Decree No. 191 / 2001 Coll.
Government Regulation laying down technical requirements for active implantable medical devices
Valid
Regulation
Effective from 15.06.2001
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191
GOVERNMENT REGULATION
of 9 May 2001
laying down technical requirements for active implantable medical devices
The Government hereby orders, pursuant to Article 22 of Act No. 22 / 1997 Coll., on the technical requirements for products and on the amendment and addition of certain laws, as amended by Act No. 71 / 2000 Coll., (hereinafter referred to as "the Act '), to implement § 11 (2) and § 11a (2), § 12 (1) and (4) and to implement Act No. 123 / 2000 Coll., on medical devices and on the amendment of certain related laws (hereinafter referred to as" the Law on medical devices'):
Preliminary provisions
This Regulation lays down technical requirements for active implantable medical devices in accordance with the law of the European Communities (1) and the international contract (2). (3)
(1) The specified products under Section 12 (1) of the Act are active implantable medical devices for the purposes of conformity assessment under this Regulation. The active implantable medical devices are those referred to in Section 2 (2) (f) of the Medical Devices Act.
(2) An active implantable medical device shall also be considered as:
(a) an active implantable medical device manufactured individually in accordance with a prescription by which a doctor issues, under his responsibility, an individual design of the characteristics of the device intended only for use by a designated natural person (hereinafter referred to as the "custom active implantable medical device"),
(b) an active implantable medical device intended for use by a physician with competence appropriate to the use of the device in research conducted in an appropriate human clinical environment (hereinafter referred to as an active implantable medical device intended for clinical evaluation).
For the purposes of this Regulation, the following definitions shall also apply:
(a) by the manufacturer, the person referred to in the Law on Medical Devices, 4)
(b) the intended purpose of use for which the active implantable medical device is intended and suitable according to the information provided by the manufacturer in the instructions;
(c) putting into service an active implantable medical device for use by a doctor for implantation;
(d) a user-sick natural person (hereinafter referred to as "patient") and a natural or legal person who uses an active implantable medical device for the intended purpose of use in the provision of health care;
General principles
(1) An active implantable medical device, a custom active implantable medical device and an active implantable medical device intended for clinical trial must comply with the essential requirements set out in Annex 1 to this Regulation (hereinafter referred to as "essential requirements") taking into account the intended purpose of use.
(2) The essential requirements set out in Annex 1 to this Regulation shall also be deemed to comply with the requirements of the harmonised norem5) relating to a specific active implantable medical device.
(3) Where harmonised standards (5) do not fully cover the essential requirements referred to in paragraph 1, the Office for Technical Standardisation, Metrology and State Testing (hereinafter referred to as "the Office") shall follow the law. 6)
(4) Active implantable medical devices using nuclear energy or sources of ionising radiation must be assessed from the point of view of radiation protection by an authorized person, unless the international treaty to which the Czech Republic is bound provides otherwise.
Labelling of active implantable medical devices
(1) Active implantable medical devices, with the exception of prohibited active implantable medical devices and active implantable medical devices intended for clinical evaluation, must be marked with CE, (8) if, after assessment of conformity pursuant to Article 11 of this Regulation, they have been found to comply and an EC declaration of conformity has been issued.
(2) The indication of the active implantable medical device referred to in paragraph 1 shall be placed visibly, legibly and indelibly on the sterile packaging of the active implantable medical device, the instructions for its use and, where appropriate, the sales packaging.
(3) The identification number of the authorised person (9) responsible for carrying out the acts provided for by law and annexes must be attached to the identification of the active implantable medical device referred to in paragraph 1.
No 3, 7 and 9
on this Regulation.
(4) The active implantable medical device referred to in paragraph 1 shall not be accompanied by any other marking which may, as regards the meaning and shape of:
CE marking, 8)
mislead third parties. Other markings may be affixed to the packaging of the active implantable medical device or to the instructions accompanying the device, unless the visibility and legibility of the Czech mark of conformity is reduced) or the CE.8 marking)
(5) Prohibited active implantable medical devices and active implantable medical devices intended for clinical trial must not bear the mark CE.8)
(6) If the active implantable medical device referred to in paragraph 1 has been labelled with an illegally Czech conformity mark (7) or CE marking (8) in particular if it is a device which:
(a) does not comply with the requirement set out in Paragraph 4 (2) if the manufacturer has chosen this method of conformity assessment; or
(b) does not conform to the type approved; or
(c) complies with an approved type which does not, however, meet the relevant essential requirements; or
(d) where the manufacturer has failed to fulfil the obligations arising from the relevant
the EC declaration of conformity,
the authorised person takes appropriate measures pursuant to § 11 (2) and (3) of the Act.
