Decree No. 154 / 2004 Coll.
Government Regulation laying down technical requirements for active implantable 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
Regulation
Effective from 01.05.2004
Zobrazeno prvních 200 z celkem 575 ustanovení tohoto předpisu.
Zobrazit celý předpis →
Pro stažení celého znění použijte tlačítko Stáhnout výše.
154
GOVERNMENT REGULATION
of 17 March 2004
laying down technical requirements for active implantable 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 mandates pursuant to Article 22 of Act No. 22 / 1997 Coll., on the Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 71 / 2000 Coll., Act No. 205 / 2002 Coll., Act No. 226 / 2003 Coll. and Act No. 277 / 2003 Coll., ("the Act ') to implement § 2 (b), (c) and (d), § 3 (2), § 11 (1) and (2), § 11a (2), § 12 and 13, and to implement Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related Acts, as amended by Act No. 130 / 2003 Coll. (" the Act on Medical Devices'):
TECHNICAL REQUIREMENTS FOR ACTIVE IMPLANTABILITY HEALTH
Preliminary provisions
(1) This Regulation implements the relevant European Union1 provisions and regulates technical requirements for active implantable medical devices ("active devices"). Medical devices are active in accordance with § 2 (2) (f) of the Medical Devices Act, including all accessories under § 2 (3) of the Medical Devices Act. Active devices may also be manufactured with an integrated medicine or human blood derivative pursuant to § 2 (2) (b) or (g) of the Medical Devices Act, and as custom medical devices or medical devices intended for clinical trials under § 2 (2) (d) or (e) of the Medical Devices Act.
(2) This Regulation shall apply to active medicinal products.
(3) This Regulation shall not apply to:
(a) medicinal products under the Drug Act;
(b) human blood, blood products, human blood plasma or blood cells of human origin, or devices containing, at the time of their placing on the market, such products of blood, plasma or cells, with the exception of those referred to in § 2 (2) (g) of the Medical Devices Act;
(c) transplants, tissues or cells of human origin and products containing or derived from tissues or cells of human origin, with the exception of those referred to in Section 2 (2) (g) of the Medical Devices Act;
(d) 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.
For the purposes of conformity assessment under this Regulation, the specified products under Section 12 (1) of the Act are active means under Section 1.
For the purposes of this Regulation, the following definitions shall also apply:
(a) manufacturer - person mentioned in the Law on Medical Devices, 2)
(b) intended use - such use for which the active substance is intended by the manufacturer,
(c) putting into service - the moment when the active substance is ready for use by the implantation physician for the first time.
General principles
(1) Before placing on the market an active device must comply with the requirements set out in Annex 1 to this Regulation (hereinafter referred to as "essential requirements") and other requirements laid down in this Regulation which apply to that device taking into account the intended purpose of use. Where there is an appropriate risk, an active device, which is also machinery under a government regulation setting out the technical requirements for machinery, shall also comply with the essential health and safety requirements set out in that regulation of the Government to the extent that these essential requirements are more specific than those set out in Annex 1 to this Regulation.
(2) If the active substance complies with the relevant provisions
(a) harmonised European standards to which a reference is published in the Official Journal of the European Union;
(b) harmonised Czech technical standards transposing the standard referred to in (a); or
(c) foreign technical standards in a Member State of the European Union transposing the standard referred to in (a);
which relate to the relevant essential requirement, it shall be considered that this essential requirement is met taking into account the intended purpose of use. This does not apply if the reference from the Official Journal of the European Union has been withdrawn.
(3) For the purposes of this Regulation, the European Pharmacopoeia monograph, in particular the interaction between medicinal products and materials used in active products containing those medicinal products, shall also be considered a harmonised technical standard referred to in paragraph 2, provided that the reference to that monograph has been published in the Official Journal of the European Union. This does not apply if the reference to the monograph has been withdrawn from this Journal.
(4) Where harmonised standards do not fully cover the essential requirements referred to in paragraph 2, the Office for Technical Standardisation, Metrology and State Testing (hereinafter referred to as "the Office ') shall proceed under the law (4).
(5) Active devices using nuclear energy or sources of ionising radiation must be assessed for radiation protection by a person with appropriate accreditation (5) for this activity and authorised under specific legislation6).
(6) In assessing the active substance in terms of its electromagnetic compatibility, the Government Regulation on Technical Requirements for Products in terms of their electromagnetic compatibility shall not apply.
