Decree of the Ministry of Health No. 316 / 2000 Coll.
Decree of the Ministry of Health laying down the formalities for the final report on the clinical evaluation of the medical device
Valid
Order
Effective from 14.09.2000
Text versions:
14.09.2000
316
DECLARATION
Ministry of Health
of 29 August 2000
laying down the formalities for the final report on the clinical evaluation of the medical device
According to Section 12 (c) of Act No. 123 / 2000 Coll., on Medical Devices and on the Amendment of Certain Related Acts, hereinafter referred to as "the Act":
(1) Upon completion of a clinical trial (including a clinical trial) of a medical device (hereinafter referred to as "clinical trial"), the contracting entity shall draw up a final clinical trial report indicating:
(a) particulars of the registration nature
1. name, provider's identification number, (1) for which the clinical trial has been conducted;
2. name of clinical trial,
3. the name of the clinical trial medical device,
4. the brief characteristics of the clinical trial, indicating the outcome;
5. the name, surname and permanent residence of the natural person or the name (trade name) and the registered office of the legal person who provides for the conduct of the clinical trial (hereinafter referred to as "the contracting authority"),
6. the name, surname and permanent residence of the clinical researcher (the investigator),
7. the name, surname and address of the assistant contracting entity, if agreed by the contracting entity;
8. Individual sections of the clinical trial,
9. Date of initiation of clinical trial,
10. the date of early termination of the clinical trial, if any,
11. Date of end of clinical trial,
12. date of preparation of the final clinical trial report;
(b) the content, indicating the numbers of the pages, including the Appendices and Tables;
(c) a list of abbreviations and definitions of terms used;
(d) the qualifications and experience of the examiner;
(e) the list of other persons involved in the clinical trial;
(f) details of the verification of the suitability of the medical device for the intended purpose of use
1. objectives and rationale,
2. citation of related legislation and recommendations of state bodies, authorised persons or other persons in relation to the clinical trial concerned;
3. Clinical trial plan
3.1. Description of the clinical trial plan,
3.2. Selection of the control group,
3.3. Population for clinical trial,
3.3.1. criteria for the inclusion of patients or healthy persons performing the function of a comparator group and voluntarily undergoing clinical trials (hereinafter referred to as "subjects"),
3.3.2. Criteria for excluding the subject from the clinical trial,
3.3.3. the registration of the subjects of the evaluation (name, surname, birth number),
3.3.4. the detailed characteristics of the assessment body;
4. medical care for subjects of evaluation
4.1. Identification of the medical device used,
4.2. prior and existing therapy of the subject,
4.3. Treatment regimen during clinical trial,
5. variables characterising the effectiveness and safety of the medical device
5.1. Determination of efficacy and safety levels,
5.2. Primary values evaluated,
5.3. Description of the measurement methods and analysis of the suitability of their use,
6. ensuring the reliability of clinical trial data,
7. statistical methods used;
8. Data on the assessment of the effectiveness of the medical device declared by the manufacturer with regard to the intended purpose of use, in particular:
8.1. Analysed data sets on the medical device,
8.2. Assessment of the application methods of the medical device,
8.3. Results of the effectiveness and suitability of the medical device for the intended purpose of use; and
8.4. the interaction and its possible occurrence,
9. safety assessment of the medical device from the point of view of the assessment subjects
9.1. Results of monitoring vital functions, physical findings and other observations associated with the safety of the assessed medical device;
9.2. Laboratory evaluation and chemical analyses, where appropriate,
9.2.1. laboratory examination of individual subjects,
9.2.2. evaluation of laboratory values,
9.3. Adverse Events,
9.3.1. description and analysis,
9.3.2. a list of the assessment bodies concerned by the adverse event,
9.3.3. speeches and complications leading to the death of the subject;
(g) discussion, general summary and conclusion.
(2) The annexes to the final clinical trial report are:
(a) the written consent of the relevant Ethics Commission to carry out the clinical trial;
(b) the opinion of the Ethics Committee concerned on the consistency of the clinical trial carried out with ethical principles;
(c) informed consent, including instructions2) information on how the informed consent was obtained;
(d) tables and graphs from clinical trial data not included in the text;
(e) a list of the professional literature used;
(f) Appendices, in particular:
1. a copy of the contracts concluded between the contracting entity, the assistant contracting entity and the investigator and the provider for which the clinical trial was carried out;
2. a randomisation scheme and codes enabling the identification of the subjects of the evaluation and the appropriate application of the medical device;
3. Publications based on a clinical trial.
(3) The data referred to in paragraph 1 shall be provided in the case of a clinical trial including a clinical trial and to an extent consistent with the clinical trial carried out. Where the necessary clinical data have been obtained from a summary of available relevant literature corresponding to the level of scientific and technical knowledge at the time at which the clinical trial was conducted, the final clinical trial report shall apply mutatis mutandis to the particulars referred to in Section 1.
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Prof. MUDr. Fisher, CSc.
1) § 3 (d) of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws.
2) § 10 of Act No. 123 / 2000 Coll.
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Regulation Information
| Citation | Decree of the Ministry of Health No. 316 / 2000 Coll., laying down the formalities for the final report on the clinical evaluation of the medical device |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 14.09.2000 |
|---|---|
| Effective from | 14.09.2000 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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