Updates on the IVDR

RAQA Café

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

In this episode of the RAQA Café Podcast, our host engages with Warren Jameson (NAMSA’s Sr. Manager, Regulatory & Quality) and Christele Perrin-East (NAMSA’s Sr. Regulatory Consultant, IVD), to explore the extension of the EU IVDR deadline and its implications for the industry.

Our experts highlight the importance of maintaining progress towards IVDR compliance and registration despite the delay. The discussion also reflects on lessons learned from the EU MDR and examines how the IVDR extension might impact both new product registrations and updates to existing products previously regulated by the EU IVDD.

“I think manufacturers have to be very careful when they look at the dates. It’s not actually that far, because if you work backwards, like 2025 is actually. If you can’t 12 or 18 months period to get a technical file reviewed, you have to send your technical file like almost right now.” -Christelle Perrin-East, Sr. Regulatory Consultant

Key Discussion Topics:

The IVDR Extension
Lessons from the MDR
Negative Impact of the IVDR Extension • Impact on Existing Products Covered by the IVDD

Links:

Blog – Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

Blog – MDCG 2022-11Rev 1: Urgency for MDR and IVDR Compliance

RAQA Café Podcast – The EU IVDR: What Do You Need to Know?

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

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.

Christèle East, PhD

Christèle currently serves as a Senior Regulatory Consultant (IVD) at NAMSA. She has been in the MedTech industry for over 20 years with 10 years focused on IVD products. She gained experience on IVD product development in small biotechnology companies, including AmikanaBioLogics and HalioDx. Before joining NAMSA, Christèle worked for nexialist, a consulting company specializing in regulatory intelligence and compliance of health products. As a Medical Device and IVD consultant, she was involved in ensuring compliance with classification, technical documentation for CE marking, performance evaluation within the framework of IVDD and IVDR, regulatory support; and biological risk assessment (plan & report), clinical evaluation and PMS for Medical devices. Christèle obtained her PhD in Cellular Biology from University of Joseph Fourier, Grenoble (France). After several years working on the development of IVD products, she completed a University Diploma in Clinical Research at the Faculty of Medicine of Marseille.

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.

Updates on the IVDR

Published:

RAQA Café

Richard M. Granquist

Christèle East, PhD

Warren R. Jameson, PhD

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