Stephen Lee, Director of Diagnostic Regulation at the Association of British Health-Tech Industries, presented a session at MedTech Summit on the practical considerations for preparing for the EU IVDR. Offering a Competent Authority perspective, he focused on:
- The 2-year countdown has started – where are we?
- Feedback on available guidance’s for the EU IVDR
The session was followed by a Q&A where Lee answered some of the audience's questions.
Watch the full on-demand session and Q&A by clicking on the video right.