Get a head start on TD assessment under In Vitro Diagnostic Devices Regulation (IVDR)

The technical documentation (TD) is a critical element of the In Vitro Diagnostic Regulation (IVDR) conformity assessment. Compared to the Directive, the TD requirements are more stringent and add complexity to the documentation, which – in our experience – made great demands on manufacturers and Notified Bodies during the last 24 months. Thus, this hands-on session will concentrate on central aspects of TD reviews and provide additional guidance for preparing the technical documentation. Ultimately, this session will help you avoid the common pitfalls when defining and completing the technical documentation and ensure you have an actionable roadmap to IVDR compliance.

Date and time: Thursday, 27 October 2022, 1.00 pm (CEST) / 7.00 am (EDT)

Your speakers: Dr Ines Labugger, Product Specialist for In Vitro Diagnostic Devices

Register for free »