Services We Perform as Your Authorized Representative
Emergo Europe is one of the largest Authorized Representatives for medical device and IVD companies in Europe and one of only a few with offices in Europe and the United States and Asia. Many companies enjoy the 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:
- Act as your primary point of contact for all European regulatory agencies
- Review your Technical File(s) or Design Dossier(s) for completeness
- Review proposed labeling for your device(s) to ensure they meet EU requirements
- Allow you to place the Emergo Europe contact information on your device labeling (Instructions for Use, labels, packaging, etc.)
- Assist with general questions about your product in the EU
- 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 contact us for a free consultation and no-obligation proposal on European Authorized Representative services.
* Please note that additional consulting work beyond the scope of what is included in the EU Authorized Representative contract will require additional fees.
Emergo Europe is a member of the European Association of Authorised Representatives.