(7) Where an active device is intended for the administration of a medicinal product under a special legislative provision (7), it shall be covered by the Law on medical devices and by this Regulation, without prejudice to the provisions of the special legislation7), with regard to the medicinal product.
Labelling of active devices
(1) The manufacturer shall affix an active device which is neither custom nor intended for clinical trials, before it is placed on the market or put into service, the CE8 marking) if, following the assessment of conformity with the essential requirements ("conformity assessment") referred to in Section 10, it has been found satisfactory taking into account the intended purpose of use.
(2) The indication of the active substance referred to in paragraph 1 shall be placed visibly, legibly and indelibly on the sterile packaging of the active substance, the instructions for its use and, where appropriate, on the sales package. If the CE marking is reduced or enlarged, the relative proportions of the dimensions of the CE.8 marking shall be respected) The individual parts of the CE8 marking shall have the same vertical dimensions which shall not be less than 5 mm; this minimum dimension may be adjusted for active devices, except for custom active devices and active devices intended for clinical trials of small sizes.
(3) The identification number of the notified person responsible for carrying out the acts laid down by law and Annexes 2, 4 and 5 to this Regulation shall be attached to the identification of the active device referred to in paragraph 1.
(4) The active substance referred to in paragraph 1 shall not be accompanied by other indications the meaning or shape of which may be confused with the CE marking. Other markings may be affixed to the packaging of the active device or to the instructions accompanying it only if the visibility and legibility of the CE marking are not reduced.
(5) If there is a reasonable suspicion that the CE marking has been affixed to an active device unjustly, the notified person may be requested under a special legislation (9) to participate in the assessment of such active device. If the suspicion according to the first sentence is confirmed, the manufacturer or his authorised representative shall remove the unlawful situation as per the Czech Trade Inspection Guidelines. 7)
(6) If the manufacturer or his authorised representative fails to comply with the conditions for the CE marking and the Czech Trade Inspection Instructions concerning the active device concerned under paragraph 5, the procedure shall be followed in accordance with specific legislation. 10)
(7) 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 (11) of the measures referred to in paragraphs 5 and 6.
Placing on the market and putting into service
(1) Active devices may only be placed on the market or put into service after compliance with the requirements of the Act, the Law on Medical Devices and this Regulation, provided that they are properly supplied, properly implanted or installed, maintained and used in accordance with their intended purpose of use.
(2) Active devices must comply with the essential requirements set out in Annex 1 to this Regulation, taking into account the intended purpose of application.
(3) In the Czech Republic
(a) may be placed on the market or put into service:
1. active devices bearing the CE marking; that indication indicates that the conformity of active means has been assessed in accordance with Article 10 of this Regulation; or
2. custom-made active devices if they comply with the conditions laid down in Annex 6 to this Regulation and are accompanied by a declaration under that Annex made available to a particular patient,
(b) active devices intended for clinical trials shall be made available to specialist doctors if they comply with the conditions laid down in Section 14 and Annex 6 to this Regulation.
The CE marking shall not be affixed to custom active devices and active devices intended for clinical trials.
(4) Where active devices are intended to be put into service in the Czech Republic, they shall be equipped with the information listed in Annex 1 to this Regulation in points 13, 14 and 15, in the Czech language.
Placing on the market and putting into service after exposure
Active devices which do not comply with the requirements of this Regulation may be displayed but must be visibly marked in such a way that this fact is sufficiently obvious; such devices may be placed on the market or put into service only if the manufacturer or authorised representative places them in such a condition that they comply with the requirements laid down in this Regulation.
Procedure for possible threats to health and, where appropriate, the life of people by active means
(1) Where:
(a) active devices and custom active devices, properly placed on the market and put into service and used in accordance with the intended purpose of use, endanger the health or safety of users and, where appropriate, other persons; or
(b) non-compliant active devices bear the CE marking;
the law, the law on medical devices and the specific legislation shall be followed. 7)
(2) Cases and safeguard measures
(a) paragraph 1 (a) shall be immediately informed by the European Commission, stating the reasons for this decision and, in particular, whether a safeguard measure has been imposed on the basis of:
1. non-compliance with essential requirements if the active substance does not comply with fully or partially harmonised standards;
2. incorrect application of harmonised standards when declared to have been applied; or
3. Lack in the harmonised standards themselves,
(b) paragraph 1 (b) shall be immediately informed by the European Commission and the competent authorities of the other Member States.
