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Who must register with MHRA

Regulatory basis

MHRA registration requirements are established by the UK MDR 2002 as amended by SI 2019/791 and subsequent statutory instruments. Registration via the MHRA Submissions portal has been mandatory for all relevant parties placing devices on the GB market since 1 January 2021.

Who must register​

Three categories of entity must register with MHRA before placing medical devices on the GB market:

1. UK-established manufacturers​

Any manufacturer that is legally established in the United Kingdom (England, Scotland, Wales, or Northern Ireland) must register with MHRA before placing any device on the GB market.

This includes:

  • UK companies that design and/or manufacture medical devices
  • UK companies that act as own-label manufacturers (commissioning manufacture from a contract manufacturer but placing devices on the market under their own name)
  • UK companies that substantially change a device and re-release it under their own name

2. Non-UK manufacturers via their UK Responsible Person (UKRP)​

Any manufacturer not established in the UK who wishes to place devices on the GB market must appoint a UKRP. The UKRP registers both:

  • The UKRP entity itself
  • The overseas manufacturer (on the manufacturer's behalf)
  • The devices placed on the GB market

The manufacturer does not register directly — all GB registration is handled through the UKRP.

3. Authorised representatives​

UK-established authorised representatives who have been explicitly authorised in writing by a manufacturer to carry out registration and MHRA interactions on that manufacturer's behalf.

Who does NOT need to register directly​

EntityRegistration requirement
ImportersNo direct MHRA registration — but must verify manufacturer/UKRP is registered
DistributorsNo direct MHRA registration
Hospitals manufacturing in-house (own-institution use only)Separate exemption provisions may apply; consult MHRA
Clinical investigation sponsorsSeparate clinical investigation notification process

What information is required for registration​

Registration is completed via the MHRA Submissions portal at submissions.mhra.gov.uk. The portal requires:

For the registering entity (manufacturer or UKRP):

  • Legal name and registered address
  • Contact person details
  • Nature of role (manufacturer, UKRP, authorised representative)
  • DUNS number or equivalent business identifier (where available)

For each device registered:

  • Device name and description
  • Classification (Class I, IIa, IIb, III, AIMD, IVD category)
  • Intended purpose
  • Model or catalogue numbers
  • Whether sterile / has measuring function / is a reusable surgical instrument
  • UKAB name and certificate number (for devices requiring UKAB involvement)
  • Reference to Declaration of Conformity
  • Whether device is novel or if a substantially equivalent device exists

For CE-marked devices (under transitional acceptance):

  • EU Notified Body name and certificate number
  • EU regulatory framework under which CE marking was obtained (EU MDR, EU MDD, etc.)

When to register​

Registration must be completed before the device is placed on the GB market. There is no grace period for new devices.

For manufacturers already on the GB market at 1 January 2021 (when registration became mandatory), MHRA provided a phased registration process. All existing market participants should by now be registered.

Fees for registration​

MHRA charges fees for registration. The fee structure depends on:

  • The nature of the registering entity
  • The number of devices being registered
  • Whether the entity qualifies as a small or medium enterprise (SME)

Current fees are published on gov.uk/guidance/register-as-a-manufacturer-to-sell-medical-devices. Fees are subject to change — always check the current MHRA fee schedule.

Consequences of failing to register​

Placing a medical device on the GB market without completing MHRA registration is a criminal offence under the UK MDR 2002. MHRA can:

  • Issue enforcement notices
  • Require withdrawal of the device from the market
  • Prosecute the manufacturer or UKRP
  • Publicise non-compliance

MHRA takes registration compliance seriously and conducts market surveillance to identify unregistered devices.

Official references​

ReferenceDescription
UK MDR 2002, as amendedRegistration requirements
SI 2019/791Post-Brexit amendments establishing registration
MHRA: Register as a manufacturerMHRA registration guidance and portal
MHRA: Registration feesCurrent fee schedule