Pathways’ Pick of the Week: IVDR Revision This Month?

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European device stakeholders want to ward off the worst possible impacts of the IVD Regulation taking effect before it is ready. Excerpted from Pathways’ Picks September 29.

European device stakeholders are looking for potential action next month to ward off the worst possible market and product-shortage impacts of the IVD Regulation taking effect in May before it is ready. Industry and notified body groups have been warning of major impending product shortages if there is not a pressure-valve release before May, citing a severe lack of notified bodies to address the massive influx of tests that will need NB oversight as a central challenge. Stakeholders have proposed an outright postponement from the May 26, 2022, IVDR date of application, or, alternatively, reforms that would apply the IVDR grace period to a broader sweep of tests, allowing them to rely on legacy EU directive certificates past the IVDR application date. EU Health Ministers have taken on the call to the European Commission to act well in advance of next May.

“I’ve heard something about October,” said Thomas Møller, device manager at the Danish Medicines Agency and chair of the EU-wide Competent Authorities for Medical Devices, regarding when action may be expected. The Danish Health Minister does not support an outright delay to IVDR implementation, but he is willing to expand the grace period, Møller noted during a September 28 panel at The MedTech Conference. “The new IVDR is coming into place because it is a very underregulated area,” Møller said, expressing support of implementing the regulation on schedule.

Excerpted from Pathways’ Picks September 29: US Shutdown Looms, User Fee Gap Widens,” Market Pathways, September 29, 2021.


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