Health Commissioner touts swifter reform of EU medical devices rules

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.

Short-term actions on medical devices

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 measures, such as resolving delays in market access for orphan medical devices, particularly in paediatric care.

“These products can’t enter the market fast enough,” he said and this has led to shortages. A leaked draft of the Commission’s working program seen by Euronews suggests these measures are expected within the first 100 days of the new Commission.

One key obstacle has been the slow designation of bodies responsible for assessing product compliance, raising fears that essential devices might become unavailable.

“We’re also looking into other possibilities to drag down the costs and red tape of notifying bodies so we can have products entering the market faster,” he added.

Stakeholders divided

Várhelyi’s and ministers’ call for urgent action aligns with MedTech Europe, the EU manufacturers’ association, which has pressed for comprehensive reforms in both the short and mid-term.

However, not all stakeholders agree with the need for swift revisions.

The European Patients’ Forum (EPF) has warned against “quick fixes” emphasising the importance of thorough evaluations.

Similarly, a European Parliament resolution in October urged the Commission to propose revisions but refrained from setting a timeline, advocating changes only after impact assessments.

In the hemicycle, the centre-right European People’s Party (EPP) has championed accelerated reforms, while liberal, green, and socialist groups have cautioned against speed, insisting that any legal framework updates should be grounded in rigorous analysis.