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
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 EP 1023 SUB
: Allow safe "legacy" devices—those already on the market under old rules—to remain available while they undergo the new certification process. This report covers , a legislative proposal from
: Reduce the immediate administrative and financial pressure on small and medium-sized enterprises (SMEs) active in the medical tech sector. Device Classifications & Risks This report covers