“Other Clinical Trials” for Medical Devices

On 26 May 2021, after the transition period and a postponement of one year due to the pandemic, 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 concretisations for Germany and clearly exceeds the requirements of the EU MDR. This replaces the Medical Devices Act (MPG).

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.