May 28, 2020
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework in the sphere of medical devices, issued guidance dedicated to the safety reporting in clinical investigations under the...
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Apr 30, 2020
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused at the improvement of the medical devices regulatory framework, issued a guidance document on clinical evidence for medical devices already marked with the CE marks under...
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Apr 27, 2020
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of the EU Member States` representatives and focused on the improvement of the medical devices regulatory framework, issued guidance documents for medical device...
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Mar 25, 2020
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issued guidance highlighting the way the clinical trials of medical products should be conducted during the COVID-19 pandemic. The scope of the document covers all...
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Jan 29, 2020
Europe
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK authority responsible for medical device regulation, has issued guidance on clinical investigations of medical devices in order to assist manufacturers in complying with any and all applicable...
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