Government Regulation No. 55 / 2015 Coll.
Government regulation on technical requirements for active implantable medical devices
Valid
Effective from 01.04.2015
Text versions:
01.04.2015
31.03.2015
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55
GOVERNMENT REGULATION
of 25 March 2015
on technical requirements for active implantable medical devices
The Government mandates pursuant to Article 22 of Act No. 22 / 1997 Coll., on the Technical Requirements for Products and on the Amendment and Amendment of Certain Acts, as amended by Act No. 71 / 2000 Coll., Act No. 102 / 2001 Coll., Act No. 205 / 2002 Coll., Act No. 34 / 2011 Coll., Act No. 100 / 2013 Coll. and Act No. 64 / 2014 Coll., (hereinafter "Act on Technical Requirements for Products') to implement § 2 (d), § 11 (1) and (9) Coll., Section 11a (2), § 12 and 13 of the Act on Technical Requirements for Products and pursuant to Article 96 (1) of the Act No. 268 / 2014 Coll., on Medical Devices and Amendment to Act No. 634 / 2004 Coll., as amended, (hereinafter" the Act on Medical Devices') to implement § 5 (l):
Subject matter
(1) This Regulation implements the relevant provisions of the European Union1) and regulates the technical requirements for specified products.
(2) The specified products under this Regulation are within the meaning of Article 12 (1) (a) of the Act on technical requirements for products of active implantable medical devices. This Regulation also applies to active implantable medical devices intended for administration of a medicinal product within the meaning of the Drug Act.
General principles
(1) An active implantable medical device must comply with the essential requirements set out in Annex 1 to this Regulation (hereinafter referred to as "essential requirements") which apply to a particular active implantable medical device, taking into account its intended purpose.
(2) The assessment of active implantable medical device in terms of its electromagnetic compatibility shall not be carried out in accordance with the Government Regulation laying down technical requirements for products with regard to their electromagnetic compatibility (2).
(3) If there is an appropriate risk, active implantable medical devices, which are at the same time machinery, must also comply with the essential health and safety requirements set out in the Government Regulation on technical requirements for machinery (3), provided that these essential health and safety requirements are more specific than the essential requirements.
(4) The essential requirements shall be deemed to be met if the active implantable medical device complies with the requirements of the harmonised norem4) which apply to that medical device taking into account its intended purpose. For the purposes of this Regulation, the reference to harmonised standards shall also include the monographs of the European Pharmacopoeia, in particular the interaction between medicinal products and materials used in medical devices containing those medicinal products, to which references have been published in the Official Journal of the European Union.
Conformity assessment procedures
(1) In the case of an active implantable medical device which is not individually constructed or intended for clinical testing, the manufacturer shall assess the conformity of the CE marking prior to its action, taking into account the intended purpose of use, in accordance with the procedure laid down in:
(a) the full quality assurance system referred to in Annex 2 to this Regulation; or
(b) the type-examination referred to in Annex 3 to this Regulation, in conjunction with the verification procedure set out in Annex 4 to this Regulation or with the quality assurance procedure set out in Annex 5 to this Regulation.
(2) For an active implantable medical device for which conformity has been assessed in accordance with paragraph 1, the manufacturer shall issue a written declaration of conformity in accordance with the relevant Annex to this Regulation before it is placed on the market.
(3) For an individually manufactured active implantable medical device, the manufacturer shall issue a written declaration as set out in Annex 6 to this Regulation before placing on the market or putting into service.
(4) By way of derogation from paragraphs 1 to 3, the Ministry of Health may, on duly justified request, authorise the placing on the market and the putting into service of an individual active implantable medical device for which the procedure referred to in paragraphs 1 to 3 has not been carried out and the use of which is in the interest of health protection.
(5) The procedures laid down in Annexes 3, 4 and 6 to this Regulation may be carried out by its authorised representative instead of the manufacturer.
(6) Records and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall be kept in the Czech language or in a language agreed between the notified person and the manufacturer and, where appropriate, his authorised representative.
(7) When assessing the conformity of an active implantable medical device, the manufacturer, the authorised representative or the notified person shall take into account the results of all assessment and verification operations carried out, where appropriate, in accordance with this Regulation in the intermediate production process.
