The EU IVDR: What do you need to know?

The RA QA Café

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_en.pdf (europa.eu) - MDCG 2022-2 Guidance on general principles of clinical evidence for in vitro Diagnostic medical devices (IVDs)

• MDCG 2021-4 en.pdf (europa.eu) – MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

• https://www2.namsa.com/RAQA_Cafe_IVDR_Clinical_Evidence