UK Responsible Person (UKRP)
Are you a medical device and/or IVD manufacturer based outside the UK, but selling in the UK? If so, you need a UK Responsible Person (UKRP).
Qarad UK Ltd. – part of the QbD Group – is an independent partner that can act as your UK Responsible Person (UKRP). Find out more about our UKRP service below.
What is a UKRP?
The United Kingdom has decided to leave the European Union. In addition to the political and economic consequences, this also has implications for the medical device and IVD industry.
The UK Medical Devices (Amendment etc.) (EU Exit) Regulations have introduced a new economic operator in the UK market, namely the UK Responsible Person (UKRP).
The UKRP is defined as a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in connection with specific duties relating to the manufacturer’s obligations under these Regulations. Under the current version of the UK MDR, a manufacturer may only appoint one UK responsible person.
The UK Responsible Person will take on the responsibility for the manufacturer to register the devices with the electronic system set up by the Secretary of State and will act as the point of contact for that manufacturer.
There will be a grace period to allow time for compliance with the new registration process. These registration requirements will not apply until after the transition period.
The following devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as of:
January 1, 2022
- Class I medical devices
- General IVDs
- Active implantable medical devices
- Class III medical devices
- Class IIb implantable medical devices
- IVD List A product
September 1, 2021
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B products
- Self-test IVDs
It will be possible to register devices ahead of the above dates, but there will be no legal obligation to do so.
Why QbD Group?
To ensure easy access to the UK market, it is important to choose a good UK Responsible Person who can guide you through the process.
Qarad UK Ltd. – part of the QbD Group – builds on its expertise as a European Authorized Representative and Swiss Authorized Representative, as well as the regulatory and technical competence of its team.
We can act as an independent UKRP and keep your regulatory interests separate from your supply chain.
Qarad is a member of the UK Responsible Person Association. The UKRPA is an alliance of service providers as UK Responsible Persons as defined in the MDR who have joined forces to promote professional conduct and competence.
Our team of Regulatory Experts will familiarize you with local regulations, help you with regulatory actions against your company, and communicate with the Medicines and Healthcare products Regulatory Agency (MHRA).
All of this requires excellent regulatory and technical-scientific skills and a smooth communication style. The team at Qarad has the experience and qualities to serve as the ideal UKRP.
We also offer you independence. In order to separate your commercial and regulatory interests in the UK, it is not a good idea to appoint a UK importer as UKRP. As an independent organization, Qarad can act as your guide on regulatory matters.
The concept of a UK Responsible Person is very similar to, and fully based on, the European concept of an Authorized Representative in the MDR/IVDR.
Qarad has been active for many years as a European Authorized Representative for more than a hundred different companies. Our assistance guarantees easy access to the UK market.
Contact us for more information or to request a free, no-obligation proposal.