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The MHRA Submissions portal — how-to

Regulatory basis

The MHRA Submissions portal is the official registration system under the UK MDR 2002 as amended. Registration via the portal is mandatory for manufacturers, UKRPs, and authorised representatives placing devices on the GB market.

What is the MHRA Submissions portal?​

The MHRA Submissions portal at submissions.mhra.gov.uk is MHRA's online platform for:

  • Device registration — registering manufacturers, UKRPs, and devices with MHRA
  • Vigilance reporting — submitting serious incident reports and FSCA notifications
  • Export certificates — applying for Certificates of Free Sale for export
  • Pre-submission meetings — requesting advisory meetings with MHRA

Who needs a portal account?​

Any of the following parties who place devices on the GB market must have a portal account:

  • UK-established manufacturers — registering their own devices
  • UK Responsible Persons (UKRPs) — registering on behalf of overseas manufacturers
  • UK-established authorised representatives — registering on behalf of manufacturers

Setting up an account​

  1. Visit submissions.mhra.gov.uk
  2. Select "Create account"
  3. Provide your organisation's legal name, address, and contact details
  4. Verify the account via email
  5. Log in and begin the registration process

Device registration: key steps​

  1. Log in to the portal
  2. Select "Register a medical device" or "Register as a manufacturer/UKRP"
  3. Provide the required information:
    • Organisation details (manufacturer and/or UKRP)
    • Device name, description, classification
    • UKAB certificate reference (where applicable)
    • Declaration of Conformity reference
  4. Pay the applicable registration fee
  5. MHRA assigns a registration number

Vigilance reporting via the portal​

To submit a serious incident report or FSCA notification:

  1. Log in to the portal
  2. Navigate to "Report an adverse incident" or "Notify an FSCA"
  3. Complete the structured report form with all required information
  4. Attach supporting documentation
  5. Submit — MHRA assigns a case reference number

Official references​

ReferenceDescription
MHRA Submissions portalThe portal
MHRA: Registering medical devicesRegistration guidance
MHRA: Adverse incident reportingVigilance reporting guidance