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。
There was significant evolution in the ecu regulatory landscape over the past 10 years, notably regarding necessities for clinical evaluation.
‘Clinical knowledge’ signifies data regarding security or efficiency that is certainly produced from the usage of a device and is sourced from the subsequent:
That’s why we know what agents expect, We're going to get ready your crew and documentation accordingly to their specifications.
The CER is distinct to one gadget and must be consistently up to date all through the lifetime-cycle of the document, and thus wants regular upkeep.
Its depth and extent shall be proportionate and suitable for the classification, meant function and challenges on the medical product in dilemma, along with to the Manufacturer’s promises.
Adequacy from the manufacturer’s information materials, Should the intended purpose and hazard reduction measures are satisfactory, discrepancies.
It is acknowledged that selected reports involve assist from brands (including large-scale pre-market place acceptance scientific tests) or might be performed by suppliers (like PMCF scientific tests). A discussion in the extent of involvement of brands or sponsors must variety A part of the analyze report as well as the critical Examination contained within the CER.」
Device registry: an organised procedure that employs observational research solutions to collect described clinical info under usual situations of use relating to a number of devices to evaluate specified results for any population outlined by a particular sickness, problem, or exposure Which Clinical evaluation report for medical devices serves predetermined scientific, clinical or coverage purpose(s).
確認目標醫材的安全、臨床效能需求 (Outline needs with regards to clinical protection and clinical overall performance with the device)；
To aid medical gadget suppliers recognize the overall movement and information on the CER, right here’s a FREE sample or CER template you could obtain. This document is meant to provide only as reference/advice for medical device suppliers.
Observe two This doc doesn't utilize to in vitro diagnostic medical devices. However, there may be scenarios, depending on the machine and national or regional needs, the place sections and/or prerequisites of the document could be relevant.
Presentation of Clinical research knowledge with good and detrimental approaches is extremely highly recommended to present in CER. They can be (a) Textual content-primarily based summaries of specific studies or of specific endpoints and (b) Visible summaries of pooled info.
Although this sequence is often represented as being a step-by-stage process, in apply, interaction could generate suggestions loops inside the cycle. Examples of these kinds of conversation include things like: