The clinical trial types blog series will be interrupted by our “Christmas Special” in December. We would like to inform you comprehensively about the important changes to clinical trials due to the MDR this year so that you are prepared for 2021.
The special thing about our campaign is that the contribution grows until Christmas. New sections are added every week. The topic of DiGA studies will continue in January.
The first part of our December special gives you a guide to the application procedures for various types of applications to the higher federal authority and the ethics committees:
Abbreviations.
BOB (higher federal authority)
EK (Ethics Commission)
KP (clinical examination)
MDR (medical device regulation; Regulation 2017/745)
MPEUAnpG (the Medical Devices EU Adaptation Act was passed as law by the Bundestag on May 25, 2020. This MPAnpG-EU describes the Medical Devices Implementation Act (MPDG) in Article 1)
MPDG (the MPDG will gradually replace the Medical Devices Act (MPG) from May 26, 2021 and will be legally binding for all manufacturers and operators of medical devices in Germany).
Part 1: Application procedure - Approval process for clinical trials as part of the conformity procedure (approval studies) - Article 62 paragraph 1 MDR
1 Introduction
Currently and until the MDR is valid from May 21, 2021, Sections 20 ff MPG currently apply to the approval of clinical trials for clinical trials carried out in Germany. For clinical trials with CE-marked products, the “exception” to clinical trials according to Section 20 MPG can be found in Section 23b MPG. This covers the so-called PMCF studies. The MEDDEV Guideline for Post-Market Clinical Follow-up Studies (MEDDEV 2.12/2 Rev. 2), which is subordinate to the MPG, also applies to this. This means that only an application for professional advice must be submitted to the ethics committee responsible for the test center and the examiner in accordance with Section 15 BO (professional regulations for doctors) and the ethics committee (EK) does not give a vote. However, this only applies if the product is used within the scope of this clinical trial for its intended purpose and/or no additional stressful examinations are carried out. If this is the case, Section 20 MPG applies again.
All of this is now changing with the MDR, as the approval process and the national procedure for the ECs are described and defined in the associated MPDG.
2. Approval process for clinical trials as part of the conformity procedure (approval studies) - Article 62 paragraph 1 MDR
2.1 Application to the ethics committee according to § 33 MPDG via DIMDI (now BfArM)
Submission of documents from Annex XV Chapter II of the MDR
plus
- a German synopsis (short summary of the clinical trial)
- German documents for the exam participants:
- The documents for the test participants (test subjects, patients) must be written in German (§ 38 MPDG).
Application deadlines: (§ 36 MPDG)
The EC checks whether the application is correct and confirms it within 10 days.
In the event of defects, the sponsor has 10 days to correct them. The EC prepares its statement (vote) on the application. In the case of multicenter clinical trials, the statements of the other participating ECs are made within 20 days: " If the clinical trial is to be carried out in more than one testing center, the responsible ethics committee evaluates the application in consultation with the
ethics committees responsible for the ethics committees under state law Investigators or main investigators are responsible (ethics committees involved). The ethics committees involved check the qualifications of the examiners and the suitability of the testing bodies in their area of responsibility.
The opinions of the ethics committees involved must be submitted to the responsible ethics committee within 20 days of receipt of the proper application are defects, the sponsor has 45 days to rectify them.
The EC “ sends its opinion to the sponsor within 30 days of receipt of the proper application .” This period is extended by 15 to 45 days if EK seeks advice from experts.
The EC examines: (§ 34 and § 35 MPDG)
- Is the application correct?
- The test plan and the required documents are discussed and checked, particularly from an ethical and legal perspective.
- In addition, the EC is obliged to give a clear vote (approval or rejection § 37 MPDG).
2.2 Application for approval of a clinical trial from the BOB in accordance with Article 70 MDR via EUDAMED
Documents to be submitted:
- Documents from Annex XV Chapter II, German or English.
- Statement by the EC (Section 37 MDG)
This means that the order in which the application for a clinical trial is submitted is now determined by the MDR: If the application was previously possible in parallel with BOB and EK, according to the MDR, the vote of the EK must first be obtained in accordance with national requirements. This positive vote must then be submitted to the BOB together with the other documents for the clinical trial. From now on, this procedure is subordinate to that of the ethics committee.
Application deadlines:
The BOB checks whether the application is complete and confirms it (within 10 days).
- If the application is incomplete: The sponsor has 10 days to resolve the additional requests from the authority.
- An extension of a maximum of 20 days is possible.
The BOB confirms the completeness within 5 days (can be extended for another 5 days): Date of validation of the application
- Checked by BOB
- additional documents may be requested, the deadline is suspended for this period
A. Procedures for Class I and Non-Invasive Class IIa Devices
If the BOB has not objected within 10 days, the sponsor can begin the KP.
This procedure will now replace the procedure according to Section 7 MPKPV, which currently requires an application to the BOB for exemption from the approval requirement via DIMDI (BfArM) for Class I products and non-invasive Class II products. This is a shortened and simplified procedure for low-classified products.
B. Procedures for Class IIa (invasive), IIb and Class III devices
Once the BOB has informed the sponsor, he can begin the clinical trial.
- The BOB deadline for this is 45 days after the validation date.
- These 45 days will be extended by a further 20 to 65 days if the BOB seeks advice from experts.
The BOB checks:
The test plan and the submitted documents are checked in accordance with Article 71 Paragraphs 1-3 of the MDR.
3. Outlook
Our “ Christmas Special ” has just begun and will focus next week on changes to the approval process for PMCF studies. What happens to Section 23b MPG? We will once again provide you with comprehensive information about the important changes to clinical trials brought about by the MDR this year so that you are prepared for 2021.
The special thing about our campaign is that the contribution grows until Christmas. New sections with further changes are added every week.
DiGA studies will continue in January.
4. How we can help you
At medXteam we clarify whether and if so which clinical trial needs to be carried out under what conditions and according to what requirements during the pre-study phase: In 3 steps we determine the correct and cost-effective strategy in relation to the clinical trial required in your case Data collection.
Do you already have some initial questions?
You can get a free initial consultation here: free initial consultation