The EU IVDR: What Do You Need To Know?

In the seventh episode of the NAMSA RAQA Café Podcast, our hosts sit down with Warren Jameson (NAMSA Senior Manager of Regulatory and Quality) and examine the European Union (EU) In Vitro Diagnostic Regulation (IVDR). IVDR 2017/746 was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC).

“In regards to the IVDR, you have three things that you have to formalize—you have scientific validity, clinical performance and analytical performance.” – Warren Jameson

Discussion topics include:

• What is IVDR?
• What is the major change compared to the EU’s In Vitro Diagnostic Directive (IVDD)?
• What is the true impact on small, mid-size and large businesses?
• Has there been a shift in the time it takes for getting IVDs to market in the EU?

Helpful Links:

• EUR-Lex – 02017R0746-20170505 – EN – EUR-Lex (europa.eu) – Regulation (EU) 2017/746
• MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
• MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
• The EU IVDR Clinical Evidence

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Meet the Speakers

Warren R. Jameson, PhD; Senior Manager-Regulatory & Quality, NAMSA

Warren is a highly experienced professional in the field of in vitro diagnostics (IVDs) and companion diagnostics (CDx), with over 14 years of industry experience. He has held various roles in research and industry, including Global IVD Regulatory Operations Manager, R&D Scientist, Project Lead, and Quality/Regulatory Affairs Manager.

Warren specializes in performance evaluation, post-market surveillance, analytical and clinical performance, scientific validation, regulatory assessment, and quality management in compliance with EU’s In Vitro Diagnostic Regulation (IVDR). He also has experience with FDA’s 510(k) and Emergency Use Authorization (EUA) submissions. Prior to joining NAMSA, Warren worked as a Quality Manager at Randox Laboratories, where he gained expertise in regulatory compliance, quality management systems, and policy development. He has extensive knowledge in developing IVD assays and quality controls, as well as creating, evaluating, and training on documentation related to IVD devices.

Linford Leitch; Former Regulatory Consultant, NAMSA

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.

Richard Granquist; Senior Quality System Consultant, NAMSA

Rich Granquist has 17 years of experience in the medical device industry and has spent extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.

Rich started in the medical device industry as a Microbiologist focusing on preclinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. He spent several years as a Quality Engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a Quality Systems Consultant. Over his 16 years in the medical device industry, he has participated in numerous AAMI ISO standards committees and currently sits on the AAMI working groups for AAMI ISO 14971, AAMI ISO/TR24971, AAMI ISO 13485 and AAMI ISO 15223.