UK Responsible Person

UK Responsible person

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.

Qarad UK Ltd. can build on Qarad’s expertise as a European Authorized Representative and on the regulatory and technical competence of the Qarad team. It can act as an independent UK Responsible Person and keep your regulatory interests separate from your supply chain.

We act as your UK Responsible Person !
Contact us for more information

Qarad UK Ltd.

Your UK Responsible Person in the heart of London!

Will you require UKRP Services?

You are

An IVD and/or MD manufacturer?
Located outside UK?
Selling your products in UK?

You need a UK Responsible Person

You are

An IVD and/or MD manufacturer?
Located in UK / outside EU?
Selling your products in EU?

You need an Authorized Representative

Role of a 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

January 1, 2022

Class I medical devices
General IVDs

May 1, 2021

Active implantable medical devices
Class III medical devices
Class IIb implantable medical devices
IVD List A products

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.

Click here for the full list of roles and responsibilities of the UK RP

Our advantages

Regulatory Experts

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.

Independence

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.

Experience as Authorized Representative

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.

UK Responsible person