Government Decree No. 336 / 2004 Coll.
Government Regulation laying down technical requirements for medical devices and amending Government Regulation No. 251 / 2003 Coll., amending certain government regulations issued for the implementation of Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended
Valid
Effective from 02.06.2004
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336
GOVERNMENT REGULATION
of 5 May 2004
laying down technical requirements for medical devices and amending Government Regulation No 251 / 2003 Coll., amending certain government regulations issued for the implementation of Act No 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended
The Government orders pursuant to Article 22 of Act No. 22 / 1997 Coll., on technical requirements for products and on the amendment and addition of certain laws, as amended by Act No. 71 / 2000 Coll. and Act No. 205 / 2002 Coll., (hereinafter referred to as "the Act ') to implement Sections 11 paragraphs 1 and 2, § 11a, § 12 and 13 of the Act and to implement Act No. 123 / 2000 Coll., on medical devices and on the amendment of certain related laws, as amended by Act No. 130 / 2003 Coll. and Act No. 274 / 2003 Coll. (hereinafter referred to as" the Act on Medical Devices'):
TECHNICAL REQUIREMENTS FOR HEALTH EQUIPMENT
Preliminary provisions
This Regulation implements the relevant provisions of the European Union1) and provides for
(a) technical requirements for medical devices (2); and
(b) detailed specifications as regards the risk of transmission of transmissible spongiform encephalopathies (TSEs) to sick individuals (patients) or other natural persons by the use, under normal conditions, of medical devices intended to come into contact with the human body, but not only with intact skin, produced using inanimate animal tissue or non-living products made from animal tissue, where such tissue originates from bovine, ovine or caprine animals, as well as deer, mink, elk and cats; the content of the detailed specifications is set out in Annex 12 to this Regulation.
(1) For the purposes of conformity assessment under this Regulation, the specified products referred to in Article 12 (1) of the Act are medical devices with the exception of:
(a) diagnostic medical devices in vitro3); and
(b) active implantable medical devices; 4)
(2) This Regulation shall not apply to:
(a) medicinal products5); When deciding whether a product falls within the scope of the Act on Medication5) or of this Government Regulation, account shall be taken in particular of the main mode of action of the product,
(b) cosmetic products,
(c) transplants or tissues or cells of human origin and products containing or derived from tissues or cells of human origin, with the exception of medical devices referred to in § 2 (2) (g) of the Medical Devices Act;
(d) human blood, blood products, human blood plasma or blood components of human origin, or medical devices containing, at the time of their entry into the market (6), such products of blood, blood plasma or blood cells, with the exception of medical devices referred to in § 2 (2) (g) of the Medical Devices Act;
(e) transplants, tissues or cells of animal origin, with the exception of those produced using non-living animal tissue or non-living animal tissue derived products.
Definition of terms
(1) For the purposes of this Regulation, as regards medical devices referred to in Article 1 (b):
(a) a cell of the smallest organised unit of any living form capable of independent existence and self-recovery in an appropriate environment;
(b) tissues of any cell organisation or, where appropriate, non-cellular components;
(c) a derivative material obtained from the production process from animal tissue such as collagen, gelatine, monoclonal antibodies,
(d) inanimate be without any possibility of metabolism or reproduction;
(e) transmissible agents of non-classified pathogenic agents, prions and agents such as bovine spongiform encephalopathies (BSE) and scrapie,
(f) by reducing, excluding or eliminating a process which reduces the number of transmissible agents or excluding transmissible agents, where appropriate, to prevent infection or pathological reaction;
(g) inactivation of a process which reduces the ability of transmissible agents to cause infection or pathological reaction;
(h) the country of origin of the country in which the animal was born, reared or slaughtered;
(i) the source materials of the raw material or any other means of animal origin from or through which the medical devices referred to in Article 1 (b) are produced.
(2) Entry into service means the moment at which a medical device complying with the requirements of this Regulation is transmitted to the user, 8) where it is installed and ready for the first time for the intended purpose of use.
General principles
(1) A medical device shall comply with the requirements set out in Annex 1 to this Regulation (hereinafter referred to as "essential requirements') and the requirements applicable to a particular device, taking into account the intended purpose of its use. Where there is an appropriate risk, medical devices, which are simultaneously machinery (8a), must also comply with the essential health and safety requirements set out in Annex 1 to the Government Regulation on technical requirements for machinery (8a), provided that these essential health and safety requirements are more specific than those set out in Annex 1 to this Regulation.
