What is the best strategy if a Notified Body disagrees with your device classification?

The best strategy when faced with a disagreement on device classification by a Notified Body involves seeking guidance from the Competent Authority. This is because the Competent Authority holds the ultimate responsibility for regulatory compliance in the respective country and has the authority to offer clarification on how regulations should be interpreted. Engaging with them can help resolve the classification dispute and ensure that the classification aligns with regulatory expectations and requirements.

By directly addressing the issue with the Competent Authority, organizations can gain a clearer understanding of their obligations and the appropriate class for their device based on current regulations. This step is crucial for ensuring compliance and moving forward with the necessary approvals and market access for the device.

The other options may not effectively resolve the classification disagreement. Changing the Notified Body might not guarantee a different outcome, as classifications can be based on objective regulatory criteria. Simply discussing the reasoning with the Notified Body may help, but it might not change their stance and does not provide the definitive resolution that an opinion from the Competent Authority would. Signing the Declaration of Conformity without resolving the classification issue could lead to significant legal and regulatory ramifications if the classification is later deemed incorrect.