"Other clinical trials" for medical devices

On May 26, 2020, in addition to the Medical Device Regulation (EU-MDR 2017/745), the requirements of the Medical Devices Implementation Act  (translated by MEDIACC, Medizinprodukterecht-Durchführungsgesetz [MPDG]) are to apply according to the current status (January 2020), which, however, is only available as a draft at this point in time. The MPDG is to contain national implementation rules and concretizations for Germany and will replace the Medical Devices Act.

In particular, the so-called "other clinical trials" (in the sense of MDR Art. 82 (1), previously "exceptions to clinical trials" (MPG, Art. 23b), will also be regulated in detail in the MPDG.

According to MPDG Art 3 (4), a clinical trial is to be designated as an "other clinical trial" if it is "not part of a systematic and planned process for product development or product surveillance, outside a clinical development plan, or not conducted with the aim of demonstrating the conformity of a device with the requirements of Regulation (EU) 2017/745."

Thus, if a clinical trial of a medical device is not intended to be planned and conducted as part of the clinical development plan - from initial feasibility studies to confirmatory clinical trials to post-market surveillance studies - but is intended to answer scientific or other questions, it is an "other clinical trial" under Article 82 (1) of MDR (EU) 2017/745.