Overview

Since the IVDR entered into force, focus has been on transitioning to the Regulation from the In Vitro Diagnostic Directive (IVDD) and on achieving initial compliance with the IVDR. Two years have passed since the the IVDR date of application and the first IVDR certificate was issued. Several certificates are now approaching re-certification. For many manufacturers the focus is shifting from achieving compliance with the IVDR to maintaining it.

The focus of this webinar will be on post-certification activities under the IVDR. For the Notified Body, post-certification activities focus on ongoing QMS assessment and technical documentation surveillance reviews. For manufacturers, once their certificates have been issued, they will need to address the requirements of PMS (Post-Market Surveillance) and PMPF (Post-Market Performance Follow-Up). As the majority of In Vitro Diagnostic devices (IVDs) under the IVDD were self-certified, manufacturers may not have significant experience of surveillance reviews and PMPF is a concept that is new to the regulations. 

Key takeaways and learning objectives

What participants will gain?

• Ability to describe IVDR post-certification activities.
• A better understanding of the requirements of MDCG 2019-13 and how Notified Bodies are implementing them to deliver IVDR technical documentation surveillance reviews.
• Ability to conduct Post-Market Performance Follow-Up activities in accordance with the EU IVDR requirements.

Presenter information

Speaker - James Kerr, IVD Technical Specialist & Scheme Manager

Speaker - Elizabeth Harrison, Global Head - IVD Medical Devices