Revision of the EU medical devices regulations

Consumers and patients use a variety of medical devices in their daily lives. These range from hearing aids to contact lenses and dental and orthopaedic implants. Ensuring that medical devices and in vitro diagnostics are safe and perform well is crucial to improve health outcomes and people’s quality of life. 

In 2017, the EU legislative framework for devices was strengthened following some safety scandals.  The new Regulations on Medical Devices (MDR) and In Vitro Diagnostics (IVDR) enhanced the oversight of notified bodies, introduced stronger requirements on clinical evidence and post-market surveillance, as well as more transparency through EUDAMED.  

Despite continued efforts over the years from the European Commission and Member States to implement the Regulations, extended transition periods have prevented consumers from reaping their full benefits, such as greater transparency. In fact, EUDAMED may only become fully functional in 2027. In parallel, there have been reports of shortages and withdrawals of medical devices, without a clear understanding of the root causes. Availability problems have been reported particularly for some types of devices, such as for rare diseases. 

BEUC supported the targeted evaluation launched by the Commission in 2024, to identify elements of the MDR and IVDR that work well, as well as any remaining challenges. The December 2025 legislative proposal to revise the Regulations includes several welcomed measures, particularly: 

• Greater coordination between notified bodies and with the Medical Devices Coordination Group (MDCG).
• Requirement for Member States to ensure that competent authorities have enough technical, financial, and human resources to implement both Regulations.
• More coordination amongst competent authorities on the regulatory status of products, including borderline cases.
• Greater role from the European Medicines Agency (EMA) in addressing device shortages beyond crisis situations.
• Specific scientific advice pathways for breakthrough and orphan devices.
• In case of online sales, new requirements for suppliers to provide certain information in the offer itself (e.g., manufacturer’s details, instructions for use).

However, we are concerned about the scope and extent of the proposed simplification. The Commission’s proposal goes beyond measures that would facilitate compliance with the safety requirements of the Regulations. In fact, some of the changes weaken both the pre-market assessment of devices and post-market surveillance, with their cumulative effects representing a step backwards. This applies to both to medical devices and in-vitro diagnostics (IVDs), a sector in rapid transformation. Over the last years, and particularly since the COVID-19 pandemic, the market for direct-to-consumer testing has expanded rapidly. The potential for consumer harm from poor quality self-tests is significant. False negative results may lead to missed diagnosis and skipped screening tests, while false positives can cause unnecessary worry and further testing. Instead of strengthening evidentiary requirements, the Commission’s proposal goes in the opposite direction. This and other proposed measures do not make the regulations future proof, as they will fail to ensure a high level of consumer protection in light of new market trends.

In this briefing, we propose several improvements to the legislative proposal to ensure much needed public trust in the safety and performance of devices placed on the market.