Adverse events
(1) The procedure for reporting, recording, investigating, documenting, evaluating and preventing adverse events (13) is governed by the Health Environment Act (14) and the Decree implementing this Act. 15)
(2) The procedure of the Ministry of Health ("the Ministry") and the State Institute for Drug Control ("the Institute") in the field of adverse events is governed by the Law on Medical Devices and the Decree implementing that Act.
Conformity assessment procedures
(1) In the case of an active device which is neither custom nor intended for clinical testing, the manufacturer shall assess the conformity with the CE marking before its action, taking into account the intended purpose of use, using the procedure for:
(a) the EC declaration of conformity referred to in Annex 2 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. EC declaration of conformity to type as referred to in Annex 5 to this Regulation.
(2) For active devices for which conformity has been assessed in accordance with paragraph 1, the manufacturer shall, before placing them on the market, issue a written declaration of conformity in accordance with the relevant Annex to this Regulation.
(3) In the case of custom-made active devices, the manufacturer shall, before placing each of these devices on the market, issue a written declaration in accordance with Annex 6 to this Regulation.
(4) The procedures laid down in Annexes 3, 4 and 6 to this Regulation may be carried out by an authorised representative instead of the manufacturer.
(5) Records and correspondence relating to the procedures referred to in paragraphs 1 to 4 must be kept in the official language of the Member State in which they are carried out or in a language agreed between the notified person and the manufacturer and, where appropriate, his authorised representative.
If, by way of derogation from Article 10 of this Regulation, conformity with an active device or with a group of active devices should be assessed by using only one of the procedures chosen between the procedures referred to in Section 10, or it is necessary to decide whether a particular product or group of products falls within one of the definitions laid down in Section 2 of the Medical Devices Act, the Ministry shall request the European Commission to comment.
(1) When assessing the conformity of an active device referred to in Article 10 (1), the notified person or manufacturer or, where appropriate, the authorised representative shall take into account the results of the evaluation and verification activities carried out, where appropriate, at the intermediate stage of production in accordance with this Regulation.
(2) Depending on the nature and type of the active device, the manufacturer or, where applicable, the authorised representative shall request the relevant notified person to participate in the conformity assessment and, where appropriate, to carry out other specific tasks defined in its notification.
(3) For the purpose of issuing the certificate and its legitimate possession, the notified person may, where justified, require the necessary information or data from the manufacturer or the authorised representative with regard to the selected conformity assessment procedure.
(4) Certificates of the notified person in accordance with Annexes 2, 3 and 5 to this Regulation are valid for a maximum period of 5 years; The validity of such certificates may be extended for a further period of 5 years, at the request of the manufacturer or authorised representative, at the time specified in the contract between him and the notified person.
(5) In order to protect health, the placing on the market and the putting into service of an active device for which procedures under Article 10 (1) and (3) have not been carried out may be authorised; the conditions under which the Law on Medical Devices may be applied are laid down. 16) The Ministry shall inform the European Commission thereof in accordance with Section 38 (m) (1) of the Medical Devices Act.
(1) If they apply to active devices and other legislation, 17) which include other aspects and also provide for the CE marking, then the label indicates that the relevant active devices are also presumed to comply with the provisions of those other legislation.
(2) 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 relevant products 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. 17) These documents, warnings or instructions shall be accessible without damaging the packaging which ensures the sterility of the active substance.
Clinical trials
(1) For active devices intended for clinical trials by the manufacturer, authorised representative or contracting entity, the Institute shall notify the intention to carry out clinical trials in the form set out in Annex 12 to this Regulation at the same time as it shall submit a declaration including the documentation referred to in point 2.2 of Annex 6 to this Regulation.
(2) Clinical trials of the active substance may be initiated by the manufacturer
(a) after 60 days from the date of notification referred to in paragraph 1, unless the Institute gives a negative opinion to the manufacturer, the authorised representative or the contracting entity within that period on the performance of those tests for the purpose of protecting the health of the body of evaluation, protection of public health or other public interest; or
(b) the positive opinion of the Constitution, even before the expiry of 60 days from the date of notification referred to in paragraph 1.
(3) The manufacturer or his authorised representative shall notify the Institute of Termination of the Clinical Test, including its justification, in the event of its 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 his authorised representative shall keep the report referred to in Article 11 (1). (c) the law on medical devices and submit it to the inspection authorities upon request.
