Checklist for submissions to gain a Notified Body Opinion according to Article 117 (Part 2) of the MDR

Continuing with the topic of our last article, we analyze the requirements to consider in Part 2 of Article 117 of the MDR in the checklist attached.

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). Requirements of this part were detailed in the checklist included in our last article.

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 2, your GSPR list created should be based on four pillars: applicability, methods, standards and evidence. This checklist provides details on the meaning and contents that should be addressed related to each pillar.

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

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