If you need to perform a clinical investigation in order to obtain UKCA/CE/CE UKNI marking for your device, the MHRA must be notified 60 days in advance. Applications must be done through the Integrated Research System (IRAS). Early termination or temporary halt of the clinical investigation must also be notified to MHRA.
What was introduced in the MHRA 60 day notice rule?
New fees were introduced in April 2023 and payment is required upon confirmation of a valid application and must accompany the notice.
MHRA will then provide a checklist to ensure applications are valid, and manufacturers should follow the MHRA guidance on compiling a submission:
A single application is made for combined medicine and device trials, with the application also going to the Research Ethics Committee for study review. There is a separate guidance for clinical investigations involving Northern Ireland while HRA and Health and Care Research Wales (HCRW) approval is required for research in the NHS in England and Wales.
MHRA can offer regulatory advice meetings which provide guidance on navigating the regulatory landscape, MHRA cannot review individual device documents. There is a 60-day assessment period within 5 working days of receiving and validating the document.
For Great Britain only (Not NI): All serious adverse events involving a device under clinical investigation within Great Britain should be reported to MHRA through the MORE portal using either MEDDEV 2.7/3 SAE reporting table, or the MDCG 2020-10/2 SAE reporting table. Quarterly Summary Reports need to be submitted to provide an update on the overall safety profile for the investigation. End of Study reports and Study Deviations must be emailed to MHRA.
If there are questions before submitting the notification they can be emailed to the MHRA here: info@mhra.gov.uk.
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If you have any questions about the MHRA 60 day notice rule for UKCA and CE marking, contact us so our expert regulatory team can assist you.
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