(8) Where the conformity assessment procedure for an active implantable medical device involves the participation of a notified person, the manufacturer or his authorised representative shall request the assessment of conformity of the notified person of his choice with an appropriate scope of authorisation and notification.
(9) The notified person may, if duly justified, request any information or data necessary to establish or maintain the verification of conformity assessment in the light of the procedure chosen.
(10) Certificates issued by the notified person and other decisions made by the notified person in accordance with Annexes 2, 3 and 5 to this Regulation shall be valid for a maximum period of five years and may be extended for a further period of no more than five years, on the basis of a request submitted at the time agreed by both Parties in a contract signed by both Parties.
(11) The conformity assessment procedures for minimising the risk of transmission of transmissible spongiform encephalopathy (TSE) to humans are governed by Commission Regulation No 722 / 2012 on specific requirements relating to the requirements laid down in Council Directives 90 / 385 / EEC and 93 / 42 / EEC with regard to active implantable medical devices and medical devices manufactured using tissues of animal origin, as amended.
CE marking
(1) The manufacturer shall affix an active implantable medical device which is neither individually made nor intended for clinical trials and which complies with the requirements laid down in this Regulation, before it is placed on the market or put into service, with the CE marking, the graphic form of which is laid down in the directly applicable European Union5).
(2) The CE marking 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, on the sales packaging.
(3) The CE marking of the active implantable medical device referred to in paragraph 1 shall be accompanied by the identification number of the notified person responsible for carrying out the operations provided for in the Medical Devices Act and Annexes 2, 4 and 5 to this Regulation.
(4) Other markings may be indicated on the packaging of the active implantable medical device or on the instructions accompanying it only if the visibility and legibility of the CE marking are not reduced. No marks and inscriptions likely to mislead third parties as regards the meaning and shape of the CE marking shall be affixed to the active implantable medical device.
(5) Where an active implantable medical device is subject, in other respects, to specific legislation requiring it to be affixed to the CE marking, that marking shall in such a case indicate that the active implantable medical device also complies with the requirements applicable to it under those specific legislation.
(6) However, if one or more laws allow the manufacturer, for a transitional period, to choose which provisions he will follow, the CE marking shall indicate compliance only with those laws or their provisions used by the manufacturer. In this case, the documentation, warnings or instructions required by the relevant legislation and annexed to the product concerned shall include a list of the legislation used and the directives as published in the Official Journal of the European Union, the requirements of which have been adopted by that legislation.
(7) An active implantable medical device not bearing the CE marking or not complying with the requirements of this Regulation or of the Law on Medical Devices may be displayed at trade fairs, exhibitions, demonstration events and other similar events, provided that the visible marking clearly indicates that the device cannot be placed on the market or put into service until it is brought into conformity with this Regulation and the Health Devices Act.
Placing on the market and putting into service
(1) An active implantable medical device may be placed on the market or put into service if:
(a) the conformity of its characteristics to the essential requirements has been assessed in the manner laid down by it and the result of that assessment has been that the active implantable medical device complies with the requirements of this Regulation and is correctly installed, maintained and used in accordance with its intended purpose, bears the CE marking, complies with the requirements set out in this paragraph and paragraphs 2 and 3, and the manufacturer has issued a written declaration thereof (hereinafter referred to as "the certificate of conformity"); and
(b) it is accompanied by information on its use in the Czech language in accordance with this Regulation.
(2) In the Czech Republic, an active implantable medical device intended for clinical trials is available to medical practitioners or authorised persons if it complies with the conditions laid down in Section 14 of the Medical Devices Act and Annex 6 to this Regulation.
(3) An individual-made active implantable medical device may be placed on the market or put into service if it has been assessed as conformity in accordance with Annex 6 to this Regulation and an individual-made active implantable medical device has been accompanied by a declaration in accordance with that Annex which is available to a specific patient.
(4) The active implantable medical device intended for clinical trials and the individually manufactured active implantable medical device shall not bear the CE marking.
Notified person
(1) The requirements set out in Annex 7 to this Regulation shall apply to the authorisation of legal persons under the Technical Requirements Act on Products. Legal persons meeting the criteria laid down in the relevant harmonised standards shall be deemed to comply with the relevant minimum criteria necessary for the assignment of the notified person.
