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  • Writer's pictureLihi Levin

How long does it take to write a clinical evaluation report (CER)?

Recently, as Israel resumed normal operations, someone asked me, "What is the typical duration for composing a clinical evaluation report (CER)?"

This is a commonly raised and pertinent question. For regulatory submissions, knowing the timing for each component is crucial.

The process of collecting and organizing the data for the CER, and crafting the report as per guidelines, usually spans at least a month. This duration varies based on factors like the number of devices and indications included, the intricacy of the clinical evaluation approach, and the volume of existing data. The technological sophistication and risk associated with the device also influence the effort involved.

For instance, a CER for a straightforward, non-invasive device with a reasonable amount of existing clinical data might take several weeks. Conversely, a range of invasive devices with extensive research might need up to two months to create a comprehensive and compliant report.

If there's a need to accumulate new clinical data through studies or Post-Market Clinical Follow-up (PMCF), this can significantly lengthen the process. These studies alone can consume considerable time for planning, conducting, and analyzing. Additionally, updates in Medical Device Regulation (MDR) might demand more detailed clinical evidence, thus extending the preparation period.

Our experience with various clients shows that expertise and innovative thinking are essential. A team proficient in regulatory norms, systematic literature review, and clinical data scrutiny can more swiftly and effectively finalize a CER, ensuring it meets the Notified Body audit standards.

Ultimately, it's important to recognize that a CER is not a one-time task. Medical device manufacturers must integrate these timeframes into their regulatory and product development schedules. This ensures compliance with regulatory submissions and successful market entry or continuity in the EU.

Feel free to contact me with any inquiries about the CER. I'm more than happy to provide assistance and answers.

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