(2) The essential requirements shall be deemed to be met if the medical device complies with the requirements of the harmonised standards, 9) which apply to that medical device taking into account the intended purpose of use.
(3) A medical device may be placed on the market or put into service if:
(a) its conformity with the essential requirements (hereinafter referred to as "conformity") has been assessed in the manner established by it and the result of that assessment has been that the medical device complies with the essential requirements, it has been provided with a written declaration thereof (hereinafter referred to as "the certificate of conformity"), with the exception of a custom medical device and a medical device intended for clinical trials, CE marking, 10), and
(b) it is accompanied by information on its use in accordance with point 13 of Annex 1 to this Regulation; when it is placed on the market in the Czech Republic, the information on its use must be in the Czech language.
(4) A medical device intended for carrying out clinical examinations (13) may, for this purpose, be transmitted to a doctor or other person authorised to carry out clinical examinations on the basis of his qualification, under the conditions laid down in the Law on Medical Devices (14) in § 15 and Annexes 8 and 10 to this Regulation; the device shall not bear the CE marking.
(5) A custom medical device (15) may be placed on the market and put into service if conformity has been assessed in accordance with Article 9 (5) and Annex 8 to this Regulation. For the purposes of this Regulation, the following definitions apply:
(6) In cases where a medical device does not comply with this Regulation or endangers the health or lives of humans or where the medical device bears the CE marking and is properly placed on the market or put into service or is properly maintained and used in accordance with the intended purpose of use, and nevertheless there is a risk that it may adversely affect the health of people, taking into account the nature of the risk to the user, the law, the law on medical devices and the specific legislation. 16) The Ministry of Industry and Trade shall immediately inform the European Commission and the Ministry of Health (hereinafter referred to as the Ministry) of such cases and follow-up. The measures implemented must be duly justified, in particular whether the safeguard measure was taken on the basis of:
(a) non-compliance with the essential requirements;
(b) incorrect application of harmonised standards in accordance with Article 4 (2) where it is stated that they have been applied; or
(c) the deficiency in the harmonised standards themselves referred to in Article 4 (2).
(7) Decisions under the Law, the Law on Medical Devices, Special Legislation (16) and this Regulation concerning refusal or restriction of the placing on the market or putting into service or carrying out clinical trials or withdrawal of medical devices from the market must contain specific reasons for doing so.
(8) A nuclear-energy medical device or source of ionising radiation shall be assessed in the light of radiation protection by a person with appropriate accreditation for that activity and with permission under specific legislation. 17)
(9) The essential requirements relating to electromagnetic compatibility shall be specified for specified products under this Regulation in Annex 1 to this Regulation and specific legislation shall not apply in the assessment of these products. 18)
(10) Where the product is intended to be used by the manufacturer as a personal protective device (7) and at the same time as a medical device within the meaning of this Regulation, it shall also comply with the relevant essential health and safety requirements under the Government Regulation laying down technical requirements for personal protective equipment (7).
Labelling of medical devices
(1) Medical devices which are neither custom nor intended for clinical trials must comply with the requirements of this Regulation before being placed on the market or put into service and bear the CE marking. If the CE marking is reduced or enlarged, the relative proportions of the dimensions of that marking shall be respected. The different parts of the CE marking shall have substantially the same vertical dimensions which shall not be less than 5 mm; this minimum size may be adjusted for small-size medical devices.
(2) Where a medical device is subject, from other points of view, to requirements laid down by other legislation requiring it to be affixed to the CE marking, that marking shall state that the medical device also complies with those provisions. However, the documentation, warnings or instructions required by the relevant legislation and annexed to the relevant health products shall include a list of the legislation applied and the directives as published in the Official Journal of the European Union, the requirements of which have been adopted by that legislation.
(3) The CE marking shall be placed visibly, legibly and indelibly on the medical device or its sterile packaging, where practicable and appropriate, and in the instructions for use. Where possible, the CE marking shall also be on the packaging of the medical device in which it is sold.
