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Medical Device
Industry associations support the commission’s MDR/IVDR revision simplification objective and aim to increase Europe’s competitiveness, but MedTech Europe also sees further room for improvement.
The just published proposed targeted revision of the Medical Device and IVD Regulations is a radical rethink of how the EU should regulate medical devices. The document is aimed at supporting industry and patients alike.
New document sets out a structured framework to help breakthrough medical devices tackling serious health needs navigate EU regulation with greater clarity, collaboration and predictability.
Just ahead of the European Commission publishing its proposed revisions of the Medical Device and IVD Regulations, it has released an equally important document on the future of notified body operations in the bloc.
With the last of the Top 100 medtech companies filing 2024-25 revenues in November, Medtech Insight now presents its latest ranking of cardiology, orthopedic, diagnostic imaging and in vitro diagnostics companies.
Six companies exceeded $20bn in the latest Top 100 ranking of global medtechs by revenues, but with a slew of structural changes ahead, the leader board could change in 2026.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
A new face seconded to the European Commission's medtech unit and changes to several EU rules impacting medtech
The rise and fall of US tariffs and the chill headwind from China’s state procurement policies have blown onto medtech’s radar. But how to monetize AI is the dominant concern up and down the industry.
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
Sponsors of higher risk device and diagnostic investigations are being invited to participate in a pilot that aims to reduce regulatory burden.
An interactive look at medtech and diagnostics deals made during November 2025. Data courtesy of Biomedtracker.