All medical devices sold in the UK market need to be registered with the Medicines and Healthcare Regulatory Agency (MHRA). Manufacturers based outside the UK are required to appoint a UK Responsible Person to carry out specified tasks in relation to the manufacturer’s obligations. The responsibilities of the UK Responsible Person are set out in the UK MDR 2002.
With more than 65 years’ combined experience in the UK orthopaedics and spine market, we’re ideally positioned to be your UK Responsible Person, and to support you with the tasks needed to market your medical device here: getting your device certified, ensuring device conformity and registering your device with the MHRA.
The service includes: