Act No. 196 / 2010 Coll.
Act amending Act No. 123 / 2000 Coll., on Medical Devices and amending certain related laws, as amended
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Law
Effective from 16.06.2010
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16.06.2010
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196
THE LAW
of 20 May 2010
amending Act No. 123 / 2000 Coll., on Medical Devices and amending certain related laws, as amended
Parliament has decided on this law of the Czech Republic:
Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws, as amended by Act No. 130 / 2003 Coll., Act No. 274 / 2003 Coll., Act No. 58 / 2005 Coll. and Act No. 227 / 2009 Coll., are amended as follows:
1. In Section 1, the current text becomes paragraph 1 and the following paragraphs 2 and 3 are added:
"(2) This Act implements the relevant provisions of the European Communities (1) (hereinafter referred to as the" Community ') and provides for
(a) conditions for the use of medical devices;
(b) clinical evaluation of medical devices,
(c) prescription, supply, purchase, storage and sale of medical devices;
(d) installation, briefing, use, maintenance, service and registration of medical devices;
(e) reporting obligations,
(f) the pursuit of state administration and other activities in the field of medical devices;
(g) control; and
(h) fines.
(3) That law was notified in accordance with Directive 98 / 34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and rules for information society, as amended by Directive 98 / 48 / EC.
1) Council Directive 90 / 385 / EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Council Directive 93 / 42 / EEC of 14 June 1993 concerning medical devices. Directive 98 / 79 / EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Directive 2000 / 70 / EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93 / 42 / EEC with regard to medical devices containing stable derivatives from human blood or human plasma. Directive 2001 / 104 / EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93 / 42 / EEC concerning medical devices. Commission Directive 2003 / 12 / EC of 3 February 2003 amending the classification of breast implants in the framework of Directive 93 / 42 / EEC concerning medical devices. Commission Directive 2003 / 32 / EC of 23 April 2003 establishing detailed specifications as regards the requirements laid down in Council Directive 93 / 42 / EEC for medical devices manufactured using tissues of animal origin. Directive 2005 / 50 / EC of 11 August 2005 on the reclassification of hip, knee and shoulder joints in the framework of Council Directive 93 / 42 / EEC concerning medical devices. Council Directive 93 / 68 / EEC of 22 July 1993 amending Directives 87 / 404 / EEC (simple pressure vessels), 88 / 378 / EEC (safety of toys), 89 / 106 / EEC (construction products), 89 / 336 / EEC (electromagnetic compatibility), 89 / 392 / EEC (machinery), 89 / 686 / EEC (personal protective equipment), 90 / 384 / EEC (non-automatic weighing instruments), 90 / 385 / EEC (active implantable medical devices), 90 / 396 / EEC (appliances of gaseous fuels), 91 / 263 / EEC (telecommunications terminal equipment), 92 / 42 / EEC (new temperature water boilers for liquid or gaseous fuels) and 73 / 23 / EEC (electrical equipment intended for use in certain voltage limits). Directive 2007 / 47 / EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90 / 385 / EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93 / 42 / EEC concerning medical devices and Directive 98 / 8 / EC concerning the placing of biocidal products on the market. Commission Decision 2002 / 364 / EEC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices. '
footnote 1 shall be renumbered footnote 1a, including the footnote references.
