Jun 17, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices intended to be marketed and used in the EU, has published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices...
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May 26, 2021
EU MDR/IVDR
Today marks a landmark event for medical device manufacturers around the globe: the date of full implementation of the EU’s MDR. Starting today all new medical device registrations that fall within the scope of the European Medical Device Regulation (MDR) must be...
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May 13, 2021
EU MDR/IVDR
The European Commission (EC), the European authority in the sphere of medical devices, has proposed a new framework for the use of Artificial Intelligence technology in medical devices. The document is intended to introduce harmonized rules for AI-based medical...
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Apr 29, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, the regulating authority in the sphere of medical devices, has published questions & answers on clinical investigation. Please note that the document does not represent the...
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Apr 23, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published a guidance document dedicated to the application of transitional provisions for certification of class D in vitro diagnostic medical devices according to the In...
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