Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...
LONDON, Dec 19 (Reuters) - Nicola Osypka's German company has been selling medical devices used in surgery on newborn babies in Europe for decades, but new European Union rules have forced her to make ...
Complex approval processes and high cost are among the challenges causing US medical device manufacturers to question whether the European Union Medical Device Regulations (EU MDR) are worth the time, ...
AI Health Law & Policy: Comparing regulatory landscapes for AI in medical devices in the EU and U.S.
Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory ...
The European Commission has published its long-awaited proposal for a regulation amending and simplifying the EU Medical Devices Regulation (EU MDR) and the In Vitro Diagnostic Medical Devices ...
As life sciences companies expand internationally, regulatory readiness must evolve into a strategic capability that supports ...
(Bloomberg) -- A European Union probe into China’s procurement of medical devices confirmed the bloc’s concerns that the Asian country discriminates against foreign firms, opening the door to ...
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