Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
Advice for investigators and sponsors of ongoing clinical investigations.
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.
If you believe COVID-19 is going to impact patient safety, contact us at info@mhra.gov.uk as soon as possible and we will deal with these issues on a case-by-case basis.
Pausing ongoing clinical investigations
If a clinical investigation needs to be paused, notify us as soon as possible and keep good records of your actions.
Once you are ready to re-start, inform us and provide a summary of the actions taken and whether there was any patient safety impact.
Amendments
If there are any actions you need to take in response to COVID-19 that are considered an amendment, tell us by emailing info@mhra.gov.uk and we will expedite the review. Please make it clear in your cover letter that the amendment is in response to COVID-19.
You must tell us about any changes made to:
- the device under investigation
- study documentation, including the clinical investigation plan
- investigators or investigating institutions
- changes requested by an ethics committee
We will assess any amendments that are not related to COVID-19 within normal MHRA processing times.
Protocol deviations
We appreciate that the impact of COVID-19 will likely result in an increase in protocol deviations. You should maintain good records of these deviations. Unless there is an impact onto patient safety, you do not need to notify MHRA of COVID-19 related deviations.
However, all other protocol deviations must be reported to us as normal.
Last updated 23 September 2020 + show all updates
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Removal of new submissions and clinical investigations about Covid-19 information.
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Added a new section on Clinical investigations about COVID-19
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First published.