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MHRA have extended the deadline for their new MORE portal to 31 August. It was initially intended to be mandatory for vigilance reporting to MHRA from April.

MHRA have provided the following information:

The MHRA has been listening to feedback and engaging with device manufacturers and stakeholders since the new MORE portal was launched in November 2022. We understand that changes to reporting processes will take time to embed within organisations. We are also aware that there are areas of the new MORE portal that could be improved. We are using your feedback about performance and functionality to improve the system and will be giving an update in due course about upcoming changes as well as expanding the guidance to facilitate the transition to the new MORE portal. We are however unable to support submissions to AICxml@mhra.gov.uk indefinitely because of the need to move to a more secure process, and because maintaining legacy processes has a significant cost and resource impact on the Agency.

Deadline to transition to the new MORE portal extended to 31st August 2023

Having considered your feedback, we are extending the deadline for full transition to the new MORE portal to the 31st August 2023. After this date, submissions via AICxml@mhra.gov.uk will be closed and all incidents must be submitted via the new portal to ensure compliance is met.

Further information can be found on the GOV.UK website including guidance for registering with the new MORE portal. Further guidance on using MORE for submissions is provided once you are logged into MORE within the Resources section. If you require further help, you can contact us at aic@mhra.gov.uk to support your transition to MORE.

Closure of the legacy MORE portal

The legacy MORE portal will be closed as planned on 30th April 2023. If you need to retrieve any reports for local use, please ensure that you download these before the 30th April as you will no longer be able to access the legacy MORE portal after this date.

What do I need to do?
  1. If you haven’t already done so, register for the new MORE portal. Information and the link to the current MORE portal can be found on the GOV.UK website
  2. Download historical reports from your old MORE account to your local system, if needed.
  3. Start submitting via the new submission routes.
Setting up the MORE API for submitting adverse incidents to Medical Devices to the MHRA

If you wish to send your vigilance reports via the API, please contact us regarding setting this up. We have also published this guidance within the Resources tile of the MORE portal.

Contact us

If you have any further questions, please contact us at aic@mhra.gov.uk

Ashleigh