由各領域的專家學者整理單一主題的多篇研究或系統回顧而成，有很具體的研究成果與臨床建議，同時也有同儕審查機制，因此正確性高，且具權威性。
The approach ought to include inclusion and exclusion requirements framed based on your device’s complexities and avoid examining exactly the same info from many sources and reducing time looking.
Stage three - Investigation with the clinical details: This stage covers the Evaluation from the collected facts. Evaluators will draw conclusions concerning the system’s compliance with security and efficiency needs and also discover any residual pitfalls, uncertainties, or unanswered issues.
Decided on supply for the literature lookup is PubMed. The desk lists the search terms used and the number of benefits.
也就是說，若未來在歐盟符合性評鑑過程中被挑出問題，製造廠不可以說：「啊當初有問專家小組，他們這樣說的啊！」(所以…專家小組可以隨便嘴砲喔？)
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For class III and a few IIb: a choice as to whether to refer to a eu specialist group in advance in the clinical evaluation,
文獻搜尋的相關資訊不足，或文獻搜尋方式品質不良導致無法再現/了解文獻探討的策略 (Inadequate info and/or very poor-high-quality search protocol that cause incapacity to reproduce or realize the literature critique system )
four. Exactly where research conclusions are expressed with regard to markers or intermediate steps of safety and overall performance, a clinically reasoned argument needs to be presented linking the review conclusions with patient centred outcomes.
Making ready a clinical evaluation report will involve numerous ways, Every single of which is important for demonstrating the Clinical evaluation report for medical devices safety and effectiveness of a device as necessary by European medical device regulation in Post 61. The elemental rule guiding a great CER is as follows;
The very first session will be the summary. It consists of a solid overview of the entire report. It will have to comprise the supposed focus on groups, the medical indications and a summary of Advantages and feasible risks which the product or service can present, together with the summary in the medical proof concerning its efficiency.
adhering to knowledge appraisal, it might come to be clear that there is not sufficient literature to feed into information analysis, which may then demand a revision on the clinical evaluation plan (CEP)
What this means is just in case exactly where your unit doesn't make clinical data, You should utilize bench testing and value to display the clinical overall performance.
This report, which files all clinical proof collected throughout the clinical evaluation, needs to be involved as A part of the technological documentation to help the notified physique evaluation from the machine’s conformity.