If your organization does not have a physical presence in Europe, but you want to sell devices in Europe, you should appoint an Authorized Representative (also abbreviated as EC REP or AR). It is now a requirement that you must retain an E.A.R as a mandatory condition to market your devices in Europe either medical device or non-medical ones.
If you are not based in Europe, the Notified Body needs an appointment of an E.A.R. in advance, after that, they will be able after compliance check to issue a CE certificate. Compliance with the relevant Directive is obligatory for any device located in the EU market; consequently, engaging and recognizing your selected representative is vital. If you do not employ a E.A.R, your devices may be stationed at the customs.
We offer Auth. Rep. service for following products:
- Medical Device
- Electrical Equipments
How do we work?
We perform a review of the applicable requirements for your type of product.
We review your product documentation and testing in reference to applicable standards.
We suggest any required activity to reach compliance.
We sign together the EU Auth. Rep. contract and mandate for your products in scope.
Ask us for a quote or initiate the assessment process.
This way you will get priority over new coming request.
We will reach out to you and set-up a call or a communication channel in order to learn more about your products and status. We will provide you with our quotation and AR Contracts.
We will review your product documentation and current status, we will advise on any necessary steps to be taken.
If all the steps above have progressed successfully we can proceed in singing the mandate and we will be your Auth. Rep. so you can place our name on your EC declaration of conformity and product labeling. In case of need, we can also issue at this point an Auth. Rep. appointing certificate