European Authorized Representative (EC REP)

for Medical Devices and In Vitro Diagnostic Devices

The appointment of an European Authorized Representative (EC REP/AR) for the Member States of the EEA is a requirement of the European Medical Device Regulation – MDR (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation – IVDR (EU) 2017/746 for all Medical Devices & In Vitro Diagnostic Medical Device Manufacturers located outside the EU to fulfill one aspect of the requirements for CE marking.

The importance of a European Authorized Representative (EC REP)!

The European Authorized Representative (EC REP) is a person or a legal entity who by designation of a manufacturer acts on their behalf. Your Authorized Representative is the main contact for the National Competent Authorities and performs certain duties under the European Medical Devices Regulations. The European Authorized Representative acts as the legal interface between you, the Manufacturer, and the EU Authorities. An Authorized Representative may be addressed by authorities and competent bodies, instead of the manufacturer themselves, with regards to the requirements of the Medical Device Regulations.

Appointing MDSS as your EC REP will set your company on the forefront of European Regulatory Requirements. We meet the full EU criteria for CE marking and, most importantly, MDSS has long-term experience in Regulatory Affairs necessary to provide this demanding and `highly responsible´ Authorized Representative service!

Contact MDSS now

When to designate the Authorized Representative?

We say: from the start! Ensure a smooth and efficient process!

We can apply for a Free Sales Certificate (FSC) in the EU on your behalf!

Article 11 - Authorised Representative

1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.

2. The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted writing by the authorised representative and shall be effective at least for all devices of the same generic device group.

Establish a Mandate with MDSS.

3. The authorized representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.

Tasks are outlined in the mandated agreement.

4. The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers.

Tasks and responsibilities are stipulated in the MDSS Mandate.