Jun 3, 2021
Uncategorized
The Medicines & Healthcare products Regulatory Agency (MHRA or the Agency), the UK`s regulating authority in the sphere of medical devices, has published an updated version of its guidance dedicated to clinical investigations. The new version describes regulatory...
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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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Jun 19, 2020
EU MDR/IVDR
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
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Feb 19, 2020
EU MDR/IVDR
In order to assist all parties involved in operations with medical devices to maintain compliance with applicable requirements under the new framework established by the recent UK Medicines and Medical Devices Bill, special Explanatory Notes have been published. In...
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Jan 16, 2020
EU MDR/IVDR
MedTech Europe, the association of companies that operate on the medical device market, is deeply concerned with the current situation regarding the implementation of Regulation 2017/745 (MDR). The association warns medical device manufacturers, importers,...
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