ARTICLE SUMMARY:
In this week’s roundup: Somewhere from one-quarter to three-quarters of in vitro diagnostics could conceivably drop off the EU market in May, industry survey results warn, plus more IVDR, MDR, and UK news. Also, industry reps are meeting with White House officials to discuss the next steps for the Medicare Coverage of Innovative Technology program, AdvaMed emphasizes COVID-19 testing priorities, and China issued a draft guidance on additive manufacturing.
Top Pick: EU IVD Shortfall
Industry survey points to big post-IVDR gaps
About 39% of in vitro diagnostics (IVDs) currently on the EU market won’t be available next May when the IVD Regulation takes full effect in a “best-case” scenario, MedTech Europe predicts based on survey results posted September 8. The industry group conducted a survey throughout July of companies representing about 90% of IVD market revenue coverage for the EU. Two key results from respondents: 22% of IVDs are being proactively discontinued in response to the IVDR and for another 17% of IVDs, manufacturers say they don’t expect to receive certification by the May 26 cut-off date. Meanwhile, there are 14,584 IVDs, or 37%, where the company either didn’t report information about IVDR certification status or reported it was uncertain about whether they would make the IVDR cut-off. That means in the worst-case scenario, up to 76% of IVDs will have to drop from the market at least temporarily, MedTech Europe suggests.
The primary bottleneck is notified body capacity. There are currently six notified bodies designated under the IVDR, compared to the 18 that are designated under the legacy IVD Directive, even though the ratio of tests requiring notified body oversight compared to those that don’t is flipping from 8:92 (IVDD) to 78:22 (IVDR), according to the survey. There are also some key bits of infrastructure such as mandatory reference laboratories and expected guidance documents that are still missing. Device companies and notified bodies have been pressing the European Commission to take some action, such as extending the existing IVDR grace period to at least a subset of tests that are being upclassified to notified body status for the first time. (See “On to the IVDR: A Paradigm Shift in Diagnostics Regulation is Coming, Ready or Not,” Market Pathways, January 21, 2021.)
“We hope these survey results will impress on the Competent Authorities and the European Commission that much time and effort is still needed to ensure that EU IVD medical tests do not fall off a cliff-edge,” MedTech Europe writes. “In particular, a viable infrastructure and necessary time to complete certification for all categories of IVDs should be provided.”