(2) The amended person and the manufacturer or his authorised representative shall, by agreement, set time limits for the completion of the evaluation and verification activities referred to in Annexes 2 to 5 to this Regulation.
(3) Where the notified person finds that the manufacturer has not complied with or no longer meets the relevant requirements of this Regulation, or where the certificate should not have been issued, the notified person shall suspend, withdraw or restrict the use of the certificate which he has issued, except where the manufacturer has ensured compliance with those requirements by introducing adequate corrective measures. In the event of suspension, withdrawal or any restriction of the certificate or where action by the Technical Standardisation, Metrology and State Testing Office (hereinafter "the Office ') may be necessary, the notified person shall inform the Office accordingly. The Authority shall inform the other Member States of the European Union, the Contracting States to the Agreement on the European Economic Area, Switzerland and Turkey (hereinafter referred to as" the Member State') and the Commission.
(4) The amended person shall inform the Office of any issued, modified, supplemented, suspended, withdrawn or refused certificates and shall also inform other persons notified of suspended, withdrawn or refused certificates and of certificates issued on request. The notified person shall also make available on request any other relevant information on certificates issued.
(5) On request, the person nominated shall provide the Office with all relevant information and documents, including budgetary documents, enabling verification of compliance with the criteria set out in Annex 7 to this Regulation.
Transitional provisions
(1) Active implantable medical devices placed on the market before the date of entry into force of this Regulation under existing legislation are considered to be active implantable medical devices placed on the market in accordance with this Regulation.
(2) Authorised and notified persons in charge of conformity assessment activities under Government Regulation No 154 / 2004 Coll., as amended, shall be deemed to be authorised and notified persons in charge of conformity assessment activities under this Regulation.
Efficacy
This Regulation shall take effect on 1 April 2015.
Prime Minister:
Sobotka v. r.
Minister for Health:
MUDr.
Příloha č. 1
Annex No 1 to Government Regulation No 55 / 2015 Coll.
Essential requirements
I.
General requirements
1. The active implantable medical device shall be designed and manufactured in such a way that, provided it is implanted under the specified conditions and for the intended purpose of use, it does not jeopardise the clinical condition or safety of patients, nor the safety and health of users or other persons, as appropriate, provided that any risks which may be associated with the intended purpose of this active implantable medical device are acceptable compared to its benefit to the patient. Active implantable medical devices shall not pose any risk to persons implanted, where appropriate, to other natural persons.
2. The active implantable medical device 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 Medical Devices Act and in accordance with the manufacturer's specifications.
3. In the case of an active implantable medical device which may occur under normal operating conditions, it shall not be adversely affected by its characteristics and performance as referred to in paragraphs 1 and 2 of this Annex to the extent that the health or safety of the patient or user or, where appropriate, by other persons may be compromised during the life of the medical device specified by the manufacturer.
4. The active implantable medical device shall be designed, manufactured and packaged in such a way that, under the conditions laid down by the manufacturer for its storage and transport, its characteristics and performance cannot be adversely affected.
5. Any side effect and adverse event may pose only acceptable risks as compared to the intended effects of an active implantable medical device.
6. The demonstration of compliance with the essential requirements shall include a clinical evaluation under the Medical Devices Act.
II.
Design and construction requirements
7.
Chemical, physical and biological characteristics
7.1. The level of safety of the active implantable medical device must correspond to the state of science and technology at the time of its placing on the market, this requirement must correspond to the solutions adopted by the manufacturer in their design and construction.
7.2. The active implantable medical device shall be designed, manufactured and packaged in disposable packaging by an appropriate procedure so that it remains sterile after placing on the market and retains this property during storage and transport under conditions specified by the manufacturer until the implantation packaging has been removed.
7.3. The active implantable medical device shall be designed and manufactured in such a way as to exclude or minimise risks to
7.3.1. physical injury related to its physical characteristics,
7.3.2. related to the energy sources used, when using electricity in particular with regard to the isolation state, conduction currents or overheating of the active implantable medical device,
7.3.3. associated with reasonably foreseeable environmental conditions, in particular magnetic fields, external electrical influences, electrostatic discharges, pressure and changes and acceleration;
7.3.4. associated with treatment, which results mainly from the use of defibrillators and high frequency surgical devices,
7.3.5. associated with ionising radiation of radioactive substances used in active agents in accordance with radiation protection requirements under specific legislation6), and
7.3.6. which may arise from the fact that an active implantable medical device cannot be maintained or calibrated, including risks arising from:
7.3 6.1. from excessive increase in water currents,
7.3.6.2.
