Regulation on clinical trials of medical devices (MPKPV)

Unofficial table of contents

MPKPV

Date of completion: 10.05.2010

Full quote:

" Regulation on clinical trials of medical devices of 10 May 2010 (BGBl. 555), as defined by Article 3 of the Regulation of 25 July 2014 (BGBl). 1227).

Status:

Amended by Art. 3 V v. 25.7.2014 I 1227

For more details, please refer to the menu under Notes

Footnote

(+ + + Text certificate: 13.5.2010 + + +) 

  

The V was adopted as Article 1 of V v. 10.5.2010 I 555 by the Federal Ministry of Health in agreement with the Federal Ministry of Economics and Technology with the approval of the Federal Council. She's gem. Art. 5 of this V entered into force on 13 May 2010. Unofficial table of contents

§ 1 Scope

(1) The Regulation shall apply to clinical trials and performance assessment tests subject to approval in accordance with § § 20 to 24 of the Medical Devices Act, the results of which shall be used:

1.

the implementation of a conformity assessment procedure in accordance with the Medical Devices Regulation,

2.

the implementation of a conformity assessment procedure with a medical device which may bear the CE marking, in order to obtain a new purpose which exceeds the intended purpose of the CE marking, or

3.

the extraction and evaluation of the experience of the manufacturer in relation to the clinical safety and performance of a medical device which may carry the CE marking, provided that additional invasive or other incriminating tests are carried out .

(2) This Regulation shall not apply to benefit assessment tests in accordance with § 24 sentence 1 (1) of the Medical Devices Act, in which a non-surgical-invasive sampling from the oral cavity takes place. Unofficial table of contents

§ 2 Labelling

(1) Medical devices intended for clinical trials must, with the exception of medical devices referred to in Article 1 (1) (3), bear the notice "only for clinical trials", products intended for performance evaluation purposes, the reference " only for (2) The labelling must ensure the protection of the test subjects, users or third parties and the traceability, enable the identification of the individual medical device and ensure proper application of the product. Ensure medical products. The relevant provisions for the provision of information by the manufacturer in Annex 1 to 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 Equipment (OJ L 196, 17), which was last amended by Article 1 of Directive 2007 /47/EC (OJ L 189, 20.7.2007, p. 21), Annex I to Council Directive 93 /42/EEC of 14 June 1993 on medical devices (OJ L 378, 27.12.1993, p. 1), as last amended by Article 2 of Directive 2007 /47/EC (OJ L 378, 27.12.2007, p. 21), and Annex I to Directive 98 /79/EC of the European Parliament and of the Council of 27 June 2007, of the European Parliament and of the Council of 27 June 2007, October 1998 on in vitro diagnostic medical devices (OJ L 327, 28.12.1998, p. 1), which was last amended by Regulation (EC) No 596/2009 (OJ L 327, 22.12.2009, p. 14), it is appropriate to apply accordingly. Unofficial table of contents

§ 3 Application

(1) The application pursuant to § 22 (1) sentence 1 and § 22a (1) sentence 1 of the Medical Devices Act must be submitted via the central collection system of the German Institute for Medical Documentation and Information. The application must contain the information listed in the relevant annex to the legal regulation in accordance with Section 37 (8) of the Medical Devices Act. The German Institute for Medical Documentation and Information informs the sponsor, the competent federal authority and the competent authority in accordance with § 22 (1) of the Medical Devices Act via an automated electronic procedure. Ethics Commission (responsible Ethics Commission) that the application has been submitted. In the case of multi-center clinical trials or performance assessment tests conducted in the scope of the Medical Devices Act in more than one test site, the German Institute for Medical Documentation and (2) The request referred to in paragraph 1 shall be submitted by the examiner or the principal investigator or by the head of the ethics committee. (2) the clinical trial or the head of the performance assessment test as well as the Sponsor or its representative signed audit plan or performance assessment tests of the evaluation plan as well as the manual of the clinical auditor. Unless already contained in the annexes referred to in the first sentence, the following shall be attached to the application referred to in paragraph 1 in German or, unless otherwise specified, in English language annexes:

1.

a summary of the essential contents of the audit plan or in the case of performance evaluations of the evaluation plan in the German language if the plan is presented in English in accordance with the first sentence,

2.

the description of the prescribed medical procedure and examination methods as well as any deviations from medical standards,

3.

the pre-clinical assessment, including the underlying scientific evidence,

4.

