MHRA UK Medical Device Registration & Approval

Medical devices and IVDs placed on the market in Great Britain are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The primary legislation is the UK Medical Devices Regulations 2002 (UK MDR 2002), and its amendments following the UK’s withdrawal from the European Union.

Devices must comply with the applicable UK regulatory requirements and, in most cases, bear the UKCA mark before being placed on the market. EU CE marking is still recognized for certain devices during transitional periods, with final transition deadlines in 2028. Manufacturers must also register their devices with the MHRA’s Device Online Registration System (DORS).

Foreign manufacturers must appoint a UK Responsible Person (UKRP) if they do not have a UK-based legal presence. The UKRP acts on behalf of the manufacturer to carry out specific regulatory obligations, including device registration in DORS and communications with the MHRA.

United Kingdom medical device and IVD classification

The UK applies a risk-based classification system aligned with EU rules. General medical devices are classified as Class I, IIa, IIb, and III under the UK MDR 2002. Active implantable medical devices follow specific provisions. In vitro diagnostic devices are classified as general IVDs, IVDs for self-testing, and Annex II List A and List B IVDs. Classification determines the conformity assessment route and level of Notified Body involvement.

MHRA medical device regulatory pathways

There are two principal conformity assessment pathways for Great Britain: UKCA marking through a UK Approved Body or, during applicable transitional periods, CE marking under EU legislation. The appropriate route depends on device classification, manufacturer location, and current regulatory timelines.

UKCA marking is not recognized in Northern Ireland, where different authorization rules apply.

UKCA Route (Great Britain market)

• Process: The manufacturer completes a conformity assessment in accordance with the UK MDR 2002 and its Amendments with a UK Approved Body. Upon successful assessment, the manufacturer affixes the UKCA mark, appoints a UKRP (as applicable) and registers the device in DORS.

• Requirements: Documentation includes a technical file or design dossier demonstrating conformity with the Essential Requirements, a Declaration of Conformity, evidence of an appropriate quality management system (typically certified to ISO 13485), clinical evidence where applicable, and labeling compliant with UK requirements.

• Timeline: Review timelines depend on device classification and the scope of UK Approved Body assessment. Higher-risk devices will have longer assessment periods.

• Renewal: UKCA certificates issued by a UK Approved Body are typically valid for up to five years. DORS must be maintained and updated as required.

CE Marking Route (Recognized during transitional periods)

• Process: The manufacturer completes conformity assessment under applicable EU legislation with an EU Notified Body where required. During recognition periods established by UK law, CE-marked devices may be placed on the UK market. To do so, the manufacturer shall appoint a UKRP (as applicable) and must register the CE-marked devices in DORS.

• Requirements: Required documentation includes a technical dossier that meets EU requirements, an EU Declaration of Conformity, applicable CE certificates, and compliance with UK registration and labeling provisions, including identification of the UK Responsible Person where applicable.

• Timeline: Driven primarily by EU conformity assessment procedures and availability.

• Renewal: CE certificates must remain valid under EU rules. Continued placement on the Great Britain market depends on compliance with applicable UK transitional provisions.
  

Key MHRA registration requirements

• UK Responsible Person: Required for manufacturers established outside the UK placing devices on the Great Britain market. The UK Responsible Person must be established in the UK and is responsible for registering devices with the MHRA, maintaining technical documentation access, and facilitating communication with MHRA as applicable

• Registration with MHRA: All medical devices and IVDs must be registered with the MHRA before being placed on the Great Britain market. Registration is completed through the MHRA Device Online Registration System (DORS). Fees apply.

• Labeling: Devices must bear the UKCA or CE Mark as applicable. In the case of UKCA marking, the label shall include the name and address of the UK Responsible Person. UKRP details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings. Instructions for Use and labeling must be in English.

• Post-market obligations: Manufacturers, with the support of their UKRP, must establish post-market surveillance systems, report serious incidents and field safety corrective actions to the MHRA, and comply with vigilance requirements set out in the UK MDR 2002.

What documentation is required to register a medical device or IVD in Great Britain?

Documentation requirements depend on device classification and the selected conformity assessment route. In general, manufacturers should prepare:

• A complete technical documentation file demonstrating conformity with the Essential Requirements of the UK MDR 2002 for the UKCA marked device. If leveraging CE marking, then a complete technical documentation file demonstrating conformity with the applicable EU legislation is required.

• A Declaration of Conformity referencing applicable UK legislation for UKCA marked devices. If leveraging CE marking, the Declaration of Conformity must reference applicable EU legislation.

• Quality management system certification, where required.

• Clinical evaluation or performance evaluation documentation, as applicable.

• UKCA or CE certification from an Approved Body or EU Notified Body, where required.

• Pay the applicable fees once the draft MHRA device registration is submitted.

What is a UK Responsible Person and why do you need one?

A UK Responsible Person (UKRP) is a legal entity established in the United Kingdom that acts on behalf of a manufacturer located outside the UK. The UK Responsible Person ensures that the Declaration of Conformity and technical documentation have been prepared, registers the device with the MHRA, cooperates with the MHRA on corrective actions, and maintains copies of technical documentation for inspection. Non-UK manufacturers cannot place devices on the Great Britain market without appointing a UKRP.

What is a UK Approved Body?

A UK Approved Body is an organization designated by the UK government to perform conformity assessments under the UK MDR 2002. Approved Bodies review quality management systems, technical documentation, and clinical evidence for higher-risk devices before issuing UKCA certificates. Only Approved Bodies with an appropriate scope of designation may assess specific device types.

What are the deadlines for leveraging EU CE Marking in Great Britain?

CE Marked devices can be placed on the Great Britain market up until these deadlines:

• EU MDD or EU AIMDD general medical devices: earlier of certificate expiry or 30 June 2028

• EU IVDD IVDs: earlier of certificate expiry or 30 June 2030

• EU MDR general medical devices (including custom-made): 30 June 2030

• EU IVDR IVDs: 30 June 2030

• Self-declared Class I devices under EU MDR: 30 June 2030

• Self-declared Class I devices under MDD (declared before 26 May 2021 and upclassified under MDR): 30 June 2028

• Class I sterile or measuring devices with valid MDD certificate: 30 June 2028

Not eligible for the above timelines:

• Class I self-certified medical devices under the EU directives that do not meet the EU transitional timelines.

• General IVDs under the EU directives that do not meet the EU transitional timelines.

• Custom-made devices compliant with EU MDD or EU AIMDD

Devices placed on the Great Britain market after these deadlines must comply with the UK conformity assessment process and bear the UKCA mark (unless a new legislative extension is introduced). Devices lawfully placed on the Great Britain market before the deadline may continue to be made available or put into service. However, any new placement after the deadline requires UKCA compliance.