After a recent update of the UK MHRA’s guidance on “Regulating medical devices from 1 January 2021“, the British medical device regulatory consultancy Quality First International has updated its UK Responsible Person Programme, which offers UK representation services for medical device manufacturers that are located outside the United Kingdom and who want to place or continue to place their products with the CE mark of conformity on the UK market.
The UK Competent Authority, the MHRA, has advised that manufacturers not domiciled in the UK must appoint a formal UK Responsible Person (UKRP) to be able to continue placing medical devices on the UK market.
The UKRP will act on behalf of such a manufacturer to fulfil obligations of the latter under Regulation 7A (Amendment of Part II of the 2002 Regulations) in the draft version of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.
With its UKRP programme, QFI offers the following services:
- registration of medical devices with the MHRA
- examination of conformity of products to standards required by the MHRA
- notification of adverse incidents and other notifiable situations to the MHRA
- serving as a legal entity and point of contact pursuant with the applicable UK Medical Devices Regulations 2002
- ensuring permanent availability of technical documentation to the MHRA pursuant to the UK Medical Devices Regulations 2002
Medical device manufacturers interested in this service may contact QFI by email [email protected].