Government Decree No. 286 / 2001 Coll.
Government Regulation laying down technical requirements for in vitro diagnostic medical devices
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Regulation
Effective from 07.08.2001
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286
GOVERNMENT REGULATION
of 2 July 2001
laying down technical requirements for in vitro diagnostic medical devices
The Government hereby orders, pursuant to Article 22 of Act No. 22 / 1997 Coll., on the technical requirements for products and on the modification and addition of certain laws, as amended by Act No. 71 / 2000 Coll., (hereinafter referred to as "the Act '), to implement Sections 11, 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, hereinafter referred to as" the Law on medical devices':
Preliminary provisions
This Regulation lays down technical requirements for in vitro3 diagnostic medical devices (in vitro medical devices) in accordance with European Community law (1) and with the relevant international contract (2).
(1) In vitro medical devices are those referred to in Section 2 (2) (c) of the Medical Devices Act. In vitro medical devices are specified products in accordance with Article 12 (1) of the Act for which conformity of their characteristics under this Regulation is assessed.
(2) This Regulation shall also apply to:
(a) in vitro medical devices manufactured and intended for use for analysis in clinical laboratories without being traded;
(b) mechanical laboratory equipment specially designed for in vitro diagnostic examinations;
(c) in vitro medical devices made from tissues, cells or substances of human origin;
(d) in vitro medical devices which are treated as separate in vitro medical devices.
(3) This Regulation shall not apply to:
(a) instruments, apparatus, equipment or other objects, including software, intended for use for research purposes without any medical objective;
(b) internationally proven reference materials and materials used for external quality assessment programmes for in vitro medical devices;
(c) reagents which are manufactured in laboratories of a medical establishment for use in the environment of those laboratories and are not subject to trade;
(d) medical devices (4) for invasive human sampling;
(e) in vitro medical devices which have been manufactured in a medical facility and are only used in that medical facility without being transmitted to another user, 5)
(f) medical devices (4) manufactured using substances of human origin.
Interpretation of terms
For the purposes of this Regulation, the following definitions shall also apply:
(a) an in vitro medical device for self-testing an in vitro medical device intended by the manufacturer for use in the domestic environment;
(b) a summary of the in vitro properties of the medical device established by the manufacturer for the purpose of its use;
(c) in vitro medical devices for in vitro medical devices designated by the manufacturer for the verification of performance carried out in clinical laboratories or other appropriate environments; the activity is not carried out in the manufacturer's premises,
(d) by an authorised representative, a natural person with a permanent residence or a legal person having its registered office in the States of the European Communities who is authorised in writing by the manufacturer to act for him with the authorities and authorities in the States of the European Communities, having regard to the requirements resulting from this Regulation for manufacturers,
(e) placing on the market the moment when an in vitro medical device which is not intended to verify its performance passes, for the first time, either on a fee or free of charge, from the stage of manufacture or importation into the distribution phase as goods intended for sale, whether new or fully renewed,
(f) putting into service the moment when an in vitro medical device prepared for the first time for the intended purpose of use is provided to the end user;
(g) calibration and control materials of the substance, materials or articles intended by their manufacturer to determine the extent of measurement or to verify the performance of the medical device in vitro in accordance with its intended purpose of use;
(h) accessories an article which is not an in vitro medical device but is intended by the manufacturer specifically for use together with an in vitro medical device to enable its use in accordance with the purpose specified by the manufacturer; In vitro medical devices are not considered to be accessories (4) for invasive sampling of the human body.
General principles
(1) In vitro medical devices must comply with the essential requirements set out in Annex 1 to this Regulation, hereinafter referred to as "essential requirements," taking into account the intended purpose of use. The essential requirements shall also be deemed to be met if in vitro medical devices conform to the relevant harmonised standard (6).
(2) Where reference is made in this Regulation to harmonised standards (6), this also includes international technical documents6) (hereinafter referred to as technical specifications).
(3) The supervisory and control authorities for in vitro medical devices, their responsibilities and responsibilities are laid down in the Law on medical devices. (7) The obligations of the persons checked and the reimbursement of the costs of checking are laid down in the Law on medical devices. 8)
(4) The collection and use of substances derived from the human body shall be carried out in accordance with the international contract (9) and ethical principles. 10)
(5) Where in vitro medical devices referred to in Articles 5 (1) and 5 (6) are properly installed, maintained and used in accordance with the intended purpose of use and may nevertheless endanger the health or life of users or property, the law, the law on medical devices and specific legislation shall apply. 11) These are mainly cases
(a) non-compliance with the essential requirements referred to in Article 4 (1);
(b) incorrect application of the technical specifications referred to in Article 7 where they are declared to have been used; or
(c) shortcomings in the standards themselves.
