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MHRA Review registration

By DTA | 5th October 2021 | News

The updated MHRA guidance  states that:

'You should review your registration frequently to make sure it is up to date. It is a legal requirement to inform MHRA of any changes to your registration per section 7A (general medical devices), section 33A (in vitro diagnostic medical devices) and section 21A (active implantable medical devices) of the Medical Devices Regulations (2002) SI 618 (as amended) concerning registration of persons placing medical devices on the market, as and when they occur. Please do not wait for reminder emails.

Please review all your 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 we urge you to provide the UDI-DIs for your devices as these will be crucial for monitoring and ensuring patient safety.

We have implemented a renew 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. You will receive automated email reminders 3, 2 and 1 month before your renewal date - you can review and submit the Renew registration application from 3 months before the renewal date. There is no fee for this application.

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. Please follow the Renew Registration instructions in the Account Management Reference Guide  and watch the Renew Registration video tutorial.


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