Decree No. 198 / 1999 Coll.
Government Regulation laying down technical requirements for active implantable medical devices
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Regulation
Effective from 01.01.2000
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198
GOVERNMENT REGULATION
of 21 July 1999
laying down technical requirements for active implantable medical devices
The Government orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts (hereinafter referred to as "the Act") to implement Sections 12 (1) and (4) and 13 (2) and (4) of the Act:
Preliminary provisions
(1) This government regulation applies to medical devices, (1) whose activity depends on a source of electrical or other energy which is not produced directly by the human body or gravity, intended for the complete or partial introduction by a doctor into the human body, while remaining at the place of introduction, even if it is intended to be administered by medication2) or containing as an integral part a substance which may be considered as a medicinal product, 2) ("active implantable medical devices').
(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 to be used by a healthcare professional (m3) in research under the conditions laid down by the manufacturer (hereinafter referred to as an active implantable medical device intended for clinical evaluation).
(3) The products provided for in Article 12 (1) of the Act are active implantable medical devices referred to in paragraphs 1 and 2.
For the purposes of this Regulation, the following definitions shall also apply:
(a) by the manufacturer, the natural or legal person responsible for the design, manufacture, packaging and labelling of the active implantable medical device, before being placed on the market under his own name, whether or not those activities are carried out by a third party. The obligations of the manufacturer under this Regulation shall also apply to the natural or legal person who compiles, packs, processes, modifies, or denotes, where appropriate, one or more of the active implantable medical devices produced, the purpose of their use with the intention of placing them on the market under his name; the preceding part of this sentence does not apply to a natural and legal person who merely compiles or modifies for the intended purpose an active implantable medical device already on the market,
(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 activity that makes an active implantable medical device applicable 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;
(e) adverse event
1. deterioration of the characteristics and efficacy of the active implantable medical device, or inaccuracy in the instructions for its use, which have led or could lead to the death of the patient or to deterioration of his health; or
2. the technical or medical reason for which the manufacturer withdrew the active implantable medical device from the market.
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) Compliance with the essential requirements set out in Annex No 1 is also considered as meeting the harmonised norem4) relating to a specific active implantable medical device.
(1) Active implantable medical devices, with the exception of prohibited active implantable medical devices, may be placed on the market if they comply with the requirements of this Regulation and, after assessing their conformity with the essential requirements referred to in Article 7 (2), if they have been found to comply, have been marked with the Czech conformity mark (5) ("conformity mark"). Active implantable medical devices may be operated if they are properly implanted in the human body and are maintained and used in accordance with the intended purpose of use.
(2) If active implantable medical devices intended for clinical trial and custom-active implantable medical devices comply with the requirements set out in Annex 6 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.
(3) Prohibited active implantable medical devices may be placed on the market and put into service if they comply with the requirements set out in Annex 6 to this Regulation.
(4) Active implantable medical devices intended for clinical trial may only be placed on the market after completion of the clinical trial after compliance with the requirements set out in Section 3 and Annex 6 to this Regulation.
(5) Where active implantable medical devices properly put into service and used in the provision of health care in accordance with the intended purpose of use could adversely affect the health and safety of users and other persons, they shall not be placed on the market and put into service; where the funds are already on the market, they must be withdrawn from the market.
(1) Active implantable medical devices intended for exposure which do not comply with the requirements of this Regulation must be visibly marked in such a way as to be sufficiently obvious; such devices may be put into service only if they are put into service by the manufacturer in such a way that they meet the requirements set out in Article 3 (1) or (2) of this Regulation, the conformity has been assessed and the relevant declaration issued.
(2) 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, points 13, 14 and 15, in the Czech language.
Conformity marking
(1) Active implantable medical devices, with the exception of prohibited active implantable medical devices and active implantable medical devices intended for clinical trial which, taking into account the intended purpose of use, satisfy the essential requirements set out in Annex 1 to this Regulation, must bear a mark of conformity.
(2) The mark of conformity must be placed visibly, legibly and indelibly on the sterile packaging of the active implantable medical device, the instructions for its use and, where appropriate, on the sales packaging.
(3) The conformity mark for active implantable medical devices referred to in paragraph 1 must be accompanied by an identification number of the authorised person6) responsible for assessing the procedures used in Annexes 2, 4 and 5 to this Regulation.
(4) The active implantable medical device referred to in paragraph 1 shall not be accompanied by any other marking which may mislead third parties as regards the meaning and shape of the conformity mark. Other markings may be affixed to the packaging of the active implantable medical device or to the instructions accompanying it only if this does not reduce the visibility and legibility of the conformity mark.
