Timetable for reforms of rules affecting medical devices not defined after calls for thorough impact assessment. 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 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.
