Authorized Representative

Frequently Asked Question

All non-EU manufacturers must appoint an Authorized Representative (AR or EC Rep) in the European Community Market. As Authorized Representative, CEpartner4U is your interface with the EU Competent Authorities.

CEpartner4U FAQ Authorized Representative (PDF) >

1. Why choose an independent AR?
An independent AR deals with regulatory affairs only and does not distribute or sell devices. If you select a master-distributor to fulfill the position of Authorized Representative, his commercial interests may conflict with your regulatory obligations. (e.g. warehouse conditions, information supply to customers etc.) Next to that, other distributors might be reluctant to handle devices with the name of the master-distributor printed on the label (as AR).

2. How to select an AR?
Per definition, the Authorized Representative is a natural or legal person established in the EU who has received and accepted a written mandate from a manufacturer to act on his behalf with regard to the obligations under the medical devices directives.
Hence, choose an experienced Authorized Representative who is well versed in both the medical device industry and regulatory compliance. CEpartner4U has sample agreements clearly outlining the essential duties of an Authorized Representative.

3. What are the manufacturer’s main duties? 

  • Guaranteeing device safety and performance
  • Providing the technical documentation to the AR
  • Printing the AR’s name and address on the product label
  • Notifying the AR of any incidents with the devices
  • Cooperating with the requests of Competent Authorities
  • Indemnifying the AR from product liability

4. What are the essential duties of the AR?

  • An AR acts and can be addressed by the EU authorities instead of the manufacturer with regard to his regulatory obligations
  • Registering risk class I and IVD devices
  • Keeping the technical documentation available to the Competent Authorities
  • Reporting vigilance cases

5. What is the reason for placing part of the technical documents on file in the EU?
 An AR must be able to provide all documentation and information that an authority may require for the purpose of market surveillance.

6. Is the technical information confidential?
Confidentiality is secured by the AR-agreement. The regulations require that all parties, Competent Authorities included, are bound to observe confidentiality with regard to all information.

FAQ, CE marking, 2017