The MHRA has put a new process in place for medical device and IVD vigilance reporting. The process is outlined: HERE

After 31 August 2023, manufacturers must have an account in the new version of the MHRA vigilance reporting platform MORE, to report adverse incidents or initiate field safety corrective actions (FSCAs).

We reviewed the MHRA’s 43-page user guide and outlined the key steps to create a new account.

What is the deadline to create a MORE vigilance account?

The new Manufacturer’s On-Line Reporting Environment (MORE) system becomes mandatory for vigilance reporting starting 1 September 2023. However, it is recommended to create a MORE account as soon as possible, and not wait until the deadline.

Please see below for more details on how to report outside of the MORE system, before that date. 

What if I already have a MORE account, in the previous MORE portal?

The old version of the MORE platform has been obsoleted. You will need to create an account in the new MORE platform.

No new vigilance could be submitted into the old MORE portal after 21 November 2022. From then onward, it was ‘read-only’ until 30 April 2023.

Any information you had in the old MORE platform has not been, and will not be, migrated to the new MORE platform. Instead, manufacturers must have downloaded any information from the read-only version prior to 30 April 2023.

How do I register for a new MORE account?

The MHRA has issued a user guide, available: HERE

Process for companies who had an account in the old MORE platform

• • Go to the MORE portal sign-in page: HERE
  • Click “Create an account”
  • Click your Account Type, e.g., manufacturer
  • Search for your company’s name under “Manufacturer Association”
  • Select your company
    • Ensure that the company name and address match the information from your MHRA registration record
    • Your MHRA registration account number is included in the company name; please cross-reference to ensure you are linking yourself to the correct account; this number will be on your MHRA registration confirmation letter and in the public registration database
  • Enter your ‘personal details’, e.g., name, email, phone number and address
    • The account will be for you as an individual
    • The first person to register will have the highest level access (“Organisation Lead”) and can approve access for others in the organization
    • It is highly recommended to add other employees to the account later, in case the original account creator leaves the company or is unavailable if vigilance must be urgently reported
    • The MHRA strongly recommends against using an email distribution group, in order to maintain the traceability of actions
  • If the person requesting the new MORE account has the same email address and is associated with the same manufacturer from the old MORE account, then no further supporting information is required for the MHRA to review the request and make a decision
    • If the person requesting the new MORE account does not have the same email address as a previous user in the old MORE account, then they will be treated like a completely new account creator and must supply ‘supporting documentation’ referenced further below

Process for companies who did not have an account in the old MORE platform

• • Go to the MORE portal sign-in page: HERE
  • Click “Create an account”
  • Click your Account Type, e.g., manufacturer
  • Search for your company’s name under “Manufacturer Association”
  • Select your company
    • Ensure that the company name and address match the information from your MHRA registration record
    • Your MHRA registration account number is included in the company name; please cross-reference to ensure you are linking yourself to the correct account; this number is on your MHRA registration confirmation letter and in the public registration database
  • Enter your ‘personal details’, e.g., name, email, phone number and address
    • The account will be for you as an individual
    • The first person to register will have the highest level access (“Organisation Lead”) and can approve account access for others in the organization
    • It is highly recommended to add other employees to the account later, in case the original account creator leaves the company or is unavailable if vigilance must be urgently reported
    • The MHRA strongly recommends against using an email distribution group, in order to maintain the traceability of actions
  • You will have limited access MORE workspace until the account registration is approved by the MHRA
  • Proceed to submit the ‘supporting documentation’ to the MHRA, following the steps outlined in the section below

What is the ‘supporting documentation’ required and how do I provide it?

This is a letter that is signed by the manufacturer’s CEO and emailed as an attachment to the MHRA.

For the fastest processing time, the MHRA requests companies use the draft e-mail and letter templates provided in their user guide.

Template e-mail provided by the MHRA

Send to: AIC@mhra.gov.uk

Subject: MORE registration supporting documentation – MANUFACTURER NAME

Dear AIC team,

Please see attached validation documentation for MORE registration.

Registration was completed using the email address EMAIL on DATE for organisation MANUFACTURER NAME .

Kind regards,

FULL NAME

ATTACHMENT: letter from CEO

Template letter from the CEO provided by the MHRA

Casus transposed the template text included in the MHRA user manual to the Word document linked below. Customize the template with the relevant changes, have your CEO sign it, and then email it to the MHRA.

Download File

How can I submit vigilance between now and 31 August 2023?

Companies may create an account in MORE prior to 31 August 2023. You do not have to wait until that date to start using the system.

However, if you are unable to create the account in time to report vigilance or initiate a field safety corrective action (FSCA), then you can email the MHRA at: AICxml@mhra.gov.uk

This email address will accept vigilance submissions until 31 August 2023. After this date, the email system will no longer accept new reports.

Note that if you submit by email, instead of the MORE portal, that emailed submission will not be visible in MORE. Therefore, the earlier you start using the MORE system, the earlier you can begin centralizing your UK vigilance reporting history.

Alternate solution for companies with a high volume of vigilance reporting

The MHRA allows the option to set up an Application Programming Interface (API), which would allow you to submit reports directly from your internal system into the MHRA’s.

If this is of interest, you must contact the MHRA at: aic@mhra.gov.uk

The MORE platform API set-up user guide is available: HERE