Response

BSI Observation

§18 of the CER does not seem to specify a regular cadence for the update frequency of the CER (e.g. every 2 years, etc). Please provide a clear update frequency cadence for the clinical evaluation as aligned to requirements in Articles 61 (11) and Article 86.

Response

We thank the reviewer for this observation. We have updated both the Clinical Evaluation Report (CER) and the Clinical Evaluation Plan (CEP) to explicitly state a clear, regular update cadence that aligns with the requirements of MDR Articles 61(11) and 86.

The update frequency has been set to an annual cadence, which is formally defined in our Clinical Evaluation procedure (GP-015) and aligns with the Periodic Safety Update Report (PSUR) cycle for this Class IIb device.

In addition, we have clarified that the first update is scheduled for one year after the initial CE marking, ensuring alignment with the first PSUR and the results of the initial PMCF cycle.

Documentation updated

1. R-TF-015-003 Clinical Evaluation Report: Section "Date of the next Clinical Evaluation" has been updated to explicitly state the annual update frequency, referencing MDR Articles 61(11) and 86, and establishing that the first update will occur one year after initial CE marking. The outdated reference to MEDDEV 2.7/1 has been removed.
2. R-TF-015-001 Clinical Evaluation Plan: Section "Mechanism for Future Updates" has been updated to reflect the same annual update cadence and the timeline relative to the initial CE marking.