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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Dec 2, 2020
EU MDR/IVDR
The Medicines and Healthcare products Regulating Agency (MHRA), the UK agency responsible for medical devices regulations, has published guidance describing the way the study sponsors should notify the authority about a clinical investigation for a medical device. The...
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Jul 23, 2020
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to clinical investigations for prostate tissue ablation devices. The document constitutes a final version of the draft guidance initially published on June 29, 2019. The document has...
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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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