Process of EAR Appointment
Who must act as European (EEA/EU/EC) Authorised Representative ?
A European Authorised Representative is a legal person in the European Economic Area who is specifically deputed by a non-Euroepan manufacturer to act on his behalf in carrying out responsibilities detailed in the Medical Device Directives.
EEA - European Economic Area. EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EEA single market. Switzerland is neither an EU nor EEA member but is part of the single market.
Responsibility of EU Authorized Representative(EAR)?
- European Authorized Representative serves as a liaison between your COMPANY outside EU and the national Competent Authorities (Ministries of Health).
- Non EU manufacturers must be identified on their product labelling throughout Europe.
- Organize current copy of your Technical File or CE Declaration of Conformity when Competent Authority request.
- Assist with Incident and Field Safety Corrective Action (FSCA) by contacting distributors and Legal manufacturers.
- Assist with Vigilance Reporting.
Why choose QualiMEDtech as your European Authorized Representative?
- QualiMEDtech office is equipped with sufficient technical team for quick processing.
- QualiMEDtech dedicated PEPAL software sends automated reminders and latest press release to all clients.
- QualiMEDtech consultants will review your Technical File or if required can prepare Technical File and Design Dossier
- QualiMEDtech consultants reply Technical File Review comments sent by Notified Body concerning to your product.
Change of Authorized Representatives is possible?
Yes it is possible, but keep in mind your EC REP name and address with contact information will be printed on your labelling. You must inform to the notified Body and update the new label in the Technical File.
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