Placing on the market, putting into service and exposure to in vitro medical devices
(1) For a market (12), in vitro medical devices may be indicated if they comply with the essential requirements and other provisions of this Regulation which apply to them and a declaration of conformity has been issued in accordance with the law. 13) In vitro medical devices may only be put into service if they fulfil the conditions set out in the previous sentence and have been supplied and installed accordingly in accordance with the intended purpose of use.
(2) In vitro medical devices intended to verify their performance may be provided to laboratories or other persons meeting the requirements set out in Section 8 (4) and Annex 8 to this Regulation for this purpose.
(3) Demonstration at exhibitions, fairs and otherwise in vitro medical devices which do not comply with the requirements of this Regulation may be carried out only if they are visibly marked to show that they cannot be placed on the market and put into service until they comply with the requirements of this Regulation; samples taken from its participants shall not be used for in vitro demonstration of medical devices.
(4) The information provided to the user in accordance with Annex 1 (B) (8) to this Regulation must be in the Czech language.
(5) Post-market medical devices shall be monitored for safety and quality in accordance with Section 12.
(6) The provisions of paragraphs 1 and 5 also apply to in vitro medical devices provided for the verification of their performance.
Free movement of in vitro medical devices
In vitro medical devices may be placed on the market and put into service if:
(a) conformity has been assessed in accordance with Article 8;
(b) meet the conditions set out in Article 5 (1); and
(c) the CE marking has been affixed to them. 14)
Technical specifications
(1) The technical specifications shall specify:
(a) criteria for:
1. verification and re-evaluation of the performance of in vitro medical devices;
2. release of production batches,
(b) reference
1. methodologies; and
2. materials;
in vitro medical devices listed in Annex 2 to the List And on this Regulation, and where necessary, for in vitro medical devices listed in Annex 2 to List B to this Regulation.
(2) Technical specifications may be replaced when designing and producing in vitro medical devices by other solutions which achieve the same or, where appropriate, higher level of safety and quality of in vitro medical devices.
Conformity assessment procedures
(1) Before placing in vitro medical devices on the market, with the exception of those listed in Annex 2 to this Regulation and those for the verification of performance, the manufacturer shall proceed with the affixing of the marking in accordance with Section 9 and in accordance with Annex 3 to this Regulation and shall produce, within the meaning of the law:
(a) a declaration of conformity for in vitro medical devices of origin
1. in the Czech Republic and the States of the European Communities, until the publication of the sectoral Annex "Medical devices" to the Protocol to the Europe Agreement establishing an association between the Czech Republic, of the one part, and the European Communities and their Member States, of the other part, on conformity assessment and acceptance of industrial products in the Collection of International Treaties,
2. in States with which the relevant international agreement has not been negotiated, 2)
(b) EC declaration of conformity for in vitro medical devices originating in the States between which the relevant international agreement is negotiated;
except in vitro medical devices listed in Annex 2 to this Regulation and in vitro medical devices intended for the verification of performance, the manufacturer shall comply with the additional requirements set out in point 6 of Annex 3 to this Regulation or in accordance with the procedures referred to in paragraphs 2 or 3 for in vitro medical devices for self-testing prior to drawing up the certificate of conformity.
(2) For in vitro medical devices listed in Annex No 2 to List A to this Regulation, except in vitro medical devices intended for the verification of performance, the manufacturer shall, for the purpose of affixing the marking in accordance with Section 9:
(a) Annex 4, or
(b) Annex 5
together with the procedure laid down in Annex 7 to this Regulation.
(3) For in vitro medical devices listed in Annex No 2 to List B to this Regulation, with the exception of in vitro medical devices for the verification of performance, the manufacturer shall, for the purpose of affixing the marking in accordance with Section 9, proceed to:
(a) Annex 4, or
(b) Annex 5
together with the procedure laid down in Annex 6 or Annex 7 to this Regulation.
(4) When providing in vitro medical devices for verification of performance, the manufacturer shall proceed to this Regulation in accordance with Annex 8 and shall draw up the written declaration provided for in this Annex before providing such devices. This provision does not apply to ethical principles10) in conducting studies to verify the performance of in vitro medical devices using tissues or substances of human origin.
(5) When assessing the conformity of an in vitro medical device, the manufacturer or, where appropriate, the authorised person shall take into account the results of the evaluation and verification procedures, provided that they have been carried out, where appropriate, in accordance with this Regulation in each intermediate production process.
