01/17/2023
Photo by Christian Wiediger on Unsplash
The European Union, excluding Great Britian, regulates medical devices under the Medical Device Regulation (MDR) (Regulation EU 2017/745) which entered into force May 2017 and into application May 26, 2021 with a three year transition period. The MDR application date was originally planned for May 2020 but was delayed for one year due to the pandemic. The MDR has more extensive requirements than the Medical Device Directive (MDD) (Directive 93/42/EEC) it replaced. This includes the implementation of the medical device database EUDAMED and the requirement for notified bodies to consult with an expert panel before a final decision for the certification is taken on certain high risk devices.
Medical devices in the EU do not follow a premarket authorization. Instead, medium to high risk devices have a conformity assessment procedure with a notified body. Notified bodies are independent, third party conformity assessment groups that are frequently privately held and for-profit. Currently, there are too few notified bodies to keep up with their increased usage under the MDR. This is partly due to more stringent standards per the MDR increasing the length of the designation process and partly due to the pandemic.
On January 6, 2023, the European Commission proposed an extension of the MDR transition period for ‘legacy devices’, medical devices that were already covered in the original transition period, with proposed extensions as follows:
High risk devices until December 31, 2027, and
Low to medium risk devices until December 31, 2028.
Custom class III medical devices, such as a device manufactured for a specific patient, were not part of the original transition, but the Commission proposed an extension until May 26, 2026 for the manufacturers to get approval from notified bodies for their Quality Management Systems.
The transition allows more time to close the gap on the number of approved notified bodies and allows manufacturers more time to adjust to the new requirements. The Commission stated that the lengthened transition time does not compromise patient safety, but instead allows medical devices to continue be marketed efficiently in the interim. The MDR remains in application during the proposed transition time.
- The Clinical Pathways Team
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