Regulatory
UK Responsible Person(UKRP)
In one line
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.
Why it matters
UKRP and EC REP are not interchangeable - Brexit created two parallel obligations for any manufacturer selling into both markets.
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.
Sources
- MHRA UKRP Guidance · MHRA
- FDA - Medical Devices · FDA
- European Commission - Medical Devices · European Commission