UK Responsible Person Services
The United Kingdom has decided to leave the European Union. Besides the political and economic consequences, it also affects the Medical Device and IVD industry.
The UK Medical Devices (Amendment etc.) (EU Exit) Regulations has introduced a new economic operator in the UK market, namely the “UK Responsible Person” (UKRP). The UKRP has been 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 relation to specified tasks with regard to the manufacturer’s obligations under these regulations.
According to the current version of the UK MDR a manufacturer shall designate only 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 MHRA from:
It will be possible to register devices ahead of the above dates, but there will be no legal obligation to do so.
Qarad UK Ltd. is member of the UK Responsible Person Association.
The UKRPA is an alliance of providers of services as UK Responsible Persons as defined in the MDR who have joined forces to promote professional conduct and competence.
A good UKRP guides you through the local regulations, assists in case of regulatory actions against your company and communicates with the Medicines and Healthcare products Regulatory Agency (MHRA).
This all requires exquisite regulatory and technical-scientific skills and a fluent communication style. Qarad’s team has adequate experience and qualities to serve as the ideal UK Responsible Person.
To separate your commercial and regulatory interests in the United Kingdom, it is not a good idea to appoint a UK Importer as UK Responsible Person.
As an independent organization, Qarad can act as your regulatory guide.
The concept of a UK Responsible Person is very similar to the European idea of an Authorized Representative.
Qarad has been active for many years as European Authorized Representative for about a hundred different companies.
Our assistance guarantees easy access to the EU/UK market.