Agreement – EU Authorized Representative Template Agreement (MDR & IVDR)

This generic template is providing the minimum requirements that need to be written on a Manufacturer – European Authorized Representative Agreement. On this template, some elements are highlighted so you complete them. There is also some section marked in blue which should guide you on what are some elements you can mention.

If you are a Medical Device manufacturer located outside of Europe, you need to appoint an Authorized Representative and an Importer to place your devices on the EU market. Theses agreement will help you define the right requirements to meet the regulation.

The final document should still be reviewed and approved prior to use. This can be done internally by a subject matter expert or by a lawyer.