The EU and the UK have a requirement very similar in comparison with the US, where an EU / UK medical device authorized representative must be designated by non-European Union (EU) manufacturers to represent them in the EU and UK. The EU / UK authorized representative service provided must ensure their compliance with the European and UK Directives / Regulations. Technically, the medical device authorized representative is called a European Authorized Representative in the EU (EUAR) or UK Responsible Person (UKRP) in the UK, but understand some times they are confusing, and internally we can use the term EU / UK medical device authorized representative
Your European / UK medical device authorized representative (UK Responsible Person) provides a point of contact between you (the non-European medical device manufacturer) the national EU / UK Competent Authorities (Ministry of Health) and Notified Bodies.
