A Step-by-Step Guide to EU IVDR Certification

Placing in vitro diagnostic medical devices (IVDs) on the European Union market requires compliance with Regulation (EU) 2017/746, the In Vitro Diagnostic Regulation (IVDR). The IVDR establishes the framework for conformity assessment, including the involvement of a Notified Body (NB) for most IVD Devices.

This complimentary webinar provides an informative overview of the IVDR certification process. Presenter Mari Levula will outline the regulatory steps involved in conformity assessment, highlight the core requirements of the IVDR and discuss important considerations for manufacturers navigating the certification pathway.

Products within the scope of the IVDR range from COVID-19 and pregnancy tests to blood glucose meters and diagnostic software. This session is designed to help attendees develop a clearer understanding of how IVDR certification works and the expectations set out in the regulation.

Agenda

• Introduction to the IDVR
• IVDR certification process phases
• Key considerations for the certification process
• Q&A

Who should attend?

This webinar is designed for all IVD device manufacturers preparing for upcoming IVDR certification or seeking IVDR certification for new devices.

Register now

This webinar takes place on March 26, 2026, at 10:00 AM (Central European Time).