Government Decree No. 25 / 2004 Coll.
Government Regulation laying down technical requirements for medical devices
Valid
Effective from 01.05.2004
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25
GOVERNMENT REGULATION
of 17 December 2003
laying down technical requirements for medical devices
The Government orders pursuant to Article 22 of Act No. 22 / 1997 Coll., on technical requirements for products and on the amendment and addition of certain laws, as amended by Act No. 71 / 2000 Coll. and Act No. 205 / 2002 Coll., (hereinafter referred to as "the Act ') to implement Sections 11 paragraphs 1 and 2, § 11a, § 12 and 13 of the Act and to implement Act No. 123 / 2000 Coll., on medical devices and on the amendment of certain related laws, as amended by Act No. 130 / 2003 Coll. and Act No. 274 / 2003 Coll. (hereinafter referred to as" the Act on Medical Devices'):
Preliminary provisions
This Regulation lays down, in accordance with the law of the European Communities,
(a) technical requirements for medical devices (2); and
(b) detailed specifications as regards the risks of transmission of transmissible spongiform encephalopathies (TSEs) to sick individuals (patients) 3 or other persons by use, under normal conditions, medical devices manufactured using non-living animal tissue or non-living products derived from animal tissue originating from certain bovine, ovine or caprine species, and from deer, moose, mink and cats listed in Annex 12 to this Regulation.
(1) For the purposes of conformity assessment under this Regulation, the specified products referred to in Article 12 (1) of the Act are medical devices with the exception of:
(a) diagnostic medical devices in vitro4); and
(b) active implantable medical devices. 5)
(2) This Regulation shall not apply to:
(a) medication6) including medicinal products derived from human blood;
(b) cosmetic products,
(c) transplants, tissues or cells of human origin and products containing or derived from them;
(d) human blood, blood products, plasma or blood components of human origin, or medical devices containing, at the time of their entry into the market (7), blood, plasma or cells, with the exception of medical devices referred to in § 2 (2) (g) of the Medical Devices Act;
(e) personal protective equipment covered by specific legislation, 8)
(f) transplants, tissues or cells of animal origin, with the exception of those manufactured using non-living animal tissue or non-living animal tissue derived products.
Definition of terms
(1) For the purposes of this Regulation, as regards medical devices manufactured using tissues of animal origin, the following definitions shall apply:
(a) a cell of the smallest organised unit of any living form capable of independent existence and self-recovery in an appropriate environment;
(b) tissues of any cell organisation or, where appropriate, non-cellular components;
(c) a derivative material obtained from the production process from animal tissue such as collagen, gelatine, monoclonal antibodies,
(d) inanimate be without any possibility of metabolism or reproduction;
(e) transmissible agents of non-classified pathogenic agents, prions and agents such as bovine spongiform encephalopathies (BSE) and scrapie;
(f) by reducing, excluding or eliminating a process which reduces the number of transmissible agents or excluding transmissible agents, where appropriate, to prevent infection or pathological reaction;
(g) inactivation of a process which reduces the ability of transmissible agents to cause infection or pathological reaction;
(h) the country of origin of the country in which the animal was born, reared or slaughtered;
(i) the source materials of raw material or any other means of animal origin from or through which the medical devices referred to in Article 1 (b) are produced.
(2) Entry into service means the moment at which a medical device complying with the requirements of this Regulation is transmitted to the user, 9) where it is installed and prepared for the first time for the intended purpose of use.
General principles
(1) A medical device shall comply with the requirements set out in Annex 1 to this Regulation (hereinafter referred to as "essential requirements') and the requirements applicable to a particular device, taking into account the intended purpose of its use.
(2) The essential requirements shall be deemed to be met if the medical device complies with the requirements of the harmonised standards, 10) which apply to that medical device taking into account the intended purpose of use.
