Nov 9, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published and questions-and-answers document dedicated to repacking and relabeling activities by the Medical Devices Regulation 2017/745...
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Nov 4, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published a guidance document dedicated to the applicable classification rules. The document is intended to provide medical device...
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Oct 27, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the current classification rules. The document is intended to assist medical device manufacturers...
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Oct 20, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the applicable classification rules. At the same time, the MDCG emphasizes that the document...
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Aug 19, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a guidance document dedicated to the performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. Please...
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