Checklist for submissions to gain a Notified Body Opinion according to Article 117 (Part 1) of the MDR
Are you planning to gain a Notified Body Opinion for your device? Make sure you are taking everything into account with our checklist.
When creating your documentation submission file for a Notified Body Opinion, two core elements should be present. On the one hand, a device description allowing the notified body to understand what kind of device is present (Part 1). On the other hand, the documentation on conformity with the applicable General Safety and Performance Requirements (GSPR) described in Annex I, as the assessment focus of the notified body is set on Annex I (Part 2).
Within Part 1, you should identify and characterize the device, describe its features (attributes) and give information on its development context. This checklist provides details on the contents that should be addressed in the device description.
Would you like to know more about what this means for your business or what to do about it? Then don’t hesitate to reach out.
Stephanie Goebel