Placing on the market and putting into service
(1) Active implantable medical devices, with the exception of prohibited active implantable medical devices and active implantable medical devices intended for clinical trial, may be placed on the market if:
(a) satisfy the essential requirements taking into account the intended purpose of use;
(b) an EC declaration of conformity has been issued; and
(c) are marked CE.8)
These devices may only be put into service if they comply with the requirements laid down in the previous sentence, their use is ensured in accordance with the intended purpose of use, their maintenance and if they are properly prepared to be used by a doctor for implantation into the human body.
(2) Prohibited active implantable medical devices may be placed on the market if they comply with the essential requirements and other provisions of this Regulation which apply to them. These devices may only be put into service if they comply with the requirements set out in the previous sentence, their use is ensured in accordance with the intended purpose of use, their maintenance and if they are properly prepared for implantation by a doctor into the human body.
(3) If active implantable medical devices intended for clinical trials comply with the requirements set out in Section 17 and Annex 11 to this Regulation, they shall not be obstructed by the availability of such devices to doctors who are to carry out clinical evaluation of such devices.
(4) After completion of the clinical trial of active implantable medical devices, such devices may be placed on the market only after the requirements laid down in Section 4 and Annex 11 to this Regulation have been met.
(5) Prohibited active implantable medical devices may be placed on the market and put into service if they meet the requirements set out in Annex 11 to this Regulation and are accompanied by the declaration provided for in this Annex.
(6) Where active implantable medical devices are intended to be put into service in the Czech Republic, they shall be equipped with the information listed in Annex 1 to this Regulation in points 13, 14 and 15, in the Czech language.
Activation of active implantable medical devices after exposure
Active implantable medical devices intended for exposure which do not comply with the requirements of this Regulation shall be visibly marked in such a way as to be sufficiently obvious; such devices may only be put into service if:
(a) the manufacturer or importer; or
put them in such a condition as to comply with the requirements set out in Paragraph 4 (1) or (2) of this Regulation.
Procedure for endangering the health and / or life of humans by active implantable medical devices
(1) Procedure where:
(a) active implantable medical devices, with the exception of prohibited active implantable medical devices, shall be provided with:
the CE marking, 8); and
(b) custom active implantable medical devices;
which have been properly put into service, used in accordance with the intended purpose of use and yet may adversely affect the health and, where appropriate, the lives of people, shall be subject to specific legislation. 10)
(2) In cases where active implantable medical devices and custom implantable medical devices properly placed on the market or put into service and used in accordance with the intended purpose of use do not comply with this Regulation and may also adversely affect the health and / or the lives of people, the law, the law on medical devices and the specific legislation are followed. 10) In particular, cases where non-compliance with this Regulation results from:
(a) non-compliance with the essential requirements referred to in Article 4 (1) of this Regulation where the appropriations do not comply fully or partially with the standards referred to in Article 4 (2) of this Regulation;
(b) incorrect application of standards where it is claimed that they have been applied; or
(c) shortcomings in the standards themselves.
Adverse events
(1) Announcement, registration, investigation, documentation, evaluation of adverse events (11) and prevention of such events are governed by the Law on Medical Devices and the Decree implementing this Act. 12)
(2) Notwithstanding Article 8 of this Regulation, the Ministry of Health (hereinafter referred to as "the Ministry") and the State Institute for Drug Control (hereinafter referred to as "the Institute") proceed in the field of adverse events (11) under the Law on Medical Devices and the Decree implementing this Act. 13)
Conformity assessment procedures
(1) For an active implantable medical device which is neither custom nor intended for clinical trial, the manufacturer or importer before its designation CE8) shall assess conformity taking into account the intended purpose of use in accordance with the procedure for:
(a) EC declaration of conformity pursuant to Annex 2 to this Regulation; or
(b) EC type-examination in accordance with Annex 3 to this Regulation, in conjunction with:
1. in accordance with the EC verification procedure laid down in Annex 4 to this Regulation; or
2. in accordance with the procedure for the EC declaration of conformity to the type referred to in Annex 5 to this Regulation.
