UK Responsible Person (UKRP)
Attention! Foreign Medical 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 Person.
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FSC & Apostille
Usually 6-8 Working Days
UK Responsible Person For 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 “MHRA UK Responsible Person” to regulate medical devices after Brexit.
Why should you choose I3CGLOBAL as your UKRP?
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
- 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 Biocompatibility and Safety Testing in multiple countries
- Clinical Investigation, Clinical Evaluation and Risk Analysis and risk benefit analysis
MHRA UK Responsible Person Responsibilities
The responsibilities of the UK Responsible Person 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
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.
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
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 Annual Fee
♦ Class I: £950 ( Additional GMDN Code £50 each)
♦ Class Is/m/r: £1050 ( Additional GMDN Code £75 each)
♦ Class IIa: £1200 ( Additional GMDN Code £100 each)
♦ Class IIb: £1300 ( Additional GMDN Code £125 each)
♦ Class III: £1400 ( Additional GMDN Code £150 each)
MHRA Registration Fee (Each Device / GMDN Code)
♦ MHRA Registration – Class I : £600 and additional device(s) £200 each
♦ MHRA Registration – Class Is/m/r : £600 and additional device(s) £300 each
♦ MHRA Registration – Class IIa, IIb : £600 and additional device(s) £300 each
♦ MHRA Registration – Class III : £600 and additional device(s) £300 each
MHRA Fees included. ( Applicable for Non-UK Legal manufacturers)