Information on the safe use of the medical device in German,

5.

an assessment and consideration of the foreseeable risks, disadvantages and burdens in relation to the probable significance of the medical device for the medicine and against the expected benefit for the test persons,

6.

an assurance that the medical device in question complies with the basic requirements laid down in § 7 of the Medical Devices Act, with the exception of the items which are the subject of the tests, and that all precautions relating to these points shall be taken into account: for the protection of the health and safety of the test persons, the users and third parties,

7.

a plan for the follow-up and medical care of the subjects,

8.

Reasoned negative assessments of the relevant ethics committees of other Member States of the European Union or of other States Parties to the Agreement on the European Economic Area, as well as offences by the competent authorities of the European Union Authorities of other Member States of the European Union or of other States Parties to the Agreement on the European Economic Area,

9.

a proxy for the representative appointed by the sponsor in accordance with Section 20 (1) sentence 4 (1a) of the Medical Devices Act.

(3) Insofar as not already contained in the annexes referred to in the first sentence of paragraph 2, the application to the Ethics Committee shall be accompanied by the following:

1.

Information on the suitability of the test site, in relation to the examination requested, in particular on the existing personnel, spatial, equipment and emergency medical equipment as well as, where appropriate, for the spatial connection to a hospital with emergency care, further information on the ongoing and planned clinical studies already carried out at the test site, indicating the scope of the application,

2.

the proof of qualification of the examiners in accordance with § 9,

3.

the information on the necessary qualification of other persons applying the medical devices to be tested in the context of clinical trials,

4.

the information and the intended declaration of consent, as well as information received by the persons pursuant to Section 20 (4) (4) and § 21 (3) of the Medical Devices Act, in the German language and, where necessary, in the language the subjects and their legal representatives, as well as a description of the procedure for obtaining consent,

5.

a justification for the inclusion of persons in accordance with § 20 (4) and (5) and § 21 (2) of the Medical Devices Act (Medical Devices Act) in the clinical examination or performance assessment test,

6.

proof of insurance in accordance with § 20 (1) sentence 4 (9) of the Medical Devices Act, as well as information on the financial and other compensation of the test persons,

7.

a statement of inclusion, possibly by the sponsor or auditor of dependent persons, in the clinical trial or performance assessment test,

8.

a declaration and a description of the procedures to ensure compliance with data protection;

9.

all the essential elements of the contracts provided for by the sponsor and the auditor, including information on remuneration and financing,

10.

Criteria for the interruption or early termination of the clinical trial or performance assessment test.

(4) Insofar as not already contained in the annexes referred to in the first sentence of paragraph 2, the application to the competent authority shall be accompanied by the following:

1.

the results of a biological safety test or other tests required for the intended purpose of the medical device in accordance with § 20 (1) sentence 4 (5) of the Medical Devices Act,

2.

the proof of safety safety in accordance with § 20 (1) sentence 4, point 6 of the Medical Devices Act,

3.

the descriptions and explanations necessary for the understanding of the functioning of the medicinal product;

4.

the risk analysis and assessment, including the description of the known residual risks,

5.

a list of compliance with the basic requirements of the relevant directives in accordance with § 7 of the Medical Devices Act, including the specification of the standards and common technical specifications applied in whole or in part, and a list of Description of the solutions for compliance with the basic requirements, provided that these standards have not been complied with or are missing,

6.

in the case of products to be re-used and in the case of products which are to be sterilized prior to use, information on appropriate preparation or sterilisation procedures,

7.

the description of the procedures for the documentation, evaluation and reporting of serious adverse events to the competent federal authority.

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§ 4 Supplementary information of the approval authorities

The competent federal authorities publish on their Internet pages further information, in particular on the applications, advertisements and procedures in accordance with § 20 paragraph 1 as well as on § § 22a to 24 of the Medical Devices Act and to § § 1, 3, 6, 7 and 8 of this Regulation. Unofficial table of contents

