New Update to MHRA Guidance

New update to MHRA Guidance – Notify about a clinical investigation for a medical device

4th January 2022 saw new guidance on how to notify the MHRA about a clinical investigation for a medical device.

The guidance is aimed at manufacturers who need to carry out a clinical investigation as part of their process to obtain UKCA / CE / CE UKNI marking for their medical device. Manufacturers must now inform the MHRA if they are planning on doing so at least 60 days before starting the investigation.

The latest update, issued on Tuesday, sees a new MHRA and HRA coordinated assessment pathway guidance document. This new regime is testing MHRA and HRA submissions  side by side, which involves both organisations sharing information during their assessments of clinical investigations. So, the MHRA device application is required to be submitted first, followed by the REC (Research Ethics Committee) application, which enables both authorities to share information on their findings.

This move is intended to streamline the process and decrease the waiting period for manufacturers.

You can take part in this new test by submitting an application to Devices.Regulatory@mhra.gov.uk with “MHRA/HRA Coordinated assessment pathway” in the subject bar; making sure to include the following information about your study;

• Confirmation that the REC application has not yet been made
• Confirmation that the study does not involve adults lacking capacity
• Confirmation that the study is not also a CTIMP
• The estimated application date
• The IRAS Project ID number (if available)

But if you need assistance with your submission, an IMed specialist is always just a phone call or an email away, so just get in contact on 01295 724286 or via alison@imedconsultancy.com…