Agreement – Importer Template Agreement (MDR & IVDR)


This generic template is providing the minimum requirements that need to be written on an Importer 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.

Sample Importer Agreement Template MDR 2017/745 ivdr 2017/746 - Easy Medical Device Shop

This Importer Agreement is necessary for Medical Device Manufacturers that are located outside of EU and want to place a Medical Device on the EU market.

All necessary requirements to fulfill EU MDR 2017/745 and EU IVDR 2017/746 were reviewed and included. Reference to ISO 13485 is also provided.

You will need also to appoint an Authorized Representative. Contact us if you need us to help you find one.

Below you can see the table of content.

Table of Content TOC Importer Agreement Medical Devices - Easy Medical Device Shop


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