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UKRP: UK Responsible Person
For Medical Device & IVD Manufacturers 

Seamless Solutions That Give You More Commercial Control in the United Kingdom

If you’re a medical device and IVD manufacturer without a registered office in the UK, you must appoint a local representative, a UKRP. Your UKRP is responsible for managing your device registration as well as any relevant importer relationships and liaising with the Medicines & Healthcare Products Regulatory Agency (MHRA) on your behalf.

Post-Brexit, MHRA has indicated that medical devices and IVD regulations will align closely with the EU Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR).

 

CE-Marked devices will initially be recognized in the UK, but manufacturers will have to obtain UK Conformity Assessment (UKCA) certification starting in July 2023.

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As Your UKRP We Will:

Ensure the declaration of conformity and Technical Documentation complies with United Kingdom MHRA requirements 

✓ Keep a copy of the Technical Documentation, declaration of conformity and, if applicable, relevant certificates, including any amendments and supplements for inspection by the MHRA

✓ Provide the MHRA, upon request, with all the information and documentation necessary to demonstrate the conformity of a device

✓ Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices

✓ Inform the manufacturer immediately about complaints and reports from healthcare professionals, patients, and users about suspected incidents related to a device for which they have been appointed.

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Trusted by 550+ Medical Device & IVD Manufacturers Worldwide

Commonly Asked Questions About Our UKRP Services

What is a UK Responsible Person?

A UKRP is defined as being any natural or legal person established within the UK who has received and accepted a written mandate from a manufacturer located outside the UK, to act on the manufacturer’s behalf in relation to specified tasks about the latter’s obligations under the Regulations.

Why is a UK Responsible Person Necessary?

If you’re a medical device or IVD manufacturer without a registered office in the UK, you must appoint a local representative, your UKRP. Your UKRP is responsible for managing your device registration as well as any relevant importer relationships and liaising with the MHRA on your behalf.

How do I appoint a UKRP?

Identify any natural or legal person established within the UK who is willing to act in this capacity and is willing/able to sign a legally binding agreement appointing themselves as your UK Responsible Person.

How do the roles of a UK Importer and UKRP differ?

One of the key differences between the UK Responsible Person and the UK Importer has to do with exposure. Your contract with your UKRP takes into account the fact that they can be held legally liable for your defective devices sold in the UK. Similarly, your Importer has significant exposure in that they can be held financially liable for your non-compliance with the MDR.

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Convenient. Consistent. Responsive.

Three European Markets. One Representative.

Let’s Get Started!

Ask a question or request a free, no obligation UKRP proposal.