EU Authorized Representative

Why does your company need an EU-Representative?

The international MDR (Medical Devices Regulation) directive requires that any manufacturer of medical devices outside the European Community (EU) must select a company within the EU as its authorized representative.

What are the tasks of the EU Authorized Representative?

• Registration of your devices with national competent authorities, prior to placing on the market.
• Main contact for all national competent authorities.
• Keeping an up-to-date copy of your Technical Documentation, for inspection by the European Competent Authorities.
• Applying our name and address to your product labeling, packaging and instructions for use.
• Contact between you and the national competent authorities.
• In consultation with you and your distributors, responsible for reporting incidents to the appropriate authorities.
• Responsible for protecting the confidentiality of your documentation. The EU-Representative will only submit the Technical Documentation to the Competent Authorities.
• Representation to the European Commission to seek advice on the recall of a medical device by one or more Member States.
• Retain critical evaluation reports of all data collected during the clinical evaluation for review by the Competent Authorities.
• Informing or notification by authorized authorities.

Together with our partner Sallmann Medical GmbH in Austria, we can help you get your product on the market in the EU.