Full text of Act No. 346 / 2003 Coll.
Full version of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws, as seen from subsequent amendments
Valid
Declared full text
Text versions:
15.10.2003
Contents
ČÁST PRVNÍ
HLAVA I
§ 1
§ 2
§ 3
HLAVA II
§ 4
§ 5
§ 6
§ 7
HLAVA III
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
§ 15
§ 16
HLAVA IV
§ 17
§ 18
§ 19
HLAVA V
§ 20
§ 21
§ 22
§ 23
§ 24
§ 25
§ 26
§ 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
§ 47
HLAVA XI
§ 48
§ 49
§ 50
§ 51
§ 52
ČÁST ČTVRTÁ
§ 58
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346
PRESIDENT OF THE GOVERNMENT
Announces
the full text of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws, as follows from the amendments made by Act No. 130 / 2003 Coll. and Act No. 274 / 2003 Coll.
HEALTH ENVIRONMENT LAW
Parliament has decided on this law of the Czech Republic:
ON HEALTH EQUIPMENT
INTRODUCTORY PROVISIONS
Subject matter
The purpose of this Act is to ensure that health care is provided by appropriate, safe and effective medical means so that, when properly used for the purposes for which it is intended, human health is not harmed.
Definition of terms
(1) A medical device means an instrument, apparatus, device, device, material or other article, or a product used alone or in combination, including the necessary software intended for human use by the manufacturer or importer for the purpose of:
(a) diagnosis, prevention, monitoring, treatment or mitigation of disease;
(b) diagnosis, monitoring, treatment, mitigation or compensation of injury or disability;
(c) investigation, replacement or modification of the anatomical structure or physiological process;
(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 whose function may be supported by such effects.
(2) A product shall be considered as a medical device,
(1) However, if the product is placed on the market in such a way that the medical device and the medicinal product are the only integral product intended exclusively for single use in this combination, it shall be subject to a specific regulatory act. 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 medicine1) and which acts on the body with an effect complementary to that 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 the primary control and protection 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 individually in accordance with a prescription by which a physician issues an individual design of the characteristics of a medical device intended only for use by a natural person;
(e) designated by the manufacturer for clinical trial or clinical trials carried out by a clinical researcher (the examiner) in accordance with § 8 to 14; medical qualifications and specialisations 4) or other qualified natural persons to conduct clinical trials or clinical trials shall be responsible for:
1. to the tested medical device, and
2. Health
2.1. Sick natural persons (hereinafter referred to as "patients"); or
2.2. Natural persons who are included in the benchmark group;
which voluntarily undergo clinical trials (hereinafter referred to as "the entity '),
(f) the activity of which 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 to be fully or partially introduced by the doctor into the human body, while remaining at the place of introduction, even if it is intended to be administered by the medication1) or containing as an integral part a substance which may be considered as a medicinal product when used separately. 1) This device can be produced even
1. to order referred to in point (d);
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 by the manufacturer;
(d) the provider of the person authorised to provide health care, 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 person established in a Member State of the European Communities who is authorised in writing by the manufacturer to act after him, having regard to the requirements resulting from this Act for manufacturers and from specific legislation.3)
BASIC PRINCIPLES
Conditions for use of medical devices
(1) A medical device may be used for the intended purpose of providing healthcare,
(a) for which the conformity of its characteristics has been assessed in a specified manner with the technical requirements laid down in specific legislation3 ("conformity"), taking into account the intended purpose of use, it shall be indicated in the manner specified, 7a) and the manufacturer or importer has issued a written declaration thereof ("the declaration of conformity"); or
(b) which providers use when meeting the conditions set out in Articles 7 and 52 (2) to (6);
(c) in the case of an in vitro diagnostic medical device, when the manufacturer has not used the conformity assessment procedure under the special legislation 7b) for placing that device on the market and putting into service, the manufacture, import and export of that device shall only be reported to the Ministry of Health (hereinafter referred to as "the Ministry"). The report shall be accompanied by instructions in the Czech language and a method of verifying the safety, efficacy and suitability of this device for its use in the provision of health care (who verified and according to which documents). Compliance with the requirements of the previous sentence shall be without prejudice to the obligation to place on the market only safe products. (c)
(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 declaration of conformity and 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 shall not use medical devices for the provision of medical care 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
(d) they do not have a copy of the written assurance that the manufacturer or importer has issued a declaration of conformity in accordance with the specific legislation, 7d) except in the cases referred to in Sections 7 and 52 (2) to (6), the requirements laid down in the special legislature7b) and in cases where such assurance is not issued. 7e)
(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 care to those medical devices which have been properly put into service and are legally maintained and used, and may nevertheless adversely affect the health or safety of users or others.
