In Vitro Diagnostics

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.

Roadmap version 1.0 is a living document, not a legislative instrument, that will be updated and tweaked for timings as necessary.

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.

A new face seconded to the European Commission's medtech unit and changes to several EU rules impacting medtech

Sponsors of higher risk device and diagnostic investigations are being invited to participate in a pilot that aims to reduce regulatory burden.

Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?

The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.

Medtech companies should not look at the current period as a regulatory hiatus, but as an opportunity to avoid a crisis two to three years down the line.