(5) Where the mark of conformity has been affixed to an active implantable medical device referred to in paragraph 1, in particular if it is a means of
(a) not complying with the requirement referred to in Article 3 (2) if the manufacturer has chosen this method of conformity assessment; or
(b) not conforming to the type approved; or
(c) corresponding to an approved type which does not meet the relevant essential requirements; or
(d) where the manufacturer has failed to fulfil the obligations arising out of the relevant certificate of conformity;
the manufacturer or importer is obliged to remove the unlawful situation referred to immediately. In the event of inaction by the manufacturer or importer or, where appropriate, unjustified delays, action shall be taken under specific legislation. 7) Where an authorised person finds such a case, he shall take appropriate measures and inform the Ministry of Health immediately thereof (hereinafter referred to as the Ministry).
Conformity assessment procedures
(1) The manufacturer or importer shall carry out or ensure, for an active implantable medical device, a conformity assessment of its properties with the essential requirements taking into account the intended purpose of use ("conformity assessment"), the procedures referred to in paragraph 2.
(2) In the case of an active implantable medical device which is neither custom nor intended for clinical trial, the manufacturer or importer shall proceed to:
(a) an assessment of the full quality assurance system of the authorised person (6) as set out in Annex 2 to this Regulation; or
(b) testing of the type of active implantable medical device manufactured by an authorized person (6) in accordance with Annex 3 to this Regulation with:
1. verifying the conformity of an active implantable medical device with its certified type and with the requirements of this Regulation by checking and testing that device on its statistically selected sample, as set out in Annex 4 to this Regulation; or
2. an assessment of the quality assurance of production as set out in Annex 5 to this Regulation.
(3) Before placing on the market
(a) 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, shall be issued by its manufacturer to declare compliance with the requirements set out in paragraphs 1 and 2 of Section 3 and to comply with the procedures referred to in paragraph 2;
(b) a custom active implantable medical device and an active implantable medical device intended for clinical trial shall be carried out by its manufacturer in accordance with Annex 6 to this Regulation.
(1) The procedures laid down in Annexes 3, 4 and 6 to this Regulation are carried out by the natural or legal persons listed in those Annexes and, where appropriate, by the natural or legal person authorised in writing as his representative by the manufacturer.
(2) Records and correspondence relating to the procedures referred to in Article 7 (2) must be kept in the Czech language or in a language agreed between the authorised person and the manufacturer.
(3) When assessing the conformity of an active implantable medical device, the manufacturer or authorised person shall take into account the results of evaluation and verification activities obtained at appropriate stages of the production process.
(4) Depending on the nature and type of the active implantable medical device, the manufacturer shall request the authorised person concerned to participate in the conformity assessment in accordance with Section 7 (2). For the purpose of issuing the certificate and its legitimate possession, the authorised person shall be entitled to require the necessary information or data in justified cases with regard to the selected conformity assessment procedure.
(5) The certificate of authorised person in accordance with Annexes 2 and 3 to this Regulation shall be valid for a maximum period of 5 years; Such decisions may be extended for a further period of 5 years, at the request of the manufacturer at the time specified in the contract between him and the authorised person.
(1) If the active implantable medical devices are covered by other specific legislation, 8) which includes other aspects which are presumed to have a mark of conformity (Section 12 (3) of the Act), then this marking means that these devices are also presumed to comply with other specific legislation. 8)
(2) If one or more special legislation allows the manufacturer to choose for a transitional period the procedure to be followed, the conformity mark used shall only indicate compliance with those specific legislation applied by the manufacturer; the accompanying documentation, warnings or instructions accompanying the relevant active implantable medical devices shall include a list of the specific legislation applied. Those documentation and warnings or instructions shall be accessible without damaging the packaging which ensures the sterility of the active implantable medical device.
Declaration of conformity
(1) The declaration of conformity referred to in Annexes 2, 4 and 5 shall be drawn up in the Czech language and shall contain the following particulars:
(a) identification details of the domestic manufacturer or importer of the active implantable medical device (name and surname, residence, place of manufacture and identification number of the natural person or name or, where applicable, business name, registered office and identification number of the legal person);
(b) the name (trade name), registered office and identification number of the authorised person responsible for assessing the conformity assessment procedures used;
(c) identification data on active implantable medical devices (e.g. name, type, brand, model), for imported active implantable medical devices also identification data on the manufacturer;
(d) a description of the active implantable medical device, its intended purpose of use and, where appropriate, any further information on it at the discretion of the manufacturer or importer;
(e) a list of technical regulations and standards and other specific legislation applied;
(f) a declaration by the manufacturer or importer that:
1. the properties of the active implantable medical device comply with the essential requirements set out in Annex 1 to this Regulation and, where appropriate, with other technical regulations and procedures;
2. an active implantable medical device is suitable and safe for the intended purpose of use under normal conditions;
3. the active implantable medical device is intended for single or repeated use only under specified hygiene conditions; and
4. take measures to ensure compliance of all active implantable medical devices placed on the market with their technical documentation and with the essential requirements;
(g) the date and place of issue of the declaration of conformity, the names and functions of the responsible persons of the manufacturer or importer and their signatures.
