Medical Devices Clinical Investigations during the Coronavirus (COVID-19) outbreak

On 30 March 2020 the MHRA published the updated this guidance for investigators and sponsors of ongoing clinical investigations and new applications.

MHRA is aware of the challenges arising from COVID-19 and will maintain a flexible and pragmatic approach to the regulatory requirements for the ongoing clinical investigations. Any new submissions for clinical investigations that will have a direct impact on the COVID-19 emergency will get a fast-track review.

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