ARTICLE SUMMARY:
MedTech Europe’s new report on the administrative burden of MDR and IVD regulations. Excerpted from Pathways’ Picks March 19: Dr. Oz Hearing, FDA Office Challenges, China Picks, and More.
MedTech Europe issued a detailed report March 18 outlining sources of “administrative burden” under the EU Medical Device and IVD Regulations (MDR/IVDR). The report is intended to contribute to the European Commission’s ongoing “targeted evaluation” of the regulations and potential reforms, under which public comments are due this Friday. The trade association explores potentially unnecessary burdens, such as overly frequent reporting requirements, unneeded duplication, or requiring paper-based information when electronic materials will suffice. It organizes its observations within 10 topic categories including IVD performance evaluation, device clinical evaluation and investigations, notified bodies assessment, and EUDAMED. The 100-plus-page report, says the industry association, “attempts to be as concise as possible, however, MedTech Europe is happy to provide more comprehensive information where needed. “The group also released several other individual papers and reports this week to address specific MDR/IVDR issues, including advocating for the digitalization of technical documentation; urging smooth implementation of the still-unfinished EUDAMED Clinical Investigation and Performance Studies module; and calling on policymakers to eliminate duplicate reviews of device vigilance data by competent authorities and notified bodies.
The EU device trade group joined with five other industry groups in a March 19 paper urging more centralized governance of MDR and IVDR activities to improve efficiency and consistency. Building a stronger government structure, either in the European Commission or European Medicines Agency has been a major focus of discussion in ongoing debates around reforms to the EU medtech regulations.