European Parliament softens stance on overhaul of medical device rules

MEPs partially readdressed their stance on reforming the EU's medical device law on Wednesday in a non-binding resolution which removed any timeline for when reforms should take place and advocated only for changes deemed necessary after impact assessment.

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

Due to repeated extensions of the transition period for certifying medical devices under the new rules, there has been growing concern that the existing safety regulations are inadequate and in need of revision.

The Parliament’s resolution calls on the EU executive to propose "a systematic revision of all relevant articles of these regulations, accompanied by an impact assessment, to be conducted as soon as possible."

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

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

Opposition to fast-tracking the reform came primarily from liberals, greens, and socialists, who argued for amending the legal framework only after a thorough evaluation.

EPP health coordinator, German MEP Peter Liese, expressed frustration over the outcome, stating that while it was positive the Parliament had agreed to some targeted changes, the lack of a clear timetable for comprehensive reform was a missed opportunity to address pressing issues.

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

Socialist lawmakers, however, pushed back, emphasising the importance of a more cautious stance. "We do not want to slow it down; we want it to be done right to avoid repeating past mistakes," a socialist source told Euronews.

Socialist MEP Tiemo Wölken argued that rushing to amend the regulations without an impact assessment and eliminating recertification requirements could jeopardise patient safety and contradict expert recommendations.

Greens MEP Tilly Metz echoed this sentiment on social media X, noting that a long-term revision 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 cautioned against "quick fixes" to the regulations and warned against fast-tracking amendments within 100 days of the new European Commission taking office.

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

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

The medical devices industry lobby MedTech Europe welcomed the Parliament’s call for a systematic revision, urging the Commission to quickly outline a clear timeline for the review and identify areas for necessary intervention.