The new European Regulation 2017/745 will introduce a new clinical document: the “summary of safety and clinical performance”. This document will be mandatory for all implantable devices and class III devices.
The “Summary of safety and clinical performance”, is described in the Article 32 of the new European Regulation 2017/745. In this document, manufacturers shall summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation, as well.
The Article 32 of the new European Regulation 2017/745 also describes the different aspects that should be considered in the “Summary of safety and clinical performance”, included among these:
- The identification of the device and the manufacturer related data
- The description and the intended use of the device
- The available diagnostic or therapeutic alternatives
- Warnings and information concerning potential residual risks
The summary shall be clear and comprehensible to the intended user or to the patient; it should be noted that the document will be made available to the public via Eudamed database, once the database will be active. It should include the place of the device in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when compared to the diagnostic or therapeutic alternatives and the specific conditions under which that device and its alternatives can be considered.
The manufacturer shall mention on the label or instruction for use where the summary is available. Furthermore, for class III devices and implantable devices, the “summary of safety and clinical performance” shall be updated at least annually by the manufacturer.
Finally, the draft of the summary will be part of the documentation to be submitted to and evaluated by the notified body involved in the CE conformity assessment.
Don’t be caught unprepared!
The RPN team is ready to support you in the transition from the old Directive to the new European Regulation and in the preparation of the Clinical Evaluation Report and related documents.