Medical devices clinical investigations during the coronavirus (COVID-19) outbreak, MHRA

Ongoing clinical investigations We are aware of the challenges arising from COVID-19 and we will maintain a flexible and pragmatic approach to the regulatory requirements for clinical investigations. We recognise that clinical investigation resource may be absent or redeployed from research activities. Investigators and sponsors should keep us updated on how COVID-19 is impacting their studies. The first priority is the safety of participants of clinical investigations and this will remain our focus. Therefore, carefully document all actions and risk assessments you take in response to COVID-19 to determine the impact.
Source: Current Awareness Service for Health (CASH) - Category: Consumer Health News Source Type: news