Clinical trials with medical devices

The innovations in the EU Medical Devices Regulation (EU MDR 2017/745), if strictly implemented, will mean that equivalence via comparator products will no longer be recognized. In that case, separate clinical trials must be conducted prior to marketing. In addition, clinical data must also be collected, documented and evaluated after the device has been placed on the market. For medical devices in risk class III, this tends to become the rule with only a few exceptions. Clinical trials will also be necessary for medical devices newly included in the MDR.

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.

The main changes brought about by the MDR:

• Extension of the scope of application of the MDR (also to products without a medical purpose)
• Establishment of an EU database on medical devices (EUDAMED)
• Higher qualification of products (including medical software)
• Allocation of a UDI (Unique Device Identification)
• Changes in relation to notified bodies
• Designation of a person responsible for regulatory compliance (PRRC).
• Clinical evaluation

In the Medical Devices Regulation (EU) 2017/745 (EU MDR 2017/745), for clinical evaluation (Annex XIV, Article 61), in addition to clinical trials (Annex XIV, Articles 62-82), there are also

• post-market clinical follow-up (PMCF, Annex XIV) and
• Post-market surveillance (PMS, Article 83)

regulated.

The clinical evidence for PMCF and PMS can be obtained via observational studies in compliance with the regulations.

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