While each new designation of a notified bodies in the medtech space is good news, many more organizations are needed rapidly to help manage growing demand. Capacity warnings continue.
Bureau Veritas Italia has become the eighth notified body to be designated in Italy under the EU’s Medical Device Regulation and the 32nd in the EU.
The Italian notified body, based in Milan, has been designated for a range of active non-implantable devices and non-active non-implantable...
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MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.
The European Commission is focusing on how tiny particles behave to help create an EU industrial “powerhouse.”
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
