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Who needs to comply?

Regulatory basis

This page is based on the UK Medical Devices Regulations 2002 (SI 2002/618, as amended), particularly the definitions of manufacturer and related economic operators, and MHRA registration requirements. The UKRP role was introduced by SI 2019/791 as part of the post-Brexit framework.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult MHRA guidance and the legislation text before determining your regulatory obligations.

Overview of economic operators​

The UK MDR 2002 places obligations on several categories of economic operator — not just manufacturers. Understanding which role you occupy (and you may occupy more than one) is essential to knowing what you must do before placing a medical device on the GB market.

Economic operatorMust register with MHRA?UKCA / compliance obligationKey obligation
ManufacturerYesPrimary responsibilityDesign, manufacture, technical documentation, Essential Requirements
UK Responsible Person (UKRP)YesShares responsibility with manufacturerLegal representative in GB for overseas manufacturers
Authorised RepresentativeYes (if UK-established)No direct compliance — representative roleRegisters, transmits, liaises with MHRA on behalf of manufacturer
ImporterYesVerify, not create complianceVerify device is compliant before placing on GB market
DistributorNo (generally)Verify, not create complianceVerify device has UKCA mark / transitional CE; proper storage

Manufacturers​

Who is a manufacturer?​

Under UK MDR 2002, a manufacturer is any natural or legal person who:

  • Designs and/or manufactures a medical device with a view to placing it on the market under their name, whether or not that device is designed or manufactured by that person or by other persons on their behalf.

The definition covers:

  • Companies that both design and manufacture their own devices
  • Companies that design devices and contract manufacture to a third party (the commissioning company is still the manufacturer)
  • Companies that substantially change or reprocess a device and re-release it under their own name
  • Own-label manufacturers who rebrand devices designed and manufactured by others — they take on full manufacturer responsibility

Manufacturer's key obligations​

  1. Design and develop the device to meet the Essential Requirements (Schedule 1 / Schedule 1A of UK MDR 2002)
  2. Maintain a technical file (or design dossier for higher-risk devices) demonstrating conformity
  3. Conduct clinical evaluation (or performance evaluation for IVDs)
  4. Apply the conformity assessment procedure appropriate to the device class
  5. Appoint a UK Approved Body where required (Class IIa, IIb, III, AIMD, IVD List A and B)
  6. Issue a UK Declaration of Conformity before placing the device on the GB market
  7. Affix the UKCA mark (or rely on CE marking under transitional acceptance)
  8. Register with MHRA via the Submissions portal
  9. Maintain a Quality Management System (QMS) — typically to ISO 13485
  10. Fulfil post-market obligations — PMS, vigilance reporting, PSUR (where applicable), distribution records

If the manufacturer is not established in the United Kingdom, they must appoint a UKRP to represent them with MHRA for the GB market.

UK Responsible Persons (UKRPs)​

What is a UKRP?​

The UK Responsible Person (UKRP) is a role introduced specifically for the GB post-Brexit market. Any manufacturer not established in the United Kingdom who wishes to place a device on the GB market must appoint a UKRP.

A UKRP must:

  • Be established in Great Britain (England, Scotland, or Wales)
  • Be appointed by the manufacturer through a formal written agreement
  • Register with MHRA as the legal representative of the overseas manufacturer
UK-unique concept

The UKRP has no direct equivalent in most other jurisdictions at this level of prominence. It is analogous to — but distinct from — the EU Authorised Representative (EU REP). Unlike the EU REP, the UKRP is explicitly described in UK law as sharing responsibility with the manufacturer for regulatory compliance, not merely acting as a point of contact.

UKRP's key obligations​

  1. Register with MHRA as the UKRP for the manufacturer
  2. Register the manufacturer's devices with MHRA if the manufacturer has not done so directly
  3. Maintain a copy of the Declaration of Conformity and the technical file (or know where they are held and be able to retrieve them)
  4. Transmit reports of serious incidents and FSCAs to MHRA
  5. Cooperate with MHRA on investigations, audits, and enforcement actions
  6. Notify the manufacturer of any complaints or field reports relating to the device
  7. Appear on the device label — the UKRP's name and address must be on the label or packaging of devices placed on the GB market by an overseas manufacturer

UKRP on the label​

For devices placed on the GB market by a non-UK manufacturer, the label must include either:

  • The manufacturer's name and address and the UKRP's name and address, or
  • The UKRP's name and address in a way that makes clear it is the UKRP

This labelling requirement is in addition to — not instead of — the manufacturer's own details.