2. Paragraph 2 (1) reads as follows:
"(1) A medical device means an instrument, apparatus, device, software, material or other object, used alone or in combination, together with accessories, including software intended by its manufacturer for specific use for diagnostic or therapeutic purposes and necessary for its proper use, as specified by the manufacturer for human use for the purpose of:
(a) diagnosis, prevention, monitoring, treatment or mitigation of the disease;
(b) diagnosis, monitoring, treatment, mitigation or compensation of injury or disability;
(c) investigation, replacement or modification of the anatomical structure or physiological process; or
(d) checks on conception;
and which does not achieve its main intended function in or on the body by pharmacological, immunological or metabolic action, but which may be supported by such effects. ';
3. In Article 2 (2) (c), "control and protection 'is replaced by" storage and storage';
4. in Article 2 (2) (d) to (f), including footnotes 3a and 4:
"(d) made in accordance with the Regulation of a healthcare professional (3a), by which a qualified healthcare professional issues an individual design of the characteristics of a medical device intended for use only by one particular patient (hereinafter referred to as a" custom medical device "). The mass-produced medical devices which require adaptation to meet the specific requirements of medical practitioner 3a) or other professional user shall not be considered as custom medical devices,
(e) intended to be used by health practitioners 3a) in clinical tests4), hereinafter referred to as "clinical examination medical devices"; for the purpose of carrying out clinical trials, any other person authorised to carry out those tests on the basis of his professional qualifications shall be considered equivalent to a health professional;
(f) whose activity is dependent on a source of electrical or other energy or on an energy source other than that directly produced by the human body or resulting from gravity, intended for the complete or partial introduction by the doctor into the human body, with the fact that it remains at the place of introduction ("active implantable medical device"), even if it is intended to be administered by the medication1a), or contains, as an integral part of the human blood substance or derivative, a substance or a derivative of human blood that can be considered as an ingredient in the medicinal product or medicinal product and that it has an additional effect to the effect of the medical device. This device can also be produced
1. to order referred to in (d); or
2. for the purposes of the clinical trials referred to in point (e).
3a) Act No. 95 / 2004 Coll., on the conditions for obtaining and recognising professional competence for the pursuit of the medical profession of physician, dental practitioner and pharmacist, as amended. Act No. 96 / 2004 Coll., on the conditions for acquiring and recognising the competence to pursue non-medical health professions and to carry out activities related to the provision of health care and amending certain related laws (Law on non-medical health professions), as amended.
4) Annex No. 10 to Government Decree No. 336 / 2004 Coll., laying down technical requirements for medical devices and amending Government Decree No. 251 / 2003 Coll., amending certain government regulations issued for the implementation of Act No. 22 / 1997 Coll., on Technical Requirements for Products and amending and supplementing certain acts, as amended. Annex No 7 to Government Decree No 154 / 2004 Coll., laying down technical requirements for active implantable medical devices and amending Government Decree No 251 / 2003 Coll., amending certain Government Regulations issued for the implementation of Act No 22 / 1997 Coll., on Technical Requirements for Products and amending and supplementing certain acts, as amended. '
5. in Article 3 (c):
"(c) the intended purpose of use for which the medical device is intended according to the information provided by the manufacturer on the labels, the instructions for use and, where appropriate, the promotional materials;"
6. In Paragraph 3 (l):
"(l) by an authorised representative, a natural or legal person established in a Member State of the European Union or of the European Free Trade Association, who is simultaneously a contracting party to the European Economic Area (hereinafter referred to as" the Member State "), who is expressly authorised by the manufacturer to act for him and may be contacted on his behalf by the authorities of the State with regard to his obligations under this Act, '.
7. in § 3, the following points (m) to (q) are added:
"(m) clinical data on the safety and performance of the device. Clinical data are obtained through:
1. one or more clinical trials of the medical device concerned,
2. one or more clinical trials or other studies reported in the literature concerning a similar medical device for which equivalence with the device concerned can be demonstrated; or
3. Published or unpublished reports of other clinical experience with either the medical device concerned or similar medical device for which equivalence with the medical device concerned can be demonstrated,
(n) a subgroup of medical devices a set of medical devices having common areas of intended use or common technology;
(o) a group of generic medical devices, a set of medical devices having the same or similar intended use or common technology, allowing them to be classified generically without taking into account specific characteristics;
(p) a disposable medical device such as a medical device for single use only in one patient,
(q) a derivative of human blood, a product of human blood or human plasma according to the Drug Act. ';
8. in Article 4 (1) (b), the words "in § 7 and § 52 (2) to (6)" shall be replaced by "in § 7 or § 52 (2) to (6)," at the end of (b) the comma shall be replaced by a dot and point (c) shall be deleted;
