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

Contact us for more information

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. 

 

Contact us for more information

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ISO 13485 and ISO 27001

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