(3) A medical device may be placed on the market if:
(a) the conformity of its characteristics with the essential requirements, hereinafter referred to as "conformity," has been assessed in the manner established by it, and the result of that assessment has been that the medical device complies with the essential requirements, is accompanied, with the exception of a custom medical device and a medical device intended for clinical trials, CE marking, 11) meets the other requirements referred to in paragraph 1 and production12) or by an authorised representative 13) has issued a written declaration thereof (hereinafter referred to as "the certificate of conformity"); and
(b) it is accompanied by information on its use in accordance with point 13 of Annex 1 to this Regulation; when it is placed on the market in the Czech Republic, the information on its use must be in the Czech language.
(4) Entry into service means the moment at which a medical device complying with the requirements of this Regulation is transmitted to the user, 9) where it is installed and prepared for the first time for the intended purpose of use.
(5) The device placed on the market and, where appropriate, put into service shall be maintained and used in accordance with the instructions for use and the intended purpose of use.
(6) A medical device intended for carrying out clinical examinations (14) may, to this end, be transmitted to a doctor or other person who, on the basis of his qualifications, is entitled to carry out clinical examinations under the conditions laid down in the Law on Medical Devices (15) in Section 15 and Annexes 8 and 10 to this Regulation; the device shall not bear the CE marking.
(7) A custom medical device (16) may be placed on the market and put into service if conformity has been assessed in accordance with Article 9 and in accordance with Annex 8 to this Regulation and the manufacturer draws up a declaration to that medical device in accordance with that Annex. A custom medical device shall not bear the CE marking.
(8) Where a medical device does not comply with this Regulation and endangers the health or lives of humans or where the medical device bears the CE marking and is properly placed on the market or put into service or is properly maintained and used in accordance with the intended purpose of use, and there is nevertheless a risk that it 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 shall be followed. 17) The Commission of the European Communities shall be informed without delay of such cases and follow-up. The measures implemented must be duly justified, in particular whether the safeguard measure was taken on the basis of:
(a) non-compliance with the essential requirements if the medical device does not comply with the harmonised standards referred to in Article 4 (2);
(b) incorrect application of the harmonised standards referred to in Article 4 (2) where it is stated that they have been applied; or
(c) the deficiency in the harmonised standards themselves referred to in Article 4 (2).
(9) Decisions under the Law, the Law on Medical Devices, Special Legislation (18) and this Regulation concerning refusal or restriction of the placing on the market or putting into service or carrying out clinical trials or withdrawing medical devices from the market must contain specific reasons for doing so.
(10) A nuclear-energy medical device or source of ionising radiation shall be assessed in the light of radiation protection by a person with appropriate accreditation for that activity and with permission under specific legislation. 18)
Labelling of medical devices
(1) The manufacturer shall affix a medical device which is neither custom nor intended for clinical trials or its packaging before being placed on the market and put into service with the CE marking if:
(a) compliance with the essential requirements of this device, taking into account its intended purpose of use, has been verified by assessing the conformity with one of the procedures referred to in Article 9; and
(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. The list of regulations used by the Government 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) The CE marking shall be accompanied, with the exception of a Class I medical device which is neither sterile nor with a measuring function, by the identification number of the notified person who assessed the conformity of the medical device with any of the procedures set out in Annexes 2, 4, 5 and 6 to this Regulation.
(5) No marks and descriptions may be affixed to the medical device which could be misinterpreted as being of relevance or graphically similar to the CE marking. Another character may be placed on the medical device, its packaging or in the instructions accompanying the medical device provided that it does not reduce the visibility or legibility of the CE marking.
(6) Where, for the purposes of demonstrating a medical device at exhibitions, fairs or otherwise, a medical device which does not comply with the requirements of this Regulation is used, that device shall be visibly marked to show that it cannot be placed on the market and put into service until it is brought into conformity with this Regulation.
Illegal connection of the CE marking
(1) If there is a reasonable suspicion that the CE marking has been affixed to a medical device unjustly, a notified person may be requested to participate in the assessment of such medical device under the special legislature19. If the suspicion according to the first sentence is confirmed, the manufacturer or his authorised representative shall remove the unlawful situation under the measures imposed by the Czech Trade Inspection Office.
