We would like to bring your attention to a significant change in the UK Vigilance reporting process that will be mandatory after August 31, 2023 in the UK (see our Newsletter dated April 26, 2023).
The AICXML mailbox, which has played a vital role in reporting adverse incidents related to Medical Devices to the MHRA, will no longer be operational beyond August 31, 2023. It is being replaced by the MORE (Manufacturer Online Reporting) portal. It is essential to highlight that any submissions sent to AICxml@mhra.gov.uk after August 31, 2023, will not reach the MHRA. This could result in a failure to report, which is a critical noncompliance.
MDSS has been entrusted with the mandate to report Vigilance events by most of our clients. For these clients we have consistently utilized the MORE platform for reporting since its inception. During the transition, the MHRA actively sought feedback from users, and we are pleased to share that our inputs were taken into consideration to enhance the platform.
For those of you who report directly as manufacturers, reporting via the MORE portal requires mandatory registration. Detailed instructions for both registration and submission through the portal, along with relevant guidance and useful links, can be found on the official GOV.UK website. We advise strict adherence to these guidelines. Furthermore, if you choose to report directly, it is crucial to keep MDSS, if we are your UK Responsible Person, informed of the submissions, as outlined in the guidance: "The manufacturer should also ensure that these guidelines are made known to their UK Responsible Person ..., who should be kept informed of incident reports. This will enable their UK Responsible Person ... to fulfil their obligations."
We are excited that we introduced the new portal seamlessly in our QM System for our clients to transition to the MORE portal, aligning with the guidelines to ensure a smooth and uninterrupted submission process. MDSS will continue to offer the submission of vigilance reports to the MHRA through the MORE portal specifically for its clients.
We value your feedback and would greatly appreciate your thoughts on the helpfulness of this Newsletter in the comment section below.