(2) If there is a change in the facts on which the declaration of conformity for an active implantable medical device to be placed on the market and put into service is issued, and if such changes may affect the properties of an active implantable medical device in respect of the essential requirements, the manufacturer or importer shall, after verification by an authorised person, issue a new certificate of conformity. Other amendments which do not change the intended purpose of use shall be indicated in the Appendix to the declaration of conformity.
Transitional provision
Active implantable medical devices which have been approved in accordance with the regulations in force prior to the entry into force of the law and authorised for use in the provision of medical care under a special law, 10) may be marketed by 30 June 2000 at the latest.
Efficacy
This Regulation shall enter into force on 1 January 2000, with the exception of Article 6, which shall take effect on 1 January 2001.
Prime Minister:
Ing. Zeman v. r.
Minister for Health:
Dr. David, CSc.
Příloha č. 1
Annex No. 1 to Decree No. 198 / 1999 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 performance specified by the manufacturer and be suitable for one or more of the functions specified in the separate legislation11) and in accordance with the manufacturer's specification.
3. Where active implantable medical devices which may occur under normal operating conditions are loaded, they shall not be adversely affected by their functional characteristics and efficacy within the meaning of points 1 and 2 to such an extent as to avoid endangering the clinical conditions or safety of users or, where appropriate, other persons, during the lifetime of those devices declared by the manufacturer.
4. Active implantable medical devices shall be designed, manufactured and packaged so that their characteristics and performance as specified by the manufacturer are not adversely affected by storage and transport conditions (e.g. temperature, humidity).
5. Any adverse effects of active implantable medical devices shall be only acceptable risks compared to their anticipated effects in the areas covered by the specific legislation. 11)
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 12) 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 ambient 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 the protection requirements of specific legislation; 13)
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 enlargement 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. the selection of materials used, in particular with regard to toxicity;
9. 2. mutual compatibility between the materials used and the biological tissues, cells and body fluids, taking into account the anticipated use of active implantable medical devices;
9. 3. the compatibility of active implantable medical devices with substances to be administered;
9. 4. the quality of the points connected, 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 as an integral part a substance which, when used alone, can be considered as a drug (2) and which acts on the body by its effect complementing the effect of that device, the safety, quality and efficacy of that substance must be verified for the intended purpose by the methods used for the testing of medicinal products. 14)
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.
13. If the active implantable medical device or its accessories contain instructions necessary for its operation or visually visible data for the setting or operation of the device, these data shall be understandable to the natural person providing medical care, if necessary to the patient.
14. The following particulars shall appear legibly and indelibly on the active implantable medical device:
14.1. on sterile packaging
14.1.1. method of sterilisation,
14.1.2. a label enabling the pack to be considered sterile,
14.1.3. the name, surname, residence, place of manufacture and identification number if the manufacturer is a natural person, or the name (trade name), address of the registered office and identification number if the manufacturer is a legal person,
14.1.4. a description of the active implantable medical device,
14. 1. 5. the inscription "Exclusive for clinical trial" in respect of active implantable medical devices intended for clinical trial,
14. 1. 6. the inscription "Custom-made means" in the case of a custom-made active implantable medical device,
14. 1. 7. Declaration on the sterility of the device,
14.1.8. Month and year of manufacture,
14.1.9. time limit for the safe implantation of this device,
14.2. on the sales packaging
14.2.1. the name (trade name) and address of the manufacturer's registered office,
14.2.2. a description of the device,
14.2.3. the intended purpose of its application,
14.2.4. adequate characteristics for its use,
14. 2. 5. the inscription "Exclusive for clinical trial" in respect of an active implantable medical device intended for clinical trial,
14. 2. 6. The inscription "Custom-made means" in the case of a custom-made active implantable medical device,
14. 2. 7. Declaration of Sterility,
14.2.8. Month and year of manufacture,
14.2.9. Time limit for safe implantation of this device,
14. 2. 10. Conditions for the transport and storage of this device.
Such data may also be expressed using appropriate, generally accepted symbols.
