Decree No. 181 / 2001 Coll.
Government Regulation laying down technical requirements for medical devices
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Regulation
Effective from 08.06.2001
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181
GOVERNMENT REGULATION
of 25 April 2001
laying down technical requirements for 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 amendment and addition of certain laws, as amended by Act No. 71 / 2000 Coll., (hereinafter referred to as "the Act") to implement Sections 11 (2), 12 (1) and (4) and 13 (2) 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 medical devices in accordance with the law of the European Communities (1) and the international Treaty (2). (3)
(1) The products provided for in Article 12 (1) of the Act are medical devices for conformity assessment purposes under this Regulation (3), with the exception of:
(a) in vitro diagnostic medical devices, (4) and
(b) active implantable medical devices as defined in Section 2 (2) (f) of the Medical Devices Act.
(2) Furthermore, this Regulation shall not apply to:
(a) medicines, 5)
(b) cosmetic products,
(c) products which, at the time they are placed on the market (6), contain human blood, human blood products, human plasma or human blood cells;
(d) transplants, tissues or cells of the human organism and products containing or derived from them;
(e) transplants, tissues or cells of animal origin, with the exception of medical devices manufactured using inanimate or dead animal tissue or inanimate products derived from animal tissue; and
(f) personal protective equipment covered by specific legislation (7)
General principles
(1) The medical device must comply with the essential requirements set out in Annex I to this Regulation (hereinafter referred to as "the essential requirements"), taking into account the intended purpose of use; the essential requirements shall also be deemed to be met if the medical devices comply with the relevant harmonised standards. 8)
(2) For the purposes of this Regulation, the provisions of the European Pharmacopoeia containing technical requirements concerning medical devices, in particular surgical suture materials and the interaction between medicinal products and the material from which medical devices have been manufactured, shall also be considered as harmonised standards (8), provided that the references to these articles have been notified in the Official Journal of the European Community.
(3) Medical devices may be placed on the market if they comply with the essential requirements and other provisions of this Regulation which apply to them. Medical devices may be put into service only if they meet the conditions for placing on the market and have been supplied and installed accordingly in accordance with the intended purpose of use. Entry into service means the moment at which a medical device prepared for the first time for the intended purpose of use is transmitted to the user.
(4) Medical devices placed on the market and put into service must be maintained and used in accordance with the intended purpose of use.
(5) Medical devices for clinical examinations (9) may be transmitted to doctors and other persons who, on the basis of their qualifications, are entitled to carry out clinical trials or clinical trials without clinical trials under the conditions laid down in the Medical Devices Act (10) in § 15 of this Regulation, in Annex XVII to this Regulation and in Annex XV to this Regulation.
(6) Prohibited medical devices (11) may be placed on the market and put into service if conformity has been assessed in accordance with Article 9 and Annex XVk to this Regulation; custom medical devices of Classes IIa, IIb and III shall have a declaration in accordance with Annex XV to this Regulation.
(7) In cases where medical devices do not comply with this Regulation and endanger the health or lives of people or where medical devices bear the CE12 marking) and are properly placed on the market or put into service, or the medical devices referred to in paragraph 6 are properly put into service, maintained and used in accordance with the intended purpose of use, and yet there is a risk that they may adversely affect human health, taking into account the nature of the risk to users, the law, the law on medical devices and the specific legislation. 13) In particular, those cases where the non-compliance of the medical device with this Regulation results from:
(a) non-compliance with the essential requirements;
(b) incorrect application of standards where it is claimed that they have been applied; or
(c) shortcomings in the standards themselves.
(8) Medical devices may be placed on the market in the Czech Republic only if the information on their use is given in the Czech language in accordance with point 13 of Annex I to this Regulation.
(9) Medical devices using nuclear energy or sources of ionising radiation shall be assessed for radiation protection by a person with appropriate accreditation (14) for this activity.
