Many medical device manufacturers will be strongly impacted by new requirements for more clinical evidence once the European Medical Devices Regulation (MDR) comes fully into effect in May 2021. In order to obtain and renew their CE Mark certifications, companies will need to collect this evidence via clinical investigations or post-market clinical follow-up (PMCF) activities.
The proper conduct of medical device clinical activities will be regulated by the MDR, by national laws and regulations and finally by Good Clinical Practice (GCP) standards such as ISO 14155.
Generally, any clinical activity will require Ethics Committee or Institutional Review Board review, and a positive assessment of a submitted research proposal from one of these entities is needed. Also depending on a device’s risk class, market approval status and study design, European Competent Authorities might need to be notified or even approve the research proposal before the clinical study may start.
Whereas requirements provided by the MDR are easily identified, it is more difficult to understand country-specific regulations and legislations, which are often not available in English.