7.3.6.3. Excessive heat produced by an active implantable medical device; and
7.3.6.4 from reduced accuracy of measuring or checking mechanism.
7.4. The active implantable medical device shall be designed and manufactured in such a way as to guarantee its characteristics and performance as set out in points 1 to 6 of this Annex, with particular regard to:
7.4.1. selection of materials used, in particular with regard to toxicity,
7.4.2. mutual compatibility between the materials used and the biological tissues, cells and body fluids, taking into account the anticipated use of an active implantable medical device;
7.4.3. compatibility of the active implantable medical device with the substances to be administered;
7.4.4. quality of connections, in particular with regard to safety,
7.4.5. the reliability of the energy source,
7.4.6. tightness, if applicable, and
7.4.7. proper operation of programming and control systems, including software.
7.5. In the case of an active implantable medical device which contains software or which itself is software, software shall be validated according to the latest knowledge, taking into account the principles of life cycle development, risk management, validation and verification.
7.6. Provisions for medical devices with an integrated medicine or a human blood derivative
7.6.1. If an active implantable medical device contains, as an integral part of it, a substance that can be considered as a medicinal product under the Drug Act (7), and which can act on the body by complementary action to the effect of an active implantable medical device, the quality, safety and usefulness of that substance shall be verified by analogy using the methods set out in the Drug Code.
7.6.2. For the substances referred to in point 7.6.1. of this Annex, after verifying the usefulness of the substance as part of an active implantable medical device and taking into account the intended purpose of an active implantable medical device, the notified person shall request a technical opinion on the quality and safety of the substance, including a clinically verified risk-benefit ratio for the inclusion of the substance in an active implantable medical device, from one of the competent authorities of the Member States or from the European Medicines Agency (the Agency). Where the opinion of the State Institute for Drug Control (hereinafter referred to as "the Institute ') is given, it shall take into account the production processes and data on the usefulness of the inclusion of the substance in an active implantable medical device, as indicated by the notified person.
7.6.3. Where an active implantable medical device contains, as an integral part, a human blood derivative, the notified person shall, after verifying the usefulness of that human blood derivative as part of an active implantable medical device and taking into account the intended purpose of an active implantable medical device, request the Agency's expert opinion on the quality and safety of that human blood derivative, including a clinically verified risk / benefit ratio of the incorporation of the human blood derivative into an active implantable medical device.
7.6.4. Where changes are made to a complementary substance incorporated into an active implanatble medical device, in particular as regards its manufacturing process, the notified person shall be informed of the modification, who shall request the expert opinion of the competent authority which issued the original expert opinion to confirm that the quality and safety of the complementary substance is maintained. Where a professional opinion is requested by the Institute, it shall take into account data on the usefulness of the inclusion of the additional substance in an active implantable medical device, as indicated by the notified person, in order to ensure that the changes have no negative impact on the clinically verified risk-benefit balance when integrating the additional substance into the medical device.
7.6.5. If the Institute which issued the initial expert opinion receives information on the additional substance that could affect the clinically verified risk-benefit ratio when it is incorporated into an active implantable medical device, it shall communicate to the notified person whether or not this information has an impact on the established clinically validated risk-benefit ratio for the inclusion of the additional substance in an active implantable medical device. The notified person shall take into account the updated expert opinion when reassessing his conclusion from the conformity assessment procedure.
Information provided by the manufacturer
8.
8.1 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.
8.2. The active implantable medical device shall be provided with a code enabling the unique identification of the individual device and its manufacturer. This code shall be legible if necessary without the need for surgical intervention.
8.3. If the instructions necessary for its operation or visual data for the setting or operation of the device are provided on an active implantable medical device or its accessories, this data shall be understood by the health service provider, if necessary, to the patient.
9.
