The European Commission’s proposed Data Act, which is among a growing number of horizontal regulations set to impact the medtech industry, is one step away from becoming law.
European Trade Groups Offer Unified Perspective On Pending Data Act
With The European Parliament’s adoption of the Data Act, which establishes rules on sharing data — and allows users to access data they generate — pending, two trade associations representing the medtech industry are offering a joint perspective on how the final law should look.

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Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?
A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.
“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.
Industry waits to see if there will be a surge in demand for orthopedic and cardiology devices as IHI’s EU Ambulatory Surgical Centers proposal awaits sign-off.