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.