(4) Clinical trials shall be carried out in accordance with Annex 7 to this Regulation.
Notified persons
(1) The conditions laid down in Annex 8 to this Regulation shall apply to the authorisation of legal persons under Article 11 (2) of the Act. Legal persons meeting the criteria set out in the relevant harmonised standards shall be deemed to comply with the relevant minimum criteria necessary for the delegation of the notified authority.
(2) The dates for completing the evaluation and verification activities referred to in Annexes 2 to 5 to this Regulation shall be determined by agreement between the manufacturer or the authorised representative and the notified person.
(3) The amended person shall inform the Office of all certificates issued, modified, supplemented, suspended and withdrawn, as well as of the refusal to issue the certificate, and shall also inform the other notified persons within the scope of this Regulation of the suspended and withdrawn certificates, as well as of the refusal to issue the certificate, and shall inform them on request of the certificates issued. The notified person shall also make available on request all information on certificates issued.
(4) Where the notified person finds that the relevant requirements of this Regulation have not been met or are no longer met by the manufacturer or that the certificate should not have been issued, he shall take a decision to suspend or withdraw the issued certificate or restrict the scope of its validity unless the manufacturer ensures compliance with the relevant requirements by introducing appropriate corrective measures. In the event of suspension, withdrawal or any restriction of the certificate or where action by the Office may be necessary, the notified person shall inform the Office thereof. When informing the competent authorities of other Member States and the European Commission of certificates which the notified person has suspended or withdrawn, the procedure shall be followed by law.
(5) The person nominated shall, upon request, provide the Office with all relevant information and documents, including budgetary documents, allowing verification of compliance with the criteria set out in Annex 8 to this Regulation.
Notification obligations
(1) A manufacturer who, in accordance with the procedures referred to in Article 6 (3), places active devices on the market or enters into service or notifies the Ministry in electronic form
(a) start-up in accordance with Annex 9 to this Regulation;
(b) the cessation of activities in accordance with Annex 9 to this Regulation;
(c) placing an active device on the market in accordance with Annex 11 to this Regulation before the active device is placed on the market;
(d) the cessation of the placing on the market of an active substance in accordance with Annex 11 to this Regulation; and
(e) an amendment to any of the data notified under (a) and (c).
The data referred to in Annex 11 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 9 to this Regulation.
(2) The person placing a medical device on the market or putting it into service on the territory of the Czech Republic is required to provide, at the request of the Ministry, information enabling the active device to be identified and supporting documents used to assess conformity.
(3) Where a manufacturer intending to place active devices on the market under his name as referred to in paragraph 1 or 2 is not established in a Member State, he shall entrust an authorised representative who is his only authorised representative within the Member States to the marketing of those active devices.
(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 performing the service of the active means are notified to the Ministry in electronic form
(a) start-up in accordance with Annex 10 to this Regulation;
(b) the cessation of activities in accordance with Annex 10 to this Regulation; and
(c) an amendment to any of the data notified under (a).
Data set
(1) Data
(a) persons and active means referred to in Section 16;
(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 5 to this Regulation;
(c) obtained in accordance with the procedure governing the notification and registration of adverse events (15); and
(d) clinical trials
are processed in accordance with this Regulation in an information system pursuant to Section 41 of the Medical Devices Act until the person handling the active means has notified the Ministry of Discontinuation and for a further 20 years. Data from the information system are accessible to the Ministry, the Office, the Institute, the State Office for Nuclear Safety for sources of ionizing radiation, the Institute of Health Information and Statistics of the Czech Republic and the Czech Trade Inspection. Data from the information system on adverse events 13) and clinical trials of active devices are accessible only to the Ministry, Institute and Institute of Health Information and Statistics of the Czech Republic.
(2) The information referred to in paragraph 1 (a) and (d) shall be made available in electronic form in accordance with Annexes 9 to 12 to this Regulation.
Transitional and final provisions
Transitional provisions
(1) The valid documents issued pursuant to Article 11 of Decree No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices, as amended by Decree No. 337 / 2001 Coll. and Decree No. 251 / 2003 Coll., can be used as evidence for the assessment of conformity under this Regulation unless they are cancelled under the conditions laid down by the Act.
