The provisionally agreed EU’s Product Liability Directive is set to place the burden of proof on medtech companies and extend the latent damage clause from 10 to 25 years. Both updates will have financial and operational impacts on the medtech industry.
In December last year, the European Union reached a provisional political agreement on the text for the proposed revision of the EU’s Product Liability Directive (PLD).
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Ireland’s NSAI reinstated under IVD Regulation designation list
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.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
