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).
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