The EU IVDR: What Do You Need To Know?

Operating room with monitor

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RAQA Café

A podcast series that tackles trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry.


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?

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

Richard M. Granquist

Richard M. Granquist

In 2014, Rich joined NAMSA as a Quality Systems Consultant and has now been with the company for eight years. Over his 16 years in the industry, he has participated in numerous AAMI ISO standards committees and currently sits on the committees for ISO 14971, ISO 13485 and ISO 15223. Rich’s medical device industry experience also includes 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 aseptic technique and terminal sterilization at Cook Medical. During his 8-year career at Cook, he expanded his responsibilities to include coordination of preclinical testing, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices.

Linford Leitch

Linford Leitch

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.

Warren R. Jameson, PhD

Warren R. Jameson, PhD

Over 15 years experience in IVD research, development, manufacturing, regulatory affairs and quality management. Served in Research and Development as well as Quality and Regulations Manager ensuring compliance with legislation, managing quality documentation, risk assessment, risk management and audits. Expert in reviewing technical files and guiding IVD sponsors for IVDR compliance. Creating technical documentation such as Performance Evaluation Plans (PEP) and Reports (PER) for IVD devices to be used as part of technical file submissions for IVDR compliance and to carry out performance evaluation. Significant experience in gap analysis reviews of analytical performance and clinical performance data and determination of the data is to the latest guidelines for performance, acceptable to IVDR standards and advise on solutions. Clinical performance creation including review of clinical performance protocol, studies and literature to determine the needs of devices and any gaps for IVDR compliance or US submissions. Scientific Validity report creation with search and review of scientific literature for analyte link to pathological or physiological conditions as stated in the IVDR for legacy and novel devices.