Who can be a UKRP?​

Any legal or natural person established in Great Britain may act as a UKRP, provided they:

  • Are not the same entity as the manufacturer
  • Have the operational capability to fulfil the UKRP's obligations
  • Have a written agreement with the manufacturer defining their responsibilities

Many specialist regulatory affairs consultancies, contract regulatory organisations (CROs), and UK-based subsidiaries of overseas companies act as UKRPs.

Importers​

Who is an importer?​

An importer is any natural or legal person established in the United Kingdom who places a device from a third country on the GB market.

Note: if you import a device from an overseas manufacturer and place it on the GB market under your own name, you are acting as the manufacturer — not merely the importer.

Importer's key obligations​

  1. Verify that the device bears the UKCA mark (or transitional CE mark) before placing it on the market
  2. Verify that the manufacturer has registered with MHRA (or that a UKRP is appointed and has registered)
  3. Verify that the manufacturer has issued a Declaration of Conformity
  4. Verify that the device is properly labelled and accompanied by appropriate instructions for use
  5. Inform the manufacturer and/or UKRP if a device appears not to conform to UK MDR 2002 requirements — and not place it on the market until compliant
  6. Report any device that presents a serious risk to MHRA
  7. Maintain records of importation, including supplier details and device identification, for a period of at least five years (ten years for implantable devices)
  8. Store and transport devices according to the manufacturer's conditions

Distributors​

Who is a distributor?​

A distributor is any natural or legal person in the supply chain — other than the manufacturer or importer — who makes a device available on the GB market.

Examples include wholesalers, dealers, hospital procurement teams receiving and re-supplying devices, and online retailers of medical devices.

Distributor's key obligations​

  1. Verify before supplying that the device bears the UKCA mark (or transitional CE mark)
  2. Verify that the device is properly labelled
  3. Not supply a device they believe does not conform to UK MDR 2002
  4. Inform the manufacturer, UKRP, and MHRA of devices suspected of being non-compliant or presenting a serious risk
  5. Maintain traceability records to enable recall if necessary
  6. Store and transport devices according to the manufacturer's conditions

Distributors do not generally need to register with MHRA, but they are subject to MHRA's market surveillance powers.

Authorised Representatives​

An authorised representative in the UK MDR 2002 context refers to a person established in the UK who is explicitly authorised in writing by the manufacturer to act on the manufacturer's behalf with MHRA for specified tasks. This role overlaps significantly with the UKRP for non-UK manufacturers.

For UK-established manufacturers, an authorised representative may be appointed to handle MHRA interactions, though the manufacturer retains all legal obligations.

Consultants and auditors​

Regulatory affairs consultants and quality system auditors are not defined economic operators under UK MDR 2002 — they do not have direct regulatory obligations. However, they play an important practical role:

  • Regulatory consultants assist manufacturers and UKRPs in preparing technical files, declarations of conformity, and MHRA submissions
  • Quality management auditors (internal and external) assess conformity to ISO 13485
  • UK Approved Body auditors conduct formal conformity assessment audits on behalf of UKABs

MHRA does not regulate consultants or auditors directly, but any consultant acting as a UKRP is subject to UKRP obligations.

Multiple roles​

It is possible and common for one entity to occupy more than one economic operator role:

  • A UK importer who rebrands a product becomes the manufacturer
  • A UK subsidiary of an overseas manufacturer may act as both the UKRP and the importer
  • A large hospital system that custom-assembles procedure packs may become a manufacturer for those packs

Carefully assess which role(s) your organisation occupies — each role carries distinct obligations.

Official references​

ReferenceDescription
UK MDR 2002, Reg 2(1)Definitions of manufacturer, importer, distributor
SI 2019/791, Schedule 1UKRP provisions inserted into UK MDR 2002
MHRA: Guidance on UKRPsMHRA's published guidance on the UKRP role
MHRA: Registering medical devicesMHRA registration requirements for all economic operators
ISO 13485:2016Quality management systems for medical devices