Act No. 123 / 2000 Coll.
Law on medical devices and on the amendment of certain related laws
Valid
Law
Effective from 01.07.2000
Contents
ČÁST PRVNÍ
HLAVA I
§ 1
§ 2
§ 3
HLAVA II
§ 4
§ 5
§ 6
§ 7
HLAVA III
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
HLAVA IV
§ 17
§ 18
§ 19
HLAVA V
§ 20
§ 21
§ 22
§ 23
§ 24
§ 25
§ 27
§ 28
§ 29
§ 30
HLAVA VI
§ 31
§ 32
§ 33
§ 34
§ 35
HLAVA VII
§ 36
HLAVA VIII
§ 37
§ 38
§ 39
§ 40
§ 41
HLAVA IX
§ 42
§ 43
§ 44
§ 45
HLAVA X
§ 46
§ 46a
§ 47
HLAVA XI
§ 49
§ 50
§ 51
§ 52
ČÁST TŘETÍ
§ 54
ČÁST ČTVRTÁ
§ 58
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123
THE LAW
of 15 April 2000
on medical devices and amending certain related laws
Parliament has decided on this law of the Czech Republic:
ON HEALTH EQUIPMENT
INTRODUCTORY PROVISIONS
Subject matter
(1) The purpose of this Act is to ensure the provision of health services by appropriate, safe and efficient medical means so that, when properly used for the purposes for which they are intended, human health is not harmed.
(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.
Definition of terms
(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;
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.
(2) A product shall be considered as a medical device,
(a) intended for administration; (1a) where, however, the product is placed on the market in such a way that the medical device and the medicinal product constitute a single integral product intended exclusively for single use in this combination, it shall be subject to specific legislation. 2) Specific legislation applies to the safety and efficacy requirements of such a medical device, 3)
(b) which contains, as an integral part, a substance which, when used alone, can be considered as a drug (1a) and which has an effect on the body that completes the effect of the medical device;
(c) which is the reagent, the result of a reaction, calibrator, control material, set, instrument, apparatus, apparatus or system used alone or in combination intended by the manufacturer for the use of in vitro samples, including donated blood and tissues derived from the human body, in order to obtain information on physiological or pathological status, or on a congenital anomaly, or for the determination of safety and compatibility with potential recipients or for the monitoring of therapeutic measures (in vitro). A vacuum vessel or other type specifically designated by the manufacturer for primary storage and storage of samples derived from the human body for in vitro diagnostic testing shall be considered as an in vitro medical device. General laboratory use products are not in vitro medical devices unless they are specifically intended for in vitro use by the manufacturer in terms of their characteristics,
(d) manufactured in accordance with the Regulation of Healthcare Officer 3a), by which a qualified healthcare professional issues an individual design of the characteristics of a medical device intended to be used only for 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),
(g) containing, as an integral part of, a substance which, when used separately, may be considered as an ingredient in a medicinal product or as a preparation of a medicinal product (2) derived from human blood or human plasma under a special regulatory provision (2) and which may have an additional effect on the human body to the effect of the product. In that case the product shall be assessed and approved as a medical device.
(3) A product other than a medical device referred to in paragraph 1 shall also be considered as a medical device, but shall be designated by the manufacturer specifically for use together with the medical device in order to allow its use in accordance with the purpose specified by the manufacturer ("accessories').
For the purposes of this Act:
(a) the person proposing, producing, packaging and designating the medical device is responsible for and responsible for such activities before they are placed on the market under his name and surname, firm or name, whether or not those activities are carried out by himself or on his behalf by a third party who is responsible in writing for the manufacturer's conduct, taking into account the requirements resulting from this Act and the specific legislation, 3)
(b) by the distributor, the person referred to in the specific legislation governing the technical requirements for products, 5)
(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;
(d) the provider of the person authorised to provide health services under the Health Services Act, 7)
(e) the user of the patient, the provider and, where appropriate, other persons using the medical device for the intended purpose of use;
(f) placing on the market the moment when a medical device which is not intended for clinical trials or for clinical trials as referred to in Article 2 (2) (e) passes for the first time on a fee or charge free of charge from the stage of manufacture or import into the stage of distribution as goods intended for sale, whether new or fully renewed;
(g) adverse event
1. any failure or deterioration of the characteristics and, where appropriate, the effectiveness of the medical device, or inaccuracy in the identification of the medical device or, where appropriate, in the instructions for its use, which may or may lead to the death of the user or other natural person or to a serious deterioration of their health,
2. a technical or medical reason relating to the characteristics or effectiveness of a medical device and leading, for the reasons set out in point 1, to the systematic withdrawal of a medical device of the same type from the market;
(h) the side effects of an adverse accompanying event that are noted during or after the use of the medical device in accordance with its intended purpose of use;
(i) by having an adverse effect on each other or on medical devices and other objects or medical devices and medicinal products, when used in accordance with the intended purpose of use;
(j) demonstration of the medical device at trade fairs, exhibitions or advertising (hereinafter referred to as "demonstration");
(k) by the importer, the person mentioned in the specific legislation governing the technical requirements for products, 5)
(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 specifically entrusted by the manufacturer to act for him and may be contacted on his behalf by the authorities with regard to his obligations under this law,
(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 human blood derivative product from human blood or human plasma under the drug law,
(r) dispensing of medical devices means providing them on medical prescription.
