Pathways' Pick of the Week: What's New with IVDR?

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A status report and new resources for the EU IVD Regulation. Excerpted from Pathways' Picks March 1: AdvaMed Agenda, IVDR Focus, HTA Updates, and More.

Diagnostics firms overwhelmingly say they benefited from transition extensions granted under the IVDR last year and the proportion of the current EU IVD market with IVDR certifications has jumped three-fold over the past year-and-a-half, but serious bottleneck risks remain. This from new IVD industry survey results issued by MedTech Europe February 28. The survey, conducted in September and October 2022 with results from 110 companies representing about 75% of the EU market share, found that more than half of companies with Class D IVDs that remain on the market via legacy CE marks do not yet have an agreement with an IVDR-designated notified body. The results also suggested that about 17% of today’s IVDs will be discontinued and it showed a 28% drop in manufacturers who would prioritize the EU for first product launches compared to a prior survey.

“Attention should be given to further building up the infrastructure of the regulatory system, and making conformity assessment shorter, more efficient and more predictable.” MedTech Europe concluded.

Also over the past week, both MedTech Europe (MTE) and the EU notified body association, TEAM-NB, issued technical guides designed to support compliance with the IVDR:

  • On February 23, MTE published the third edition of its eBook on “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation.” The Q&A-style document is intended to help manufacturers respond to IVDR performance evaluation obligations.
  • On March 1, TEAM-NB issued a “best practice guidance” on submitting technical documentation for the IVDR, representing consensus from its IVD notified body members. “Manufacturers of all classes of IVD medical devices are expected to demonstrate conformity of the IVD medical device to the General Safety and Performance Requirements of the IVD Medical Devices regulation through the preparation and holding of technical documentation that shows how each IVD medical device was developed, designed, and manufactured together with the descriptions and explanations necessary to understand the manufacturer’s determination with respect to such conformity,” the guide notes.

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