Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations

Medtech stakeholders say there needs to be a reform of the European medtech regulatory system to improve efficiency, consistency and agility.

Cracks in the current system have become more apparent as manufacturers work to transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), Petra Zoellner, director for IVDR and MDR at MedTech Europe, told attendees at the 2023 MedTech Conference.

“We shouldn’t light a match and set fire to the two regulations, but I do think we need reform,” she said…