§ 5 Assessment procedure

(1) The competent Ethics Committee shall confirm to the sponsor and to the Ethics Committees involved within ten days the receipt of the correct application, indicating the date of receipt. If the application documents are missing or the application is not correct for other reasons, the relevant Ethics Committee shall invite the sponsor to correct the form defects it has designated. The notice indicates that the period of time specified in § 22 (4) sentence 1 of the Medical Devices Act only begins after the proper application has been received. (2) The relevant Ethics Committee shall carry out the evaluation procedure. Multi-centre clinical trials or performance assessment tests carried out in the scope of the Medical Devices Act by more than one investigatory agency, assesses the relevant Ethics Committee in consultation with the parties concerned. Ethics commissions. The ethics committees involved shall examine the qualification of the examiners and the suitability of the verifiers in their area of competence. The opinions shall be submitted to the relevant Ethics Committee within 30 days of the date of receipt of the correct application. Additional comments from a participating Ethics Committee must be documented by the relevant Ethics Committee and can be included in the final evaluation of the Ethics Committee. (3) During the examination of the application for approval, the following documents must be included. The relevant Ethics Committee may request a one-time additional information from the sponsor. The expiry of the period in accordance with § 22 (4) sentence 1 of the Medical Devices Act is inhibited from the request to the receipt of the additional information. (4) The responsible Ethics Committee shall verify whether the ethical and legal requirements are met a clinical trial or a performance assessment test is observed and whether the quality of the test is in accordance with the state of scientific knowledge. It shall ensure that the protection of the test persons is guaranteed. In particular, it shall examine

1.

the relevance of the clinical examination or the performance assessment test and whether its planning is appropriate to answer the question,

2.

whether the benefits to be expected outweigh the likely risks and whether these risks are acceptable to the test persons,

3.

the representability of the risks of the additional examination and treatment methods resulting from the clinical trial or the performance assessment test,

4.

the qualification of the examiners and the qualification requirements for the staff and staff who apply the products to be tested,

5.

the evidence of proficiency of the auditor in connection with existing standards and principles on clinical trials or performance assessment tests,

6.

in the case of clinical trials, the test plan or, in the case of performance assessment tests, the evaluation plan,

7.

the manual of the clinical examiner for completeness and comprehensibility,

8.

the suitability of the test facilities;

9.

the suitability of the procedure for the selection of subjects,

10.

whether the information on the proband, in particular on the conduct of the clinical trial or assessment of the performance assessment, the expected benefits, the existing and possible risks of the medical device to be tested, the associated risk assessment, the foreseeable burdens, the alternatives available, the rights of the test persons and the procedures for the assertion of those rights in a general manner and are complete,

11.

whether the inclusion of pregnant, breast-feeding, underage or non-eligible persons is justified;

12.

how consent is obtained from persons who are not able to agree to themselves,

13.

whether the necessary aftercare of the test persons is guaranteed,

14.

how damage suffered by the subjects during the clinical trial or the performance assessment test is being replaced and whether a person is killed or the body or the health of a person in the course of the conduct of the clinical trial is subject to a people are injured or impaired, insurance is provided which also provides benefits if no other is liable for the damage,

15.

how reviewers and subjects are to be compensated,

16.

the criteria for interrupting and discontinuation of the clinical trial or performance assessment test provided by the sponsor.

(5) The Ethics Committee responsible shall inform the sponsor of its evaluation in writing and shall transmit it simultaneously to the competent authority of the Federal Republic of Germany by means of data transmission via the central collection system of the German Institute for Medical documentation and information. Unofficial table of contents

§ 6 Approval Procedure

(1) The competent federal authority shall confirm to the sponsor within ten days the receipt of the proper application, indicating the date of receipt. In the confirmation of receipt, the time limit laid down in § 22a (4) sentence 1 of the Medical Devices Act, the conditions for the start of the deadline and the legal sequence attached to the deadline is to be mentioned. If documents on the application are missing without justification for this or if the application is not correct for other reasons, the competent federal authority shall ask the sponsor to correct the form defects which it has designated. The notice indicates that the time limit set in § 22a (4) sentence 1 of the Medical Devices Act begins only after receipt of the correct application. (2) During the examination of the application for approval, the competent authority may: Bundesoberbehörde one-time additional information from the sponsor request. The expiry of the period in accordance with § 22a (4) sentence 1 of the Medical Devices Act is inhibited from the request to the receipt of the additional information. (3) Submitted to the sponsor in writing for reasons provided by the competent federal authority Objections are also referred to the time limit laid down in Article 22a (4) sentence 2 of the Medical Devices Act, to the legal sequence linked to the deadline and to the remedies available. The sponsor may amend the application within the time limit set out in sentence 1 in order to take into account the objections raised. In this case, the competent federal authority shall decide within 15 days of receipt of the amendments. It informs the sponsor of its decision in writing and transmits it simultaneously to the relevant Ethics Commission by means of data transmission via the central collection system of the German Institute for Medical Documentation and the German Institute for Medical Documentation. Information. (4) The competent federal authority shall verify that the medical devices to be tested are sufficiently secure and that the clinical trial is designed in such a way that any residual risks can be justified. In the course of clinical trials of medical devices, it shall examine in particular

