Authorized Representatives for In-Vitro Diagnostics Regulation
An Authorized Representative is any person naturally or legally established in the European Union who is explicitly designated by the manufacturer to act on their behalf. This person may be addressed by authorities and bodies within the Community, instead of the manufacturer themselves, with regards to the requirements of this Directive.
What are the duties of an E.A.R?
The role of a European Authorized Representative is both varied and challenging. The main duties include, but are not limited to, the following:
- Providing a registered address within the European Union
- Keeping all technical documentation available for inspection by the European Authorities
- Completing notifications to European Authorities
- Completing any registrations to national databases
- Taking care of any incident reporting
- Representing the manufacturer towards the European Commission, Authorities and Notified Bodies
- Safeguarding and ensuring compliance with constant regulatory updates
- Consulting on European Regulations
Expanded responsibilities under the In-Vitro Diagnostics Regulation include:
- Designation of Person Responsible for Regulatory Compliance (PRRC)
Non-EU based manufacturers are obligated to appoint a European Authorized Representative to serve as their vigilance contact point and ensure continued compliance at all times.
- The Regulation: IVDR 2017/746/EU
- Technical Documentation
- Path to EU Market Entry: Conformity Assessment Procedures
- Notified Bodies under the IVDR
- Clinical Evidence and Performance Evaluation
- Clinical Performance Studies
- Person Responsible for Regulatory Compliance
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