The following data shall be shown legibly and indelibly on the active implantable medical device:
9.1. on sterile packaging
9.1.1. method of sterilisation,
9.1.2. a label enabling the package to be considered sterile,
9.1.3. the name or business name and address of the registered office or, where applicable, the address of the main business establishment or place of residence if the manufacturer is a natural person; the name or business name and address of the registered office if the manufacturer is a legal person;
9.1.4. Description of active implantable medical device,
9.1.5. the inscription "Exclusive for clinical trials" when it is an active implantable medical device intended for clinical trials,
9.1.6. the inscription "Individual-made active implantable medical device" in the case of an individual-made active implantable medical device,
9.1.7. Declaration on the sterility of the device,
9.1.8. Month and year of manufacture; and
9.1.9. time limit for safe implantation of this device,
9.2. on the sales packaging
9.2.1. with the authorised representative, where the manufacturer does not have his registered office in one of the Member States, the name or business name and address of the registered office or, where applicable, the address of the main commercial establishment or place of residence, if the authorised representative is a natural person; the name or business name and address of the registered office if the authorised representative is a legal person;
9.2.2. Description of the device,
9.2.3. the intended purpose of its application;
9.2.4. adequate characteristics for its use;
9.2.5. the inscription "Exclusive for clinical trials" when it is an active implantable medical device intended for clinical trials,
9.2.6. the inscription "Individual-made active implantable medical device" in the case of an individual-made active implantable medical device,
9.2.7. a declaration of sterility,
9.2.8. month and year of manufacture,
9.2.9. time limit for safe implantation of this device,
9.2.10. Conditions for the transport and storage of the device;
9.2.11. an indication that an active implantable medical device contains a human blood derivative under the Law on medical devices,
9.3. the particulars referred to in points 9.1 and 9.2 of this Annex may also be expressed by means of appropriate marks specified in the harmonised standards,
9.4. the active implantable medical device must be equipped with instructions for use in the Czech language, which contains:
9.4.1. Year of conformity assessment under this Regulation for the purpose of the CE marking measure;
9.4.2. the data referred to in paragraphs 8.4.1. to 8.5.7. and 8.5. of this Annex,
9.4.3. data on its performance as referred to in Annex 1, point 2, to this Regulation and any adverse side effects;
9.4.4. information enabling doctors to select an appropriate active implantable medical device, appropriate software and accessories; and
9.4.5. information which is included in the instructions for use and which enables the physician and, where appropriate, the patient to use this device, its accessories and software properly, as well as information on the nature, scale and frequency of the operational checks and tests, as well as maintenance instructions, where appropriate,
9.4.6. information on the possibility of preventing the risks associated with its implantation, where applicable,
9.4.7. information on the risk of adverse effects on the device resulting from the interaction of the device and apparatus present at the time of the health investigation or treatment of natural persons,
9.4.8. the necessary instructions in the event of a breach of the sterile packaging of the device and details of the appropriate method of sterilisation, where applicable,
9.4.9. an indication that this device may only be reused after its renovation under the responsibility of the manufacturer in such a way as to meet the essential requirements if this option is applicable; and
9.5. Instructions to the physician on contraindications and precautions to be taken, in particular:
9.5.1. information by which the lifetime of the energy source can be determined;
9.5.2. measures in the event of a change in the performance of the device;
9.5.3. measures in the event of magnetic fields acting in the vicinity of active acceleration, pressure and its changes or other negative effects on the device, where justified;
9.5.4. adequate information on the medicinal products to be administered by the device; and
9.5.5. Date of issue or date of last revision of the instructions for use,
9.6. a declaration 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 obtained under the Medical Devices Act.
Příloha č. 2
Annex No 2 to Government Regulation No 55 / 2015 Coll.
EC declaration of conformity
Full quality assurance system
1.
1.1. The manufacturer shall ensure that the approved quality system referred to in paragraphs 2, 3 and 4 of this Annex is applied for the design, manufacture and exit of the active implantable medical device.
1.2. The quality system shall be subject to surveillance in accordance with point 5 of this Annex. A complete quality assurance system shall be the procedure whereby the manufacturer or, where appropriate, the authorised representative fulfilling the obligations referred to in point 1 guarantees and declares that the relevant active implantable medical device complies with the requirements of this Regulation.
1.3. The manufacturer or authorised representative shall affix the active implantable medical device to the CE marking and attach the identification number of the notified person concerned.
