UK Responsible Person For Medical Devices & IVDs!
According to UK MDR 2019, the UK Responsible Person must be appointed to ensure compliance with the Medicines Health and Regulatory Authority guidelines for placing medical devices and Invitro Diagnostic devices in the United Kingdom.
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
UK Responsible Person 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 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) 18 September 2019, published new guidelines regarding the role and responsibilities of the “UK Responsible Person” 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.
Benefits of Collaborating with UK Responsible Person for MHRA Registration
Working with I3CGLOBAL as your UK Responsible Person 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 UKRP services, 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 evaluation, Investigation, 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 UK Responsible Person 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.
Submit your email for more information and get complete details in less than 2 minutes.
UK Responsible Person Requirements
The UK Responsible Person 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
Place your Medical Devices and Invitro Diagnostic Devices in the UK Market with the super fast and economical UK Responsible Person and UKMHRA service offered by I3CGLOBAL