(2) If the manufacturer or his authorised representative fails to comply with the conditions for the CE marking and the measures imposed by the Czech Trade Inspection Office concerning the medical device concerned under paragraph 1, the procedure shall be followed in accordance with specific legislation. 20)
(3) The Commission of the European Communities and the competent authorities of the Member States of the European Communities shall be informed of the measures referred to in paragraphs 1 and 2.
(4) The provisions of paragraphs 1 to 3 shall also apply where the CE marking has been affixed in accordance with the procedures laid down in this Regulation to products not covered by this Regulation.
Classification
(1) Medical devices shall be classified according to the degree of risk posed by their use to users and, where appropriate, to other natural persons in Classes I, IIa, IIb and III; the inclusion of a medical device in one of those classes shall be carried out by the manufacturer in accordance with the rules set out in Annex 9 to this Regulation.
(2) Medical devices manufactured with the use of animal tissues or their non-living derivatives belong to Class III, except medical devices which are only intended to come into contact with intact skin.
(3) Where the Ministry of Health (hereinafter referred to as the Ministry) concludes that:
(a) the application of the classification rules set out in Annex 9 requires a decision on the classification of a particular medical device or category of medical devices;
(b) a particular medical device or category of medical devices should be classified in another class by way of derogation from the provisions of Annex 9 to this Regulation; or
(c) the conformity of a medical device or category of medical devices should be assessed exclusively in accordance with one of the procedures referred to in Section 9;
request the Commission of the European Communities to take the necessary measures; the request must be duly substantiated.
Conformity assessment procedures
(1) The manufacturer or the authorised representative shall carry out or carry out, for a medical device, the conformity assessment procedures and operations referred to in paragraphs 9 to 12.
(2) At the manufacturer's direction, the authorised representative shall be entitled to initiate the procedure laid down in Annexes 3, 4, 7 and 8 to this Regulation.
(1) For Class III medical devices which are neither custom nor intended for clinical testing, the manufacturer shall follow the CE marking for its action in accordance with the procedure laid down in:
(a) the EC declaration of conformity referred to in Annex 2 (Full Quality Assurance System) to this Regulation; or
(b) EC type-examination in accordance with Annex 3 to this Regulation in conjunction with the procedure for:
1. EC verification according to Annex 4 to this Regulation; or
2. The EC declaration of conformity referred to in Annex 5 (Quality assurance of production) to this Regulation.
(2) In the case of Class IIa medical devices which are neither custom nor intended for clinical trials, the manufacturer shall, for his action, follow the CE marking in accordance with the procedure for the EC declaration of conformity referred to in Annex 7 to this Regulation in conjunction with the procedure for:
(a) EC verification in accordance with Annex 4 to this Regulation; or
(b) the EC declaration of conformity referred to in Annex 5 (Quality assurance of production) to this Regulation; or
(c) the EC declaration of conformity referred to in Annex 6 (Quality assurance of the medical device) to this Regulation;
or in accordance with paragraph 3 (a).
(3) In the case of Class IIb medical devices which are neither custom nor intended for clinical trials, the manufacturer shall follow the CE marking for its action in accordance with the procedure for:
(a) the EC declaration of conformity referred to in Annex 2 (Full Quality Assurance System) to this Regulation, with the exception of point 4 thereof; or
(b) EC type-examination in accordance with Annex 3 to this Regulation in conjunction with the procedure for:
1. EC verification as set out in Annex 4 to this Regulation,
(2) the EC declaration of conformity referred to in Annex 5 (Quality assurance of production) to this Regulation, or
3. The EC declaration of conformity referred to in Annex 6 (Quality assurance of the medical device) to this Regulation.
(4) For Class I medical devices which are neither custom-made nor intended for clinical testing, the manufacturer shall follow the CE marking for its action in accordance with the procedure set out in Annex 7 to this Regulation and draw up an EC declaration of conformity prior to the placing on the market of that medical device.