1.4. The manufacturer or authorised representative shall draw up a written declaration of conformity which he is obliged to keep. This declaration shall cover one or more active devices precisely identified by the name of the active implantable medical device, the product code of the active implantable medical device or any other clear reference.
2.
Quality system
2.1. The manufacturer shall submit a written request to the notified person for assessment of the quality system.
2.2. The application shall contain:
2.2.1. the name or business name and address of the registered office or, where applicable, the address of the main business establishment, if the manufacturer is a natural person; the name or business name and address of the registered office where the manufacturer is a legal person, or, where appropriate, a business name or the name and address of the registered office of the authorised representative, if the manufacturer does not have its registered office in a Member State;
2.2.2. all information on the active implantable medical device the production of which is expected,
2.2.3. documentation of the quality system,
2.2.4. the manufacturer's guarantee shall comply with the obligations arising from the approved quality system;
2.2.5. the manufacturer's guarantee to maintain the quality system in a usable and efficient condition; and
2.2.6. a commitment by the manufacturer to implement and update a systematic process for obtaining and evaluating the information and experience of users acquired with active implantable medical devices placed on the market, including a clinical trial in accordance with the Medical Devices Act; Part of this obligation of the manufacturer is to notify the Institute of Adverse Events under the Law on Medical Devices without delay and no later than 15 days after the date of the finding.
2.3. The application of the quality system shall ensure the quality of the production of the active implantable medical device in such a way that the manufactured device complies with the provisions applicable to it from this Regulation at every stage from its design to its output control.
2.4. The elements, requirements and measures adopted by the manufacturer for the quality system in its application shall be systematically and properly documented in the form of written principles and procedures enabling their uniform interpretation, in particular the quality records, quality programmes, quality plans and the quality manual. This includes, in particular, appropriate documentation, data and records based on the procedures referred to in section 2.5.3.
2.5. The quality system documentation shall contain in particular an adequate description of:
2.5.1. the quality objectives specified by the manufacturer;
2.5.2. organisation of the business plant and production activities with the manufacturer, in particular:
2.5.2.1. organisational structures, definition of the responsibilities of management staff and their competence in relation to the quality of design and manufacture of active implantable medical devices;
2.5.2.2. methods for monitoring the effectiveness of the quality system, in particular its ability to achieve the required design quality and the active implantable medical device produced, including the handling of this active implantable medical device which is below the required quality;
2.5.2.3. where the design, manufacture or exit check and testing of an active implantable medical device or parts thereof are carried out by a third party, methods of monitoring the effective functioning of the quality system, and in particular the manner and extent of the control carried out over the third party;
2.5.3. procedures for monitoring and verifying the design of an active implantable medical device, in particular:
2.5.3.1. the design specifications, including the harmonised standards to be applied, a description of the solutions adopted to meet the essential requirements applicable to the active implantable medical device, if the harmonised standards are not fully applied,
2.5.3.2. methods for the control and verification of proposals, procedures and systematic measures to be used in the design of an active implantable medical device,
2.5.3.3. a statement as to whether an active implantable medical device contains, as an integral part of, the substance or human blood derivative referred to in point 7.6.3 of Annex 1 to this Regulation, and the data on the tests carried out in this context required to assess the safety, quality and usefulness of that substance or human blood derivative, taking into account the intended purpose of using an active implantable medical device;
2.5.3.4. preclinical evaluation,
2.5.3.5. clinical evaluation according to the Law on Medical Devices,
2.5.4. methods for controlling and ensuring the quality of the active implantable medical device at the stage of its manufacture, in particular:
2.5.4.1. methods and procedures to be used for sterilisation and purchase, including relevant documents;
2.5.4.2. the procedures for identifying the active implantable medical device developed and updated for all stages of production on the basis of drawings, specifications and other relevant documents;
2.5.4.3. a statement as to whether a medical device is manufactured using tissues of animal origin pursuant to Commission Regulation No 722 / 2012 on specific requirements relating to the requirements laid down in Council Directives 90 / 385 / EEC and 93 / 42 / EEC with regard to active implantable medical devices and medical devices manufactured using tissues of animal origin; and
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Regulation Information
| Citation | Government Regulation No. 55 / 2015 Coll., on Technical Requirements for Active Implantable Medical Devices |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.03.2015 |
|---|---|
| Effective from | 01.04.2015 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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