From 1 January 2021, MHRA (Medicines and Healthcare products Regulatory Agency) requires all medical device manufacturers based outside the UK to have their products registered with the MHRA via a UK Responsible Person, to be able to export into the UK. Diaqual LTD acts as a UK Responsible person for Medical Device Manufacturers. This is also known as Authorised Representative or UK Rep.
All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland). Diaqual LTD conducts all required registration services on behalf of such manufacturers.
The UKCA mark is a product marking, which demonstrates a medical device meets the requirements in the UK MDR 2002 by carrying out a conformity assessment, before it can be placed on the UK market. The assessment route depends on the classification of the device. Diaqual Ltd provides consultancy and carries out application procedures on behalf of its clients to obtain a UKCA mark.
Professional services provided for all stages of establishing a medical laboratory in the UK.
