Ep 1023 Sub Direct

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

: Address the high risk of device unavailability due to slow certification processes and a lack of "notified bodies" (independent certification organizations). EP 1023 SUB

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

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 While there are for MDR and 19 for