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On 15 July 2026, the European Consumer Organisation (BEUC) and organisations representing standardisation, consumers, digital rights, doctors, pharmacists and hospitals are calling EU policymakers to maintain medical devices in the scope of the AI Act.
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From basic care to life-saving treatments, around two million different types of medical devices shape patient and consumers’ daily lives worldwide. The revision of the EU legislative framework in 2017 was a necessary step to enhance patient safety after past scandals across Europe like faulty breast implants illustrated that weak rules put consumers at real risk. Despite some enhanced coordination efforts between national authorities, the European Commission’s current proposal to amend these rules risks reversing previous patient safety gains by simplifying rules too far.
Position papers
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BEUC's position on the revision of the Medical Devices Regulation and the In-Vitro Diagnositcs Regulation
Press releases
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This morning, the EU agreed on its Critical Medicines Act to strengthen its supply of antibiotics, vaccines, insulin and other medicines for chronic or rare diseases. This is positive news for patients and consumers at a time when Europe faces persistent shortages of critical medicines, affecting access to essential treatments.
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Biotechnologies like vaccines, gene-therapies, or alcoholic fermentation in bread to enhance flavours are increasingly shaping Europe’s health and food systems, directly affecting patients and consumers. Innovation and competitiveness matter but must never compromise safety or public trust. Simplification must ensure rigorous risk assessment, and respect for the precautionary principle. Transparency and clear safeguards are essential to ensure innovation serves the public interest.
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Europe faces persistent shortages of critical medicines, affecting patients’ access to essential treatments. COVID-19 and the geopolitical context have exposed the fragility of medicine supply chains and the EU’s reliance on limited sources of production.
The ongoing inter-institutional negotiations should ensure the Critical Medicines Act is decisive in strengthening supply security, ensuring timely and uninterrupted access to critical medicines and reinforcing health system’s resilience.
BEUC's new two-pager summarises our main recommendations for trilogue negotiations. To find out more, read our new publication here.
The ongoing inter-institutional negotiations should ensure the Critical Medicines Act is decisive in strengthening supply security, ensuring timely and uninterrupted access to critical medicines and reinforcing health system’s resilience.
BEUC's new two-pager summarises our main recommendations for trilogue negotiations. To find out more, read our new publication here.
Position papers
Available in
English
This document compiles BEUC's recommendations for targeted revision of EU medical devices rules after the EU's public consultation on medical devices rules.