Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

9

Notified bodies under IVDR = 10 (As of March 2023)

The Organisation for Professionals in Regulatory Affairs

9

10

Some potential transition issues (IVDD to IVDR)

Impact on legacy devices especially re-classification Conversion to IVDR •How far should technical documentation follow the exact order and structure of Annexes II and III? Conformity with IVDR general safety and performance requirements rather than IVDD essential requirements Number of technical files which might need revision Availability and resources of notified bodies Additional clinical evidence which might be required Impact of common specifications, implementing acts, updated guidance Resources required to maintain technical documentation

The Organisation for Professionals in Regulatory Affairs

10