Why an Authorized Representative is Required for CE Marking

An overview of who needs to appoint an EU Authorized Representative and the regulations that require your company to do so.

Who Needs to Appoint an European EC REP

Medical device manufacturers without a physical location within Europe must appoint an European Authorized Representative (EC REP) and maintain the services of that representative for as long as they sell in Europe.

Several European CE Marking Directives spell out the need to appoint an EC REP including the:
Medical Devices Directive (MDD) - 93/42/EEC
In Vitro Diagnostic Devices Directive (IVDD) – 98/79/EC
Active Implantable Medical Devices Directive (AIMDD) – 90/385/EEC

The EC REP is a person/company that acts as a liaison between you and the European Ministries of Health, particularly with vigilance. The US FDA has a similar requirement called a US Agent.

The Directives outlined above also require the EC REP have access to the manufacturer’s Technical File or Design Dossier for review by Competent Authorities if needed.

The Authorized Representative is much more than a name and address to put on your product labeling. The EC REP can perform many tasks on your behalf including a review of your technical documentation, product registration, incident reporting, notifications of change to Competent Authorities, regulatory updates and more.