Clinical Studies with Medical Devices

The innovations in the EU Medical Device Regulation (EU MDR 2017/745) could, if implemented strictly, result in the fact that equivalence of comparable products will no longer be recognised. In this case, own clinical investigations must be carried out before placing the product on the market. In addition, clinical data must also be collected, documented and evaluated after the products have been placed on the market. For medical devices in risk class III, this becomes the rule with only a few exceptions. Clinical investigations will also be necessary for new medical devices included in the MDR.

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.

The main changes brought about by MDR:

• Extension of the scope of application of the MDR (also to products without medical intended purpose)
• Establishment of an EU database on medical devices (EUDAMED)
• Higher qualification of products (e.g. medical software)
• Assignment of a UDI (Unique Device Identification)
• Amendments concerning notified bodies
• Designation of a person responsible for regulatory compliance (PRRC)
• Clinical Evaluation

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