Due to Brexit, there is a new route to market in the UK including new product marking, the UK Conformity assessment mark (UKCA). Manufacturers outside the UK will have to designate a UK Responsible person (UK Rep) to register their devices with the UK Health Authority (MHRA).
Qserve UK Responsible Person acts as an independent party that supports you with the registrations and keeps you up to date with the regulatory framework in the UK.
Qserve will offer this service and Qserve’s office in London will be registered with MHRA as a UK Representative with access to the MHRA database for registering manufacturers’ medical devices and IVDs. One of the responsibilities of a UK Rep is accessing the technical documentation and ensuring it is appropriate.
For more information, please have a look at our UK Responsible Person flyer below or contact us as info@qservegroup.com.