UK Responsible Person

UK Responsible Person Medical Devices

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 “UK responsible person” to regulate medical devices after Brexit.

Why should you choose I3CGLOBAL as your UKRP?

I3CGLOBAL is a world-leading medical device regulatory consulting firm with national representatives for a 7 countries and regulations. 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 manufactures 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 manufactures beyond UKRP and MHRA registration service

 

♦   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 compliances

♦   Friendly team for business relationships with Multiple payment options from multiple countries

♦   Identification of appropriate GMDN Code for no charges

♦   Associated Laboratories for Biocompatablity and Safety Testing in multiple countries

♦   Clinical Investigation, Clinical Evaluation and Risk Analysis and risk benefit analysis

Responsibilities of the UK Responsible Person

 

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

 

♦  Ensure correct medical device classification followed

♦  Ensuring manufacturer has considered appropriate conformity assessment procedure

♦  Assure 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 manufacturer If any request for samples or device from MHRA

♦  Cooperate with the MHRA on any CAPA action taken to eliminate potential risks

♦  Inform 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 represents

♦  Support PMS activities

MHRA Registration

To sell, lease, rent, or trade your device on the UK market, you must have MHRA Registration for Medical Devices and In-Vitro Diagnostic Devices. Prepare to register with the Medicines and Healthcare Products Regulatory Agency (MHRA). It is a requirement of the UK MDR 2002 that you notify the MHRA before placing your device on the market in the United Kingdom. To register with the MHRA, all non-UK entities must designate a UK Responsible Persons (UKRP) with a registered place of business in the UK.

 

The following devices must be registered with the MHRA before 1 May 2021.

 

»  Active implantable medical devices

»  Class III medical devices

»  Class IIb implantable medical devices

»  IVD List A products

 

The following devices must be registered with the MHRA before 1 September 2021.

 

»  Class IIb non-implantable medical devices

»  Class IIa medical devices

»  IVD List B products

»  Self-test IVDs

 

The following devices must be registered with the MHRA before 1 January 2022.

 

»  Class I medical devices

»  General IVDs

 

MHRA Registration must be renewed one year after your registration application or confirmation was made and every two years after this date. Failure to renew your registration will result in the removal of your records from our database, after which you will need to complete a new registration application or you will no longer be able to place your device on the UK market.

Documents needed for MHRA registration

A. Manufacturer (Facility) Information:

»  Legal manufacturer name, address, designation, telephone and email

»  Activity carried out by the legal manufacturer.

»  Person responsible to communicate with MHRA (Name, Email & Contact Information)

»  Mutually signed agreement with legal manufacturer and UK Responsible person.

 

B. Medical Device Information:

»  Applicable Regulation

»  Device Risk Classification

»  GMDN Code applicable to the device in scope

»  Basic UDI-DI ( Presently not enforced, but soon will come into effect)

»  Medical device brand/trade or proprietary name

»  Device model or versions

»  IFU / User Manual / Catalogue reference number

»  UK Approved Body Or Notified Body name and address for all classes other than class I

»  Type of Sterilization (If applicable)

»  Details about Latex and phthalates.

»  Medical Device MRI compatibility issues

»  Conformity assessment certificates

»  Signed and dated Declaration of Conformity

»  Technical File latest revision number with date.

UK Responsible Person (UKRP) Annual Fee

♦  Class I: 950 GBP ( Additional GMDN Code 50 GBP each)

♦  Class Is/m: 1050 GBP ( Additional GMDN Code 75 GBP each)

♦  Class IIa: 1200 GBP ( Additional GMDN Code 100 GBP each)

♦  Class IIb: 1300 GBP ( Additional GMDN Code 125 GBP each)

♦  Class III: 1400 GBP ( Additional GMDN Code 150 GBP each)