(5) Before placing on the market any custom medical device, the manufacturer shall proceed in accordance with Annex 8 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 the conformity of a medical device, the manufacturer or, where appropriate, the notified 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 a notified person, the manufacturer or his authorised representative shall, at his choice, request that service from a notified person with an appropriate scope of authorisation.
(3) The Notified Person may request the necessary information to verify conformity with regard to the chosen conformity assessment procedure.
(4) Certificates issued by the notified person and other decisions taken in accordance with Annexes 2 and 3 to this Regulation shall be valid for a maximum period of 5 years and may be extended for a further period of 5 years, at the request of the manufacturer, at the time indicated in the contract between the manufacturer and the notified person issuing the certificate.
(5) The accompanying and manufacturing documentation of the medical device, records and correspondence relating to the procedures referred to in Article 9 may be obtained in the official language of the Member State of the European Communities in which the procedures are carried out and, where appropriate, in another language acceptable to the notified person.
Specific procedure for medical device systems and kits
(1) In the case of systems and sets of medical devices, by way of derogation from Sections 9 and 10.
(2) A person who compiles medical devices bearing the CE marking for the intended purpose of use in order to place them on the market as a system or kit shall draw up a declaration stating that:
(a) verify the compatibility of the medical devices assembled in accordance with the instructions of their manufacturers and carry out operations for operation under these guidelines;
(b) package the system or kit of medical devices and attach 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 met, in particular if the medical devices constituting the system or the medical device assembly are not bearing the CE marking or if the medical devices system or assembly is not compatible with the initial intended uses of the individual medical devices, such a medical device system or assembly shall be considered as a separate medical device subject to the procedure laid down in paragraphs 9 and 10.
(4) A person who, for the purposes of placing on the market, sterilises medical devices or medical devices or sets and systems referred to in paragraph 2 which have been bearing the CE marking and have been designated by their manufacturers for sterilisation before their use in the framework of the provision of healthcare shall choose one of the procedures set out in Annexes 4, 5 or 6 to this Regulation. The use of those Annexes and the activity of the notified person shall be limited to the procedure needed to achieve sterility. The sterilisation person shall draw up a declaration that the sterilisation has been carried out in accordance with the manufacturer's instructions.
(5) The medical devices referred to in paragraphs 2 and 4 shall not be subsequently bearing the CE marking, but shall be accompanied by information in accordance with point 13 of Annex 1 to this Regulation, which shall contain the manufacturer's data on the medical devices which have been assembled. The declaration referred to in paragraphs 2 and 4 shall be kept by the person referred to in the preceding 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 administration.
Conformity assessment procedures and specifications concerning requirements for medical devices manufactured using tissues of animal origin
(1) Before submitting an application for conformity assessment pursuant to Article 9 (1) for a medical device referred to in Article 1 (b), the manufacturer shall carry out a risk analysis and risk management ("risk management ') in accordance with Annex 12 to this Regulation.
(2) Collagen, gelatine and tallow used in the manufacture of medical devices referred to in § 1 (b) must meet at least the requirements which they would have had to meet if they were intended for human consumption.
(3) Medical devices referred to in Article 1 (b) may be placed on the market and put into service only if they comply with the specifications set out in Annex 12 to this Regulation.
(4) The assessment of the conformity of a medical device referred to in Article 1 (b) includes an assessment of compliance with the essential requirements and specifications set out in Annex 12 to this Regulation. Notified persons shall evaluate the manufacturer's intention to analyse risk analysis and risk management, in particular:
(a) the information provided by the manufacturer;
(b) justification for the use of tissues or derivatives of animal origin;
(c) the results of elimination or deactivation studies or research on specialised literature, where appropriate;
(d) the manufacturer's inspection of his suppliers, source materials and finished products;
(e) the need to verify the origin of the source materials, including supplies from suppliers of the manufacturer.
(5) Notified persons in the risk analysis and risk management assessment shall take into account, where available for source materials, the TSE absence certificate issued by the European Directorate for the Quality of Drugs (hereinafter referred to as the TSE certificate) in the framework of the conformity assessment.
