MHRA Renewal Notifications – What Members Need to Know

MHRA is currently contacting registered medical device manufacturers, UK Responsible Persons, and Authorised Representatives as part of its routine registration maintenance programme. These emails are sent in phases, so receiving one does not indicate a problem or enforcement action. It simply means MHRA requires a review of your registration to keep the account active and compliant.

If you receive this notification, you must:

MHRA Device Registration - Quick Review & Renew Checklist

Step 1 - Log In

• Go to DORS (Device Online Registration System)
• Enter your username & password

Step 2 - Check Organisation Details

• Navigate: Account Management → Edit Organisation Details
• Update if your company name or address has changed (fee applies)
• Skip if no changes

Step 3 - Review Devices

Navigate: Medical Devices → Manage Registered Devices

For each device:

• Check device name, model, and GMDN term
• Remove any "pseudo" GMDN entries
• Add or remove products as necessary
• Upload or link Conformity documents
• Add UDI-DI if applicable (not needed for custom-made dental devices)

Step 4 - Update Missing Fields

• Fill in any fields left blank at initial registration
• Linking documents, removing obsolete devices, or updating device details does not incur a fee

Step 5 - Submit Renew Registration

• Navigate: Account Management → Renew Registration
• Submit your review
• No fee if no paid changes were made

⚠️ Key Reminders

• Deadline: 90 days from MHRA email
• Failure to renew → account suspension
• Suspended accounts cannot place devices on the UK market or appear in the public MHRA database
• Only certain changes trigger a fee (company name/address, new devices, role changes, etc.)

Any queries must be sent to device.registrations@mhra.gov.uk