(2) Before placing on the market an active implantable medical device, with the exception of a custom active implantable medical device and an active implantable medical device intended for clinical trial, its manufacturer shall make a declaration of compliance with the requirements set out in Article 4 (1) or (2) and the procedures set out in paragraph 1.
(3) In the case of custom-made active implantable medical devices, the manufacturer shall make a written declaration in accordance with Annex 11 to this Regulation prior to the placing on the market of each such device.
(5) Records and correspondence relating to the procedures referred to in paragraphs 1 to 4 must be kept in the official language of the Member State of the European Communities in which they are carried out or in a language agreed upon by the authorised person,
(a) with the manufacturer,
(1) When assessing the conformity of an active implantable medical device, the authorised person or manufacturer, if applicable
(b) Importers, if they are on conformity assessment pursuant to Article 11 (1), subject to an international agreement on these funds, 2)
take into account the results of evaluation and verification activities obtained at appropriate stages of the production process.
(2) Depending on the nature and type of the active implantable medical device, the manufacturer shall, where appropriate:
(a) importers, if they are on conformity assessment pursuant to Article 11 (1),
(b) an authorised representative, if applicable, for conformity assessment in accordance with Article 11 (1);
the relevant authorised person to participate in conformity assessment and, where appropriate, to carry out other specific tasks defined in its authorisation.
(3) For the purpose of issuing the certificate and its legitimate possession, the authorised person shall be entitled to require, in justified cases, from:
(a) the manufacturer; or
necessary information or data.
(4) The certificate of authorised person in accordance with Annexes 3 and 5 to this Regulation shall be issued for a maximum period of 5 years; The validity of these certificates may be extended for a further period of 5 years, at the request of the manufacturer, or, where appropriate, by:
(b) an importer, if the conformity has been assessed pursuant to Article 11 (1), subject to an international agreement, 2)
submitted at the time specified in the contract between him and the authorised person.
(1) Where they apply to active implantable medical devices and other specific legislation, 15) which cover other aspects and also provide for
CE marking, 8)
then the label shall also indicate compliance with the provisions of these other specific legislation. 15) Other specific legislation15) shall be included in the declaration of conformity.
(2) If specific legislation is permitted, 15) for a transitional period, the manufacturer shall choose the procedure to be followed,
designation CE8)
Expresses compliance only with those specific legislation, 15) which the manufacturer has used; the accompanying documentation, warnings or instructions accompanying the relevant active implantable medical devices shall include a list of the specific legislation applied. 15) Those documentation and warnings or instructions shall be accessible without damaging the packaging which ensures the sterility of the active implantable medical device.
Registration of persons responsible for placing active implantable medical devices on the market
(1) A manufacturer who places active implantable medical devices on the market, under his own name, in the Member States of the European Communities, in accordance with the procedures laid down in paragraphs 1 to 3 of Article 11, shall inform the competent authorities of the Member State of the European Communities in which he has registered his registered office, if he is a legal person, or the place of business and permanent residence, if he is a natural person, of the address of those places, and at the same time communicate a description of the relevant active implantable medical devices; inform the Ministry in the Czech Republic.
(2) In the case of active implantable medical devices, Member States of the European Communities may request data enabling the identification of such devices together with their identification and instructions for use, provided that such devices are put into service in their territory; in the Czech Republic, the Ministry shall communicate the information. 19)
(3) Where a manufacturer who places active implantable medical devices on the market in the Member States of the European Communities, as referred to in paragraph 1, does not have a registered registered office in a Member State, if it is a legal person or a permanent residence and the place of business, if it is a natural person, in a Member State of the European Communities, he shall designate the person responsible for trading such devices, who shall inform the competent authorities of the Member State of the European Communities in which he has registered his registered office, if he is a legal person or a permanent residence and the place of business, if it is a natural person, their address and the category of the relevant active implantable medical devices; in the Czech Republic, this person informs the Ministry.