9. In Article 4 (2), the words "in the declaration of conformity and 'are deleted.
10.Paragraph 4 (6) reads as follows:
"(6) The Ministry shall decide whether to withdraw a medical device or a group thereof from the market, to restrict or prohibit the placing on the market of a medical device or their group, or to make such placing subject to specific requirements where it is not possible to ensure the protection of health and safety or to comply with public health requirements by other means, only to the extent necessary to achieve that purpose. ';
11. in Article 4, the following paragraph 7 is added:
"(7) The Ministry shall immediately inform the Commission of the European Communities (hereinafter referred to as the Commission) and all other Member States of the decisions taken pursuant to paragraph 6, together with the reasons for the decision to withdraw the medical device from the market or to prohibit, restrict or restrict the placing on the market or put into service of the medical device.";
12. in Article 6 (2), the first sentence is replaced by the following: "In the event of confusion concerning clinical trials, the Institute gives its opinion."
13. The heading of Title III shall read "CLINICAL ASSESSMENT."
14.
General provisions
(1) The medical device shall be suitable for use in the provision of healthcare; the suitability of the medical device for the intended purpose of use must be verified by clinical evaluation, except for in vitro medical devices. Clinical evaluation of a medical device (hereinafter referred to as "clinical trial ') means a critical evaluation of clinical data.
(2) Clinical examination of a medical device (hereinafter referred to as "clinical trials") means systematic testing of a medical device, subject to a specified purpose of use, under conditions established by the manufacturer, carried out by the examiner in accordance with a pre-established clinical trial plan, which consists of its application to clinical trial subjects with a view to:
(a) demonstrate that the medical device is suitable for use in the provision of health care while respecting the intended purpose of use, in particular in terms of safety and efficacy;
(b) identify the impact of the medical device on the subject; and
(c) specify the side effects of the medical device and assess whether they pose acceptable risks to the subject.
(3) A clinical trial plan means a document containing detailed information on the reasons, purpose, objectives, methodology, management and monitoring of clinical trials and record keeping thereof. The clinical trial plan shall be binding on all participants in the clinical trials.
(4) The investigator's manual shall contain a set of clinical and preclinical information on the medical device being tested that is essential for the tests carried out by the clinical trial subjects.
(5) Source documents shall be all information in the original and identification records and verified copies of the original records of clinical findings, observations or other clinical trial activities necessary for the assessment of clinical trials.
(6) The procuring entity of the clinical trials shall be the natural or legal person who subcontracts the clinical trials and is responsible for the initiation, management, organisation, control and, where appropriate, financing, and for the damage caused by the specific nature of the clinically tested medical device. The contracting authority may only be a person who is resident or established in the territory of the Czech Republic or one of the Member States, or a person who has appointed an authorised representative to fulfil this condition.
(7) The assistant of the contracting authority shall be the person designated by the contracting authority for the performance of certain tasks set out by the contracting authority in Section 12 with whom the contracting authority shall conclude a contract for that purpose.
(8) The investigator shall be the person responsible for the conduct of the clinical trial in one place. It shall be entrusted to the clinical examination by the contracting authority or, where appropriate, the provider to which the examiner is employed.
(9) The main examiner shall be the person designated by the contracting authority to coordinate the work of performing the multicentre clinical trials or the person designated by the sponsor to coordinate the activities of clinical trials carried out at several workplaces or, where appropriate, the person who leads the team of persons involved in the clinical examination at one test site.
(10) The multicenter clinical trial is a trial performed according to one clinical trial plan at 2 or more workplaces and therefore several examiners, where workplaces can be located in the Czech Republic, or in other Member States or in third countries.
