Overview

The In Vitro Diagnostic Regulation (IVDR (EU) 2017/746) details the requirements which IVD manufacturers have to meet to place In Vitro Diagnostic devices in the European Union market. Under the IVDR, around 80% of in vitro diagnostic medical devices require a Notified Body conformity assessment for CE marking. For small and medium enterprises (SMEs) with limited or no experience in working with a Notified Body, this interaction can be challenging and could lead to delayed applications and longer review times.   

Key takeaways and learning objectives

This webinar charts the key steps in BSI’s Certification/Review Process for CE marking under the IVDR and provides an overview of the key deliverables. We also share our lessons learnt to facilitate your interaction with Notified Bodies.

Presenter information

Speaker - Charlotte Hess, Business Development Manager

Speaker - Victoria Cox, IVD Sales Manager - EIMEA

Speaker - Reyna Pulliam, Business Development Manager - Americas

Speaker - Nathalie Beaudoin, Business Development Manager – Americas and Canada

Speaker - Todd Moorman, Moorman VP Sales for IVD Solutions - Americas