ARTICLE SUMMARY:
Next Picks in the EU, and the regular new roundup. Topics this week include: Notified body progress, Eudamed, and more on EU MDR/IVDR; Medicare Coverage of Innovative Technology on tap; the latest CPT code additions; COVID-19 home test study considerations; FDA funds from COVID relief; Brazil guide on submission quality; China draft on emergency approvals; and more.
What’s next and what’s new in the EU, MCIT on tap, CPT code update, FDA insights, global check-ins, and dates to remember in this latest Pathways’ Picks. (Updated with “MCIT on Tap” brief March 11.)
Next Picks
Three things we’re watching for, EU edition:
- Notified body number 20. The slowly rising count of EU notified bodies designated under the Medical Device Regulation should reach the big 2-0 very soon, following last week’s closed-door Medical Device Coordination Group meeting, where MDCG recommended a new, yet-unnamed MDR notified body—the final step before official designation.
- Custom device guide. Also at MDCG’s March 4 gathering, the policymaking body endorsed a guidance document addressing custom-made devices under the oncoming MDR, which means the document could be published imminently. According to a prior description of the pending document by MDCG, it will be a Q&A format guidance addressing the “status of custom-made devices, adaptable devices and so-called intermediate products” and a common understanding of definition changes in the MDR.
- Standards, round 2. Later this month, the European Commission expects to file its revised request for the EU standards organizations (CED/CENELEC) to harmonize existing medtech technical standards with the MDR and IVDR. The move comes after the standards groups unexpectedly rejected the Commission’s first request last June, slowing down companies’ ability to leverage a “presumption of conformity” to certain regulation requirements based on compliance with relevant standards.
