Authorized Representative for Medical Devices

The EU and the UK have a requirement very similar in comparison with the US, where a representative must be designated by non-European Union (EU) manufacturers to represent them in the EU and UK and ensure their compliance with the Directives / Regulations - this representative is called an Authorized Representative or AR for short. Your Authorized Representative provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.