(6) The manufacturer shall keep a certificate of conformity, the technical documentation referred to in Annexes 3 to 8 to this Regulation, reports and certificates drawn up by authorised persons for a period of five years after the last in vitro medical device has been manufactured and made available to the competent authorities of the State administration for control purposes.
(7) If the manufacturer does not have its registered office in the Czech Republic, he shall, upon request, provide the documentation referred to in paragraph 7 with his authorised representative.
(8) Where the conformity assessment procedure involves the participation of an authorised person, the manufacturer or, where appropriate, his authorised representative shall apply for such participation at his choice, an authorised person with an appropriate scope of authorisation. The authorised person may require the information or data necessary for the approval and compliance with the chosen conformity assessment procedure.
(9) Certificates of an authorised person issued in accordance with Annexes 3, 4 and 5 to this Regulation are valid for a maximum period of five years and may be extended for a further period of five years at the request of the manufacturer at the time indicated in the contract between the manufacturer and the authorised person issuing the certificate.
(10) Records and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall be made in the Czech language and, where appropriate, in another language agreed upon by the authorised person with the manufacturer and, where appropriate, with the authorised representative.
(11) A procedure for cases where, exceptionally, in vitro medical devices need not be assessed for conformity is laid down in the Law on medical devices. 15)
(12) The provisions of paragraphs 1 to 10 shall apply mutatis mutandis to persons who produce in vitro medical devices and put them into service by using them as part of their professional activities.
In vitro labelling of medical devices
(1) In vitro medical devices which meet the essential requirements, except for those for which verification of the essential requirements has not been carried out or completed,
(a) must bear the CE marking on the market, (14) as regards in vitro medical devices referred to in Article 8 (1) (b); or
(b) may bear the Czech mark of conformity (16) when placed on the market with regard to in vitro medical devices referred to in § 8 (1) (a).
(2) The Czech mark of conformity or CE marking must be placed visibly, legibly and indelibly on the in vitro medical device, where practicable and appropriate, and in the instructions for use. Where possible, the Czech mark of conformity or CE marking shall also be placed on the packaging of the in vitro medical device in which it is sold. The Czech mark of conformity or CE marking shall be accompanied by the identification number of the authorised person involved in the procedures laid down in Annexes 3, 4, 6 and 7 to this Regulation.
(3) The in vitro medical device shall not contain signs and descriptions which may, by mistake, be regarded as being of importance or graphically similar to the Czech mark of conformity or CE marking. Another character may be placed on an in vitro medical device, its packaging or in a manual accompanying it, provided that it does not reduce the visibility or legibility of the Czech conformity mark or CE marking.
(4) Where in vitro medical devices are subject from other aspects to other specific legislation which provides for the affixing of the CE marking or the affixing of the Czech mark of conformity, they shall in such a case indicate that in vitro medical devices also comply with the requirements applicable to them under those specific legislation. However, if the manufacturer allows this Regulation or several government regulations issued under the law to choose the measures to be applied during the period of validity of the transitional provisions, the CE marking or the Czech conformity mark shall indicate that in vitro medical devices comply only with the provisions of those specific legislation applied by the manufacturer. A list of the provisions of the government regulations used shall be provided in documents, notices or instructions accompanying in vitro medical devices in accordance with this Regulation.
Incorrect use of the Czech conformity mark or CE marking
(1) If an in vitro medical device is found to be
(a) an incorrect Czech mark of conformity has been affixed, the manufacturer removes this unlawful situation in accordance with the instructions of the Czech Trade Inspection Office; 17) the authorised person may be invited to participate in the assessment of the device concerned under special legislature18),
(b) the CE marking has been improperly affixed,
1. manufacturer,
2. the manufacturer or his authorised representative shall act mutatis mutandis in accordance with point (a).
(2) If the unlawful situation referred to in paragraph 1 has not been remedied, it shall be treated in accordance with specific legislation. 19)
(3) In the cases referred to in paragraphs 1 and 2, Article 4 (6) shall not be taken into account; the Office shall inform the European Commission and the competent authorities of the Member States of the European Communities of the measures referred to in those paragraphs.
In vitro registration of persons and medical devices
(1) The manufacturer or the person responsible for placing the medical device on the market in vitro shall, in accordance with the Law on medical devices: 20) The Ministry of Health (hereinafter referred to as "the Ministry ') shall have pre-printed data on forms the models of which appear in Annexes 10 and 11 to this Regulation.
