ARTICLE SUMMARY:
In this week’s roundup: Next EU Medical Device Regulation enhancement priorities identified in the wake of new, virtually finalized, MDR transition extensions; FDA takes several key steps on post-pandemic transition pathway; the Biden administration issues FY 2024 budget request, including increases for FDA; digital therapeutics legislation; pharmacogenomics guidance; and dates to remember.
EU MDR Picks
Extensions finalized, what’s next?
EU policymakers were set to provide final sign-off March 15 on legal measures to extend Medical Device Regulation transition times and remove supply-chain “sell-off” deadlines. EU country health ministers praised the reforms during a March 14 hearing held by the Council of the EU in Brussels. During the hearing, Stella Kyriakides, Europe’s Health Commissioner, pledged further actions to improve the MDR and the EU IVD Regulation, which are detailed in an accompanying information note prepared by the European Commission. Next steps include:
- Speeding up notified body designations: In addition to the broad MDR extensions, the Commission separately finalized regulations March 8 to lengthen the time interval between required reassessments of notified bodies that have been designated under the MDR and IVDR. The step is intended to reduce burdens on national designating authorities. And the Commission is in parallel pressing the authorities to issue preliminary assessment reports for new notified bodies seeking designations “without undue delay.”