(11) The assessment body shall be a natural person participating in the clinical trial as a recipient of the test medical device.
(12) Informed consent means voluntary and demonstrable expression of the intention of the subject or, where applicable, his legal representative to undergo clinical trials under the conditions set out in point (i) of this paragraph; the assessment body shall be informed in advance of these conditions by the examiner. Informed consent shall continue throughout the clinical trials; in the event of withdrawal of this consent, the subject of the evaluation may not continue the clinical trials. In the event that new information relevant to the informed consent is present, the assessment body shall be informed immediately to the investigator of this fact. The instruction shall be written, comprehensible and in a language to which the assessment body is well understood; the instruction, which is part of the informed consent, must include:
(a) adequate information on clinical trials, including their target;
(b) the expected duration and participation of the subject in clinical trials;
(c) a description of the medical device being tested;
(d) a description of the procedures, in particular test procedures;
(e) information on the potential benefits of clinical trials for the subject;
(f) information on foreseeable risks and potential difficulties associated with clinical trials;
(g) information on other treatment or diagnosis options;
(h) information on the processing of the personal data obtained by the subject of the evaluation, including information on confidentiality, with the possibility that such data may be accessible to persons who have not been informed of them during the clinical trials and only with its prior consent;
(i) the rights and obligations of the evaluation body, including:
1. the right of the subject to withdraw from clinical trials at any time and the right to information on the manner and consequences of their interruption;
2. the right to reimbursement of travel expenses (14) and compensation of salary, salary or remuneration from the employment agreement resulting from the participation of the evaluation body in clinical trials; and
3. the right to compensation in the event of damage to the health of the subject of the evaluation as a result of its submission to clinical trials. ';
15. in Paragraph 9 (1), the words "pursuant to paragraphs 15 and 16" shall be deleted;
16. in Article 9 (3), the word "Ministry" is replaced by the word "Constitution";
17. in Article 9 (4), the words "Paragraph 12 (2) (a), with the exception of point 4," shall be replaced by "Paragraph 11 (1) (a), with the exception of point 5."
18. in Paragraph 9 (9), "Ministry" is replaced by "Institute";
19. Sections 10 to 14, including the headings, read:
Conditions for conducting clinical trials
(1) Clinical trials may only be initiated and carried out in subjects for evaluation if:
(a) foreseeable risks and difficulties do not outweigh the expected benefit for the assessor, where appropriate, for the protection of public health14a);
(b) the informed consent of the subject or his legal representative is obtained immediately before the start of the clinical trials;
(c) written agreement has been obtained with the clinical trial plan of the Ethics Commission of the provider for which the clinical trials are to be carried out, or the approval of the Ethics Committee established by the Ministry, unless the Ethics Committee has been established by the provider;
(d) are initiated and carried out under the authority of the examiner;
1. which is a physician with appropriate qualifications and specialisation for that purpose; or
2. which is another, qualified for this purpose, natural person, in an appropriate environment, within the intended purpose of using a medical device and under the conditions laid down by the manufacturer,
(e) where necessary:
1. a biosafety test has been carried out corresponding to the current state of scientific knowledge or any other test required to verify the intended use of the medical device;
2. the safety and safety of the use of the medical device is demonstrated, taking into account its technical condition, occupational safety and health rules and prevention rules against accidents at work; and
3. the ethical principles 14b),
(f) the examiner has been informed of the results of the tests referred to in (e) as well as of the potential risks associated with the conduct of clinical trials;
(g) persons involved in the design, approval, implementation, control, documentation and evaluation of clinical trials;
1. have adequate qualifications to perform their tasks; and
2. they shall not exert disproportionate influence on the subject;
(h) contracts and agreements concluded in the framework of clinical trials have been recorded in writing and signed by their participants;
(i) insurance has been arranged in the event of damage to the health of the subject and third party in the course of clinical trials; the insurance performance must also apply where the fault of a particular person has not been established for the damage suffered; and
(j) The Institute shall not give a negative opinion on the initiation of clinical trials.