(6) The Ministry shall inform the Commission of the European Communities of the measure referred to in paragraph 5.
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 or clinical trials, the opinion of the Ministry shall be given. 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, on its labelling shall state 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 business name or registered office, if 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 AND CLINICAL TESTS
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 trials or clinical trials, except:
(a) in vitro medical devices;
(b) a medical device placed on the market in the Member States of the European Communities and bearing the CE conformity mark.
(2) Clinical evaluation of a medical device (hereinafter referred to as "clinical evaluation") means its expert evaluation by the investigator, according to the available technical literature, technical documentation and other documents to verify his safety for use in the provision of medical care and compliance with his intended purpose of use by the manufacturer. If clinical data and experience on a medical device are sufficiently and reliably documented in advance and to the extent necessary, a clinical trial is sufficient. The necessary clinical data are obtained from:
(a) a description of the methodology and results of clinical trials of the medical device, including clinical tests on animals;
(b) published clinical trials, in particular:
1. randomized (where random selection into experimental and control groups takes place according to predetermined criteria, such as age and gender, is comparable in baseline parameters and cannot be conducted retroactively on the basis of results already obtained) controlled studies,
2. different types of evaluable non-randomized studies, such as cohort studies (carried out in groups of individuals selected on the basis of certain common characteristics, the group exposed to the expected risk factor and the group not exposed to the expected risk factor, both groups being monitored and compared over a certain time interval, in particular in the long term; selection can be done retroactively), multicohort (multiple cohort studies), or open controlled cohort studies,
3. case studies,
4. reports from the controlled use of the medical device, upon fulfilment of the reporting obligation under this law;
(c) research or other evaluation of published literary data from available domestic or foreign databases; or
(d) available data from other persons, such as health insurance companies, authorities whose competence is to conduct supervision (vigilance), professional associations.
(3) Clinical examination of a medical device (hereinafter referred to as "clinical examination") means systematic testing of a medical device in accordance with the intended purpose of use under conditions laid down by the manufacturer to be carried out by the examiner in accordance with a pre-established clinical trial plan consisting of its application to natural persons 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 its influence on the body;
(c) specify its adverse side effects and assess whether they pose acceptable risks to the entity.
(4) A clinical trial plan means a document containing detailed information on the reasons, purpose, objectives, methodology, management and monitoring of clinical trials. The plan shall be drawn up in accordance with the latest state of scientific and technical knowledge and shall be drawn up in such a way that the results of the clinical trials clearly demonstrate the level of safety and effectiveness of the medical device. The clinical trial plan shall be binding on all participants in the clinical trials.
(5) The person subjecting the clinical trial or clinical trials (hereinafter referred to as the "contracting entity") to be carried out is responsible for the initiation, proceedings, organisation, control, and, where appropriate, financing of the specific nature of the medical device to be tested. The contracting authority may perform some of its tasks as defined in Section 13 through an assistant, and to this end it shall conclude a contract with one another. The contract shall address its relationship and define the tasks of the assistant, such as the supervision of the assistant on clinical trials, the verification of the availability of the necessary number of subjects throughout the clinical trials, the security of material technical equipment and the submission of reports on the test procedure by the contracting entity.
(6) The examiner shall be entrusted with carrying out clinical trials or clinical trials by the contracting authority or, where appropriate, the provider to which the examiner is employed; in the case of clinical trials, the investigator shall be responsible for these activities and for the health status of the subjects.
(7) The main examiner is the examiner, who is designated by the contracting authority to coordinate activities in clinical trials carried out at several workplaces.
Ethics Committee
(1) The Ethics Commission is set up by a provider competent to carry out clinical trials under Sections 15 and 16 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 care 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 shall notify the Ministry of the establishment of the 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 the documentation referred to in Article 12 (2) (a) together with the notification, with the exception of point 4. 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 Ministry 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.
Informed consent
(1) Informed consent means a voluntary and verifiable expression of the entity's or its legal representative's will to undergo clinical trials under the conditions laid down in paragraph 2; the entity must be informed in advance of these conditions.
(2) The instruction shall be written, comprehensible and in a language which the body understands well; the instruction, which is part of the informed consent, must include:
(a) adequate information on clinical trials, including their target;
(b) information on the potential benefits of clinical trials for the subject;
(c) information on foreseeable risks and potential difficulties associated with clinical trials;
(d) information on other treatment or diagnosis options;
(e) information on the confidentiality of the data obtained relating to the subject, with the prior agreement of the subject, that such data may be accessible to persons who have not been informed during the clinical trials;
(f) the rights and obligations of the body, including:
1. the right of the entity to withdraw from clinical trials at any time and information on the manner and consequences of their interruption;
2. the right to reimbursement of the necessary travel expenses (14) and compensation of the body's proven loss of earnings (profits) as a result of its participation in clinical trials; and
3. the right to compensation in the event of damage to the health of the entity as a result of its submission to clinical trials.
