MHRA – authority responsible for registration and market surveillance

Medicines and Healthcare products Regulatory Agency (MHRA) is in charge of authorising medical devices and IVDs for the Great-Britain market, maintaining registers, supervising UK Approved Bodies, reviewing technical documentation and carrying out enforcement. The agency handles submissions for England, Scotland and Wales. Northern Ireland follows EU rules in part because of the Northern Ireland Protocol.

The UKCA mark – the British equivalent of CE

UKCA (UK Conformity Assessed) marking is required for most devices placed on the Great-Britain market, covering both MDs and IVDs. Conformity-assessment routes are defined in UK MDR 2002, which transposed the former EU directives (MDD, IVDD). Ongoing amendments will align the UK system with MDR/IVDR, but for now the legacy rules still apply.

UKCA certificates can be issued only by UK Approved Bodies. CE certificates may be accepted during a transition period, with deadlines depending on the device class.

Device classification and conformity-assessment routes

The UK keeps the legacy EU scheme:

  • Class I – low risk; self-declaration possible
  • Classes IIa, IIb, III – certification by a UK Approved Body required
  • IVDs – classified under the IVDD until new regulations take effect

Manufacturers must compile UK MDR-compliant technical documentation, issue a declaration of conformity and affix the UKCA mark. IVDs must meet performance-validation and labelling requirements similar to those in the EU.

UKRP – the UK responsible person

Manufacturers located outside Great Britain must appoint a UK Responsible Person (UKRP), a legal entity established in the UK. The UKRP:

  • registers the device with MHRA,
  • holds the technical documentation on the manufacturer’s behalf,
  • communicates with MHRA and handles enforcement actions,
  • co-operates on post-market surveillance and incident reporting.

The UKRP role is similar to the EU authorised representative (EC-REP) but applies only to the UK market.

Device registration with MHRA

Every medical device and IVD—whatever its class—must be registered with MHRA before it is placed on the British market. The application is submitted by the UK-based manufacturer or the appointed UKRP; an importer cannot file on the manufacturer’s behalf.

MHRA requires annual renewal of the registration and immediate notification of any changes to:

  • contact details,
  • UKCA/CE certification,
  • device scope or its documentation.

Failure to update may lead to removal from the register and administrative penalties. MHRA has powers to inspect and enforce under the relevant market-surveillance regulations.

Specifics of IVD registration in the UK

IVDs are still regulated under the IVDD-based rules; classification follows the list-based and risk-based approach of the old directive. MHRA is preparing to switch to an IVDR-like system, but until then manufacturers must comply with the legacy requirements.

IVDs must be registered with MHRA, and performance data, IFU and labels must meet the language and regulatory demands of the British market.

How Pure Clinical can help with MD & IVD registration in the United Kingdom

UK registration calls for knowledge of UK MDR 2002, the CE/UKCA transition routes and MHRA’s local expectations. Pure Clinical supports manufacturers and UKRPs throughout the entire preparation and submission process.

Our services include:

  • selecting the correct UKCA route and conformity-assessment pathway,
  • reviewing technical files and labels for UK MDR compliance,
  • managing MHRA registration,
  • assisting in appointing and operating the UKRP,
  • analysing CE certificates in the context of transitional provisions,
  • monitoring legislative changes affecting MDs and IVDs in the UK.

With experience in both EU and UK regulations and local partners, we ensure safe and compliant market entry for your product in Great Britain.