EU Health Commissioner Paves the Way for Faster Medical Device Regulation Reforms

EU Medical Device Regulations to Be Revisited Sooner Than Expected
EU Health Commissioner Olivér Várhelyi has confirmed that the review of the EU’s medical device regulations is now all but certain to occur earlier than initially expected. This marks a shift in the European Commission’s stance, which had previously refrained from committing to such revisions. The current regulations, established in 2017, cover a wide array of medical products, from complex equipment like X-ray machines and pacemakers to everyday items like contact lenses and bandages. However, delays in implementing these rules and concerns over safety gaps have prompted the need for reassessment. The European Commission has now committed to consultations on the issue, moving forward with a potential review well before the original deadline of May 2027.

Urgent Measures and Immediate Action on Medical Devices
In the short term, Várhelyi emphasized that the Commission will focus on addressing immediate bottlenecks in the medical device market, such as delays in market access for orphan medical devices, especially for paediatric care. A leaked draft of the Commission’s working program suggests that these measures will be introduced within the first 100 days of the new Commission’s term. The goal is to accelerate the market entry of essential devices by resolving slow product compliance designations, which have led to shortages and delays in essential treatments. The Commission also aims to reduce bureaucratic red tape and costs associated with notifying bodies to facilitate faster market access for vital products.

Stakeholder Reactions: Calls for Swift Action vs. Caution
While the MedTech Europe association, which represents EU medical device manufacturers, has pushed for swift reforms, not all stakeholders agree on the speed of implementation. The European Patients’ Forum (EPF) has warned against hasty decisions, calling for thorough evaluations before implementing any revisions. Similarly, a European Parliament resolution in October urged the Commission to propose changes, but with an emphasis on impact assessments to ensure that reforms are based on sound evidence. On the political front, the centre-right European People’s Party (EPP) has advocated for quicker reforms, while liberal, green, and socialist groups caution that changes should be driven by careful analysis, ensuring patient safety and regulatory effectiveness are not compromised.