The New European Medical Device Regulation: Balancing Innovation and Patient Safety

The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and extends requirements for rigorous clinical surveillance of benefits and harms to the entire life cycle of devices. New expert panels have been established by the European Commission to advise in the assessment of devices toward certification, and the role of previous notified bodies (private companies charged by the Commission with ensuring that manufacturers follow the requirements for device testing) is being expanded. The MDR does not contain a grandfathering clause; thus, all existing medical devices must be recertified under the stricter regulation. The recertification deadline has recently been extended to 2027 or 2028, depending on the device's risk class. Whether most device manufacturers can meet these new requirements is uncertain, and the MDR will likely have important consequences for manufacturers, researchers, clinicians, and patients. Enhanced collaborations between the medical device industry and physician partners will be needed to meet the new requirements in a timely manner to avoid shortages of existing devices and to mitigate barriers to development of new devices.

Automated summary

The European Union has implemented stricter regulations for medical devices through the Medical Device Regulation (MDR), which includes increased requirements for clinical trials and surveillance throughout the device's life cycle. New expert panels have been established to assess devices for certification, and the role of previous notified bodies has been expanded. All existing medical devices must be recertified under the MDR, with a deadline extension to 2027 or 2028. Meeting these new requirements may be uncertain for most manufacturers and the MDR is expected to have significant consequences for various stakeholders.