Labelling of medical devices
(1) The manufacturer shall place a CE marking on a medical device which is neither custom nor intended for clinical trials, or on its packaging before it is placed on the market and put into service, 12) if:
(a) compliance with the essential requirements of this device, taking into account its intended purpose of use, has been verified by assessing compliance with one of the procedures referred to in Article 9;
(b) an EC declaration of conformity has been issued.
(2) Where a medical device is subject, from other aspects, to other regulations of the Government which envisage the CE marking, the latter shall state that the medical device also complies with those other regulations of the Government. A list of the provisions of the Government regulations used shall be given in documents, notices or instructions accompanying the medical device in accordance with this Regulation.
(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) To be indicated
CE shall be accompanied, except for Class I medical devices which are neither sterile nor with a measuring function, by the identification number of the authorised person who has assessed the conformity of the medical device with any of the procedures set out in Annexes III, VII, IX and XI 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 medical devices which do not comply with the requirements of this Regulation are otherwise used for the purpose of demonstrating medical devices at exhibitions, fairs or fairs, these devices shall be visibly marked to show that they cannot be placed on the market and put into service.
Illegal connection of the CE marking
(1) If there are reasonable grounds for suspecting that the CE marking has been affixed to a medical device unjustly, an authorised person may be requested to participate in the assessment of the medical device concerned, pursuant to a specific legislation (16). If the suspicion according to the first sentence is confirmed,
(a) the manufacturer or importer; or
removes the unlawful situation according to the Czech Trade Inspection Guidelines.
(2) For the purposes of this Regulation, the authorised representative referred to in point (b) of paragraph 1 shall mean a natural person with a permanent residence or place of business or a legal person with a registered office in the States of the European Communities who is authorised in writing by the manufacturer to act for him or her by the authorities and authorities in the States of the European Communities, taking into account the requirements resulting from this Regulation for manufacturers.
(3) If
(a) the manufacturer or importer fails to comply with the conditions for the CE marking; or
(b) the manufacturer or his authorised representative fails to comply with the conditions for the CE marking:
and the Czech Trade Inspection Guidelines on the medical device concerned pursuant to paragraph 1 shall be followed by specific legislation. 17)
Classification
Medical devices shall be classified according to the degree of risk posed by their use to users, (18) for any other natural person, in Classes I, IIa, IIb and III; the inclusion of a medical device in one of those classes shall be carried out by the manufacturer or importer in accordance with the rules set out in Annex XVI to this Regulation.
Conformity assessment procedures
(1) The manufacturer or importer shall carry out or ensure, for a medical device, the conformity assessment procedures and actions referred to in Sections 9 to 11.
(2) Where a manufacturer intends to affix a CE marking to a medical device, he shall use one of the recommended conformity assessment procedures referred to in Section 9 and Annexes III, V, VII, IX, XI and XIII to this Regulation.
(3) Upon instruction from the manufacturer, the authorised representative shall be entitled to initiate the procedure set out in the Annexes referred to in paragraph 3.
(1) In the case of Class III medical devices which are neither custom nor intended for clinical testing, the manufacturer shall follow the procedure laid down in:
(a) EC declaration of conformity pursuant to Annex III (Full quality assurance system) to this Regulation; or
(b) EC type-examination in accordance with Annex V to this Regulation in conjunction with the procedure for:
1. the EC verification referred to in Annex VII to this Regulation; or
2. EC declaration of conformity pursuant to Annex IX (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, when attaching the CE marking, follow the EC declaration of conformity procedure set out in Annex XIII to this Regulation in conjunction with the procedure for:
(a) EC verification according to Annex VII to this Regulation; or
(b) EC declaration of conformity pursuant to Annex IX (Quality assurance of production) to this Regulation; or
(c) EC declaration of conformity pursuant to Annex XI (Quality assurance of a medical device) to this Regulation;
or in accordance with paragraph 3 (a).