1.

the proof of safety-related safety of the medical devices to be tested,

2.

the scientific and appropriateness of the biological safety tests carried out or any other necessary tests;

3.

whether the solutions used by the manufacturer for risk minimisation are described in harmonised standards where the manufacturer does not use harmonised standards, the equivalence of the level of protection compared with harmonised standards,

4.

The plausibility of the planned measures for safe installation, commissioning and maintenance,

5.

the adequacy and scientific nature of the statistical models underlying the clinical trial;

6.

whether the design of the clinical trial is capable of achieving the objectives intended by the sponsor with the examination, and

7.

for products which are used in a sterile manner, the evidence for validation of the sterilization procedures on the manufacturer's side or information on the preparation and sterilization procedures which must be carried out by the test site.

(5) In the case of performance assessment tests of in vitro diagnostic medical devices, the competent federal authority shall examine in particular:

1.

the safety of the sampling systems,

2.

where applicable on a case-by-case basis, compliance with the common technical specifications, with the exception of the aspects to be examined

3.

the aspects referred to in the second sentence of paragraph 4, points 3 and 6, and

4.

the appropriate preclinical validation of analytical and diagnostic accuracy and predictive and prognostic benefit.

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§ 7 Procedure for clinical trials and performance assessment tests of medical devices with low safety risk

(1) For the following medical devices, the sponsor may release from the competent federal authority an exemption from the permit requirement in accordance with § 20 paragraph 1 sentence 2 of the Medical Devices Act on the central collection system at the German Institute for Apply for medical documentation and information:

1.

Class I medical devices,

2.

non-invasive medical devices of class IIa,

3.

Medical devices which, in accordance with § § 6 and 10 of the Medical Devices Act, may bear the CE marking and whose clinical trial includes additional invasive or other incriminating examinations, unless this test has another Purpose of the medical device to the content,

4.

In-vitro diagnostic medical devices intended for a performance assessment test in accordance with § 24 sentence 1 (1) and (2) of the Medical Devices Act.

(2) By way of derogation from § 3 (2) and (4), the following annexes shall be attached to the application for the examination by the competent federal authority:

1.

a summary risk assessment,

2.

proof that one of the criteria referred to in paragraph 1 has been met, and

3.

in the case of medical devices which are used in a sterile manner, the evidence of the validation of the sterilisation processes on the manufacturer's side, or information on the preparation or sterilisation procedures, which must be carried out by the testing body, because it is a clinical trial as referred to in paragraph 1 (3).

(3) The competent federal authority shall immediately confirm to the sponsor the receipt of the application stating the date of receipt of the application. The second sentence of Article 6 (1) and the second sentence shall apply accordingly. The exemption from the permit requirement pursuant to Section 20 (1) sentence 2 of the Medical Devices Act shall be deemed to have been granted if the competent federal authority does not object to the application within ten days of receipt. The application may only be contradicted if the submitted documents are incomplete in accordance with paragraph 2 or do not meet the requirements set out in paragraph 2. (4) Without prejudice to paragraphs 1 to 3, the sponsor shall have the following sentence in accordance with § 20 (1) of the To apply for a medical-product-law in accordance with § 3 (1) to (3), required additional evaluation. Unofficial table of contents

