How are "other clinical investigations" defined in the EU Regulation 2017/745 (Medical device regulation, MDR) and what requirements apply to them?

The EU Regulation 2017/745 (MDR) defines "other clinical investigations" as studies that do not serve the purpose of conformity assessment, but must still adhere to important ethical and scientific standards, whilst the precise implementation is left to the individual EU member states

Other clinical investigations are those not conducted for the purpose of conformity assessment. They often serve to answer scientific questions or for basic research.

Even though these clinical investigations do not serve conformity assessment, they must comply with certain parts of Article 62, particularly regarding:

-     Protection of the rights, safety and dignity of participants

-      Scientific and ethical review

-      Informed consent

-      Protection of vulnerable groups

-      Qualification of investigation personnel

-      Involvement of authorities, where applicable

The European MDR leaves it to the member states to establish additional requirements for this type of investigation. In Germany, this is regulated in the Medical Devices Law Implementation Act (MPDG) (see also §3 (4) and §47 MPDG).

This ensures that high ethical and scientific standards are maintained even in research projects that do not directly serve product approval.

Benefit from our many years of experience in the conception and implementation of clinical studies and contact us for an initial consultation.

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