Klinische Prüfung eines Medizinprodukts

The clinical testing of a medical device is regulated by the Medical Device Law Implementation Act (MPDG) and EU Regulation 2017/745 (MDR). Depending on the approval status and objectives, Art. 62, Art. 74 or Art. 82 MDR apply to the clinical trial of a medical device. 

Applications to the responsible ethics committee are submitted via the German Medical Device Information and Database System (DMIDS). 

Exception:

Research projects with CE-marked medical devices that are carried out within the scope of the respective intended purpose and without additional stressful or invasive measures are advised in accordance with Section 15 of the professional regulations for doctors in Baden-Württemberg (other research projects). 

Telephone consultation is desirable for feasibility studies (proof of concept) or studies with an unapproved medical device that are not intended for approval. 

Information on the regulatory classification of studies with medical devices can be found at this link

Application

Applications for clinical trials of medical devices are submitted via the German Medical Device Information and Database System (DMIDS). The Ethics Committee is informed by DMIDS that an application has been submitted via an automated electronic procedure. For details on the application, deadlines and evaluation process, see § 33 ff and § 48 ff MPDG.

 Deutsches Medizinprodukte-Informations- und Datenbanksystem (DMIDS)

 

The application for a positive assessment by the Ethics Committee must contain the documents and information listed in Annex XV Chapter II MDR. Please also note the checklist for application documents for studies according to MPDG (2021) from the working group of medical ethics committees.

Arbeitskreis Medizinischer Ethik-Kommissionen

To simplify matters, the Working Group of Medical Ethics Committees has created sample texts on patient information, which are linked here.


In vitro diagnostics The legal requirements and practical framework for the marketing, approval and implementation of performance studies with in vitro diagnostic devices are regulated in the “In vitro Diagnostic Medical Devices Regulation” (IVDR, Regulation (EU) 2017/746). For performance studies with in vitro diagnostic devices (IVDR), the following AKEK checklist must be observed:

Checkliste