Clinical trials
(1) In the case of active implantable medical devices intended for clinical testing by the manufacturer, where appropriate
(a) the importer; or
submit at least 60 days before the start of clinical trials to the competent authority of the Member State of the European Communities in which those tests are to be carried out the declaration set out in Annex 11 to this Regulation; in the Czech Republic, the said declaration shall be submitted to the Ministry and the Institute.
(2) Clinical trials of active implantable medical devices may be initiated
(a) after 60 days following the notification referred to in paragraph 1 to the competent authority of the Member State of the European Communities, in the Czech Republic to the Ministry, unless such bodies notify the manufacturer or, where appropriate, the manufacturer,
1. importers; or
not agree to carry out such tests for reasons of public health and public interest within that period; or
(b) with the agreement of the competent authority of the Member State of the European Communities, before the 60-day period expires, provided that the Ethics Committee concerned has given its consent to the plan of such tests.
(3) In connection with carrying out a clinical examination of the active implantable medical device, the Ministry shall take appropriate measures where necessary.
Authorised persons
(1) Basic criteria for authorised persons to carry out procedures under:
Article 11
This Regulation and other specific tasks are set out in Annex 13 to this Regulation. Persons who comply with the requirements of harmonised standards shall be presumed to comply with the relevant criteria.
(2) The dates for the completion of evaluation and verification activities shall be determined by agreement concluded by the authorised person; and
(b) the manufacturer or importer, if the activities listed in Annexes 3 to 11 apply to active implantable medical devices of international origin, (2); or
on this Regulation.
Data set
(1) Data
(a) the products, persons and active implantable medical devices referred to in Article 16;
(b) certificates issued, modified, cancelled or, where appropriate, refused;
(c) obtained in accordance with the procedure for reporting and recording adverse events, 20)
(d) clinical trials
shall be kept in accordance with this Regulation in the Data group on Medical Devices established and maintained within the framework of the Information System, 21) which is accessible to the Ministry, the Institute, the State Office for Nuclear Safety, when it comes to sources of ionising radiation, and the Institute of Health Information and Statistics of the Czech Republic so that they can carry out their tasks under this Regulation.
(2) The information referred to in paragraph 1 shall be provided on forms; their models shall be provided for in specific legislation. 22)
Provisions common and final
Transitional provisions
(1) Paragraphs 15 (1), 16 (1) and 19 shall not apply, with the exception of active implantable medical devices imported from States not members of the European Union, to the Protocol to the Europe Agreement establishing an association between the Czech Republic, of the one part, and the European Communities and their Member States, of the other part, on conformity assessment and acceptance of industrial products in the Collection of International Treaties or from the date of entry into force of the Treaty of Accession of the Czech Republic into the European Union, if that date is earlier.
(2) The activities which result for the authorised representative from Annexes 3, 5, 7, 9 and 11 to this Regulation may be carried out by active implantable medical devices, provided that they are covered by an international contract, (2) the importer until the date of entry into force of the Treaty of Accession of the Czech Republic into the European Union.
Repeal
Government Decree No. 198 / 1999 Coll., laying down technical requirements for active implantable medical devices, is hereby repealed.
Efficacy
This Regulation shall enter into force on the day of its publication, except for:
(a) Paragraph 5 (1), § 5 (3), § 5 (4), § 5 (6) (d), § 6 (1) (c), § 8 (1) (a), § 11 (1) to (3), § 13 (1) (a), § 13 (2) (a), § 13 (4) (a), § 14 (1), § 14 (2), § 16 (1), § 16 (3), § 17 (2) (b), § 18 (2) (a), and § 18 (2) (a), which take effect on the date of publication of the Sectoral Annex to the European Agreement establishing an association between the Czech Republic and the European Communities and their Member States on the other part of conformity assessment and acceptaching of industrial products in the international treaties;
(b) Annexes 3, 5, 7, 9 and 11 to this Regulation, which shall take effect as referred to in (a); the provisions concerning the authorised representative in these Annexes shall become effective on the date of entry into force of the Treaty of Accession of the Czech Republic to the European Union and Article 3 (e), Article 7 (b), § 11 (4), § 11 (5) (b), § 12, § 13 (1) (b), § 13 (2) (b), § 13 (4) (b), § 13 (5), § 16 (2) and (4), § 17 (1) (b), § 17 (2) (a) (2) (a) (2) and Article 18 (2) (b) of this Regulation, which take effect from the date of entry into force of the Treaty on the European Union.
