UK Responsible Person
UK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market.
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. The UKRP also keeps the declaration of conformity available, cooperates with the MHRA on corrective actions, and passes on complaints and incident reports. Its name and address must appear on the label or packaging, or in accompanying documents.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.
- •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
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Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1MHRA UKRP GuidanceTier 2 VerifiedMHRAgov.uk
- 2FDA - Medical DevicesTier 2 VerifiedFDAfda.gov
- 3European Commission - Medical DevicesTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.