Under the current legislation, the European Authorized Representative is assigned a pivotal role in the CE Marking process of medical devices. If you don’t have one, you can simply not sell your products within the European Union. We can assist you during the process of understanding the corresponding obligations.
European Authorized Representative under the MDR / IVDR
The European medical devices legislation stipulates the role of a European Authorized Representative, also known as EU Auth. Rep., EC Rep or AR, for manufacturers who don’t have their own location in Europe. EU Authorized Representatives act on behalf of manufacturers to assume, among others, communication with competent authorities.
Under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulataion (EU) 2017/746 (IVDR), the EU Authorized Representative is assigned a narrowly defined role with the belonging obligations.
As per definition “‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations […]”.MDR & IVDR
How you find corresponding information about EU Authorized Representation on mdi-Europa.com
Read page “EU Authorized Representative Responsibilities”
Read page “EU Authorized Representative vs. Distributor”
Read article “How to change your EU Authorized Representative”
Browse our extensive Supportive Information Section
Search our website by keyword “EU Authorized Representative”
For further information, please contact our team.