(4) The CE marking shall be accompanied, with the exception of a Class I medical device which is neither sterile nor with a measuring function, by the identification number of the notified person who assessed the conformity of the medical device with any of the procedures set out in Annexes 2, 4, 5 and 6 to this Regulation.
(5) No marks and descriptions may be affixed to the medical device which could be misinterpreted as being of relevance or graphically similar to the CE marking. Another character may be placed on the medical device, its packaging or in the instructions accompanying the medical device provided that it does not reduce the visibility or legibility of the CE marking.
(6) Where, for the purposes of demonstrating a medical device at exhibitions, fairs or otherwise, a medical device which does not comply with the requirements of this Regulation is used, that device shall be visibly marked to show that it cannot be placed on the market and put into service until it is brought into conformity with this Regulation.
Illegal connection of the CE marking
(1) If there is a reasonable suspicion that the CE marking has been affixed to the medical device unjustly or is missing, the latter shall be treated in accordance with the specific legislation19).
(2) If the manufacturer or his authorised representative fails to comply with the conditions for the CE marking and the measures imposed by the Czech Trade Inspection Office concerning the medical device concerned under paragraph 1, the procedure shall be followed in accordance with specific legislation. 20)
(3) The European Commission and the competent authorities of the Member States of the European Union or of the European Free Trade Association, which is a Contracting Party to the European Economic Area, hereinafter referred to as "the Member State," shall be informed by the Ministry of Industry and Trade of the measures referred to in paragraphs 1 and 2.
(4) The provisions of paragraphs 1 to 3 shall also apply where the CE marking has been affixed in accordance with the procedures laid down in this Regulation to products not covered by this Regulation.
Classification
(1) Medical devices shall be classified according to the risk to users and, where appropriate, to other natural persons in Classes I, IIa, IIb and III; the inclusion of a medical device in one of those classes shall be carried out in accordance with the rules set out in Annex 9 to this Regulation.
(2) Where the Ministry concludes that:
(a) the application of the classification rules set out in Annex 9 to this Regulation requires a decision on the classification of a particular medical device or category of medical devices;
(b) a particular medical device or category of medical devices should be classified in another class by way of derogation from the provisions of Annex 9 to this Regulation;
(c) the conformity of a medical device or category of medical devices should be assessed only in accordance with 1 of the procedures set out in Section 9;
(d) it is necessary to decide whether a particular product or product group complies with any of the definitions in Section 2 of the Health Devices Act; or
(e) the classification rules set out in Annex 9 to this Regulation require adaptation for reasons of technical progress or information that becomes available in the adverse event log system;
request the European Commission to take the necessary measures; the request must be duly substantiated.
Conformity assessment procedures
(1) The manufacturer or the authorised representative shall carry out or carry out, for a medical device, the conformity assessment procedures and operations referred to in paragraphs 9 to 12.
(2) At the manufacturer's direction, the authorised representative shall be entitled to initiate the procedure laid down in Annexes 3, 4, 7 and 8 to this Regulation.
(1) For Class III medical devices which are neither custom nor intended for clinical testing, the manufacturer shall follow the CE marking for its action in accordance with the procedure laid down in:
(a) the EC declaration of conformity referred to in Annex 2 (Full Quality Assurance System) to this Regulation; or
(b) EC type-examination in accordance with Annex 3 to this Regulation in conjunction with the procedure for:
1. EC verification according to Annex 4 to this Regulation; or
2. The EC declaration of conformity referred to in Annex 5 (Quality assurance of production) to this Regulation.
(2) In the case of Class IIa medical devices which are neither custom nor intended for clinical trials, the manufacturer shall, for his action, follow the CE marking in accordance with the procedure for the EC declaration of conformity referred to in Annex 7 to this Regulation in conjunction with the procedure for:
(a) EC verification in accordance with Annex 4 to this Regulation; or
(b) the EC declaration of conformity referred to in Annex 5 (Quality assurance of production) to this Regulation; or
(c) the EC declaration of conformity referred to in Annex 6 (Quality assurance of the medical device) to this Regulation;
or in accordance with paragraph 3 (a).
