UK MHRA Announcement: New Dates for UK Regulation & CE Marking
April 27, 2023
Team Notified Body Issues MDR Transition Extension Letter Template
May 8, 2023
Page Last Updated: 19 September 2023
As of September 1, 2023, the MHRA has a new process for medical device and IVD vigilance reporting. The process is outlined: HERE
Manufacturers must create 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.
Deadline to create a MORE vigilance account
The new Manufacturer’s On-Line Reporting Environment (MORE) system became mandatory for vigilance reporting starting 1 September 2023. As of this date, the old vigilance email (AICxml@mhra.gov.uk) no longer accepts new vigilance reports.
What if I already have an old MORE account?
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.
Vigilance Requirements Tool
EU, UK and Switzerland: vigilance contacts, links to forms, reporting process and reporting timeframes
How do I register for a new MORE account?
We have outlined the key steps below. The MHRA has also issued a 43-page 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 will be on your MHRA registration confirmation letter and in the public registration database
- Enter your ‘personal details’, e.g., name, email,
- 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
- You will have a 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’ 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 the 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.
NOTE: the CEO does not have to personally email the letter to the MHRA. Another person from the company, e.g., the person who is submitting the MORE registration request, may send the email and attach the CEO’s letter. Further, if the company does not have a CEO, then the most appropriate person may sign the letter instead, e.g., Director, Owner, President, etc.
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