(2) The manufacturer who places in vitro medical devices on the market and has registered his seat or place of business in the Czech Republic shall notify the Ministry of Health
(a) the address of that place,
(b) information relating to:
1. reagents, results of reagent reaction, calibration and control materials or analysts; and
2. In vitro medical devices not listed in point 1
having regard to their general technological characteristics, their substantial changes, including the interruption of marketing,
(c) for in vitro medical devices listed in Annex 2 to this Regulation and in vitro medical devices for self-testing
1. data enabling them to be identified;
2. analytical and, where applicable, the basic diagnostic data referred to in Annex 1 (A) (3) to this Regulation,
3. the results of the performance assessment referred to in Annex 8 to this Regulation;
4. certificates; and
substantial changes relating to points 1 to 4, including interruption of marketing.
That marketing authorisation does not replace compliance with the requirements for placing in vitro medical devices on the market and putting into service.
(3) Where the notification referred to in paragraph 2 is also subject to an in vitro medical device which:
(a) for the analyte concerned, in relation to any other basic technical information; or
(b) use analytical technology in the process of its use;
has not been continuously on the market in the Member States of the European Communities (hereinafter "the new in vitro medical device ') in the last 3 years. Where the new in vitro medical device is accompanied by a CE marking, the manufacturer shall indicate this in the notification referred to in paragraph 2.
(4) The Ministry may require in vitro medical devices listed in Annex 2 to this Regulation and in vitro medical devices for self-testing provided that they are placed on the market and put into service in the Czech Republic:
(a) information enabling them to be identified;
(b) information on their labelling;
(c) instructions for their use.
(5) Where a manufacturer who places in vitro medical devices on the market does not have his registered office or place of business registered in the Czech Republic, the information referred to in paragraph 2 shall be communicated to the Ministry by an authorised representative.
(6) The data referred to in paragraphs 2 and 5, including those relating to new in vitro medical devices, shall be inserted immediately into the set of medical devices data collected according to the aspects of the European Communities (hereinafter referred to as the "Data set ') and stored in accordance with Paragraph 13.
Procedure for preventing and developing adverse events
(1) The prevention and development of adverse events shall be carried out in accordance with the provisions of Section 4 (6) and the Law on Medical Devices. 21)
(2) As regards the adverse event of the new in vitro medical device to which the CE marking has been affixed, the manufacturer shall indicate this in the adverse event report.
(3) The State Institute for Drug Control (hereinafter referred to as "the Institute") may, where justified, require information, within 2 years of the notification of an adverse event, on the experience of the new in vitro medical device after its placing on the market.
Data set
(1) Data
(a) products and distributors of in vitro medical devices, persons performing their service and in vitro medical devices pursuant to Article 13;
(b) certificates issued, modified, cancelled or, where appropriate, rejected in accordance with the procedures laid down in Annexes 2 to 7 to this Regulation; and
(c) obtained in accordance with the procedure governing notification and registration of adverse events, 22)
shall be kept in accordance with this Regulation in the Data set up and maintained in the Czech Republic under the Information System established under the Medical Devices Act; 23) its users are in particular the Ministry, the Institute for Adverse Events of In vitro Medical Devices, the State Institute for Nuclear Safety for Ionizing Radiation Sources and the Institute of Health Information and Statistics of the Czech Republic; the data are provided to the Ministry.
(2) Data
(a) products of in vitro medical devices and, where appropriate, their authorised representatives and in vitro medical devices in accordance with Article 11 (2) to (6);
(b) the certificates issued, modified and cancelled and, where appropriate, the refusal to issue the certificate, in accordance with the procedures laid down in Annexes 2 to 7 to this Regulation; and
(c) data obtained in accordance with the procedure laid down in Article 12 (2) and (3);
are provided in a standardised format; Such data shall be kept in the European database, (1) which shall be accessible to the competent authorities of the Member States of the European Communities for the performance of their tasks in accordance with the law of the European Communities. 1)
Restrictions on the availability of in vitro medical devices and the adaptation of lists of such devices as set out in Annex 2
Where it is found that the availability of in vitro medical devices should be prohibited or restricted or should be subject to specific requirements, the competent authorities shall, for a transitional period, take appropriate measures in accordance with specific legislation to ensure the safety and health and / or public health24. 25)
Authorised persons
(1) The authorisation conditions are set out in Annex 9 to this Regulation; (6) persons who comply with the requirements of harmonised standards are presumed to comply with the relevant criteria for authorisation.
(2) Authorised person; and
(a) the manufacturer; or
(b) the manufacturer or his authorised representative:
establish deadlines for the completion of the evaluation and verification activities referred to in Annexes 3 to 7 to this Regulation by agreement.
