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UK Responsible Person
UK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
The UKRP registers the manufacturer and devices with the MHRA, holds technical documentation, and supports market surveillance. Required for all non-UK manufacturers selling to Great Britain. What the regulation says
The UK Medicines and Healthcare products Regulatory Agency (MHRA) Guidance on Submitting registration applications for medical devices specifies the obligations and responsibilities of the UK Responsible Person. These include registering devices with the MHRA, holding technical documentation, and cooperating with the MHRA during market surveillance activities. The UKRP must be a legal person established in the UK.
What this means in practice
UKRP and EC REP are not interchangeable - Brexit created two parallel obligations for any manufacturer selling into both markets.Examples
- A Canadian MedTech manufacturer appoints a UK-based regulatory consultancy firm to act as its UKRP to manage device registrations with the MHRA.
- An Asian MedTech company, having placed CE marked devices on the EU market via an EC REP, must also appoint a separate UKRP to register those same devices for sale in England, Scotland, and Wales.
- During a post-market surveillance inquiry, the MHRA contacts the UKRP of a US-based manufacturer to request specific technical documentation related to a reported adverse event.
Common pitfalls
- •A common pitfall is the failure to properly define the contractual agreement between the manufacturer and the UKRP, leading to misunderstandings regarding responsibilities and liabilities.
- •Manufacturers may mistakenly believe that their EU-based Authorized Representative can also act as their UKRP, leading to non-compliance for the Great Britain market.
- •Inadequate access to the manufacturer’s technical documentation by the UKRP can hinder their ability to respond effectively to MHRA requests, resulting in regulatory delays or enforcement actions.
- •Neglecting to keep the UKRP informed of significant changes to devices or quality management systems can invalidate registrations and lead to non-compliance.
- •Choosing a UKRP without sufficient regulatory expertise can lead to errors in device registration and ongoing compliance.
Frequently asked questions
The primary role of a UK Responsible Person (UKRP) is to act as a point of contact in the UK for manufacturers not based in the UK, ensuring their medical devices comply with UK regulations and are properly registered with the MHRA.
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
MHRA·1FDA·1European Commission·1
- 1
MHRA UKRP GuidanceVerifiedMHRAgov.uk
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.