Submitting your technical documentation to a Notified Body is only the beginning of the CE certification journey.
Many manufacturers assume that a strong initial submission guarantees a smooth approval. In reality, most CE certifications involve structured review rounds ? formal cycles of questions, clarifications, and documentation updates.
Understanding how these review rounds work ? and how to strategically respond to them ? can significantly reduce delays and prevent unnecessary regulatory friction.
In this second part, we explain how CE review rounds typically unfold, what to expect during each stage, and how to strengthen your technical file throughout the process.
CE Review Rounds & Technical Documentation Assessments
The review of a technical file submitted for CE certification is rarely completed in a single step. Typically, it occurs in review rounds, consisting of formal cycles of questions and responses between the Notified Body and the manufacturer.
Although there is no formal limit on the number of review rounds established by legislation, in market practice most CE certification processes are generally limited to three rounds. This approach aims to keep the process efficient and predictable, allowing approval once all regulatory requirements are fully satisfied.
Each round may include both outstanding questions from previous rounds and new issues identified by the Notified Body. Round 1 generally addresses the primary gaps and initial concerns identified during the first evaluation of the technical documentation. Round 2 reviews the responses previously provided but may also introduce new requests for information or additional documentation. Round 3, when necessary, follows the same logic?reviewing prior responses and potentially raising new points?until all regulatory requirements are met.
It is important to note that during any review round, the manufacturer may submit new documentation, either in response to specific questions or to strengthen the technical file. This may include additional clinical studies, revised risk analyses, supplementary performance data, or updated manufacturing procedures. All new documentation must be clearly referenced and properly linked to the original technical file to ensure an organized and efficient assessment by the Notified Body.
Although there is no formal legislative limit on review rounds, market practice typically limits CE certification processes to three rounds to maintain efficiency and predictability, enabling approval as soon as full regulatory compliance is demonstrated.
CE certification success is rarely about responding to questions ? it is about anticipating them.
A structured response strategy, supported by robust technical documentation and regulatory intelligence, can dramatically improve approval timelines.
If your company is navigating MDR or IVDR review rounds, our team can help you strengthen your submission and minimize deficiencies.
Contact us at contact@grinn.co to optimize your CE certification strategy.
