Authorised Representatives for In-Vitro Diagnostics Regulation
An Authorised Representative is any person naturally or legally established in the 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 Regulation.
What are the duties of an E.A.R?
The role of a European Authorised 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 technical documentation, EU Declaration of Conformity and CE Certificates available for inspection by the European Authorities
- Completing registration obligations on behalf of manufacturers to EUDAMED
- 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)
- Terminate the mandate if the manufacturer acts contrary to its obligations
Non-EU based manufacturers are obligated to appoint a European Authorised 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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