Non-European Union (EU) and non-UK medical device manufacturers are required to designate an authorized representative to act on their behalf to ensure compliance with applicable regulatory requirements. In the EU, this role is known as the European Authorized Representative (EUAR), while in the UK, it is referred to as the UK Responsible Person (UKRP).
While the terminology differs, both roles serve a similar purpose: acting as the manufacturer’s official point of contact with regulatory authorities and ensuring that devices placed on the market meet all applicable requirements. For simplicity, these roles may be collectively referred to as the EU/UK Medical Device Authorized Representative.
