UK Responsible Person Programme

20 February 2020

Where a manufacturer is based outside the United Kingdom (UK), the UK enforcement authorities must be able to contact an entity or person who is based within the UK and acts on behalf of a manufacturer. A UK Responsible Person is an individual or a legal person established in the UK who acts on behalf of a manufacturer established outside the UK in relation to specified tasks regarding the manufacturer’s obligations under the relevant British laws, which may be sector specific. For instance, for medical devices this means the UK Medical Devices Regulations 2002 (as amended in 2019).

A UK Responsible Person assures various legal obligations, duties and liabilities on behalf of a principal such as a medical device manufacturer.

QFI operates a fully documented UK Responsible Person service designed to meet clients’ needs when placing a product on the UK market. The service is managed by Technical Specialists from Competent Authority and industry backgrounds with relevant adverse incident and compliance enforcement action skills. Key features of the programme are as follows:

  • registration of products with the relevant enforcement authority (for example, for medical devices, the Medicines and Healthcare products Regulatory Agency or MHRA)
  • Certificate of Appointment, containing product registration details
  • initial technical documentation audit to ensure the relevant enforcement authority (for example, for medical devices, the MHRA) procedures are accommodated for your product
  • full adverse incident notification and support
  • annual review of complaints profile for notifications
  • change notification to the relevant enforcement authority (for example, for medical devices, the MHRA)
  • knowledge of the relevant enforcement authority (for example, for medical devices, the MHRA) compliance enforcement provisions
UKCA mark
UKCA mark

QFI provides dual services as a UK Responsible Person/UK Authorised Representative, based at our UK offices, to enable manufacturers and other relevant economic operators to be able to continue supplying products to Great Britain.

If you utilise a distributor or a supplier who brings your products to the UK, you may additionally need to confirm their status as an official UK importer. In such cases, QFI can serve in this capacity, too.

Products affected include, among others, medical devices, cosmetics, machinery, toys, personal protective equipment, and hazardous substances.

QFI can provide short- or long-term programmes, including fixed and project pricing, providing a cost-effective service with high technical competence and focus. We take the role of UK Responsible Person extremely seriously, and always support and defend clients’ interests.