UK Responsible Person for Medical Devices

To place a Medical Device on the Great Britain market (England, Wales and Scotland), Manufacturers based outside the UK are required by the UK Medical Device Regulations 2002 to appoint a UK Responsible Person*.

Without a UK Responsible Person (UKRP) in place, it is not possible for a Manufacturer located outside the UK to register their Medical Devices for sale or use within the GB Market.

Why Appoint Eurolink Europe as your UK Responsible Person?

Eurolink Europe has specialised in providing EU Authorised Representative (EUAR) services to Medical Device manufacturers for over 20 years.  Since the UK’s formal departure from the European Union in 2019, Eurolink Europe has also provided UKRP services to those Medical Device Manufacturers who wish to continue supplying their devices to the GB market.

With experienced staff permanently based in UK, Eurolink Europe can provide its clients with knowledgeable and responsive UKRP support. 

Our UKRP Services for Medical Device and IVD Manufacturers include:

• Checking Technical Documentation to ensure the requirements of the UK Medical Device Regulations 2002 have been met and when necessary, supporting the creation of additional documentation.
• Supporting the registration of Manufacturers, Products and Importers with the Medicines & Healthcare products Regulatory Agency (MHRA).
• Use of Eurolink Europe company details on product labels and documentation, including Declarations of Conformity.
• Issuing of Declarations of Conformity on behalf of Manufacturers.
• Reviews of product labelling against the requirements of the UK MDR.
• Retention of Technical Documentation within the UK to ensure that it is at the disposal of the MHRA if requested.
• Cooperation with the MHRA on behalf of Manufacturers when required.
• Liaison, when required, with other Actors within Device supply chains, including Importers and Distributors.
• Delivery of updates on regulatory changes impacting Manufacturers’ devices.
• Provision of general Advisory Services when requested.

*Note:  A UK Responsible Person for Medical Devices is sometimes incorrectly referred to as a UK Authorised Representative (UKAR).  UKARs may be appointed by manufacturers in accordance with other UK product safety regulations and will fulfil similar responsibilities to those of a UKRP under the terms of the UK MDR 2002.