI Decree § 11. Amended by 23/2015. (IV. 28.) EMMI Decree § 105 d),
54/2016. (XII. 30.) EMMI Decree § 63 (1) c). Amended by 10/2012. (VII. 19.) EMMI Decree § 26 e).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
33/2009 will not enter into force. (X. 20.) EüM decree on the basis of § 26 (6) b). Amended by 23/2015. (IV. 28.) EMMI Decree
105. § c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) d).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Established: 29/2011. (VI. 7.) NEFMI Decree § 12 (1). Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c),
d), e), 54/2016. (XII. 30.) EMMI Decree § 63 (1) d), e).
Established: 29/2011. (VI. 7.) NEFMI Decree § 12 (2). Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c),
54/2016. (XII. 30.) EMMI Decree § 63 (1) c),
8/2018. (II. 13.) EMMI Decree § 61 a).
Modified: 16/2014. (III. 12.) EMMI Decree § 19 b). Modified: 16/2014. (III. 12.) EMMI Decree § 19 b).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Filed: 29/2011. (VI. 7.) NEFMI Decree § 13. Effective: 2011. VI. 12 onwards. Established: 29/2011. (VI. 7.) NEFMI
§ 13 of the Decree. Effective: 2011. VI. 12 onwards. Established: 29/2011. (VI. 7.) NEFMI Decree § 14 (1). Modifications
3/2012. (I. 3.) NEFMI Decree § 8 (9), 33/2012. (X. 11.) EMMI Decree § 9 (2) a), 23/2015. (IV. 28.) EMMI Decree
105. § c), 54/2016. (XII. 30.) EMMI Decree 63.
§ (1) c).
Established: 29/2011. (VI. 7.) NEFMI Decree § 14 (1). Amended by 3/2012. (I. 3.) NEFMI Decree § 8 (9),
23/2015. (IV. 28.) EMMI Decree § 105 c),
54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Established: 29/2011. (VI. 7.) NEFMI Decree § 14 (2). Amended by 23/2015. (IV. 28.) EMMI Decree § 105 d),
54/2016. (XII. 30.) EMMI Decree 63.
§ (1) c).
Amended by 3/2012. (I. 3.) NEFMI Decree § 8 (9), 23/2015. (IV. 28.) EMMI
Decree 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c). Repealed by 56/2013. (VII. 31.) EMMI
Decree 43 § b). Repealed: 1 January 2014.
Amended by: 54/2016. (XII. 30.) EMMI Decree § 63 (1) d). Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c).
Established: 29/2011. (VI. 7.) NEFMI Decree § 15. Effective: 2011. VI. 12 onwards. Amended by 23/2015. (IV. 28.)
EMMI Decree § 105 c), 37/2016. (XII. 15.) EMMI Decree § 9.
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI
Section 63 (1) c) of the Decree.
Established: 29/2011. (VI. 7.) NEFMI Decree § 16. Effective: 2011. VI. 12 onwards. It is not executable to modify
see 54/2016. (XII. 30.) EMMI Decree 63.
§ (1) f).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Filed: 33/2012. (X. 11.) EMMI Decree § 6. Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016.
(XII. 30.) EMMI Decree § 63 (1) c).
Amended by: 33/2012. (X. 11.) EMMI Decree § 9 (2) b), 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII.
30.) Article 63 (1) c) of the EMMI Decree.
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 f), 54/2016. (XII. 30.) EMMI Decree § 63 (1) g).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 e), 54/2016. (XII. 30.) EMMI Decree § 63 (1) e).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 e), 54/2016. (XII. 30.) EMMI Decree § 63 (1) e).
Filed: 29/2011. (VI. 7.) NEFMI Decree § 17. Effective: 2011. VI. 12 onwards. Amended by 23/2015. (IV. 28.) EMMI
Decree 105 d., 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 f), 54/2016. (XII. 30.) EMMI Decree § 63 (1) g).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 d), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 f), 54/2016. (XII. 30.) EMMI Decree § 63 (1) g).
Filed: 29/2011. (VI. 7.) NEFMI Decree § 18. Amended by 23/2015. (IV. 28.)
EMMI Decree § 105 f), 54/2016. (XII. 30.) EMMI Decree § 63 (1) g).
Repealed with previous subtitle: 8/2018. (II. 13.) EMMI Decree § 62 a). Repealed: 2018. II.
14 onwards.
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 d), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 d), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 d), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 d), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 d), 54/2016. (XII. 30.) EMMI Decree § 63 (1) c).
Filed: 29/2011. (VI. 7.) NEFMI Decree § 20. Effective: 2011. VI. 12 onwards. Filed: 29/2011. (VI. 7.) NEFMI
§ 20 of the Decree. Amended by 23/2015. (IV. 28.) EMMI Decree § 105 d), 54/2016. (XII. 30.) EMMI Decree § 63 (1)
c), 8/2018. (II. 13.) EMMI Decree § 62 b).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c), 54/2016. (XII. 30.) EMMI Decree § 63 (1) d).
Established: 29/2011. (VI. 7.) of the NEFMI Decree § 21. Amended by: 11/2013. (II. 7.) EMMI Decree § 32, 23/2015.
(IV. 28.) EMMI Decree § 105 g), 54/2016. (XII. 30.) EMMI Decree § 63 (1) h).
