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For medical device and in vitro diagnostic (IVD) manufacturers located outside the United Kingdom, accessing the market in Great Britain (England, Wales, and Scotland) involves a crucial step: appointing a UK Responsible Person, or UKRP. This entity serves as a vital link between non-UK manufacturers and the UK's regulatory authorities, ensuring that devices placed on the market meet the required standards of safety and performance.
By partnering with Qarad UK Ltd, manufacturers gain a knowledgeable and reliable UKRP to guide them confidently through Great Britain’s regulatory requirements.
What is a UK Responsible Person?
According to the UK's Medical Devices Regulations 2002 (as amended), a UK Responsible Person (UKRP) is defined as a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the UK. Their role is to carry out specified tasks related to the manufacturer's obligations under these regulations.
Essentially, if a manufacturer of a general medical device, active implantable medical device, or in-vitro diagnostic medical device is based outside the UK, they must appoint a sole UKRP to represent them in Great Britain.
Qarad UK Ltd provides a trusted UK-based presence, ensuring manufacturers meet all UK regulatory obligations efficiently and reliably.
Core Responsibilities of the UKRP
The UKRP holds significant responsibilities and acts as the primary point of contact for the UK’s Competent Authority, the Medicines and Healthcare products Regulatory Agency (MHRA). Their duties are extensive and are critical for ensuring regulatory compliance.
By partnering with Qarad UK Ltd as your UK Responsible Person, you benefit from a team with deep regulatory expertise, well-established processes, and a clear understanding of MHRA requirements, ensuring smooth registration and effective management of any regulatory challenges.
Legal Status of the UKRP
It's important to note that the UKRP is not just an administrative contact. The regulations state that a UKRP may be proceeded against as a person placing the device on the market.
This underscores the legal gravity of the role and the importance of appointing a responsible and competent entity. The MHRA can also require a person claiming to be a UKRP to furnish evidence of their designation by the manufacturer.
With Qarad UK Ltd as your UKRP, you gain a dedicated partner who takes this responsibility seriously, combining regulatory competence with accountability to ensure your entry into the UK market is secure and compliant.
In summary
The UK Responsible Person is a mandatory and indispensable partner for any medical device or IVD manufacturer outside the UK wishing to enter the Great Britain market.
As the regulatory liaison and compliance representative, the UKRP bears significant legal responsibilities to ensure that products placed on the market meet UK regulatory requirements and are safe and effective for patients and users.
Manufacturers should choose their UKRP carefully, ensuring they have the expertise and diligence to fulfill this critical function.
By partnering with Qarad UK Ltd, you benefit from:
With Qarad UK Ltd, you don’t just get a UK presence; you gain a trusted partner dedicated to helping you enter and succeed in the Great Britain market with confidence.
Contact Qarad UK Ltd to ensure a smooth and compliant entry into the UK market.
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