Medical Device Manufacturers that do not have a registered company address in the UK after Brexit will not be able to sell their products on the UK market unless they have an Authorised Quality Management Representative registered in the UK.
This includes EU medical device regulation for manufacturers who are not based in the UK. We offer a UK Authorised Representative service to medical device manufacturers based outside of the UK, where we will hold the technical files and perform vigilance. The quality management representative will be the primary contact with the MHRA on the company’s behalf and will be responsible for registering new products on the medical devices database.
If you would like to know more about our UK Authorised Representative service, then please contact us for further information.