UKRP - Regulatory Affairs - QbD Group (1)

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).

What is a UKRP

KEY TO PLACING YOUR DEVICE ON THE UK MARKET

The United Kingdom has decided to leave the European Union in 2020. In addition to the political and economic consequences, this also has implications for the medical device and IVD industry.

The UK The Medical Devices Regulations 2002 (UK MDR 2002) as amended by the 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.

How can we support you?

OVER 20 YEARS OF EXPERIENCE IN MD & IVD

Qarad UK Ltd., part of the QbD Group, builds on extensive experience as a European and Swiss Authorized Representative.

We are a member of the UK Responsible Person Association. The UKRPA is an alliance of service providers as UK Responsible Persons as defined in the UK MDR 2002 (as amended) who have joined forces to promote professional conduct and competence.

What we offer

Independent representation:
- We act as an independent UKRP to maintain a clear separation between your regulatory and supply chain interests.
- Avoid potential conflicts of interest associated with appointing a UK importer.
Comprehensive regulatory support:
- Guidance on UK-specific regulatory requirements.
- Assistance with regulatory actions against your company.
- Direct communication with the Medicines and Healthcare products Regulatory Agency (MHRA) on your behalf.

Why partner with QbD Group?

Proven competence:
- Decades of experience across Europe and Switzerland.
- Technical-scientific expertise paired with effective communication skills.
Alignment with global standards:
- The UKRP concept closely mirrors the European Authorized Representative framework, ensuring a smooth transition for clients.
A trusted partner for market access:
- Trusted by over 100 companies as their regulatory representative in Europe.
- Proven track record of enabling easy and compliant access to the UK market.