Ep 1023 Sub Apr 2026

: Reduce the immediate administrative and financial pressure on small and medium-sized enterprises (SMEs) active in the medical tech sector. Device Classifications & Risks

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 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. : Reduce the immediate administrative and financial pressure

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 Previous extensions (such as those during the COVID-19

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

The regulations categorize devices based on their risk level to determine the urgency and depth of the certification required: Device Type Class/Category Risk Level Pacemakers, implants Class IIb / IIa Moderate Risk Infusion pumps, hearing aids Bandages, wheelchairs In Vitro Diagnostics (IVDR) High Individual & Public Risk HIV or Hepatitis tests High Individual/Moderate Public Cancer screening tests Class B / A Moderate to Low Risk Pregnancy tests, lab reagents Current Status and Challenges