BASIC PRINCIPLES
Conditions for use of medical devices
(1) Use for the intended purpose in the provision of health services
(a) a medical device for which the conformity of its characteristics has been assessed in a specified manner with the technical requirements laid down in specific legislation3 (hereinafter referred to as "conformity"), taking into account the intended purpose of use, and which is marked by a specified modulation7a) and for which the manufacturer or authorised representative has issued a written declaration of conformity (hereinafter referred to as "the certificate of conformity"); or
(b) a medical device used by providers in compliance with the conditions laid down in Articles 7 or 52 (2) to (6).
(2) The medical device shall, throughout its use, comply with the medical and technical requirements laid down by the manufacturer. The intended purpose of use of the medical device shall be indicated in the instructions for use; where technically possible, it shall also appear on the label of this medical device and in advertising material.
(3) Medical devices for which a certificate of conformity has not been issued may only be demonstrated if this results from their visible marking. The necessary measures for the protection of persons shall be provided for the demonstration of those medical devices.
(4) Providers may not use medical devices for the provision of health services if:
(a) there are reasonable grounds for suspecting that the safety and health of users or third parties are at risk because of the knowledge of medical science, even if the medical device is properly installed or implanted in the human body, maintained and used in accordance with the intended purpose of use;
(b) their period of application has expired established by manufacturers or importers,
(c) have shortcomings in terms of their production which may jeopardise the health of users or third parties; or
(5) The Ministry may, on its own initiative or at the initiative of the State Institute for Drug Control (hereinafter referred to as "the Institute"), the State Office for Nuclear Safety, the Czech Metrology Institute, the Czech Trade Inspection, Authorised Persons and Accredited Persons, prohibit or restrict the use in the provision of health services to those medical devices that have been properly put into service and are legally maintained and used, yet they may adversely affect the health or safety of users or others.
(6) The Ministry shall decide 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.
(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.
Risk protection
(1) If the Ministry receives information on the case referred to in Section 4 (4), it shall immediately inform the Office of Technical Standardisation, Metrology and State Testing (hereinafter referred to as "the Office"), the Czech Trade Inspection and Providers of the imminent danger; warnings to the general public shall be admissible in the event of a danger of delay and, where no other equally effective action could be taken.
(2) The Ministry shall inform the Czech Trade Inspection Department in writing of the occurrence of an adverse event as soon as the information referred to in Section 32 (4) has been received.
(1) The obligations of the manufacturer shall also apply to the person who compiles, packs, processes, modifies, where appropriate identifies the medical device and determines the purpose of its use with the intention of placing it on the market under his or her name, company or name; the obligations of the manufacturer shall not apply to a person who merely compiles or modifies for the intended purpose medical devices already on the market for an individual patient.
(2) In the event of confusion concerning clinical trials, the Institute shall give its opinion. In the event of a dispute between the manufacturer or importer and the authorised person regarding the application of the classification rules under the special legislature9a), the Authority shall issue an opinion after prior observations by the Ministry.
(3) The instructions for the use of the medical device and, where appropriate and possible, the name, surname, place of permanent residence or place of business of the manufacturer or importer responsible for the first placing on the market of the medical device, in the case of a natural person, or a commercial firm or name and registered office where the manufacturer or importer responsible for the first placing on the market of the medical device is a legal person.
(4) Specific legislation provides for the reimbursement of medical devices and their amount by means of public health insurance. 11)
Authorisation of exemptions
(1) The Ministry may exceptionally authorise, at the request of the provider, the use of a medical device which does not comply with the requirements laid down in specific legislation.3) If it is a medical device that uses nuclear energy or ionising radiation, the Ministry may authorise an exemption on the basis of a positive opinion of the State Office for Nuclear Safety.
(2) The requirements of the application are laid down by the Ministry by decree.
(3) There is no legal claim for authorisation of the exemption.
(4) The applicant shall be informed of the authorisation or refusal of the derogation.
(5) The exemption is published in the Bulletin of the Ministry of Health of the Czech Republic. The scope of the published data shall be determined by the Ministry by a decree.
