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