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.

Learn More:

• Scope
• The Regulation: IVDR 2017/746/EU
• Classification
• 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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