(3) The Authorised Person informs other Authorised Persons, the Technical Standardisation, Metrology and State Testing Office (hereinafter referred to as "the Office") and the Ministry about the revocation of the certificates it has issued; inform the Office and the Ministry, upon request, of the issue or refusal of certificates and provide further relevant information.
(4) Where the authorised person finds that the requirements of this Regulation have not been met by the manufacturer or are no longer fulfilled, or where the certificate should not have been issued, the certificate issued shall be revoked or amended if the conformity of the medical device in vitro with the requirements of this Regulation is not ensured by the manufacturer by the introduction of adequate corrective measures. In the event of revocation or amendment of the certificate or where action by the competent authority is necessary, the authorised person shall inform other authorised persons, the Office and the Ministry thereof.
(5) When informing the competent authorities of other States and the European Commission of certificates that the authorised person has changed or cancelled under the previous paragraphs, the procedure shall be followed by law.
(6) The authorised person shall, upon request of the Office, provide relevant information and documents, including budgetary documents, to verify the criteria set out in Annex 9 to this Regulation.
Transitional provisions
(1) In vitro medical devices which comply with the requirements of existing regulations may be placed on the market after the date of entry into force of this Regulation, but no later than 7 June 2005. In vitro medical devices placed on the market according to the previous sentence may be put into service no later than 7 June 2007.
(2) The activities provided for by the Annexes to this Regulation may be carried out by importers for in vitro medical devices until the date of entry into force of the Treaty of Accession of the Czech Republic into the European Union.
(3) Paragraphs 11 (1) and 13 (1), with the exception of in vitro medical devices imported from States not members of the European Union, shall not apply from the date of publication of the Sectoral Annex "Medical devices" to the Protocol to the Europe Agreement establishing an Association between the Czech Republic, of the one part, and the European Communities and their Member States, of the other part, on conformity assessment and acceptance of industrial products in the Collection of International Treaties or from the date of entry into force of the Treaty of Accession of the Czech Republic to the European Union, if that date is earlier.
Efficacy
This Regulation shall enter into force on the day of its publication, except for:
(a) Articles 6, 8 (1) (b), 9 (1) (a), 11 (2), (3), (4) and (6), 12 (2) and 13 (2), which take effect on the date of publication of the Sectoral Annex to the "Medical Devices" to the Protocol to the Europe Agreement establishing an Association between the Czech Republic, of the one part, and the European Communities and their Member States, of the other part, on conformity assessment and acceptance of industrial products in the Collection of International Contracts;
(b) the provisions of § 3 (d), § 8 (8), § 10 (1) (b) (2), § 11 (5), § 15 (2) (b), which take effect from the date of entry into force of the Treaty of Accession of the Czech Republic into force of the European Union.
Prime Minister:
Ing. Zeman v. r.
Minister for Health:
Prof. MUDr. Fisher, CSc.
Příloha č. 1
Annex No. 1 to Government Decree No. 286 / 2001 Coll.
ESSENTIAL REQUIREMENTS
A. GENERAL REQUIREMENTS
1. In vitro medical devices shall be designed and manufactured in such a way that their use under the specified conditions and for the intended purpose does not jeopardise, directly or indirectly, the clinical condition, the safety or health of users or, where appropriate, the property. Any risks that may arise in connection with their use must be acceptable compared to the benefit they present to patients and must correspond to a high level of health and safety protection.
2. The final solution chosen by the manufacturer for the design of in vitro medical devices shall be based on a state of science and technology corresponding to the time the device was manufactured. When selecting the most appropriate solution, the manufacturer shall comply with the following principles in order:
2.1. Eliminate or minimise risks (safe design and construction),
2.2 take appropriate protective measures against risks that cannot be excluded,
2.3. Inform users in case of persistence of risks which have not been removed due to imperfect protective measures.
3. In vitro medical devices shall be designed and manufactured in such a way as to be suitable for the purposes set out in the Law on Medical Devices (1), in accordance with the manufacturer's specification, while respecting the state of science and technology corresponding to the time of manufacture. It shall achieve the performance specified by the manufacturer, in particular taking into account sensitivity to the relevant analysis, sensitivity to diagnosis, analytical specificity, diagnostic suitability, accuracy, repeatability, reproducibility, including checks on interinterference, interference, and determination of the limit of detection declared by the manufacturer.
The values set for calibrators or control materials shall be verified by means of available reference methods of measurement, where appropriate, of higher levels of materials available.
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Regulation Information
| Citation | Government Decree No. 286 / 2001 Coll., laying down technical requirements for in vitro diagnostic medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.08.2001 |
|---|---|
| Effective from | 07.08.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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