(3) In the case of Class IIb medical devices which are neither custom nor intended for clinical trials, the manufacturer shall follow the CE marking for its action in accordance with the procedure for:
(a) the EC declaration of conformity referred to in Annex 2 (Full Quality Assurance System) to this Regulation, with the exception of point 4 thereof; or
(b) EC type-examination in accordance with Annex 3 to this Regulation in conjunction with the procedure for:
1. EC verification as set out in Annex 4 to this Regulation,
(2) the EC declaration of conformity referred to in Annex 5 (Quality assurance of production) to this Regulation, or
3. The EC declaration of conformity referred to in Annex 6 (Quality assurance of the medical device) to this Regulation.
(4) For Class I medical devices which are neither custom-made nor intended for clinical testing, the manufacturer shall follow the CE marking for its action in accordance with the procedure set out in Annex 7 to this Regulation and draw up an EC declaration of conformity prior to the placing on the market of that medical device.
(5) Prior to the placing on the market of each custom medical device, the manufacturer shall proceed to this Regulation in accordance with points 1, 2.1, 3.1 and 4 of Annex 8 (Declaration of Medical devices for special purpose) and draw up the declaration set out in this Annex. The manufacturer shall, upon request, forward to both the Czech Trade Inspection and the State Institute for Drug Control (hereinafter referred to as the Institute) a list of the custom medical devices put into service in the Czech Republic by this manufacturer.
(1) When assessing the conformity of a medical device of the manufacturer or, where appropriate, the notified person, it shall take into account the results of the evaluation and verification procedures, provided that they have been carried out in accordance with this Regulation in each intermediate production process.
(2) Where the conformity assessment procedure for a medical device involves the participation of a notified person, the manufacturer or his authorised representative shall, at his choice, request that service from a notified person with an appropriate scope of authorisation.
(3) The Notified Person may request the manufacturer to provide the necessary information to verify conformity with the chosen conformity assessment procedure.
(4) Certificates issued by the notified person and other decisions taken by him in accordance with Annexes 2, 3, 5 and 6 to this Regulation shall be valid for a maximum period of 5 years and may be extended for a further period of no more than 5 years at the request of the manufacturer at the time specified in the contract between the manufacturer and the notified person who issued the certificate.
(5) The accompanying and manufacturing documentation of the medical device, records and correspondence relating to the procedures referred to in Article 9 may be obtained in the official language of the Member State in which the procedures are carried out and, where appropriate, in another language acceptable to the notified person.
Specific procedure for medical devices systems and kits and for carrying out sterilisation of medical devices
(1) In the case of systems and sets of medical devices, by way of derogation from Sections 9 and 10.
(2) A person who compiles medical devices bearing the CE marking for the intended purpose of use in order to place them on the market as a system or kit shall draw up a declaration stating that:
(a) verify the compatibility of the medical devices assembled in accordance with the instructions of their manufacturers and carry out operations for operation under these guidelines;
(b) package the system or kit of medical devices and attach appropriate information to it for users, including instructions from manufacturers of individual medical devices; and
(c) its activities in the preparation of medical devices comply with the relevant internal control and inspection methods.
(3) If the conditions referred to in paragraph 2 are not met, in particular if the medical devices constituting the system or the medical device assembly are not bearing the CE marking or if the medical devices system or assembly is not compatible with the initial intended uses of the individual medical devices, such a medical device system or assembly shall be considered as a separate medical device subject to the procedure laid down in paragraphs 9 and 10.
(4) A person who, for the purposes of placing on the market, sterilises medical devices sets and systems referred to in paragraph 2 or medical devices bearing the CE marking, whose manufacturers are intended to be sterilised before their use in the framework of the provision of healthcare, shall choose one of the procedures set out in Annexes 2 or 5 to this Regulation. The use of those Annexes and the activity of the notified person shall be limited to the procedure necessary to achieve the sterility lasting until the sterile packaging is opened or damaged. The sterilisation person shall draw up a declaration that the sterilisation has been carried out in accordance with the manufacturer's instructions.
(5) The medical devices referred to in paragraphs 2 and 4 shall not subsequently bear the CE marking, but shall be accompanied by information in accordance with point 13 of Annex 1 to this Regulation, which shall contain the relevant manufacturer data on the medical devices which have been assembled. The declaration referred to in paragraphs 2 and 4 shall be kept by the person referred to in paragraphs 1 to 4 for at least 5 years at the disposal of the competent administrative authorities.
