Health Commissioner touts swifter reform of EU medical devices rules than expected

In his debut appearance before EU health ministers, Hungarian Commissioner Olivér Várhelyi declared that a review of the EU’s medical device regulations is practically guaranteed.

This marks a departure from the European Commission’s prior ambiguity to commit to such a move.

Current medical device rules were agreed in 2017, and govern a wide range of products from high-tech devices like X-ray machines and pacemakers to everyday items such as contact lenses and bandages.

Repeated extensions of the transition period for certifying medical devices under these rules have sparked concerns about safety gaps in the existing regulatory framework.

While the European Commission had previously refrained from committing to revisions, it did promise consultations on the matter by the end of this year—much earlier than the original May 2027 timeline.

“A reflection is going to take place next year, and I think it will be inevitable to have a review,” Várhelyi stated during a press conference on Tuesday, signalling a shift from the Commission's earlier stance.

In her mission letter to Várhelyi, Commission chief Ursula von der Leyen was also cautious, tasking him with “evaluating the need for potential legislative changes”.

The Hungarian carefully pointed out the importance of “gathering evidence on the need for potential legislative changes” only a few weeks ago, in a written response to MEPs during his confirmation process.

Várhelyi’s remarks come in the wake of a note presented by the French and German delegations, supported by Ireland, Luxembourg, and Romania, urging reforms to the medical device and in vitro diagnostic regulations.

According to Várhelyi, immediate efforts will focus on addressing bottlenecks that don’t require legislative