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MHRA Guidance on legislation: Clinical Investigations of medical devices

Posted on 06.02.2020

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently published an update of the guidance document on clinical investigations of medical devices. The paper aims at assisting the manufacturers in understanding and fulfilling clinical evidence requirements for the purpose of CE-marking. The guidance also explores other sources of clinical data and the need for clinical investigations for a non-CE marked device. To access the guidance document, click here.