(2) Clinical trials for which no preventive or therapeutic benefit is anticipated for the subject must not be carried out on persons:
(a) deprived of legal capacity or whose legal capacity is limited;
(b) whose informed consent cannot be guaranteed due to their health status;
(c) in custody or in the execution of a custodial sentence or placed in other establishments on the basis of a judgment of the court; or
(d) to whom healthcare is provided without their consent.
(3) Clinical trials for persons under the age of 18 shall be carried out under the conditions referred to in paragraph 1 only if:
(a) according to current medical knowledge
1. is the intended purpose of the use of a medical device for diagnosis and protection of health, in particular the prevention of diseases in those bodies of evaluation; or
2. clinical trials in subjects over 18 years of age would not produce satisfactory results; and
(b) the legal representative of the evaluation body has given written informed consent; where the assessment body itself is able to understand to a sufficient extent the nature, relevance and scope of the clinical trials and, depending on its ability to make a free decision and express this decision in writing, it is necessary to obtain its written informed consent.
(4) Clinical trials in pregnant or lactating women shall only be carried out under the conditions referred to in paragraph 1 if, on the basis of current medical knowledge:
(a) the intended purpose of using the medical device to protect health, in particular prevention of disease, diagnosis, treatment or mitigation of disease, in pregnant or breast-feeding women or children not yet born;
(b) the conduct of clinical trials is linked to an unborn or breast-fed child at low risk; and
(c) it is justified to conclude that satisfactory results of clinical trials can only be achieved if such tests are carried out on the subjects of the evaluation of pregnant or lactating women.
(5) In clinical trials the procedures used shall be appropriate to the medical device being tested; if unforeseen or increased risks to the subjects of the evaluation are present, the conduct of clinical trials must be discontinued and, if risks cannot be eliminated, stopped.
(6) The Institute shall be informed in writing of the intention to carry out clinical trials before commencing; in the case of multi-centre clinical trials, the competent authority of the Member State in which the clinical trials are to be carried out. The formalities for notification referred to in the first sentence shall be laid down by the Government by regulation. In the case of medical devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the contracting authority may initiate appropriate clinical trials at the end of a period of 60 calendar days following notification unless the Institute gives it a negative opinion within that period based on the protection of public health, the health of the subject or of public interest; a negative opinion shall be notified in writing to the contracting authority or, where appropriate, to the authorised representative, the provider and the relevant ethics committee. In the case of medical devices other than those referred to in the third sentence, the Institute may issue a positive opinion on the initiation of clinical trials immediately after notification, provided that the Ethics Committee concerned has given its consent to the test programme, including a review of the clinical trial plan; otherwise, the contracting authority may initiate the relevant clinical trials after a period of 60 calendar days from the date of notification, unless the Institute gives it a negative opinion within that period.
(7) The duration of clinical trials and the frequency of observations must correspond to the nature of the medical device being tested, its intended purpose of use, its declared safety, its suitability and its effectiveness, so as to guarantee the validity of professional conclusions.
Documentation of clinical trials
The documentation of clinical trials consists of:
(a) before they start
1. a written contract between the contracting authority and the provider for which the clinical trial is to be conducted;
2. a written agreement between the contracting authority or, where appropriate, the assistant contracting entity and the examiner, defining in particular their liability and confidentiality under Paragraph 49;
3. the investigator's manual,
4. clinical trial plan,
5. written agreement of the Ethics Commission,
6. informed consent,
7. documents containing the identification of the subjects and the medical device to be tested clinically; these documents form part of the clinical trial plan,
8. the list of medicinal products and the manner in which they are to be administered to the subjects; and
9. Means of compensation for damage to the health of the subjects of the evaluation due to their submission to clinical trials;
(b) during clinical trials, records of:
1. the activities carried out under the clinical trial plan,
2. unforeseen events and measures taken in excess of the clinical trial plan; and
3. any serious adverse events if they occur,
(c) the final report on clinical trials after completion, including a description of the methodology and design of clinical trials, an analysis of all concentrated data from the participating centres, including a critical assessment of their clinical evaluation, and an appropriate statistical analysis, data related to the tested medical device from all subjects of the evaluation, and no evaluation body shall be identifiable from that report or published results; the formalities for the final report on clinical trials shall be determined by the Ministry by decree.
