Commission Looks Set To Expand MDR Extension So Notified Bodies Can Focus On High-Risk Devices
Executive Summary
It looks, at long last, as if the European Commission may be making an important concession that could ease the pressure on the medical device sector as it implements the new EU Medical Device Regulation. The concession would allow more time to focus on higher-risk devices.
You may also be interested in...
Self-Care Devices May See Extension After EU Commission Admits MDR ‘Inconsistencies’
Self-care medical devices may be included in the four-year “grace period” following implementation of the new EU Medical Device Regulation as part of an incoming corrigendum to the law, a spokesperson for the European Commission suggested at a recent AESGP meeting.
Self-Care Devices May See Extension After EU Commission Admits MDR ‘Inconsistencies’
Self-care medical devices may be included in the four-year “grace period” following implementation of the new EU Medical Devices Regulation as part of an incoming corrigendum to the law, a spokesperson for the European Commission suggested at a recent AESGP meeting.
EU Regulatory Roundup, March 2024: Busy Agenda In Broad Range Of Key Areas
March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.