: Address the high risk of device unavailability due to slow certification processes and a lack of "notified bodies" (independent certification organizations).
: Reduce the immediate administrative and financial pressure on small and medium-sized enterprises (SMEs) active in the medical tech sector. Device Classifications & Risks EP 1023 SUB
The document serves as a proposal to amend and Regulation (EU) 2017/746 (IVDR) . Its primary goal is to prevent shortages of critical medical devices and in vitro diagnostics (IVDs) by extending the transition periods for manufacturers to comply with new, stricter EU standards. Key Objectives : Address the high risk of device unavailability
: Allow safe "legacy" devices—those already on the market under old rules—to remain available while they undergo the new certification process. Its primary goal is to prevent shortages of
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