October 7, 2024

The EU Authorised Representative role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives.

Since the MDR and IVDR Regulations were introduced the role of the EU Authorised Representative has become wider in scope and responsibilities.