MEPs on Wednesday partially revisited their position on reforming EU medical device law in a non-binding resolution that removed any timetable for when reforms should take place and only advocated changes deemed necessary after an analysis of impact.

In recent years, EU member states have struggled to implement current rules affecting a wide range of products, from advanced equipment like X-ray machines and pacemakers to everyday items like contact lenses, syringes and bandages.

Due to repeated extensions of the transition period for certification of medical devices under the new rules, there is growing concern that the existing safety rules are inadequate and require revision.

Parliament’s resolution calls on the EU executive to propose “a systematic review of all relevant articles of these regulations, accompanied by an impact analysis, to be carried out as soon as possible.”

This final wording adopted Wednesday in Strasbourg represents a change from previous efforts by the European People’s Party (EPP), the largest group in Parliament, to accelerate reforms.

The EPP had sought to ensure that the pre-reform impact assessment would be completed by the Commission by September 2025 at the latest, while the far-right Europe of Sovereign Nations (ESN) group pressure for a deadline of June 2025. Both proposals were rejected.

Opposition to an acceleration of reform came mainly from liberals, Greens and socialists, who argued for changing the legal framework only after a thorough evaluation.

The EPP’s health coordinator, German MEP Peter Liese, expressed frustration with the outcome, saying that while it was positive that Parliament had agreed to some targeted changes, the lack of a clear timetable for a Comprehensive reform was a missed opportunity to resolve pressing problems.

“There is no time to lose; this must be a top priority,” Liese said in a note.

Socialist lawmakers, however, backtracked, emphasizing the importance of a more cautious stance. “We don’t want to slow it down; we want it to be done well to avoid repeating the mistakes of the past,” a Socialist source told Euronews.

Socialist MEP Tiemo Wölken said rushing to change regulations without carrying out an impact assessment and removing recertification requirements could endanger patient safety and contradict expert recommendations.

Greens MEP Tilly Metz echoed the sentiment on social media X, noting that a long-term review must be guided by a thorough impact assessment to ensure patient safety.

The debate follows concerns raised by the European Patients’ Forum (EPF) last week, which warned against “quick fixes” to regulations and warned against accelerated changes within 100 days of entry depending on the new European Commission.

In a written response to MEPs, the new Health Commissioner, Olivér Várhelyi, acknowledged that the transition to the new regulatory framework, adopted in 2017, had proven more difficult than expected.

“If confirmed, my priority will be to complete the ongoing targeted assessment of current regulations and gather evidence on the need for possible legislative changes,” Várhelyi wrote.

Medical device industry lobby MedTech Europe has welcomed Parliament’s call for a systematic review, urging the Commission to quickly set a clear timetable for the review and identify areas for necessary intervention.