§ 8 Amendments

(1) Changes in accordance with § 22c (1) of the Medical Devices Act are to be reported by the sponsor via the central collection system at the German Institute for Medical Documentation and Information. Changes to the documents submitted in accordance with § 3 are to be indicated, the amended documents shall be attached to the change display. If the competent authority of the Federal Republic of Germany determines that a displayed change meets the requirements of a substantial change, it shall immediately inform the sponsor and inform the competent authorities of the central collection system. at the German Institute for Medical Documentation and Information. In the case of applications pursuant to § 22c (2) of the Medical Devices Act, the first sentence shall apply accordingly. The German Institute for Medical Documentation and Information, via an automated electronic procedure, informs the sponsor that the application or the change display has been submitted. (2) Changes in clinical trials or changes in clinical trials. The central collection system at the German Institute for Medical Documentation and Information (Deutsches Institut für Medizinische Documentation, German Institute for Medical Documentation and Information) shows the performance assessment tests for which exemption from the permit requirement has been granted in accordance with § 7 (1). Changes to the documents submitted in accordance with § 3 or § 7 (2) shall be indicated, and the amended documents shall be attached to the change display. Section 22c (2) (2) and (3) to (5) of the Medical Devices Act shall apply mutatily to the relevant amendments. Sentences 1 and 2 shall apply in accordance with the provisions of sentence 3. (3) For the evaluation of significant changes in multicentre clinical trials and performance assessment tests, § 5 (2) sentence 2 and 3 shall apply accordingly, provided that: The competent Ethics Committee considers that this is necessary in view of the impact of the essential change requested on the qualification of the examiners and the suitability of the testing facilities. The Ethics Committee responsible shall inform the Ethics Committees involved and the sponsor immediately upon receipt of the application. (4) Amendments to the applications and the application documents during the proceedings pursuant to § § 5 to 7 shall be with the exception of amendments pursuant to Article 6 (3), second sentence, not permitted. Unofficial table of contents

§ 9 Requirements for reviewers

(1) Reviewers and principal examiners shall be suitably qualified physicians or physicians, qualified dentists or dentists in the case of medical devices intended for dentistry. Persons without a medical or dental qualification may act as examiners or principal examiners, provided that they are entitled to pursue an occupation which qualifies for a clinical examination or performance assessment examination. Proof of qualification must be provided by means of a current curriculum vitae or by other meaningful documents. (2) The persons referred to in paragraph 1 must:

1.

have experience in the field of application of the product to be tested and have been trained and trained in the use thereof,

2.

with the basic principles of the medical device law, the legal and scientific foundations of clinical trials or performance assessment tests, as well as with the test plan or the evaluation plan and the manual of the clinical examiner to be included in the obligations arising therefrom.

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§ 10 Implementation of the clinical trial and performance assessment examination

(1) The sponsor and the auditor shall ensure that the clinical trial or performance assessment test, in accordance with a state of the art and technology, evaluated by the relevant Ethics Committee, and, (2) The sponsor and the auditor shall have a view to the planning, implementation and evaluation of an approved test or evaluation plan. clinical trial or performance assessment to ensure that the (3) The sponsor shall ensure, by means of appropriate measures, that the data are collected and processed correctly, and that conclusions are drawn correctly. the compliance with the clinical testing or evaluation plan is regularly and systematically reviewed by all parties involved in the assessment. He may appoint a person, body or organisational unit independent of the clinical trial or performance assessment to carry out the appropriate verifications and assessments. Records shall be made on assessments and reviews. (4) Test bodies, facilities, including laboratories, and any type of data relating to the clinical trial or the performance assessment test shall be submitted to the representatives of the in accordance with paragraph 3. (5) During the entire course of the clinical trial or performance assessment examination, sample-related data shall be treated strictly confidentially by all persons involved. All sample-related data must be protected against unauthorized access. To this end, as well as for a careful and confidential handling of all data arising in the course of a clinical trial or performance assessment, the sponsor and auditor will take all necessary measures. (6) The sponsor must take care of emergency situations. establish a procedure which enables immediate identification and, if necessary, an immediate withdrawal of the products used in the test. (7) The sponsor shall ensure that the test sheets for the competent authorities shall be Authorities shall be kept ten years after the end of the examination . Other regulations for the storage of medical records shall remain unaffected. Unofficial table of contents

§ 11 Monitoring

(1) The competent authority shall monitor to an appropriate extent, with particular regard to possible risks to sponsors, auditors, verifiers, manufacturers or producers and other interested parties, whether the clinical trial or Performance assessment shall be carried out in accordance with the test or evaluation plan as well as the medical product-related rules. (2) In the event of deficiencies identified, the competent authority shall take all necessary measures to protect the Health and safety of subjects, users and third parties against hazards in the The general administrative provision according to § 37a of the German Medical Devices Act (Medical Devices Act) regulates the connection with the clinical examination or performance assessment test.