(6) With the exception of medical devices manufactured using source materials for which a TSE certificate has been issued pursuant to paragraph 5, the Ministry shall, at the request of the provider (21), seek opinions from the competent authorities of the other Member States of the European Communities concerning their evaluation and conclusions of the risk analysis and risk management of tissues or derivatives intended to become part of the medical devices referred to in § 1 (b) carried out by manufacturers.
(7) Before issuing the EC design review certificate and the EC type-examination certificate, the notified person shall take into account the opinions adopted within 12 weeks of the date on which the opinions of the relevant persons of the Member State of the European Communities were sought.
(8) The provisions of paragraphs 1 to 7 shall apply to medical devices referred to in § 1 (b) which are intended to come into contact with the human body or which are intended to come into contact with damaged skin.
Notification obligation of persons responsible for placing medical devices on the market
(1) A manufacturer who, in accordance with the procedures laid down in paragraphs 9 (4) and 9 (5), places medical devices on the market under his name and the person involved in the activities referred to in paragraph 11 shall inform the Ministry of the address of his registered office or establishment, if he is a legal person, or the address of his establishment and residence, if he is a natural person, as well as a description of the medical devices concerned, in accordance with the law. 22)
(2) Where medical devices of Classes IIb and III are put into service in the territory of other Member States of the European Communities and their competent authorities require data enabling the identification of those medical devices together with their identification and instructions for use, the required data shall be communicated by the Ministry.
(3) Where a manufacturer placing on the market a medical device referred to in paragraph 1, as well as a person involved in the activities referred to in Paragraph 11, does not have a registered registered office or address in the Czech Republic, if it is a legal person, or a permanent residence, place of business or address of the establishment, if it is a natural person, it shall entrust the person responsible for trading in such means by written contract; This person shall inform the Ministry of the address of his registered office, permanent residence or place of business and of the category of medical devices concerned.
(4) The Ministry shall also inform the other Member State of the European Communities and the Commission of the data resulting from the previous paragraphs on request.
Data set
(1) Data
(a) the products, persons and medical devices referred to in Section 13;
(b) certificates issued, modified and cancelled; and
(c) obtained in accordance with the procedure governing the notification and registration of adverse events (23)
shall be kept in accordance with this Regulation in the information system provided for in Section 41 of the Law on Medical Devices. Data from the area of medical devices shall be collected in this system according to the aspects of the European Communities. The information system shall be accessible to the competent authorities of the Member States of the European Communities. In the Czech Republic, the users of this system are in particular the Ministry, the Institute of Adverse Events 24) of Medical Devices, the State Office of Nuclear Safety for Ionizing Radiation Sources and the Institute of Health Information and Statistics of the Czech Republic.
(2) The data referred to in paragraph 1 shall be provided in a standardised format in accordance with Annexes 13 to 16 to this Regulation.
Clinical trials
(1) For medical devices intended for clinical examinations, the manufacturer or the authorised representative shall proceed as specified in Annex 8 to this Regulation and notify the intention to carry out clinical examinations to the Ministry and the Institute.
(2) For Class III medical devices, implantable medical devices and invasive medical devices of Class IIa or IIb with long-term use, clinical examinations of the medical device may be initiated after 60 days after their notification in accordance with paragraph 1, unless the Ministry notifies them of its non-compliance within that period for reasons of public health and public interest. Such examinations may be initiated, with the agreement of the Ministry, before the 60-day period expires, if the Ethics Committee concerned has given its consent to the plan of such tests.
(3) Clinical trials or clinical trials must be carried out in accordance with the Law on Medical Devices, Annex 10 to this Regulation and with specific legislation. 25)
(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 10 to this Regulation shall remain unaffected.
(5) Clinical trials or clinical trials are not carried out for medical devices in cases provided for in the Law on medical devices. 26)
Notified persons
(1) The authorisation conditions are set out in Annex 11 to this Regulation; legal persons who comply with the requirements of the Czech harmonised standards which take over the relevant harmonised standards are presumed to meet the relevant criteria for authorisation.
