UK Authorised Representative
UKRP ltd. d.b.a. Certification Company acts as legal UK Authorised Representative for non-UK manufacturers wishing to sell (offline or online) within the Great Britain market (England, Wales and Scotland); Northern Ireland still requires an EU Authorised Representative. Certification Company can be assigned either as the UK Authorised Representative or UKRP – UK Responsible Person (for medical devices only).
Product groups for UK Authorised Representative services
The product groups for which the UK Authorised Representative can be assigned:
UKRP for Medical Devices
One of the main responsibilities of all manufacturers (including the UK manufacturers) who are planning to place medical devices on the Great Britain market is registering the medical devices with the MHRA. The MHRA only registers medical devices from manufacturers who have a registered place of business within the UK. Manufacturers outside the UK are therefore required to appoint a Responsible Person (RP) based in the UK who will act on their behalf. The appointment must be carried out as soon as possible once the manufacturer decides on placing medical devices on the GB market.
A UK Responsible Person (UKRP) must meet at least the following requirements:
- The UKRP must be appointed by a manufacturer outside the UK;
- The UKRP must have a registered name and address within the UK. In case of a UKCA-marked device, this device’s label must include the name and address of the UKRP.
According to the UK Responsible Person Association (UKRPA), there are no further specific requirements for a Responsible Person (RP). However, based on the tasks of the UKRP, as mentioned below, it is clear that the Responsible Person must be familiar with the UK legislation for certifying medical devices in the UK.
An economic operator, such as a manufacturer’s importer or distributor may act as a UKRP. However, it is important for these economic operators to have the necessary regulatory experience since a UKRP is responsible for quite a number of regulatory tasks. The UKRP will act on behalf of the non-UK manufacturer when carrying out tasks related to the manufacturer’s obligations and be the first point of contact for MHRA.
Why an UK Authorised Representative
The UK requires companies to assign a local entity responsible for product compliance information. Once designated, the UK Authorised Representative becomes the main contact person for the market surveillance authorities and should be able to:
- Verify the UK Declaration of Conformity as issued by the manufacturer
- Verify the technical documentations as compiled by the manufacturer
- Keep the documentation for the period required by the legislation (commonly for 10 years)
- Liaise with manufacturer and support in case of non-compliance risk
- Provide manufacturer with the name and contact details to be included on the the product, packaging, or labelling
What should the manufacturers prepare before assigning an UK Authorised Representative?
- Draw up technical documentation
- Compile and sign up the UKCA Declaration of Conformity
- Affix UKCA marking
How to assign Certification Company as your UK Authorised Representative
If you have all mentioned above documents, simply contact Certification Company with a copy of your UKCA Declaration of Conformity to obtain a proposal and further steps regarding the UK AR procedure. Upon acceptance of our proposal, the designation will be confirmed by a written mandate (UAR contract) and you will obtain a license (right) to use our logo and contact details.