15. The active implantable medical device must, when placed on the market, be provided with instructions for use in the Czech language containing in particular:
15. 1 year of conformity assessment under this Regulation;
15.2. the data referred to in sections 14.1 to 14.7 and 14.1 to 14.7 and 14.10;
15. 3. data on its performance within the meaning of point 2 of this Annex and any adverse side effects;
15. 4. Information enabling doctors to ascertain the suitability of this device, the corresponding software and accessories;
15. 5.
15. 5. 1. Instructions for use enabling the physician and, where appropriate, the patient to use this device, its accessories and software properly,
15.5.2. the nature, extent and frequency of the operational checks and tests and, where appropriate, the maintenance instructions;
15. 6. information on the possibility of preventing risks associated with its implantation, where applicable;
15. 7. Information on the risk of adverse effects arising from the interaction of this device to the devices present at the time of the health investigation or treatment of individuals and vice versa;
15. 8. The necessary instructions in the event of a breach of the sterile packaging of this device and details of the appropriate method of resterilisation, where applicable;
15. 9. Indication that this device may be re-used only for its renovation in order to meet the essential requirements, if that option is applicable, under the responsibility of the manufacturer;
15. 10. Instructions enabling the physician to familiarise the patient with the contraindications and precautions to be taken, in particular:
15.10.1. the information by which the lifetime of the energy source can be determined,
15.10.2. measures in the event of a change in the characteristics of the device,
15.10.3. Measures in the event of ambient effects of magnetic fields, external electrical influences, electrostatic discharges, acceleration, pressure and its changes, or other negative effects on this device, where justified,
15.10.4. Adequate information on medicinal products, 2) to be given by this device.
16. Assurance that the active implantable medical device used in accordance with the intended purpose of use and under the conditions laid down by the manufacturer complies with the essential requirements set out in this Annex; the assessment of side effects is based on clinical data.
Příloha č. 2
Annex No. 2 to Government Decree No. 198 / 1999 Coll.
ASSESSMENT OF THE AUTORISED PERSONAL QUALITY SYSTEM
(Full quality assurance system)
1. Manufacturer
1. 1. They shall ensure the application of the approved quality system referred to in paragraphs 3 and 4 of this Annex for the design, manufacture and exit of active implantable medical devices;
1.2. It shall be subject to surveillance in accordance with point 5 of this Annex.
2. Manufacturer or person empowered by him
2. 1. denotes active implantable medical devices in accordance with Article 6 of this Regulation; the identification number of the relevant authorised person must be affixed to the conformity mark;
2. issue a written declaration of conformity covering the relevant active implantable medical devices of the same type; The manufacturer shall keep the declaration of conformity for the period specified in section 6.1.
3. Quality system
3.1. Manufacturer
3.1. Submits a written request to an authorised person for the assessment (evaluation and approval) of the quality system; the application shall contain:
3.1. Adequate information on the active implantable medical device which is expected to be produced,
3.2. Documentation of the quality system,
3. 1. 3. The manufacturer's guarantee to comply with the obligations under the approved quality system,
3. 1. 4. The manufacturer's guarantee to maintain the quality system in an adequate and efficient state,
3. 1. 1. 5. The manufacturer's guarantee that it will establish and update the systematic procedure for obtaining and evaluating the information and experience of users with the means it has produced and, following that activity, to implement the appropriate necessary measures, in particular to notify the Ministry and the State Institute for Drug Control (hereinafter referred to as "the Institute") of the occurrence of adverse events as soon as they are known (after-sales supervision),
3.1.1.6. Name, surname, residence, place of production for which the quality system applies and identification number if the manufacturer is a natural person, or name (trade name), address of the registered office, identification number and address of the manufacturing site to which the quality system applies.
3.2. The application of the quality system shall ensure the quality of the production of active implantable medical devices in such a way that these manufactured devices comply with the provisions applicable to them from this Regulation at any stage from their design to the exit check.
The elements, requirements and measures adopted by the manufacturer for the quality system it applies shall be systematically and properly documented in the form of written principles and procedures which shall enable their uniform interpretation, in particular the quality records, quality programmes, quality plans and the quality manual. The quality system documentation shall contain in particular an adequate description of:
3.2. 1. the quality objectives of the manufacturer,
3.2. Organisational structures and production activities of the manufacturer, in particular:
3. 2. 1. Definition of the responsibilities of management staff and their competence in relation to the quality of design and production of active implantable medical devices,
3.2. Methods for monitoring the effectiveness of the quality system, in particular its ability to achieve both the required design quality and active implantable medical devices, including control of those active implantable medical devices which do not achieve the required quality,
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Regulation Information
| Citation | Decree No. 198 / 1999 Coll., laying down technical requirements for active implantable medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.09.1999 |
|---|---|
| Effective from | 01.01.2000 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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