Conformity assessment procedures for minimising the risk of the transmission of TSE to humans
(1) Before submitting an application for conformity assessment pursuant to Article 9 (1) for a medical device referred to in Article 1 (b), the manufacturer shall carry out a risk analysis and risk management ("risk management ') in accordance with Annex 12 to this Regulation.
(2) Collagen, gelatine and tallow used in the manufacture of medical devices referred to in § 1 (b) must meet at least the requirements which they would have to meet if they were intended for human consumption.
(3) Medical devices referred to in Article 1 (b) may be placed on the market and put into service only if they comply with the specifications set out in Annex 12 to this Regulation.
(4) The assessment of the conformity of a medical device referred to in Article 1 (b) includes an assessment of compliance with the essential requirements and specifications set out in Annex 12 to this Regulation. Notified persons shall evaluate the manufacturer's intention to analyse risk analysis and risk management, in particular:
(a) the information provided by the manufacturer;
(b) justification for the use of animal tissues or derivatives of animal origin;
(c) the results of elimination or deactivation studies or research on specialised literature, where appropriate;
(d) the manufacturer's inspection of his suppliers, source materials and finished products;
(e) the need to verify the origin of the source materials, including supplies from suppliers of the manufacturer.
(5) Notified persons in the risk analysis and risk management assessment shall take into account, where available for source materials, the TSE absence certificate issued by the European Directorate for the Quality of Drugs (hereinafter referred to as the TSE certificate) in the framework of the conformity assessment.
(6) Except for medical devices manufactured using source materials for which a TSE certificate has been issued pursuant to paragraph 5, persons who carry out an assessment of the conclusions of risk analyses and risk management of non-living animal tissues or animal origin derivatives intended for use in the manufacture of medical devices referred to in paragraph 1 (b) shall, through the Ministry, establish the opinions of the competent authorities of other Member States concerning their evaluation of the conclusions of the risk analyses and risk management of the tissues and derivatives concerned by the manufacturers.
(7) Before issuing an EC design examination certificate for a medical device (hereinafter referred to as "EC design review certificate ') and an EC type examination certificate for a medical device (hereinafter referred to as" EC type examination certificate'), the notified person shall take into account the opinions adopted within 12 weeks of the date on which the opinions of the competent authorities of the Member States were requested.
Notification obligations
(1) A manufacturer who, in accordance with the procedures referred to in Article 4 (3), places medical devices on the market or put into service, an authorised representative or a person involved in the activities referred to in Article 11 shall notify the Ministry in electronic form:
(a) start-up in accordance with Annex 13 to this Regulation;
(b) the cessation of activities in accordance with Annex 13 to this Regulation;
(c) placing a medical device on the market in accordance with Annex 15 to this Regulation before the medical device is placed on the market;
(d) the placing on the market of a medical device in accordance with Annex 15 to this Regulation; and
(e) an amendment to any of the data notified under (a) and (c).
The data referred to in Annex 15 to this Regulation shall be notified only after the notifier has received a registration number from the Ministry on the basis of compliance with the notification requirement in accordance with Annex 13 to this Regulation. The manufacturer of a custom medical device shall notify the Ministry in electronic form only of the data referred to in points (a) and (b) and of any change to any of the data notified under point (a).
(2) A person placing a medical device on the market or putting it into service within the territory of the Czech Republic is required, at the request of the Ministry, to provide information enabling the medical device to be identified and supporting documents used to assess conformity.
(3) If a manufacturer intending to place on the market, under his name, a medical device referred to in paragraph 1 or 2, does not have its head office in a Member State, he shall entrust to the marketing of such medical devices an authorised representative who is his only authorised representative within the Member States.
(4) Upon request, the Ministry shall communicate to the Member State and the European Commission the information resulting from paragraphs 1 to 3 provided by the manufacturer or his authorised representative.
(5) The distributor, importer and person serving medical devices shall notify the Ministry in electronic form
(a) start-up in accordance with Annex 14 to this Regulation;
(b) the cessation of activities in accordance with Annex No 14 to this Regulation; and
(c) an amendment to any of the data notified under (a).
