Ep 1023 Sub 〈90% TRUSTED〉

: 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 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