Obligations of the contracting authority in connection with clinical trials
(1) The procuring entity of clinical trials is required to ensure:
(a) the examiner who must:
1. have adequate qualifications, experience and knowledge of the use of the appropriate medical device;
2. be entitled to undertake appropriate professional activities; and
3. know the clinical environment in which the clinical trials are to be conducted as well as the conditions and requirements of the clinical trials;
(b) the preparation, storage, safety and completeness of documents, including:
1. clinical trial plan,
2. assessment reports,
3. the consent of the Ethics Commission pursuant to Article 9 (3),
4. information on any adverse events notified to him,
5. final reports on clinical trials; and
6. other documents containing statistical analyses, the results of tests carried out pursuant to Section 10 (1) (e), including data processed by persons involved in clinical trials,
(c) the conclusion of written agreements pursuant to Article 11 (a) (1) and (2);
(d) to inform investigators in writing of any serious adverse events in clinical trials carried out at several workplaces within 10 days of the date on which they were informed.
(2) In carrying out clinical trials, the contracting authority shall also:
(a) agree with the examiner
1. collection and evaluation of statistical data,
2. the number of subjects; and
3. methods and procedures for recording and analysing all adverse events;
(b) instruct the assistant contracting authority to supervise the conduct of clinical trials; the contracting authority does not have this obligation if it itself oversees and is responsible for clinical trials;
(c) ensure for the examiner:
1. the investigator's manual and, where appropriate, other information needed for specific clinical trials;
2. instructions, instructions and instructions, where appropriate, aimed at the intended use of the medical device;
3. technical data on the medical device tested, including the results of the risk analysis;
4. information obtained from preclinical tests relating to the subject of clinical trials; and
5. a statement by the manufacturer or authorised representative that the medical device complies with the essential requirements, in addition to the aspects which form the subject of the test, and that, in view of these considerations, all precautions have been taken to protect the health and safety of the subject of the clinical trial;
the documentation referred to in points 1 to 5 must be in the Czech, Slovak or English language or, where appropriate, in another language designated by the Institute in agreement with the contracting authority,
(d) sign:
1. clinical trial plan,
2. final report on clinical trials,
(e) to pass on to the examiner the medical device intended for clinical trials as specified in the clinical trial plan;
(f) keep records of any adverse events notified to him during clinical trials for at least 5 years and, in the case of implantable devices, at least 15 years from the date of manufacture of the last product;
(g) assess adverse events with the investigator and inform the Institute immediately of any serious adverse events;
(h) to negotiate insurance in the event of damage under Paragraph 10 (1) (i) with an insurance undertaking authorised to do business;
(i) inform the Institute in writing before starting clinical trials of the intention to carry out clinical trials;
(j) inform all major investigators in writing of any serious adverse events involving a medical device which have occurred in multi-centre clinical trials and which have been notified to the contracting authority;
(k) immediately inform the examiner or, where appropriate, the examiner, the Institute and the Ethics Committee, if the clinical trials are terminated or interrupted prematurely, on the grounds of termination or interruption of clinical trials;
(l) examine and approve any deviation from the clinical trial plan.
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Regulation Information
| Citation | Act No. 196 / 2010 Coll., amending Act No. 123 / 2000 Coll., on Medical Devices and on the Amendment of Certain Related Acts, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 16.06.2010 |
|---|---|
| Effective from | 16.06.2010 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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