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.