Data set
(1) Data
(a) the medical devices and persons referred to in Section 13;
(b) the certificates issued, modified, suspended and cancelled, as well as the refusal of applications for certification in accordance with the procedures laid down in Annexes 2 to 7 to this Regulation;
(c) obtained in accordance with the procedure governing notification and registration of adverse events (21); and
(d) clinical trials
they shall be processed in accordance with this Regulation in the information system provided for in Section 41 of the Medical Devices Act until the person handling the medical devices has notified the Ministry of Termination and for an additional 20 years. Data from the information system are accessible to the Ministry, the Office for Technical Standardisation, Metrology and State Testing (hereinafter referred to as the Office), the Institute, the State Office for Nuclear Safety for Ionizing Radiation Sources, the Institute of Health Information and Statistics of the Czech Republic and the Czech Trade Inspection. Data from the information system on adverse events (22) and clinical trials of medical devices are accessible only to the Ministry, Institute and Institute of Health Information and Statistics of the Czech Republic and to the State Office of Nuclear Safety for sources of ionising radiation.
(2) The information referred to in paragraph 1 (a) and (d) shall be made available electronically in accordance with Annexes 13 to 16 to this Regulation.
Clinical trials
(1) For medical devices intended for clinical trials, the manufacturer, the authorised representative or the contracting entity shall proceed in accordance with Annex 8 to this Regulation and notify the Institute of its intention to carry out the clinical trials in the form set out in Annex 16 to this Regulation and at the same time submit a declaration including the documentation referred to in point 2.2 of Annex 8 to this Regulation.
(2) For Class III medical devices and implantable medical devices and invasive medical devices of Class IIa and IIb with long-term use, clinical testing of the medical device may be initiated after 60 days after their notification under paragraph 1, unless the Institute notifies them of its non-compliance with the medical devices for reasons of public health or public interest within that period. Such tests may be initiated, with the consent of the Institute, before the 60-day period expires, if the Ethics Committee concerned has given a favourable opinion on the programme of such tests, including a review of the clinical trial plan.
(3) Clinical trials must be carried out in accordance with the Law on Medical Devices, Annex 10 to this Regulation and with specific legislation. 23)
(4) The provisions of paragraphs 1 and 2 shall not apply where clinical trials are carried out using medical devices for which the CE marking has been assessed for their action in accordance with Paragraph 9, unless the purpose of such tests is not to use those devices for a purpose other than that originally specified by the manufacturer. The relevant provisions of Annex 10 to this Regulation shall remain unaffected.
(5) In the case of medical devices not referred to in paragraph 2, clinical trials may be initiated with the consent of the Institute immediately after notification, provided that the Ethics Committee concerned has given a positive opinion on the test programme, including a review of the clinical trial plan.
(6) The manufacturer, authorised representative or contracting entity shall notify the Institute of Termination of the Clinical Test, including its justification in the event of early termination. If the clinical trial is terminated prematurely for safety reasons, the Institute shall forward this notification to all Member States and to the European Commission. The manufacturer or authorised representative shall keep the report referred to in Section 11 (c) of the Medical Devices Act available to the competent authorities.
Notified persons
(1) The authorisation conditions are set out in Annex 11 to this Regulation; legal persons who comply with the requirements of the Czech harmonised standards which take over the relevant harmonised standards are presumed to meet the relevant criteria for authorisation.
(2) In order to carry out the conformity assessment procedures for medical devices referred to in Section 1 (b), the notified person shall demonstrate up-to-date knowledge of this issue, in particular of the detailed specifications set out in Annex 12 to this Regulation. In the event of any deficiencies in the current knowledge of the notified person, the Office shall follow the law. 24)
(3) The amended person and the manufacturer or his authorised representative shall, by agreement, set the dates for completion of the evaluation and verification activities referred to in Annexes 2 to 6 to this Regulation.
(4) Where the notified person finds, under his or her competence, that the manufacturer has not complied with or no longer complies with the relevant requirements of this Regulation, except where the manufacturer has ensured compliance with those requirements by introducing adequate corrective measures, he or she shall amend or revoke the certificate which he or she has issued.
(5) The amended person shall inform all certificates issued, modified, supplemented, suspended and withdrawn as well as the refusal to issue the certificate, the Office and the suspended and withdrawn certificates, and the refusal to issue the certificate shall inform the other persons notified. Such notified persons shall also inform on request of certificates issued. The notified person shall also make available any other relevant information upon request.
