ARTICLE SUMMARY:
The usual end-of-year regulatory calm was replaced by a flurry of European activity aimed primarily at stemming the impending bottleneck looming in 2024 for legacy devices unable to obtain MDR certification. Here, Petra Zoellner, MedTech Europe’s newly named IVDR-MDR leader, highlights four policy areas to keep an eye on as we enter a new year likely to be fraught with concern about existing products, but are regulators losing sight of new products and their impact on EU innovation?
The Chinese expression “May you live in interesting times” is not only overused; it is often misunderstood. The phrase’s true meaning is intended to be more of a curse than a blessing, and in that sense, clearly applies to the apparent never-ending regulatory pathway for Europe’s Medical Device Regulation (MDR). One can imagine that phrase crossing Petra Zoellner’s mind when she was promoted to director, IVDR/MDR for the trade group MedTech Europe, succeeding the association’s previous MDR principal, Oliver Bisazza, who succeeds the retiring Serge Bernasconi as the organization’s CEO, beginning this new year. (Zoellner previously directed MedTech Europe’s IVDR (In Vitro Diagnostics Regulation) efforts.)
Although December is traditionally a slow period of regulatory activity, leading as it does into the holiday season, this year the month proved to be anything but calm. Zoellner’s portfolio expansion, while triggered by Bernasconi’s retirement and Bisazza’s appointment, coincided with an unusual flurry of medtech regulatory/legislative activity. This burst of movement represented the culmination of pressure that had been building up since MDR was implemented on May 26, 2021.
