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IVDs

Maintaining Compliance: IVDR Post-Certification Activities

Wednesday, May 8, 2024
11:45 – 12:45 CEST
Location: B 09
Learning Level: Advanced

Description: Since the IVDR entered into force, focus has been on transitioning to the regulation from the directive and on achieving initial compliance with IVDR. Now that two years have passed since the IVDR date of application, and more time has passed since the first IVDR certificate was issued, some certificates will soon be approaching recertification and for some, focus is starting to shift to maintaining compliance with the IVDR.

The focus of this session will be on post-certification activities under IVDR and will consider notified body and manufacturer perspectives. 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 and PMPF. As the majority of 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. Therefore, in this session the presenters will provide a brief overview of IVDR post-certification activities before providing an in depth look at what to expect from IVDR technical documentation surveillance reviews as well as explaining the requirements for PMPF, how manufacturer’s might establish PMPF that adds value and what notified body expectations of PMPF might be.

Learning Objectives:

  • Be able to describe IVDR post-certification activities.
  • Understand the requirements of MDCG 2019-13 and how notified bodies are implementing them to deliver IVDR technical documentation surveillance reviews
  • Be able to conduct Post-Market Performance Follow-Up activities in accordance with the EU IVD Regulation requirements