"Other clinical trial" for medical devices

On May 26, 2021, after the transition period and pandemic-related postponement by one year, the Medical Device Regulation (EU-MDR 2017/745) came into force, supplemented by the requirements of the Medizinprodukterecht-Durchführungsgesetz (MPDG) and designated for implementation. The MPDG specifies national implementation rules and concretizations for Germany and significantly exceeds the requirements of the EU MDR. This replaces the Medical Devices Act (MPG).

In particular, the so-called "other clinical investigations" (within the meaning of MDR Art. 82 (1)), formerly "exceptions to clinical investigations" (MPG, Art. 23b), are also regulated in the MPDG. In common parlance, post-marketing clinical trials (Art. 74 (1) MDR) within the scope of the intended purpose and without invasive or burdensome measures (Section 3 (4) MPDG) are also often referred to as "other clinical trials".

According to Section 3 (4) MPDG, the clinical investigation is to be designated as an "other clinical investigation" if it "is not part of a systematic and planned process for product development or product monitoring, outside a clinical development plan, or is not conducted with the aim of demonstrating the conformity of a device with the requirements of Regulation (EU) 2017/745." The requirements for this can be found in Section 47 MPDG.

Therefore, if a clinical trial of a medical device is not planned and conducted as part of the clinical development plan - from initial feasibility studies to confirmatory clinical trials to post-market surveillance studies - but serves to answer scientific or other questions, it is usually referred to as an "other clinical trial".