IVDR 2017/746 – GSPR Checklist


To be able to create your technical documentation for your In-Vitro Diagnostic Medical Device, the General Safety and Performance Requirements (GSPR) should be reported. This template document is collecting all the requirements of the GSPR listed on the IVDR 2017/746 for In-Vitro Diagnostic Medical Devices.

IVDR should take place by May 26th, 2022, and companies that are selling In-Vitro Diagnostic Medical Devices should start to convert all their documentation to this new legislation. With this template, you will be one step forward to the certification.

This purchase contains:

  • Template for the General Safety and Performance requirement for IVDR 2017/746 (WORD format)

No refund possible after purchase.

SKU: EMD-014 Category:


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