Who needs an Authorized Rep?
If you are a medical device manufacturer that does not have a physical location within Europe, you must appoint an Authorized Rep (AR) and maintain the services of that representative for as long as you sell in the European Union.
Several European CE Marking Directives spell out the need to appoint an Authorized Representative. They include the:
Medical Device Directive - 93/42/EEC
In Vitro Diagnostic Device Directive - 90/385/EEC
Active Implantable Medical Device Directive - 98/79/EC
The Authorized Rep is a person/company that acts as a liaison between you and the European Ministries of Health. The US FDA does the same thing in requiring the appointment of a US Agent for non-US based companies. The Directives outlined above also require that the Authorized Rep maintain a copy of the manufacturer's Technical File for review by Competent Authorities if needed.
The Authorized Representative is much more than a name and address to put on your labels. The AR 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.
Please contact us for a free consultation and no-obligation proposal on European Authorized Rep services.
Related services offered by Emergo Group:
- US Agent representation for FDA
- ISO 13485 quality system implementation or upgrade from ISO 13485:1996
- CE Mark consulting services for medical devices
- SEE ALL QUALITY ASSURANCE AND REGULATORY AFFAIRS SERVICES
Emergo Europe is a member of the European Association of Authorised Representatives
