top of page

MHRA Guidance on need to Review Registration of Medical Devices

MHRA agency on 27 September 2021, provided the advice in an update to its guidance on "registering medical devices.

MHRA has asked companies to review all their devices and products to ensure the data is correct and update any data fields that were not previously populated using the new update registered devices and products functionality. There is no fee to use this function. In particular, MHRA urges companies to provide the UDI-DIs for their devices as these will be crucial for monitoring and ensuring patient safety.

MHRA has implemented a renewal registration process as a reminder to review your registration and confirm that it is up to date.

The first reminder date is 1 year after account creation and then at least every 2 years. For accounts that were created before 01 January 2021 the first review and renewal reminder date has been set for 01 January 2022. Companies will receive automated email reminders 3, 2 and 1 month before their renewal date – Companies can review and submit the Renew registration application from 3 months before the renewal date.

There is no fee for this application.

Watch this video for more.

If you do not review your registration and submit the Renew registration application your account will be suspended. Suspended accounts are removed from the Public Access Registration Database (PARD) and you will not be able to add new devices or order Certificates of Free Sale until you have reviewed your registration and submitted the renewal application.

121 views0 comments


bottom of page