Date: May 12 2021
Time: 9:00AM – 12:00pm (EST time)
What’s this webinar about?
The In Vitro Diagnostic Regulation (IVDR) date of application is fast approaching. Manufacturers have the transition period's duration to complete their Technical Documentation to meet the requirements and comply with the Regulation before the Date of Application of the IVDR in May 2022.
The timelines for ensuring your product maintains EU market access under the new, more stringent IVDR, are challenging.
BSI Notified Body would like to share some of our experiences and lessons learned around the application process. The IVD Team will provide helpful information for updating your Technical Documentation.
Who should attend the webinar?
This webinar will offer notified body insights for all people involved in working towards an IVDR application, whether you are a novice or have significant experience of working with a notified body.
What will participants gain?
Join this insightful extended webinar to hear from Dr Erica Conway, BSI’s Global Head of IVD Medical Devices, talk about IVDR lessons learned so far, as well as tips on making applications and the Performance Evaluation requirements under the In Vitro Diagnostic Regulation (IVDR). This is a special extended webinar and Dr Conway will also be joined by subject matter experts, Dr Liz Harrison, Dr Heike Möhlig-Zuttermeister and Judith Prevoo.
We’d like to capture as many questions as we can before the day. Please submit questions to: https://bit.ly/3fb2zxz