03/14/2023
Photo by Artem Podrez
The European Union 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. On March 7, 2023 the European Council adopted a regulation to extend the medical device certification deadline, depending on type of device. High risk device manufacturers now have until the end of 2027 and low to medium risk device manufacturers have until the end of 2028 to comply with certification requirements. The “sell off” date rule is also lifted for devices that are in compliance with predicate EU medical device directives. The “sell off” date is when a device is normally withdrawn from the market if not already in use.
In January, 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. In February, the European Parliament voted to adopt the European Commission’ proposal to extend the MDR transition period and to extend some device certificates.
In the United Kingdom, the EU MDR applies to Northern Ireland. A device with a CE mark can be marketed in Great Britain until June 30, 2023, and there are plans for extending this.
The goal of these changes is to reduce the risk of medical device supply chain issues due to expected delays in medical device manufacturers’ ability to comply with the new requirements before implementation deadlines.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.