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 (EC REP) 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.
