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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.

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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 Non-compliance can result in products being refused entry or withdrawn from the UK market.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.

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
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