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Registration via the MHRA Submissions portal

Regulatory basis

Registration via the MHRA Submissions portal is mandatory under the UK MDR 2002 as amended. The portal is at submissions.mhra.gov.uk.

Account setup​

  1. Navigate to submissions.mhra.gov.uk
  2. Select "Register" / "Create an account"
  3. Enter your organisation's legal name, address, and a contact email
  4. Verify your email address
  5. Complete your organisation profile

For UKRPs: create an account in the UKRP's own organisation name. You will then link overseas manufacturer registrations to your UKRP account.

Registration workflow​

Step 1: Register the organisation​

  • For UK manufacturers: register as a manufacturer
  • For UKRPs: register as a UKRP; link to the overseas manufacturer's legal entity

Step 2: Register the devices​

For each device or device group:

  • Enter device name, intended purpose, classification
  • Upload or reference the Declaration of Conformity
  • Enter UKAB certificate details (certificate number, UKAB name) for certified devices
  • For CE-marked devices: enter the EU Notified Body certificate details and reference the EU regulatory framework
  • Pay the applicable fee

Step 3: Receive confirmation​

MHRA assigns a registration reference number. The registration is now active.

Information you will need​

Before starting registration, have ready:

  • Manufacturer legal name and registered address
  • UKRP legal name and registered address (for non-UK manufacturers)
  • Device name and description
  • Device classification and rationale reference
  • Declaration of Conformity date and reference
  • UKAB name and certificate number (for UKAB-certified devices)
  • EU Notified Body name and certificate number (for CE-marked devices)
  • DUNS number or equivalent business identifier (where available)

Official references​

ReferenceDescription
MHRA Submissions portalThe portal
MHRA: Registering medical devicesRegistration guidance