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IVDs

Experience Gain From Implementing Article 5(5) of the IVDR in a Network of European Laboratories

Wednesday, May 8, 2024
14:00 – 15:00 CEST
Location: B 09
Learning Level: Expert

Description: In vitro diagnostic medical devices, including those related to Companion Diagnostics (CDx) and Software/AI, when developed and used in-house, fall under Article 5(5) of the Regulation (EU) 2017/746 (IVDR). They are subject to regulatory requirements and surveillance by National Health Authorities. Different Union Member States may have varying perspectives on the regulation of in-house in vitro medical devices under the IVDR.

This session will focus on the different perspectives of legal and normative requirements in regulatory regions in the EU, including comparisons with the USA, Australia and Canada. At the international level, the forthcoming ISO/DIS 5649 will serve as a pertinent guide for medical laboratories, particularly in meeting the design and performance requirements of Laboratory Developed Tests (LDTs).

Meanwhile, the discussion will encompass various aspects of IVDR implementation according to Article 5(5) and other internal decisions drawn from the experiences gained within a European network of laboratories and work as external legal counsel to IVD companies, lab companies, health institutions and pharmaceutical companies. This includes exploring the scenarios and key challenges faced by health institutions in achieving compliance with IVDR.
Additionally, the session will provide guidance on considerations for contracts and organizational aspects.

Learning Objectives:

  • Describe the LDT requirements according to the EU IVDR and ISO 15189:2022 and identify potential solutions for achieving conformity from a regulatory and medical-scientific point of view
  • Being state of the art on LDT performance through ISO DIS 5649, identifying implementation concepts for the major future standard requirements in conjunction with the EU IVDR and requirements of other advanced regulatory regions
  • Identify key considerations for contracts and organizational aspects for devices companies/pharma companies working with health institutions.