EU Representative

Registration. Representation. Communication.

If a medical device manufacturer does not have a registered place of business in the EU, but wants to bring medical devices to the European market, the Medical Device Directives requires that a European Authorized Representative located in the EU is appointed, who represents the manufacturer with the national Competent Authorities.

 Our services include:

  • Registration of your device with the national Competent Authorities.
  • Contact point for all national Competent Authorities.
  • Medical Device Vigilance. Support in reporting of incidents and Field Safety Corrective Action (FSCA) to Competent Authorities.
  • Maintain a current copy of the Technical Documentation for inspection by the European Authorities.
  • Post Market Surveillance.

 The Capamed Advantage:

  • We act as an independent firm as your EU Authorized Representative.
  • We are familiar with the European regulatory environment.
  • We protect the confidentiality of your Technical Documentation.