Representative Services

UK RP (UK Responsible Person)

Your Trusted UK Responsible Person for Medical Devices

Under the UK Medical Device Regulations 2002 (UK MDR 2002), all non-UK manufacturers must appoint a UK Responsible Person (UKRP) to place their medical devices on the Great Britain market. We offer expert UKRP services, ensuring seamless compliance with UK regulatory requirements.

Our UKRP Services

UK Responsible Person Representation

  • As per UK MDR 2002, foreign manufacturers must appoint a UKRP to legally sell their devices in England, Scotland, and Wales. We act as your UK Responsible Person, ensuring full regulatory compliance.

Medical Device Registration with MHRA

  • We handle the registration of Class I, IIa, IIb, and III medical devices, as well as IVDs, with the MHRA, ensuring accurate and timely submissions.

UKCA Marking & Compliance Assistance

  • We assist in transitioning from CE marking to UKCA marking, ensuring compliance with UK-specific regulatory requirements.

Post-Market Surveillance & Vigilance

  • We monitor device safety, facilitate adverse event reporting, and liaise with the MHRA for post-market compliance.

Regulatory Updates & Compliance Management

  • We keep you informed about evolving UK medical device regulations and ensure ongoing compliance.

Who Needs a UK Responsible Person?

Contract Manufacturers & Suppliers

Non-UK Manufacturers without a local UK presence.

Medical Device & IVD Manufacturers

Medical Device Companies looking to enter the UK market.

Distributors & Importers

Regulatory Consultants seeking UK representation for their clients.

How to Appoint Us as Your UKRP?

  • Contact Us – Discuss your UK regulatory needs with our experts.
  • Agreement & Documentation – Sign an official UKRP service agreement.
  • Device Registration – We register your devices with the MHRA and ensure compliance.
  • Ongoing Compliance Support – We provide continuous regulatory guidance and vigilance services.
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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