According to the government’s own advice:
“If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised representatives that have a place of business in the UK.”
It is interesting to note that there are well-known manufacturers, based in the UK, who sell their medical devices into nursing homes and hospitals, yet they are not registered with MHRA.
As well as being the right thing to do, registering with MHRA provides a route to traceability and product safety – the MHRA hold many responsibilities, amongst which is market surveillance and the power to issue safety alerts and product recalls.
By buying off an unregistered manufacturer, there is the potential to put patients and carers at risk with untraceable products, and with so much guidance available to manufacturers, importers and distributors from MHRA and other agencies, there are no excuses.