Where a manufacturer is based outside the Competent Authority United Kingdom (UK) must be able to contact an entity or person who is based within the UK and acts on behalf of a manufacturer. UK Responsible Person is an individual or a legal person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks regarding the manufacturer’s obligations under the UK Medical Devices Regulations 2002 (as amended 2019).
We operate a fully documented UK Responsible Person service designed to meet clients’ needs when placing a product on the United Kingdom 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 Competent Authority UK (MHRA)
- Certificate of Appointment, containing product registration details
- initial technical documentation audit to ensure Competent Authority UK procedures are accommodated for your product
- full adverse incident notification and support
- annual review of complaints profile for notifications
- change notification to Competent Authority UK
- knowledge of Competent Authority UK compliance enforcement provisions.
From 1 January 2021, products placed on the market in Great Britain (England, Scotland and Wales plus other British overseas territories) must bear the UK conformity assessed marking (UKCA marking). Products which bear the CE marking of conformity and presently on the market in Great Britain, can continue to be supplied until 1 January 2022. For these products, they must achieve UKCA marking no later than 31 December 2021.
(Please note different arrangements apply to products placed on the market in Northern Ireland)
QFI provides dual services as UK responsible person/UK authorised representative, based at our UK offices, to enable manufacturers and other economic operators to be able to continue supplying product to Great Britain.
If you utilise a distributor or supplier into brings your products to the United Kingdom, you may additionally need to confirm their status as official UK importer. In such cases, QFI can serve in this capacity, too.
Products affected include machinery, toys, personal protective equipment, hazardous substances and so on.
QFI can provide short or long-term client 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 supports and always defends clients’ interests.