CLINICAL ASSESSMENT
General provisions
(1) The medical device shall be suitable for use in the provision of health services; 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 services, 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.
Ethics Committee
(1) The Ethics Committee is established by a provider competent for clinical trials or by the Ministry. It consists of health workers (4) and other members, with at least five members. The Chairman and other members of the Ethics Commission shall be appointed and withdrawn by the statutory body of the provider; The Minister for Health shall appoint and dismiss the President and other members of the Ethics Committee established by the Ministry. The Ethics Committee may only be members of fair individuals without personal interest or participation in clinical trials. A person who has not been convicted of an intentional offence committed in connection with clinical trials or clinical trials or in connection with the provision of health services shall be deemed to be a fair natural person; integrity is demonstrated by a statement from the Penal Register.
(2) The meetings of the Ethics Commission shall be oral and non-public; the decision of the Ethics Commission shall not be taken by the contracting authority or, as the case may be, the assistant contracting authority or investigator. The vote of the Ethics Committee is public, each member has one vote. A decision of the Ethics Commission shall require an absolute majority of all its members; in the event of a tie, the chairman's vote shall be taken.
(3) The Provider announces to the Institute the establishment of an Ethics Commission within 30 days of its establishment. The Ethics Committee gives its written consent to carry out clinical trials of the medical device and oversees their progress in terms of safety and respect for the rights of subjects. To this end, it shall, in particular, assess the competence of investigators, including the principal examiner, the suitability of the facilities used, the procedures chosen and the groups of bodies, independently of the contracting authority, the examiner and the administrative or other offices.
(4) The contracting authority shall notify the relevant Ethics Committee in writing in advance of its intention to conduct clinical trials; submit, together with the notification, the documentation referred to in Article 11 (1) (a), with the exception of point 5. The Ethics Committee shall give its consent to the contracting authority or notify the opposition to the conduct of clinical trials within 60 days of receipt of the notification. Until that time, the time from the request of missing documents by the Ethics Commission to their delivery by the contracting authority shall not be taken into account.
(5) Where the conditions of clinical trials approved by the Ethics Committee need to be amended, the examiner or contracting entity shall request written consent to the relevant Ethics Commission to amend the conditions of clinical trials and submit a proposal to the Ethics Committee for changes to the documentation.
(6) The Ethics Committee shall withdraw its consent in writing to carry out clinical trials if:
(a) there are new facts which adversely affect the safety of the operators where such facts cannot be removed immediately; or
(b) the contracting authority or the examiner, including the principal examiner, has seriously infringed his obligations.
(7) Details of the setting-up, composition of the Ethics Commission, the way in which the personal data of the entities are secured and the model rules of procedure of the Ethics Commission may be laid down by the Ministry by decree; while ensuring that the independent status of the Ethics Commission is not undermined.
(8) The Ethics Committee shall keep significant records of its activities, in particular written working procedures, a list of members, indicating their qualifications, submitted requests for consent to initiate clinical trials, documentation, minutes of conduct, reports and correspondence concerning clinical trials, for at least 10 years after the end of the clinical trials with the provider. The maintenance of documentation in the event of the disappearance of the Ethics Committee shall be provided by the provider; where the documentation has been transmitted to the Ethics Commission established by the Ministry, its deposit shall be ensured by the Ministry.
(9) If the Ethics Committee of the Provider is terminated, it shall immediately inform the Statutory Representatives of the Provider of the Institute and arrange for the transmission of the documentation of the Ethics Committee set up by the Ministry, which shall then exercise the competence of the Disappeared Ethics Committee.
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.
Contents
ČÁST PRVNÍ
HLAVA I
§ 1
§ 2
§ 3
HLAVA II
§ 4
§ 5
§ 6
§ 7
HLAVA III
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
HLAVA IV
§ 17
§ 18
§ 19
HLAVA V
§ 20
§ 21
§ 22
§ 23
§ 24
§ 25
§ 27
§ 28
§ 29
§ 30
HLAVA VI
§ 31
§ 32
§ 33
§ 34
§ 35
HLAVA VII
§ 36
HLAVA VIII
§ 37
§ 38
§ 39
§ 40
§ 41
HLAVA IX
§ 42
§ 43
§ 44
§ 45
HLAVA X
§ 46
§ 46a
§ 47
HLAVA XI
§ 49
§ 50
§ 51
§ 52
ČÁST TŘETÍ
§ 54
ČÁST ČTVRTÁ
§ 58
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Regulation Information
| Citation | Act No. 123 / 2000 Coll., on medical devices and on the amendment of certain related laws |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 12.05.2000 |
|---|---|
| Effective from | 01.07.2000 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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