ARTICLE SUMMARY:
After repeatedly putting off substantive efforts to address problems with MDR and IVDR by simply extending deadlines, a real effort to address these issues appears to be underway following the European Commission’s recent proposal to revise the regulations. We lay out the key provisions of that proposal, their potential impact on industry, and how key players view the possibility that these changes might actually happen.
Practically since the European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) were implemented in 2017, replacing the previous Medical Device Directive (MDD) regimen, there has been dissatisfaction with various elements of the new regulations on the part of industry, notified bodies (NBs), and regulators. Many of the concerns centered around the fact that, although there was a three-year transition period prior to the original effective dates, there was insufficient time for the EU system to adapt to the new procedures.
Concerns ranged from product companies objecting to having to recertify existing medical devices, adding cost and complexity, to notified bodies being unprepared for their own recertification requirements, creating capacity constraints, to a system-wide information technology database (EUDAMED) that was woefully ill-equipped to begin operating. The overall impact was slower market access for new technologies, casting a general pall on European medtech innovation.