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.