Application to the Ethics Committee
New type of study: Other clinical investigation (Art. 82 MDR and Sec. 3 MPDG)
“Other clinical investigations” of a product are clinical investigations which:
- are not part of a current or future manufacturer’s systematic and planned process for product development or product monitoring,
- are not implemented with the aim of demonstrating the conformity of a product with the requirements of Regulation (EU) 2017/745,
- serve to address scientific or other issues and occur outside a clinical development plan pursuant to Annex XIV Part A Number 1 (a) of Regulation (EU) der 2017/745.
Due to the change in the legal framework in the year 2010, clinical investigations according to MPDG/MDR and also ‘other clinical investigations’ are to be submitted electronically using the Deutsches Medizinprodukte-Informations- und Datenbanksystem (DMIDS) [German Medical Device information and Database System]. The Ethics Committee merely receives a notification via email from DMIDS that a study has been filed.
Documents to be submitted
All documents in accordance with Art. 62 or Art. 74 or Art. 82 MDR + Sec. 24 et seq. MPDG are to be submitted. To facilitate the compilation of the required documentation we provide the following checklists:
- Checklist for Application Documents
(Please fill out this list and submit with the full application to DMIDS.) - Curricular advanced training courses and recommendations of the German Medical Association and the Association of Medical Ethics Committees
- Experience with studies according to MPDG
Please fill out this list completely and submit.