This Supplier Agreement is necessary for Medical Device Manufacturers that are using Suppliers to provide full products or components to a Medical Device. It is clearly mandatory for Critical Suppliers as your Notified Body can have a check of them so some clauses like “Unannounced audit” will be necessary.
What is important is to show that the Manufacturer do have control over its suppliers.
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.
Tips: Create a procedure showing how you are selecting and monitoring your suppliers. This is critical to be compliant with MDR and IVDR.
Below you can see the table of content.