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