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UKCA / UK MDR

Find a UK Responsible Person (UKRP)

Post-Brexit, non-UK manufacturers placing regulated products on the GB market must appoint a UK-established Responsible Person under UKCA marking requirements, UK MDR 2002, UK RED and other UK regulations. Submit one request — ECP connects you to UK RP providers with the coverage you need.

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Who needs a UK Responsible Person?

Any manufacturer established outside the United Kingdom who places regulated products on the GB market must appoint a UK Responsible Person (UKRP). This is a post-Brexit requirement — your EU Authorised Representative cannot serve as UKRP.

RegulationRequirementScope
UK MDR 2002 (as amended)Mandatory — MHRA registration requiredAll medical devices from non-UK manufacturers
UKCA marking (general products)Required for UKCA-marked productsProducts requiring UKCA conformity marking
UK Radio Equipment Regulations 2017Required for non-UK manufacturersRadio and telecommunications equipment
UK PPE Regulations 2018Required for non-UK manufacturersPersonal protective equipment
UK Toys (Safety) Regulations 2011Required for non-UK manufacturersToys and children's products

MHRA medical device registration is mandatory before placing devices on the GB market. The UKRP must register the manufacturer and devices in the MHRA database. Non-compliance can result in products being refused entry or withdrawn from the UK market.

What the UK Responsible Person does

  • Acts as the UK-established legal contact for the manufacturer with MHRA and other UK authorities
  • Registers the manufacturer and their products in the MHRA medical devices database (for medical devices)
  • Holds copies of technical documentation, Declaration of Conformity, and other required documents
  • Cooperates with MHRA on market surveillance inquiries, vigilance, and safety actions
  • Coordinates product recalls and field safety corrective actions in the UK market
  • Ensures UKCA marking documentation is current and correct
  • Named on the product label or packaging as the UK RP

Documents and information typically required

  • Product description, intended use and applicable UK regulations
  • Existing EU CE marking certificates (if applicable)
  • Current UK MDR risk class (Class I, IIa, IIb, III) for medical devices
  • Number of distinct product models requiring UKRP coverage
  • Target launch date or current UK market presence status
  • Any existing MHRA registration numbers

Many providers offering EU Authorised Representative services also offer UK RP through affiliated UK-established entities. A combined EU AR + UK RP package from one provider reduces administrative overhead and cost.

Find your UK Responsible Person

Submit one request to ECP and receive proposals from UK Responsible Person providers with MHRA experience and UKCA marking expertise. Free, no commitment.

Related services

ServiceDescription
EU Authorized Representative (EC REP)Mandatory EU AR for non-EU manufacturers under MDR, IVDR, RED, LVD — separate from UK RP
PRRC ServicesPerson Responsible for Regulatory Compliance under MDR/IVDR Art. 15
Swiss FADP RepresentativeSwiss data protection representative — another separate jurisdiction
Compare EC REP ProvidersCompare EU AR providers including those with UK coverage