(6) When informing the competent authorities of other Member States and the European Commission of certificates that have been amended or cancelled by the notified person pursuant to paragraph 4, the law shall apply. 25)
(7) Upon request, the notified person shall provide the Office with all relevant information and documents, including budgetary documents, to verify compliance with the criteria set out in Annex 11 to this Regulation.
(8) The Authority shall, upon request by the competent authority of another Member State, provide information and documents to verify the criteria set out in Annex 11 to this Regulation.
Transitional provisions
(1) Valid documents issued pursuant to Article 9 of Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Decree No. 336 / 2001 Coll. and Decree No. 251 / 2003 Coll., may be used for the assessment of conformity under this Regulation, provided that they are not cancelled under the conditions laid down by law.
(2) The results of the tests and findings carried out pursuant to Section 8 of the Government Decree 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by the Government Decree 336 / 2001 Coll., may be used by notified persons (Section 16) as evidence for the issue of certificates and other documents under this Regulation.
(3) Medical devices for which conformity has been assessed pursuant to Article 8 of Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Decree No. 336 / 2001 Coll., may be placed on the market in the territory of the Czech Republic until 31 December 2005 at the latest, only for placing into service in the Czech Republic.
(4) Medical devices containing stable derivatives from human blood or human plasma shall be assessed within the meaning of point 7.4. of Annex 1 to this Regulation. Notified persons shall take into account the relevant information concerning the characteristics and functionality of these devices, in particular the results of tests and verifications carried out previously under Act No. 79 / 1997 Coll., on medicinal products and on amendments and additions to certain related acts, as amended by Act No. 149 / 2000 Coll., Act No. 153 / 2000 Coll., Act No. 258 / 2000 Coll., Act No. 102 / 2001 Coll., Act No. 138 / 2002 Coll., Act No. 309 / 2002 Coll., Act No. 320 / 2002 Coll., Act No. 129 / 2003 Coll. If the medical devices in question comply with the requirements of the Act according to the second sentence, they may be placed on the market in the Czech Republic until 10 January 2007 at the latest and put into service until 10 January 2009 at the latest.
(5) Medical devices pursuant to § 1 (b) for which a EC design examination certificate or EC type-examination certificate was issued in another Member State of the European Communities before 1 April 2004, or a certificate issued in accordance with § 9 of the Government Regulation No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Regulation No. 336 / 2001 Coll. and Government Regulation No. 251 / 2003 Coll., may be placed on the market and put into service no later than 30 September 2004. The holder of an EC design examination certificate or an EC type-examination certificate for the medical device concerned shall apply for a supplement to the EC design review certificate or for an amendment to the EC type-examination certificate demonstrating compliance with the specifications set out in Annex 12 to this Regulation, provided that it continues to place such device on the market and put into service after 30 September 2004.
(6) Medical devices pursuant to § 1 (b) for which conformity has been assessed pursuant to § 8 of Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Regulation No. 336 / 2001 Coll., can only be placed on the market and put into service in the Czech Republic until 30 September 2004 at the latest.
(7) Persons in charge of conformity assessment activities pursuant to Government Regulation No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Regulation No. 336 / 2001 Coll. and Government Regulation No. 251 / 2003 Coll., shall be deemed to be in charge of activities under this Regulation.
(8) The validity of certificates of notified persons and other decisions concerning breast implants for which conformity has been assessed as for Class IIb medical devices cannot be extended.
Repeal
Government Regulation No. 25 / 2004 Coll., laying down technical requirements for medical devices, is repealed.
Amendment of the Government Regulation amending certain government regulations issued for the implementation of Act No. 22 / 1997 Coll., on Technical Requirements for Products and amending and supplementing certain laws, as amended
In Government Decree No. 251 / 2003 Coll., amending certain government regulations issued for the implementation of Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended, Part 13 is deleted.
EFFECTIVE
This Regulation shall enter into force on the day of its publication.
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Regulation Information
| Citation | Government Regulation No. 336 / 2004 Coll., laying down technical requirements for medical devices and amending Government Regulation No. 251 / 2003 Coll., amending certain government regulations issued for the implementation of Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 02.06.2004 |
|---|---|
| Effective from | 02.06.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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