(3) For Class IIb medical devices which are neither custom nor intended for clinical testing, the manufacturer shall follow the procedure for attaching the CE marking to:
(a) EC declaration of conformity pursuant to Annex III (Full quality assurance system) to this Regulation with the exception of point 4 thereof; or
(b) EC type-examination in accordance with Annex V to this Regulation in conjunction with the procedure for:
1. EC verification according to Annex VII to this Regulation,
2. EC declaration of conformity pursuant to Annex IX (Quality assurance of production) to this Regulation; or
3. EC declaration of conformity according to Annex XI (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 procedure laid down in Annex XIII to this Regulation when attaching the CE marking and draw up an EC declaration of conformity before placing that medical device on the market.
(5) Before placing on the market any custom medical device, the manufacturer shall proceed, in accordance with Annex XV to this Regulation, and draw up the declaration set out in this Annex. The manufacturer shall, upon request, forward to the Czech Trade Inspection Authority 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.
(1) When assessing conformity with a 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 in accordance with this Regulation in each intermediate production process.
(2) Where the conformity assessment procedure for a medical device involves the participation of an authorised person,
(a) the manufacturer or importer; or
request this service at its choice by an authorised person with an appropriate scope of authorisation.
(3) The Authorised Person may request the necessary information to verify conformity with the chosen conformity assessment procedure.
(4) The decisions of the authorised person taken in accordance with Annexes III and V to this Regulation shall be 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 specified in the contract between the manufacturer and the authorised person making the decision.
(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 authorised person.
Specific conformity assessment procedure for medical devices systems and kits and their sterilisation
(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 as part of the intended uses of the assembled medical devices 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 ensure their operation in accordance with those guidelines;
(b) package the system or kit of medical devices and attach to it adequate information 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 fulfilled, in particular if the medical devices constituting the system or the medical device assembly are not CE marking or if the medical devices system or assembly is not compatible with the initial intended uses of individual medical devices, such a system or assembly of medical devices shall be considered as a separate medical device subject to the procedure laid down in paragraphs 9 and 10.
(4) A person who sterilises the systems or medical devices referred to in paragraph 2 or other medical devices designated for placing on the market
the CE marking, intended by their manufacturers for sterilisation before their use in the framework of the provision of health care, shall choose one of the procedures set out in Annexes VII, IX or XI to this Regulation.
The use of those Annexes and the activity of an authorised person shall be limited to the aspects of the procedure for achieving sterility. The person referred to in the previous sentence shall make a declaration that the sterilisation has been carried out in accordance with the manufacturer's or importer's instructions.
(5) Individual medical devices referred to in paragraphs 2, 3, 4 and 5 must not be marked retrospectively
the CE marking, however, shall be provided with the information referred to in point 13 of Annex I to this Regulation, which contains the data of manufacturers of medical devices which have been assembled.
The declaration referred to in paragraphs 2 to 4 shall be kept by the person referred to in the previous paragraphs for a period of 5 years from the placing on the market of the last system or medical device assembly for the purposes of the competent authorities of the State.
Registration of persons responsible for marketing medical devices
(1) A manufacturer who places medical devices on the market in the States of the European Communities in accordance with the procedures laid down in paragraphs 9 (4) and 9 (5) and a person involved in the activities referred to in paragraph 11 shall inform the competent authorities of the Member State of his registered office or place of business of the address of that registered office or place of business, if any, or the address of the place of business and permanent residence of the natural person, as well as the description of the medical devices concerned; in the Czech Republic, manufacturers inform the Ministry in accordance with the Health Devices Act. 19)
(2) For medical devices of Classes IIb and III, Member States of the European Communities may request data enabling the identification of such medical devices together with their identification and instructions for use, provided that such medical devices are put into service in their territory; in the Czech Republic, the Ministry shall communicate the information.