(2) In addition to the established rights and obligations of the notified person, the condition for assessing the conformity of medical devices under the introductory part of the provisions of Section 2 (1) and the specifications set out in Annex 12 to this Regulation shall be the current knowledge of medical devices referred to in Section 1 (b). In the event of a lack of information on medical devices referred to in Section 1 (b), the Office for Standardisation, Measurement and State Testing (hereinafter referred to as the Office) shall follow the law. 27)
(3) The amended person and the manufacturer or his authorised representative shall, by agreement, set the dates for completion of the evaluation and verification activities referred to in Annexes 2 to 6 to this Regulation.
(4) Where the notified person finds, under his or her competence, that the manufacturer has not complied with or no longer complies with the relevant requirements of this Regulation, except where the manufacturer has ensured compliance with those requirements by introducing adequate corrective measures, he or she shall amend or revoke the certificate which he or she has issued.
(5) The amended person shall take into account relevant information concerning the characteristics and performance of medical devices containing stable human blood derivatives or human plasma, in particular the results of tests and verifications carried out under previous legislation concerning those medical devices. 28)
(6) The amended person shall inform other notified persons, the Office and the Ministry of Justice of the cancellation of certificates issued to him; provide further relevant information at their request.
(7) When informing the competent authorities of other States and the Commission of the European Communities of certificates that the notified person has changed or cancelled pursuant to paragraph 3, the procedure shall be followed by law. 29)
(8) The person nominated shall provide, upon request, relevant information and documents, including budgetary documents, required by the Member State of the European Communities to verify compliance with Annex 11 to this Regulation.
(9) The Authority shall, upon request by the competent authority of another Member State of the European Communities, provide information and documents to verify the criteria set out in Annex 11 to this Regulation.
Transitional provisions
(1) Certificates issued under Government Decree No. 180 / 1998 Coll., laying down technical requirements for medical devices, as amended by Government Decree No. 130 / 1999 Coll., may be used for conformity assessment under this Regulation by 31 December 2003 at the latest.
(2) Documents issued pursuant to Government Regulation No 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Regulation No 336 / 2001 Coll., shall be deemed to be documents issued under this Regulation unless special legislature30) or other provisions of this Regulation provide for their validity by way of derogation, but not later than 31 December 2005.
(3) Medical devices which comply with the requirements laid down in Government Regulation 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Regulation 336 / 2001 Coll., may be placed on the market unless otherwise provided for in specific legislation or other provisions, by 31 December 2005 at the latest; These funds may be put into service by 30 June 2006 at the latest.
(4) Medical devices containing human blood derivatives or human plasma which comply with the requirements laid down in a specific legislation, 31) may be placed on the market until 10 January 2007; This may be put into service by 10 January 2009.
(5) Holders of an EC design examination certificate or an EC type-examination certificate for medical devices manufactured using non-living animal tissue or non-living products made from animal tissue issued before 1 April 2004 may request a supplement to the EC design review certificate or an addition to the EC type-examination certificate demonstrating compliance with the specifications set out in Annex 12 to this Regulation.
(6) Medical devices referred to in Section 1 (b) which have an EC design review certificate or an EC type-examination certificate issued before 1 April 2004 may be placed on the market and put into service and used until 30 September 2004.
(7) Persons in charge of conformity assessment activities pursuant to Government Regulation No 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Regulation No 336 / 2001 Coll., shall be deemed to be persons in charge of activities under this Regulation.
Repeal
The following shall be deleted:
1. Government Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices.
2. Government Regulation No. 336 / 2001 Coll., amending Government Regulation No. 181 / 2001 Coll., laying down technical requirements for medical devices.
Efficacy
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. 25 / 2004 Coll.
ESSENTIAL REQUIREMENTS
I. GENERAL REQUIREMENTS
1. Medical devices shall 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 the patient or the safety and health of the user or, where appropriate, other natural persons, provided that any risks which may be associated with 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.
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.
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Regulation Information
| Citation | Government Decree No. 25 / 2004 Coll., laying down technical requirements for medical devices |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 23.01.2004 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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