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.
It is Child’s Safety Week from June 7 – June 13 2021 and we would like to raise awareness for this very important topic as well. This year’s slogan of the event “Share because you care” is why we would like to share our knowledge with you.
In our last article, we discussed the confusing situation regarding remote audits and the strategies that manufacturers can follow in order to qualify for this type of inspection under the MDR. In this article we focus on analysing Notified Bodies’ experience while conducting remote audits under the MDD and giving you practical advice for successfully going through it and try to devise the future of remote audits.