(3) Where a manufacturer having its registered office or place of business in the Czech Republic which places on the market in the Member States of the European Communities does not have medical devices as referred to in paragraph 2, the manufacturer shall, in a Member State where the legal person or place of business or the place of business and permanent residence, if the natural person is the subject of a written contract in the States of the European Communities, entrust the person responsible for trading in those medical devices, who shall inform the competent authorities of the Member State of the European Communities where the registered office is situated, the address of that seat and the category of the medical devices concerned. In the Czech Republic, the person listed in the sentence shall inform the first Ministry.
(4) The Ministry shall, upon request, inform another Member State of the European Communities and the European Commission of the details relating to paragraphs 1 and 2.
Data set
(1) Data
(a) the products, persons and medical devices referred to in Article 12;
(b) certificates issued, modified and revoked; and
(c) obtained in accordance with the procedure governing notification and registration of adverse events (20)
they shall be kept in accordance with this Regulation in the Medical Device Data Compilation collected according to the aspects of the European Communities, which shall be accessible to the competent authorities of the Member States so that they can carry out the tasks provided for in this Regulation. In the Czech Republic, this file is established and managed within the framework of an information system established under the Law on Medical Devices; 21) Its users are in particular the Ministry, the Institute for Adverse Events of Medical Devices, the State Institute for Nuclear Safety for Ionizing Radiation Sources and the Institute of Health Information and Statistics of the Czech Republic.
(2) The information referred to in paragraph 1 shall be provided on forms the models of which appear in Annexes XIX, XX, XXI and XXII to this Regulation.
Clinical trials
(1) For medical devices intended for clinical trials
(a) the manufacturer or importer shall proceed as specified in the Annex;
No XV to this Regulation, or
(2) For Class III medical devices, implantable medical devices and long-term invasive medical devices of Class IIa or IIb, clinical examinations of the medical device may be initiated after 60 days after their notification pursuant to paragraph 1, unless the Ministry notifies them by the competent authority of the Member State of the European Communities, in the Czech Republic, within that period of time of disagreement with their implementation for reasons of public health and public interest. Such examinations may be initiated, with the agreement of the competent authority of the Member State of the European Communities, before the 60-day period expires, provided that the Ethics Committee concerned has given its consent to the plan of such tests.
(3) Clinical trials must be carried out in accordance with the Health Devices Act, 10) Annex XVII to this Regulation and with specific legislation. 24)
(4) The provisions of paragraphs 1 and 2 shall not apply where clinical trials are carried out on medical devices which have been carried out in accordance with Paragraph 9, unless such tests are intended to use those devices for a purpose other than that originally specified by the manufacturer. The relevant provisions of Annex XVII to this Regulation shall remain unaffected.
Authorised persons
(1) The conditions of authorisation are laid down in Law 25) and Annex XVIII to this Regulation; 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 importer shall, by agreement, set deadlines for the completion of the evaluation and verification activities referred to in Annexes III to XI to this Regulation;
(b) the manufacturer or his authorised representative shall, by agreement, set the dates for the completion of the evaluation and verification activities referred to in Annexes III to XI to this Regulation.
(3) Where the authorised person finds, under his responsibility, 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 shall amend or revoke the certificate which he has issued.
(4) The Authorised Person shall, upon request, inform the issuing, refusal or revocation of certificates of other authorised persons, the Office for Technical Standardisation, Metrology and State Testing (hereinafter referred to as the Office) and the Ministry.
(5) When informing the competent authorities of other States and the European Commission of certificates that the authorised person has changed or cancelled pursuant to paragraph 3, the law shall apply. 26)
Provisions common and final
Repeal
Government Decree No. 180 / 1998 Coll., laying down technical requirements for medical devices, as amended by Government Decree No. 130 / 1999 Coll., is hereby repealed.