Amended by: 10/2011. (III. 30.) NEFMI Decree § 65 (1) e), 23/2015. (IV. 28.) EMMI Decree § 105 h), 54/2016.
(XII. 30.) EMMI Decree § 63 (1) i).
Amended by: 10/2011. (III. 30.) NEFMI Decree § 65 (1) e), 23/2015. (IV. 28.)
EMMI Decree § 105 e), 54/2016. (XII. 30.) EMMI Decree § 63 (1) e), j). Amended by: 10/2011. (III. 30.) NEFMI
Article 65 (1) e) of Decree 8/2018. (II. 13.) EMMI Decree § 61 b).
Founded: 23/2015. (IV. 28.) EMMI Decree § 103. Amended by: 54/2016. (XII. 30.) EMMI Decree § 63 (1) k),
(2), 38/2018. (X. 31.) EMMI Decree § 14 b).
Repealed by: 29/2011. (VI. 7.) NEFMI Decree § 31 g). Repealed: 2011. VI. 12 onwards.
Built: 8/2003. (III. 13.) ESzCsM Decree 2 / A. §. Built: 8/2003. (III. 13.) ESzCsM Decree § 16 (2).
Repealed by: 8/2018. (II. 13.) EMMI Decree § 62 c). Repealed: 2018. II. 14 onwards.
Filed: 29/2011. (VI. 7.) NEFMI Decree § 22. Effective: 2011. VI. 12 onwards. Filed: 56/2013. (VII. 31.) EMMI
§ 40 of the Decree. Effective: VIII. 29 onwards. Amended by 10/2012. (VII. 19.) EMMI Decree § 26 f), 56/2013. (VII.
31.) Article 42 a) -d) of the EMMI Decree.
Amended by 10/2012. (VII. 19.) EMMI Decree § 26 f), 56/2013. (VII. 31.) EMMI Decree § 42 e) -h).
Found: 56/2013. (VII. 31.) EMMI Decree § 41 (1), Annex 1 1. Effective: VIII. 29 onwards.
Found: 56/2013. (VII. 31.) EMMI Decree § 41 (1), Annex 1 2. Effective: VIII. 29 onwards.
Found: 56/2013. (VII. 31.) EMMI Decree § 41 (1), Annex 1 3. Effective: VIII. 29 onwards.
Found: 56/2013. (VII. 31.) EMMI Decree § 41 (2), Annex 2 1. Effective: VIII. 29 onwards.
Found: 56/2013. (VII. 31.) EMMI Decree § 41 (2), Annex 2 2. Effective: VIII. 29 onwards.
Found: 56/2013. (VII. 31.) EMMI Decree § 41 (2), Annex 2 3.
Effective: VIII. 29 onwards.
Amended by: 54/2016. (XII. 30.) EMMI Decree § 63 (1) c). Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c).
Amended by: 54/2016. (XII. 30.) EMMI Decree § 63 (1) c), g). Amended by 23/2015. (IV. 28.) EMMI Decree § 105
c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 f). Amended by: 54/2016. (XII. 30.) EMMI Decree § 63 (1) d).
A 33/2009. (X. 20.) EüM shall enter into force with an amended text in accordance with Section 26 (6) c).
33/2009 will not enter into force. (X. 20.) EüM decree on the basis of § 26 (6) d). Amended by 23/2015. (IV. 28.) EMMI Decree
105. § c).
33/2009 will not enter into force. (X. 20.) EüM decree on the basis of § 26 (6) d).
A 33/2009. (X. 20.) EüM shall enter into force with an amended text in accordance with Section 26 (6) c).
33/2009 will not enter into force. (X. 20.) EüM decree on the basis of § 26 (6) d). Amended by 23/2015. (IV. 28.) EMMI Decree
105. § c).
33/2009 will not enter into force. (X. 20.) EüM decree on the basis of § 26 (6) d). Amended by: 54/2016. (XII. 30.) EMMI Decree
Section 63 (1) d).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c). Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c).
Amended by 23/2015. (IV. 28.) EMMI Decree § 105 c).
Established: 29/2011. (VI. 7.) NEFMI Decree § 23 (1), Annex 3. Effective: 2011. VI. 12 onwards.
Established: 29/2011. (VI. 7.) NEFMI Decree § 23 (1), Annex 3. Effective: 2011. VI. 12 onwards.
Amended by: 54/2016. (XII. 30.) EMMI Decree § 63 (1) g).
Amended by: 10/2011. (III. 30.) NEFMI Decree § 65 (2), Annex 29, 23/2015. (IV. 28.) EMMI Decree § 105 f).
A 33/2009. (X. 20.) EüM shall enter into force with an amended text in accordance with Section 26 (5) c). Amended by: 54/2016. (XII.
30.) Article 63 (1) l) of the EMMI Decree, 38/2018. (X. 31.) EMMI Decree § 14 c).
Repealed by: 29/2011. (VI. 7.) NEFMI Decree § 31 h). Repealed: 2011. VI. 12 onwards.
Founded: 23/2015. (IV. 28.) EMMI Decree § 104, Annex 7. Valid: 2015. IV. 29 onwards.
Filed: 3/2015. (I. 14.) EMMI Decree § 30, Annex 4. Valid: 2015. II. 1st.