Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
AFNOR Certification is the 46th notified body to be designated in the EU in the context of the Medical Device Regulation and the second in France.
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Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.
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.
India’s medical technology industry is raising the alarm over steep new US tariffs on imported medical devices. It argues for structural change to address “unequal regulatory access” and non-tariff barriers.
