"Other clinical investigation" 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 for Germany by the provisions of the Medical Devices Implementation Act (MPDG) and intended for implementation. The MPDG specifies national implementation rules and concretisations 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-market clinical investigations (Art. 74 (1) MDR) within the intended purpose and without invasive or burdensome measures (Section 3 (4) MPDG) are also often referred to as "other clinical investigations".

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 objective 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.

This means that if a clinical investigation 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 is intended to answer scientific or other questions, it is usually referred to as an "other clinical investigation".

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