Glossary Term
Authorized Representative (AR)
Definition
An Authorized Representative (AR) is an individual or entity based in a specific regulatory region, such as the European Union (EU), designated by a non-local manufacturer to act on its behalf. The AR ensures that the manufacturer complies with the region’s regulatory requirements and serves as the primary point of contact for regulatory authorities, including managing compliance documentation, registrations, and post-market surveillance.
Relevance to the MedTech Industry
An Authorized Representative is essential for facilitating market access in regions where manufacturers lack a local presence. They help MedTech companies meet regulatory requirements, including those outlined in the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), by handling tasks like documentation submission, vigilance reporting, and communication with regulatory bodies.
Additional Information & Related Terms
EU MDR Defines the role and responsibilities of the Authorized Representative in Europe.
Declaration of Conformity A key document managed by the AR to demonstrate regulatory compliance.
Post-Market Surveillance The AR helps monitor device performance and report adverse events.
Notified Body Works with the AR to assess device conformity when required by regulation.