Europe – Convergence: MDR timeline extension is smoothing transition, but concerns persist

The European Union’s Medical Device Regulation (MDR) timeline extension has addressed some of the issues manufacturers raised with the transition period but the process of recertifying products is still time and resource intensive and may cause some companies to pause before entering the European market, according to a panel of experts who spoke at RAPS Convergence 2023.

Every manufacturer will have a different experience with MDR transition depending on their size and available resources, said Gert Bos, executive director at Qserve Group in the Netherlands. “I would say, in general, we see a lot of wait and see with smaller manufacturers – small and medium sized,” he said.

Some manufacturers have expressed confusion about the guidance and other documents being released, Bos said. “[A] manufacturer keeping up to date with all of these changes, all of these guidances, is going to be very, very difficult,” he said. “It’s never complete and it’s not about the topics that they need the guidance to.”…