Efficacy
This Regulation shall enter into force on the day of its publication, except for:
(a) § 3 (6), § 4 (1), § 4 (4), § 5 (3) (a), § 7 (2), § 9, § 11 (4), § 11 (5), § 12 (1), § 12 (3), § 15 (1) (a), § 16 (2) (a) and § 16 (5), which take effect from the date of publication of the Sectoral Annex to the "Medical Devices" to the Protocol to the European Agreement establishing an association between the Czech Republic, on the one hand, and the European Communities and their Member States, on the other, on the assessment of conformity and accession of industrial products in the Collection of International Treaties;
(b) Annexes III, V, VII, IX, XI, XIII and XV to this Regulation, which shall take effect as referred to in (a); the provisions concerning the authorised representative shall take effect on the date of entry into force of the Treaty of Accession of the Czech Republic to the European Union; and
(c) § 5 (1) (b), § 5 (2), § 5 (3) (b), § 5 (4), § 7 (3), § 10 (2) (b), § 12 (2), § 12 (4), § 15 (1) (b) and § 16 (2) (b), § 16 (6) of this Regulation, which take effect on the date of entry into force of the Treaty of Accession of the Czech Republic into force.
Prime Minister:
Ing. Zeman v. r.
Minister for Health:
Prof. MUDr. Fisher, CSc.
Příloha č. I
Annex I to Decree-Law No 181 / 2001 Coll.
ESSENTIAL REQUIREMENTS
I. GENERAL REQUIREMENTS
1. Medical devices must be designed and manufactured in such a way that, when used under the specified conditions and for the intended purpose of use, they do not endanger the clinical condition, health or safety of patients (27) or the safety and health of a natural or legal person providing health care (hereinafter referred to as "the provider '), 28) or other natural persons, provided that any risks that may be related to the use of such medical devices are acceptable compared to their benefit to the patient and correspond to a high level of health and safety protection.
2. The solutions chosen by the manufacturer in the design and construction of medical devices shall comply with the principles of safety and the current level of science and technology.
When selecting the most suitable solutions, the manufacturer shall base the following principles in the following order:
2.1. Eliminate or minimise any risks (safe design and construction) of medical devices;
2.2 to take, where appropriate, appropriate protective measures including, where appropriate, warnings against hazards which cannot be excluded,
2.3. Inform users of the persistence of risks due to failure to achieve the full perfection of the safeguards implemented.
3. Medical devices shall be effective as defined by the manufacturer and shall be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Section 1 (2) in accordance with the manufacturer's specifications.
4. The load of medical devices which may occur under normal operating conditions shall not adversely affect their characteristics and efficacy within the meaning of points 1, 2 and 3 to such an extent as to avoid endangering the clinical condition or safety of patients or, where appropriate, other persons, during the life of the medical devices specified by the manufacturer.
5. Medical devices shall be designed, manufactured and packaged in such a way that:
5.1. Their characteristics and efficiency for the intended purpose of use have not been adversely affected by the conditions of transport and storage, while maintaining the manufacturer's instructions and information,
5.2. It was easy to use.
6. The potential side effects of medical devices must be only an acceptable risk compared to its anticipated effects.
II.
REQUIREMENTS FOR PROPOSAL AND HEALTH CONSTRUCTION
7. Chemical, physical and biological properties of the medical device.
7.1. Medical devices shall be designed and manufactured in such a way as to guarantee the characteristics and effectiveness of the general requirements. Particular attention shall be paid to:
7.1.1. selection of materials intended for the manufacture and packaging of medical devices, in particular in terms of toxicity and, where appropriate, flammable substances;
7.1.2. mutual compatibility between the materials referred to in paragraph 7.1.1 and biological tissues, cells and body fluids, taking into account the intended purpose of use.
7.2. Medical devices shall be designed, manufactured and packaged in such a way as to minimise the risk of pollution caused by undesirable substances and radiation constituents and their residues against users and persons involved in the transport, storage and use of medical devices in accordance with the intended purpose of use. Particular attention must be paid to tissues exposed to these pollutants, the duration and frequency of such action.
