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 in regard to the manufacturer’s responsibilities under the regulations.” A 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
UK Responsible Person For Medical Devices
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.
The UK Responsible Person (UKRP) would be the UK equivalent of the EU authorized representative the role of which will then disappear with regards to the United Kingdom. The UK MDR 2002 (as amended by the UK MDR 2019) details about UKRP.
To support his argument, documentary evidence in the form of an agreement between the manufacturer and the UK Responsible Person 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 “UKRP” to regulate medical devices after Brexit.
Who is UK Responsible Person?
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 UK Responsible Person Service 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 UK Responsible Person services.
- 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
UK Responsible Person Roles and Responsibilities
- UK Responsible Person 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 is Mandatory For Medical Device & IVD’s
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
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.