Prime Minister:
Ing. Zeman v. r.
Minister for Health:
Prof. MUDr. Fisher, CSc.
Příloha č. 1
Annex No. 1 to Decree No. 191 / 2001 Coll.
ESSENTIAL REQUIREMENTS
I. GENERAL REQUIREMENTS
1. Active implantable medical devices shall be designed and manufactured in such a way that, provided they are implanted under specified conditions and for the intended purpose of use, they do not endanger the health and safety of users and other natural persons.
2. Active implantable medical devices shall be designed and manufactured in such a way as to achieve the efficiency specified by the manufacturer and be suitable for one or more of the functions specified in the Health Devices Act (23) and in accordance with the manufacturer's specification.
3. When the active implantable medical devices, which may occur under normal operating conditions, are loaded, they shall not be adversely affected by their functional characteristics and efficiency within the meaning of points 1 and 2, for the life of the devices declared by the manufacturer.
4. Active implantable medical devices shall be designed, manufactured and packaged in such a way that their characteristics and efficiency, as determined by the manufacturer, are not adversely affected by storage and transport conditions (e.g. temperature, humidity).
5. Any side effects of active implantable medical devices shall not constitute unacceptable risks compared to their anticipated effects.
II. REQUIREMENTS FOR PROPOSALS AND CONSTRUCTIONS
6. The solutions adopted by the manufacturer when designing and constructing active implantable medical devices shall comply with the requirements for their safety 24) and the state of science and technology at the time of their placing on the market.
7. Active implantable medical devices made available on the market in sterile condition shall be designed, manufactured and packaged in disposable packaging or, by appropriate procedures, ensure that they are sterile when placed on the market and remain sterile under specified storage and transport conditions until the protective packaging is opened during implantation or damaged.
8. Active implantable medical devices shall be designed and manufactured in such a way that risks are excluded or reduced to the lowest level possible.
8.1. physical injury related to their physical characteristics (including dimensions);
8.2. Related to the energy sources used;
the use of electrical energy, in particular with regard to insulating conditions, conduction currents or overheating of active implantable medical devices;
8.3. Associated with reasonably foreseeable environmental conditions, in particular magnetic fields, external electrical influences, electrostatic discharges, pressure and its changes and acceleration;
8.4. associated with treatment, which results mainly from the use of defibrillators and high frequency surgical devices;
8.5. Associated with ionising radiation of radioactive substances used in active implantable medical devices in accordance with protection requirements under specific legislation; 25)
8.6. which may arise from the fact that active implantable medical devices cannot be maintained or calibrated, including risks arising from:
8.6.1. excessive expansion of leaking currents;
8.6.2. ageing of the materials used;
8.6.3. excessive heat induced by active implantable medical devices;
8.6.4. Reduced accuracy of the measuring or checking mechanism.
9. Active implantable medical devices shall be designed and manufactured in such a way as to guarantee their characteristics and characteristics as referred to in points 1 to 5 of this Annex, with particular regard to:
9.1. selection of materials used, in particular with regard to toxicity;
9.2. mutual compatibility between the materials used and biological tissues, cells and body fluids, taking into account the anticipated use of active implantable medical devices;
9.3. compatibility of active implantable medical devices with substances to be administered;
9.4. quality of connections, in particular with regard to safety;
9.5. the reliability of the energy source;
9.6. tightness, if applicable;
9.7. proper operation of programming and control systems, including software.
10. If an active implantable medical device contains an integral part of a substance which, when used alone, can be considered as a drug (26) and which acts on the body by its effect complementing its effect, the safety, quality and efficacy of the substance must be verified for the intended purpose by the methods used in the evaluation of the medicinal products. 27)
11. Active implantable medical devices, or parts thereof, shall be marked in such a way as to enable the necessary measures to be taken to identify the potential hazards associated with such devices or parts thereof.
12. Active implantable medical devices shall be provided with a code enabling the unique identification of the individual device and its manufacturer (in particular the type and year of manufacture). This code must be legible even without surgery.
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Regulation Information
| Citation | Decree No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.06.2001 |
|---|---|
| Effective from | 15.06.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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