Ep 1023 Sub [2026]

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

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 EP 1023 SUB

: Reduce the immediate administrative and financial pressure on small and medium-sized enterprises (SMEs) active in the medical tech sector. Device Classifications & Risks The regulations categorize devices based on their risk

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 Its primary goal is to prevent shortages of

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

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.