Module 19 2021

24/05/2021

Some potential transition issues (IVDD to IVDR)

• Impact on legacy devices especially re-classification • Conversion to IVDR and/or STED format • 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 • How soon to engage with notified body • 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

11

Technical documentation Impact of Brexit

The Organisation for Professionals in Regulatory Affairs

12

6