Ep 1023 Sub Now

As of late 2025, the number of designated notified bodies remains insufficient to handle the volume of certificates needed. While there are for MDR and 19 for IVDR , bottlenecks persist, particularly for high-risk devices. Previous extensions (such as those during the COVID-19 pandemic) have provided temporary relief, but this proposal seeks a more structured long-term transition to ensure patient safety without disrupting the internal market. COM_COM(2025)1023_EN.pdf - European Parliament

: Allow safe "legacy" devices—those already on the market under old rules—to remain available while they undergo the new certification process. EP 1023 SUB

This report covers , a legislative proposal from the European Commission discussed by the European Parliament regarding the transition to updated medical device regulations. Executive Summary As of late 2025, the number of designated