EAR Support
European Area Market Authorisation

Your European Authorized Representative serves as a link between you and the national Competent Authorities (Ministries of Health). Additionally, your appointed representative will:

• Assist with certain device registrations, as required.
• Be identified on your product labelling throughout Europe.
• Store a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request.
• Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your Europeans distributors.

It is possible to appoint a distributor as your Authorized Representative in Europe; however, it is not recommended because most distributors are not prepared to fulfil the mandatory responsibilities of the EAR .

Instead, select ETTSONS as an independent representative that focuses on regulatory affairs. Leaving your distributors to focus on sales and marketing