MHRA Updates Guidance on Regulating Medical Devices in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance document titled “Regulating medical devices in the UK”, with the latest update dated 20 February 2026 .

The guidance sets out the regulatory framework for placing medical devices on the markets of Great Britain (England, Wales and Scotland), Northern Ireland, and, where relevant, the European Union (EU).

Legislation Applicable in Great Britain

Medical devices placed on the market in Great Britain are regulated under the Medical Devices Regulations 2002 (UK MDR 2002), as amended .

The current Great Britain framework is based on requirements derived from:

• Directive 90/385/EEC on active implantable medical devices

• Directive 93/42/EEC on medical devices

• Directive 98/79/EC on in vitro diagnostic medical devices

The EU Medical Devices Regulation (EU MDR 2017/745) and the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746) do not automatically apply in Great Britain .

Registration Requirements in Great Britain

All medical devices, including:

• In vitro diagnostic medical devices (IVDs)

• Custom-made devices

• Systems or procedure packs

must be registered with the MHRA before being placed on the Great Britain market .

Failure to register a device means it cannot be lawfully placed on the Great Britain market .

Where the manufacturer is not established in the UK, a UK Responsible Person (UKRP) must be appointed .

UK Responsible Person

Manufacturers based outside the UK must appoint a UK Responsible Person to place a device on the Great Britain market .

The responsibilities of the UK Responsible Person are set out in the UK MDR 2002 and include:

• Registering the manufacturer’s devices with the MHRA

• Keeping available a copy of the technical documentation and declaration of conformity

• Providing information and documentation to the MHRA upon request

• Cooperating with the MHRA on preventive and corrective actions

• Informing the MHRA if the manufacturer acts contrary to its obligations

UKCA Marking and Approved Bodies

The UKCA (UK Conformity Assessed) marking is a UK product marking used for placing certain goods, including medical devices, on the Great Britain market .

The UKCA marking is not recognised in the EU, EEA or Northern Ireland markets .

The MHRA may designate UK approved bodies to conduct conformity assessments against the relevant requirements for the purposes of UKCA marking .

Manufacturers of:

• Class I medical devices (non-sterile, non-measuring)

• General IVDs

may self-declare conformity under UK MDR 2002 .

CE Marking on the Great Britain Market

The guidance states that CE-marked devices will continue to be accepted on the Great Britain market, depending on device type and classification, until 30 June 2030 at the latest .

This includes devices that comply with:

• EU MDD or EU AIMDD

• EU IVDD

• EU MDR

• EU IVDR .

Specific conditions relating to declaration dates, certificate validity and applicable legislation are detailed in the guidance .

Expired or Expiring CE Certificates

The guidance refers to EU transitional arrangements extending validity of certain EU MDR and EU IVDR certificates in limited circumstances .

Separate MHRA registration guidance applies to:

• Devices with expired or expiring CE certificates

• Devices up-classified under EU MDR

• IVD devices up-classified under EU IVDR .

Labelling Requirements

Medical devices placed on the Great Britain market must bear either a UKCA marking or a CE marking, depending on the applicable legislation .

Where relevant, the name and address of the UK Responsible Person must appear on the labelling or outer packaging .

Devices may display both CE and UKCA markings .

Post-Market Surveillance and Vigilance

Once a medical device has been placed on the UK market, manufacturers must report certain incidents to the MHRA and take appropriate safety actions when required .

The guidance states that legislation was introduced in 2024 to clarify and strengthen post-market surveillance requirements. These measures came into force on 16 June 2025 .

Regulation of Medical Devices in Northern Ireland

The guidance explains that the rules for placing medical devices on the Northern Ireland market differ from those applying in Great Britain .

EU MDR has applied in Northern Ireland since 26 May 2021 and EU IVDR since 26 May 2022 .

Under the Northern Ireland Regulations 2021, certain devices must be registered with the MHRA .

CE marking is required for the Northern Ireland market .

Read the full document below.