Services we perform as your EU Authorized Representative for Medical Devices
Emergo Europe is one of the largest Authorized (Authorised) Representatives for medical device and IVD companies in Europe and one of only a few with offices in the United States AND Europe. Many companies enjoy to convenience of having us available to answer questions at a time that's convenient for them. In fact, most client regulatory matters are handled in our US offices. As your European Authorized Representative, we will:
- Register your medical devices or IVD with the European Competent Authorities before they are marketed
- Act as your primary point of contact for all European regulatory agencies
- Maintain all or portions of your Technical File for inspection by the European Competent Authorities if requested (only with your permission)
- Allow you to place the Emergo Europe contact information on your device labels, packaging, Instructions for Use, etc.
- Be available to interact between you and the European Competent Authorities
- Assist with (near) incident reporting to Competent Authorities, in cooperation with you and your distributors
- Protect the confidentiality of your documentation. As your EU Authorized Representative, we can only show your documentation to the Competent Authorities.
- Represent* you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s)
- Maintain reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities
- Notify, or be notified by, the Competent Authorities of serious device incidents
*Please note that additional consulting work beyond the scope of what is included in the EU Authorized Representative contract will require additional fees.
Please contact us for a free consultation and no-obligation proposal on European Authorized Representative services.
Related services offered by Emergo Group:
- CE Marking consulting for medical devices
- ISO 13485:2003 quality system implementation support
- US Agent representation for the Food and Drug Adminstration (FDA)
- SEE ALL QUALITY ASSURANCE AND REGULATORY AFFAIRS SERVICES
