Last 28th October, MHRA (Medicines and Healthcare products Regulatory Agency) announced that starting from Monday, 5th December 2022, adverse events involving Medical Devices occurring in the UK must be reported via the new MORE portal.
The reporting and evaluation of adverse events and FSCA (Field Safety Corrective Actions) involving Medical Devices is known as the vigilance system and must be carried out, together with Periodic Summary Reports (PSRs) and Trend Reports, by the UK-based manufacturer or UK Responsible Person.
Post-market surveillance reporting of adverse events of Medical Devices must be submitted to MHRA by registered users via the MORE portal with XML report uploads or via web forms within the portal or via customised API (Application Programming Interface) for direct submission from internal systems.
The old portal was in function until 6 p.m. on Friday, 2nd December, from then on it became read-only. It will still be possible to access the old portal until 30th April 2023 to consult existing reports: however, the documents will no longer be available for consultation after this date; we therefore recommend downloading the old account’s history before 30th April 2023 to avoid losing important data.
Please note that in order to access and use the new MORE portal, it is necessary for the UK-based manufacturer or UKRP to register via MHRA and create a new MORE account.
Need you support to market your Medical Devices and IVDs in the UK in full compliance with regulation?
Choose Thema as your UK Responsible Person (UKRP). In addition to the services defined by the MHRA regulation, you will always be up-to-date with the latest regulatory developments.
Contact us for more information.