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UK Responsible Person (UKRP)

According to UK MDR 2019, the UK Responsible Person (UKRP) is “a person based in the United Kingdom who works on behalf of a foreign manufacturer based outside the United Kingdom regarding the manufacturer’s responsibilities under the regulations.” Medical devices can only be legitimately placed on the UK market by a manufacturer or a recognized UKRP.

UKRP Appointment

Usually 3-4 Working Days

MHRA Registration

Usually 4-6 Working Days

FSC & Apostille

Usually 6-8 Working Days

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UK Responsible Person for Medical Device

The UK Responsible Person for Medical Devices and IVDs would be the UK equivalent of the EU Representative, the role of which will then disappear with regard to the United Kingdom. The UK MDR 2002 (as amended by the UK MDR 2019) details the 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 UK responsible person.

 

This document must indicate that the UKRP 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) 18 September 2019, published new guidelines regarding the role and responsibilities of the “UKRP” in regulating medical devices after Brexit.

Attention! Foreign Medical Device and In-Vitro Diagnostic Device Manufacturers.

Post-Brexit all foreign manufacturers must register and list the device with MHRA before exporting to the UK. We are designated as UK Responsible Persons.

UKRP e1683307939201
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Benefits of collaborating with our UKRP Services

Working with I3CGLOBAL as your UK Responsible Person (UKRP) offers several advantages for foreign medical devices and In-vitro diagnostic device manufacturers

 

  • Experienced consultants, regulatory experts, and auditors who can study and understand any type of complicated device regulation and can provide expert opinion and advice.
  • Not limited to UK Responsible person service, we provide A to Z services for Certification and compliance
  • Friendly team for business relationships with Multiple payment options from multiple countries
  • Identification of appropriate GMDN Code for no charges
  • Associated Laboratories for Biocompatibility and Safety Testing in multiple countries
  • Clinical Investigation, Clinical Evaluation and Risk Analysis and risk-benefit analysis

 

I3CGLOBAL are hardcore medical device regulatory professionals and national representatives for seven countries. We have extensive experience in medical device regulation and conduct more than simply clerical work as UKRP Services through our United Kingdom headquarters. We’ve been delivering a variety of services to medical device manufacturers all around the world since 1999. Our clients are all assured of success.

 

We also support UKCA Technical Documentation, Clinical Evaluation, Biological Evaluation, Certification Body coordination, and ISO 13485 implementation support for the manufacturers beyond MHRA registration and UKRP services.

UKRP Roles and Responsibilities

The UK Responsible Person (UKRP) plays a critical role in ensuring that medical devices and Invitro diagnostic devices placed on the UK market comply with UK requirements. Here are the key roles and responsibilities of a UKRP

 

  • UK Responsible Person Ensure correct medical device classification followed
  • Ensuring the manufacturer has considered the appropriate conformity assessment procedure
  • Assure the manufacturer maintains the latest technical documentation and DOC
  • Maintain a copy of the technical documentation, for inspection by the MHRA
  • Provide MHRA with all the information and documentation necessary on request
  • Coordinate with the manufacturer If any request for samples or devices from MHRA
  • Cooperate with the MHRA on any CAPA action taken to eliminate potential risks
  • Inform the manufacturer about field incidents & complaints in the shortest period
  • Monitor manufacturer, if acts contrary to its obligations under MHRA Regulations
  • Notify the MHRA and, if necessary, end UKRP contact with the manufacturer.
  • Opening a single registration account on behalf of the manufacturers that we represent
  • Support  PMS activities