UK Responsible Person (UKRP)

The UK responsible person (UKRP) would be the UK equivalent of the EU Authorized Representative, whose status would thereafter be abolished in relation to the UK. The UK MDR 2002 (as updated by the UK MDR 2019) contains information about UK responsible person. According to UK MDR 2019, the UKRP is “a person based in the United Kingdom who works on behalf of a foreign manufacturer based outside the United Kingdom in regard to the manufacturer’s responsibilities under the regulations.” A medical device can only be legitimately placed on the UK market by a manufacturer or a recognized UKRP.

To support his argument, documentary evidence in the form of an agreement between the manufacturer and the UKRP must be signed. This proof should be in the form of a mutually signed agreement (letter of designation) that includes the firm name and address for both the overseas manufacturer and the UKRP.

This document must indicate that the UK Responsible Person is operating with the agreement of the overseas manufacturer and that the devices being put on the UK market are compliant with all applicable laws. United Kingdom’s Medicines and Health Care products Regulatory Agency (MHRA) On 18 September 2019, published new guidelines regarding the role and responsibilities of the “MHRA UK Responsible Person” to regulate medical devices after Brexit.

We are hardcore medical device regulatory professionals and national representatives for 7 countries. We have extensive experience in medical device regulation and conduct more than simply clerical work as UKRP through our UK headquarters. We’ve been delivering a variety of services to medical device manufacturers all around the world since 1999. Our clients are all assured to be successful.

We also support with UKCA Technical Documentation, Clinical Evaluation, Biological Evaluation, Certification Body coordination, ISO 13485 Implementation support for the manufacturers beyond UKRP and MHRA registration service

The responsibilities of the UK Responsible Person are detailed in UK MDR 2019

You must obtain MHRA Registration for Medical Devices and In-Vitro Diagnostic Devices in order to sell, lease, rent, or exchange your product on the UK market. Make arrangements to register with the Medicines and Healthcare Products Regulatory Agency (MHRA). The UK MDR 2002 requires you to inform the MHRA before placing your device on the market in the United Kingdom. All non-UK businesses must designate a UK Responsible Persons (UKRP) with a registered place of business in the UK in order to register with the MHRA.