MEPs Delay Reforms to EU Medical Device Regulations

MEPs Reassess EU Medical Device Law Reforms

On Wednesday, Members of the European Parliament (MEPs) took a significant step back from their previous stance regarding the reform of the European Union’s medical device regulations. In a non-binding resolution, they eliminated any specific timeline for when these reforms should occur and instead called for changes deemed necessary only after a thorough impact assessment.

In recent years, EU member states have faced considerable challenges in implementing existing regulations that govern a wide range of medical products. These products include advanced technologies like X-ray machines and pacemakers, as well as everyday items such as contact lenses, syringes, and bandages. The situation has been exacerbated by repeated extensions of the transition period for certifying medical devices under the new rules, leading to rising concerns that the current safety regulations may be inadequate and in urgent need of revision.

The Parliament’s resolution urges the EU executive body to initiate “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, marks a notable shift from earlier proposals put forth by the European People’s Party (EPP), which is the largest political group in Parliament. The EPP had aimed to speed up the reform process, proposing that the impact assessment be completed by the Commission by September 2025 at the latest. In contrast, the far-right Europe of Sovereign Nations (ESN) group advocated for a June 2025 deadline. However, both proposals were ultimately rejected.

Opposition to hastening the reform process was primarily voiced by liberal, green, and socialist MEPs, who emphasized the necessity of amending the legal framework only after a comprehensive evaluation. German MEP Peter Liese, the EPP’s health coordinator, expressed his frustration with the outcome, noting that while it was encouraging that Parliament agreed on some targeted changes, the absence of a definitive timetable for extensive reform represented a missed opportunity to tackle pressing issues. “There is no time to lose; this must be an absolute priority,” Liese emphasized in a statement.

Conversely, socialist lawmakers advocated for a more cautious approach, arguing that it is crucial to avoid repeating past mistakes. A socialist source pointed out, “We do not want to slow it down; we want it to be done right to avoid repeating past mistakes.” Socialist MEP Tiemo Wölken stressed that rushing to amend the regulations without a proper impact assessment and eliminating recertification requirements could endanger patient safety and contradict expert recommendations. Similarly, Greens MEP Tilly Metz echoed this view on social media platform X, asserting that a comprehensive long-term revision must be guided by a meticulous impact assessment to prioritize patient safety.

This debate comes on the heels of concerns raised by the European Patients Forum (EPF) last week. The EPF cautioned against implementing “quick fixes” to the regulations and warned against accelerating amendments within the initial 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 newly adopted regulatory framework in 2017 had proven to be more challenging than anticipated. “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 stated.

The medical devices industry lobby, MedTech Europe, welcomed the Parliament’s call for a systematic revision and urged the Commission to promptly establish a clear timeline for the review and identify the areas in need of intervention.

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