(3) Informed consent must continue throughout the clinical trials; in the event of withdrawal of such consent by the body, clinical trials may not be continued.
(4) In the event that new information relevant to the informed consent is present, the entity shall be informed of these facts without delay. The lessons referred to in this paragraph shall be subject to the provisions of paragraphs 1 to 3.
Conditions for conducting clinical trials
(1) Clinical trials may be initiated and carried out on subjects only if:
(a) foreseeable risks and difficulties do not outweigh the expected benefits for the body, possibly for the protection of public health, 14a)
(b) the informed consent of the entity or its legal representative is obtained immediately prior to 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. other qualified natural persons,
in an appropriate environment, within the intended use of the 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; and
2. the safety and safety of the use of the medical device is demonstrated, taking into account its technical condition, occupational safety and health regulations and rules on prevention of accidents at work; and
3. 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 exercise disproportionate influence on the entity;
(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 contracted in case of damage to the health of the entity and of a 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.
(2) Clinical trials for which no preventive or therapeutic benefit is expected for the subject must not be performed 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;
(d) performing military basic service, replacement service or civil service; or
(e) 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. the intended purpose is to use a medical device for diagnosis and protection of health (in particular, disease prevention) in such bodies; or
2. clinical trials in subjects over the age of 18 would not produce satisfactory results,
(b) the legal representative of the body has given written informed consent; where that body is able to understand, to a sufficient extent, the nature, relevance and scope of 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 against disease), diagnosis, treatment or mitigation of disease, in pregnant or breast-feeding women or in children not yet born;
(b) the conduct of clinical trials is linked to an unborn child at low risk; and
(c) it is justified to conclude that satisfactory results of clinical trials can only be obtained if they are carried out on subjects who are pregnant or breast-feeding women.
(5) In clinical trials the procedures used shall be appropriate to the medical device being tested; if unforeseen or increased risks to operators are present, clinical trials must be discontinued and, if risks cannot be eliminated, stopped. The intention to conduct clinical trials shall be notified in writing before commencing the clinical trials.
(a) the Ministry; or
(b) the competent authority of the Member State of the European Communities in which the clinical trials are to be carried out.
In the case of medical devices provided for by a government regulation, clinical trials may be initiated 60 days after such notification unless it is notified within that period that it does not agree to carry them out for the purpose of protecting the health of the entity or the public interest; a negative opinion shall be notified in writing to the contracting authority or, where appropriate, to the authorised representative, the provider, the relevant Ethics Commission and the Constitution.
(6) 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 in order to guarantee the validity of professional conclusions.
Clinical trial and clinical trial documentation
(1) The documentation of the clinical trial consists in particular of:
(a) a written contract between the contracting authority and the provider for which the clinical evaluation is to be carried out;
(b) a written agreement between the contracting authority (assistant contracting authority) and the examiner (s) defining, for example, the relationships between their liability and confidentiality under Paragraph 49;
(c) a set of relevant information known before the start of the clinical trial;
(d) a set of documents containing the necessary data on the medical device to be evaluated; and
(e) the final report on the clinical trial.
(2) The documentation of clinical trials consists in particular of:
(a) before they start
1. the contracts and agreements referred to in paragraph 1 (a) and (b);
2. the investigator's manual, which means a set of relevant information known before clinical trials, in particular information harmonised with the laws and recommendations of the European Communities, 14c)
3. clinical trial plan,
4. written consent of the Ethics Commission,
5. informed consent,
6. a set of documents containing the necessary data on the bodies and the medical device to be clinically tested; these documents form part of the clinical trial plan,
7. List of medicinal products and how they are to be administered to subjects,
8. Means of compensation for damage to the health of operators as a result of their submission to clinical trials;
(b) during clinical trials, records of:
Contents
ČÁST PRVNÍ
HLAVA I
§ 1
§ 2
§ 3
HLAVA II
§ 4
§ 5
§ 6
§ 7
HLAVA III
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
§ 15
§ 16
HLAVA IV
§ 17
§ 18
§ 19
HLAVA V
§ 20
§ 21
§ 22
§ 23
§ 24
§ 25
§ 26
§ 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
§ 47
HLAVA XI
§ 48
§ 49
§ 50
§ 51
§ 52
ČÁST ČTVRTÁ
§ 58
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Regulation Information
| Citation | Full text of Act No. 346 / 2003 Coll., Act No. 123 / 2000 Coll., on Medical Devices and on the Amendment of Certain Related Acts, as resulting from subsequent amendments |
|---|---|
| Regulation Type | Declared full text |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.10.2003 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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