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

Requesting an opinion from the Competent Authority can be a prudent and effective strategy when a Notified Body disagrees with your device classification. The Competent Authority has the authoritative capability to provide clarity on the appropriate classification of medical devices, given its overall responsibility for enforcing regulatory compliance in a particular jurisdiction.

When a Notified Body holds a different classification view, engaging with the Competent Authority allows for an authoritative review of the classifications based on the relevant directives and regulations. This process can lead to resolution since the Competent Authority is equipped to consider regulatory texts, guidance documents, and applicable interpretations of the law.

Additionally, while discussing your reasoning with the Notified Body can often be beneficial, this approach may not yield the necessary resolution, particularly if there is a fundamental disagreement on classification criteria. Changing Notified Bodies might not address the core issue either if the classification problem stems from regulatory criteria rather than evaluations made by the specific Notified Body. Signing the Declaration of Conformity prematurely, without resolving the classification dispute, can lead to regulatory non-compliance and potential legal challenges, as the declaration commits the manufacturer to uphold compliance with the classification standards.

In light of these considerations, seeking an opinion from the Competent Authority stands out as a method that