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.

FAQ

What is the MHRA?

The MHRA (Medicines and Healthcare products Regulatory Agency) is the UK authority responsible for authorising medical devices and IVDs for the UK market, maintaining their registration, overseeing UK Approved Bodies, and carrying out market surveillance after a device is placed on the market.

What is UKCA marking and is it mandatory?

UKCA (UK Conformity Assessed) is the UK equivalent of the CE mark, required for most medical devices and IVDs placed on the UK market. It is based on the UK MDR 2002. UKCA certificates can only be issued by UK Approved Bodies.
 

Can CE-marked devices still be sold in the UK?

Yes, on a transitional basis. Devices compliant with the MDD are currently accepted until 30 June 2028, while devices compliant with the MDR and IVDR are accepted until 30 June 2030. The MHRA is also consulting (since February 2026) on the possibility of permanently recognising CE marking.

Who must appoint a UK Responsible Person (UKRP)?

A UKRP is required for manufacturers based outside the UK who wish to place a medical device or IVD on the UK market. It is a legal entity based in the UK, acting on the manufacturer's behalf — a role analogous to the EU Authorised Representative (EC-REP), but limited to the UK market.
 

What are the responsibilities of a UK Responsible Person?

The UKRP registers the device with the MHRA, maintains compliance documentation on the manufacturer's behalf, communicates with the MHRA on post-market matters, and cooperates on post-market surveillance and incident reporting.

Does every medical device need to be registered with the MHRA?

Yes. All medical devices and IVDs, regardless of risk class, must be registered with the MHRA before being placed on the UK market. Only a UK-based manufacturer or an appointed UKRP can submit the application — an importer cannot register a device on the manufacturer's behalf.

How are medical devices classified under the UK system?

The classification system remains aligned with the previous EU system. Class I devices can rely on self-declaration of conformity, while Class IIa, IIb and III devices require certification by a UK Approved Body. IVD classification is still based on the IVDD rules.

What happens if a manufacturer fails to report a change to the MHRA?

Failing to report a change to contact details, the UKCA/CE certificate, the device's scope or its documentation can result in the device being removed from the MHRA register and in administrative sanctions. Manufacturers must also update their registration entries annually.

Does Northern Ireland follow the same rules as England, Scotland and Wales?

Not entirely. The MHRA handles registrations for England, Scotland and Wales, while Northern Ireland partially follows EU rules under the Northern Ireland Protocol.

What requirements apply to IVDs in the UK?

IVDs are still subject to rules based on the IVDD — classification is based on the annex list and diagnostic risk. The MHRA plans to update the system to align with the IVDR, but until it is fully implemented, manufacturers must apply the existing rules, including MHRA registration and compliance of IFU documentation and labelling with UK market requirements.