7.3. Medical devices shall be designed, manufactured and packaged in such a way that they can be safely used together with substances and radiation which they come into contact with in normal use and usual procedures. Where medical devices are intended for the administration of medicinal products, they shall be designed and manufactured in such a way that, for the intended purpose of use, they are compatible with those medicinal products within the limits of the provisions and restrictions governing those products and are maintained in accordance with the intended purpose of use.
7.4. If the medical device contains as an integral part a substance which may be considered as a drug when used alone and which acts on the human organism by means of a medical device, the safety, quality and efficacy of that substance shall be verified for the intended purpose by the methods used for the testing of the medicinal product. 29)
7.5. Medical devices shall be designed and manufactured in such a way that the risks caused by the substances or, where appropriate, the radiation from them are reduced to the minimum possible.
7.6. Medical devices shall be designed and manufactured in such a way that the risks of intrusion of undesirable substances into them, taking into account the medical device and the nature of the environment in which it is to be used, are reduced to the minimum possible.
8. Infections and microbial contamination.
8.1. Medical devices and manufacturing processes shall be designed in such a way as to eliminate or minimise, where possible, the risk of transmission of infection by medical devices to users and other natural persons or contamination by those persons.
8.2. The tissues of animal origin used for the manufacture of medical devices shall come from animals under veterinary supervision to the extent appropriate to the intended use of those tissues.
8.2.1 Information on the geographical origin of these animals is kept by authorised persons.
8.2.2 The processing, storage, testing and handling of tissues, cells and substances of animal origin shall be carried out in such a way as to achieve an optimum level of safety, in particular against virus contamination in the manufacture of medical devices, by introducing validated methods designed to remove or inactivate viruses.
8.3. Medical devices supplied in sterile state shall be designed, manufactured and packaged in disposable packaging, where appropriate by appropriate procedures to ensure that they are sterile when placed on the market and remain sterile under specified storage and transport conditions until the protective packaging is opened or damaged.
8.4. Medical devices supplied in sterile state must be manufactured and sterilised by the appropriate approved pozem.30)
8.5. Medical devices to be sterilised shall be manufactured in conditions with an adequate level of control. 30)
8.6. The packaging systems of non-sterile medical devices shall ensure a specified level of purity of the medical device. If medical devices are to be sterilised before use, packaging systems must reduce the risk of microbiological contamination to the minimum possible. The packaging systems shall be suitable for the application of the sterilisation method specified by the manufacturer.
8.7. Identical or similar medical devices which are sold in sterile and non-sterile conditions shall be mutually differentiated by packaging or marking.
9. The design and characteristics of the medical device in relation to the environment.
9.1. Where a medical device is intended to be used in conjunction with another medical device or equipment, the kit thus formed, including the interconnection system, shall be safe and shall not interfere with the stated effectiveness of individual medical devices. Any restriction on the applicability shall be indicated in the indication of the medical device or in the instructions for its use.
9.2. Medical devices must be designed and manufactured in such a way as to eliminate or minimise risks
9.2.1. injuries resulting from physical characteristics of medical devices, including the ratio of volume and pressure, dimensional or ergonomic characteristics,
9.2.2. Associated with reasonably foreseeable ambient conditions, in particular magnetic fields, external electrical influences, electrostatic discharges, pressure, temperature or changes in pressure and acceleration,
9.2.3. interaction with other medical devices commonly used in any particular investigation or therapy;
9.2.4. resulting from ageing of the materials used or loss of accuracy of the measuring or control mechanism and from the fact that medical devices cannot be maintained or calibrated (implants).
9.3. Medical devices shall be designed and manufactured in such a way as to eliminate or minimise the risk of fire or explosion during normal use and under one fault. Particular attention should be paid to medical devices intended for use in the environment of flammable substances or substances which may cause combustion.
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Regulation Information
| Citation | Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 08.06.2001 |
|---|---|
| Effective from | 08.06.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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