Clinical Evaluation Plan은 MDCG Guideline 2020-6에 따라서 작성해야 함.
MDD 인증을 받았던 Legacy Device들은 이 MDCG Guideline 2020-6의 Appendix II에 따라서 Plan의 내용을 채우면 됨.
Appendix II - Clinical Evaluation Plan for Legacy Device
A modified Clinical Evaluation Plan for legacy devices should include at least
An identification of the GSPR that require support from relevant clinical data.
A specification of the intended purpose of the device.
A clear specification of intended target groups with clear indications and contraindications.
A detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters.
A strategy to identify, analyse and assess alternative treatments.
A specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects;
An indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device.
An indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non- viable animal or human tissues, are to be addressed.
A strategy and methodology to identify, analyse and appraise all relevant available clinical data in light of the changed definition for clinical data.
Evidence for equivalence, if clinical data from an equivalent device is included in the clinical evaluation.
A definition of the required level of clinical evidence, which shall be appropriate in view of the characteristics of the device and its intended purpose.
A strategy and methodology to systematically collect, summarise and assess post market surveillance data to demonstrate continuing safety and performance, and to what extent complaints with regards to safety and performance have been observed with the legacy devices.
위의 내용들이 문서에 section으로 표현될 필요는 없고, Plan 안에 내용이 다 들어가 있으면 됨.
1. An identification of the GSPR that require support from relevant clinical data
GSPR 항목 중에 임상적 성능에 관련 된 항목들을 임상평가보고서에서 어떻게 다룰지에 대해서 언급해주어야 함. 해당 항목들에 대해서 Plan에 표를 집어 넣어서 Acceptable/Non-Acceptable 한지 표기 후, 그에 대한 이유 집어넣어주면 됨.
2. A strategy and methodology to identify, analyse and appraise all relevant available clinical data in light of the changed definition for clinical data.
❣ Changed definition for clinical data (변경된 임상 데이터) : 매년 임상평가를 통해서 얻게 된 논문, 자료 등.
이런 자료들이 나왔을 때, 이 데이터들을 어떻게 임상평가보고서에 반영할지에 대해서 전략화 해야 함.
