Notified Body

Selection. Preparation. Audit Support.

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

Our services include:

  • Registration of your device with the national Competent Authorities
  • A point of contact for all national Competent Authorities
  • Maintenance of a current copy of the Technical Documentation for inspection by the European Authorities
  • Medical device vigilance. We provide support in reporting incidents and Field Safety Corrective Actions (FSCA) to Competent Authorities.
  • Post-market surveillance

The Capamed Advantage:

  • Representation as your EU Authorized Representative
  • Familiarity with the European regulatory environment
  • Protection of the confidentiality of your Technical Documentation