ARTICLE SUMMARY:
In this week’s roundup: Dozens of medtech reforms made it into the US Congress’ year-end spending omnibus bill, but not everything; the first companion diagnostic gains a CE mark under the EU IVDR; the EU issues guides and recommendations on MDR safety reports, surveillance, and a shoulder implant; Medicare delays PET dementia imaging coverage decision; and more.
Top Picks
Mega-bill on Capitol Hill and safety reports guide in Europe:
Medtech mélange in Omnibus. Device cybersecurity, predetermined change plans, and remote FDA inspections are in; a diagnostics overhaul and stricter device shortage reporting requirements are out. Congress is racing ahead this week to approve a $1.7 trillion US federal spending package with many medtech provisions in the mix. Read our takeaways from the bill here:US Omnibus Bill: 10 Takeaways for Medtech.
First IVDR companion Dx. A Roche Diagnostics cancer biomarker assay is the first companion diagnostic to gain an EU IVD Regulation certificate, notified body TÜV SÜD announced December 21. Companion diagnostics didn’t require a notified body conformity assessment before the IVDR took effect earlier this year, but with the new regulation they must undergo the assessment that also includes consultation by the European Medicines Agency (EMA) or an EU country’s national drug authority, requiring more overall time for review compared to standalone diagnostics. EMA only released procedural documents for pursuing a companion diagnostic consultation earlier this year. The IVDR certificate for the Roche PDL1 assay “marks a major milestone, demonstrating that two different EU legislations are working effectively together and that this additional IVDR consultation procedure has been successfully implemented by TÜV SÜD,” said Andreas Stange, VP of IVD Global at the notified body.