(2) The results of the tests and findings carried out pursuant to Article 10 of Decree No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices, as amended by Government Regulation No. 337 / 2001 Coll., may be used by notified persons (§ 18) as evidence for the issue of certificates and other documents under this Regulation.
(3) Active devices for which conformity has been assessed pursuant to Article 10 of Decree No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices, as amended by Decree No. 337 / 2001 Coll., may be placed on the market in the Czech Republic until 31 December 2005 at the latest for placing into service only in the Czech Republic.
(4) Persons in charge of conformity assessment activities under Government Regulation No 191 / 2001 Coll., laying down technical requirements for active implantable medical devices, as amended by Government Regulation No 337 / 2001 Coll., shall be deemed to be in charge of activities under this Regulation.
Repeal
The following shall be deleted:
1. Government Decree No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices.
2. Government Regulation No. 337 / 2001 Coll., amending Government Regulation No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices.
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 acts, as amended, the 14th part is deleted.
EFFECTIVE
This Regulation shall enter into force on the date of the entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Prime Minister:
PhDr. Špidla v. r.
Minister for Health:
Dr. Součková v. r.
Příloha č. 1
Annex No 1 to Government Decree No 154 / 2004 Coll.
ESSENTIAL REQUIREMENTS
I. GENERAL REQUIREMENTS
1. Active devices shall be designed and manufactured in such a way that, provided they are implanted under the specified conditions and for the intended purpose of use, they do not endanger the health and safety of users and, where appropriate, other natural persons.
2. Active devices shall be designed and manufactured in such a way as to achieve the efficiency specified by the manufacturer and be suitable for one or more of the functions specified in the Health Devices Act (18) and in accordance with the manufacturer's specification.
3. In the case of loads of active devices which may occur under normal operating conditions, their functional characteristics and efficiency shall not be adversely affected within the meaning of points 1 and 2 of this Annex to the extent that the clinical situation or safety of users or, where appropriate, other natural persons may be compromised throughout the life of those devices declared by the manufacturer.
4. Active devices shall be designed, manufactured and packaged in such a way that, under the conditions laid down by the manufacturer for their storage and transport (e.g. temperature, humidity), the properties and efficiency of the active devices cannot be adversely affected.
5. Any side effect and adverse event may only present acceptable risks compared to the intended effects of the active substance.
5a. The demonstration of compliance with the essential requirements shall include the clinical evaluation referred to in Annex 7 to this Regulation.
II. REQUIREMENTS FOR PROPOSALS AND CONSTRUCTIONS
6. The level of safety of active devices shall correspond to the state of science and technology at the time of their placing on the market; this requirement shall correspond to the solutions adopted by the manufacturer in their design and construction.
7. Active devices shall be designed, manufactured and packaged in disposable packaging by an appropriate procedure so that they remain sterile after placing on the market and retain this property during storage and transport under conditions specified by the manufacturer until the implantation packaging has been removed.
8. Active devices must be designed and manufactured in such a way that risks are excluded or reduced to the lowest possible level
8.1. physical injury related to their physical characteristics (including dimensions),
8.2. Related to the energy sources used, when the electricity is used, especially with regard to the insulation condition, current current, or overheating of active devices,
8.3. Associated with reasonably foreseeable environmental conditions, in particular magnetic fields, external electrical influences, electrostatic discharges, pressure and changes and acceleration;
8.4. associated with treatment resulting in particular from the use of defibrillators and high frequency surgical instruments,
8.5. associated with ionising radiation of radioactive substances used in active devices in accordance with protection requirements under specific legislation, 19)
8.6. which may arise as a result of the fact that active devices cannot be maintained or calibrated, including risks arising from:
8.6.1. from excessive increase in current,
8.6.2. Of ageing materials used,
8.6.3. Excessive heat produced by active means,
8.6.4. the reduced accuracy of the measuring or checking mechanism.
9. Active devices shall be designed and manufactured in such a way as to guarantee their characteristics and efficiency as referred to in points 1 to 5 of this Annex, with particular regard to:
9.1. selection of materials used, in particular with regard to toxicity,
9.2. mutual compatibility between the materials used and biological tissues, cells and body fluids, taking into account the expected use of active agents;
9.3. compatibility of active substances with substances to be administered;
9.4. quality of connections, in particular with regard to safety,
9.5. the reliability of the energy source,
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Government Regulation No. 154 / 2004 Coll., laying down technical requirements for active implantable 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 | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.04.2004 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0