State of the art指当前高水平，在医疗器械中通常指，对于同样的适应症，目前的主流的诊断、治疗水平，通过分析，出当前主流诊断、治疗水平。分析还可以用来识别同类型器械的主流性能水平，识别bechmark器械。
与MDR，在IVDR法规中，依然强调的重要性，在性能评价（PerformanceEvaluation）中，作为评价器械受益-风险比的参照，如果申请器械的受益-风险比，不低于水平，则可认为该器械的受益-风险比是可接受的。
在IVDR法规中，提及要求的几处关键点有：
Article 56. 3)
The clinical evidence shall be such as to scientificallydemonstrate, by reference to the state of the art in medicine,that the intended clinical benefit(s) will be achieved and that thedevice is safe.
临床证据应通过参考医学，科学地证明将实现预期的临床收益，并且器械是安全的。
Article 56. 5)
A performance study as referred to in paragraph 1 may beconducted only where all of the following conditions are met:
(m) in the case of clinical performance studies, the analyticalperformance has been demonstrated, taking into considerationthe state of the art;
(n) in the case of interventional clinical performance studies,the analytical performance and scientific validity has beendemonstrated, taking into consideration the state of theart.
(o) the technical safety of the device with regard to its usehas been proven, taking into consideration the state of theart as well as provisions in the field of occupational safetyand accident prevention;
只有在满足以下所有条件的情况下，才能进行第1款所述的性能研究：
(m）当采用临床性能研究作为证据时，器械的分析性能应已被证明符合；
(n）当采用干预性临床研究为证据时，器械的分析性能和科学有效性应被证明符合；
(o）器械使用时的技术安全性应被证明，符合和相关职业安全和事故预防领域的规定。
Article 100 2)
Within the scope of their designation, the EU referencelaboratories shall, where appropriate, have the followingtasks:
(d) to provide scientific advice regarding the state of theart in relation to specific devices, or a category or group ofdevices;
在其指定范围内，欧盟参考实验室应酌情承担以下任务：
(d）就特定设备或一类或一组设备的提供科学建议；
Article 100 5)
The EU reference laboratories shall form a network in order tocoordinate and harmonise their working methods as regards testingand assessment. That coordination and harmonisation shallinvolve:
(j) reassessing the state of the art on the basis ofcomparative test results or by further studies, as requested by aMember State or by the Commission.
欧盟参考实验室应形成一个网络，以协调和统一其测试和评估的工作方法。协调和协调应包括：
(j）根据成员国或委员会的要求，在比较测试结果的基础上或通过研究重新评估现有技术。
IVDR附录中，ANNEX XIII, Part A:
1.1.Performance evaluation plan
— a description of the state of the art, including anidentification of existing relevant standards, CS, guidance or bestpractices documents;
— an indication and specification of parameters to be used todetermine, based on the state of the art in medicine, theacceptability of the benefit-risk ratio for the intended purpose orpurposes and for the analytical and clinical performance of thedevice;
在性能评价方案中应包含
—对的描述，包括现有相关标准、CS、指南或佳实践文件的识别；
—基于，对器械的预期用途以及器械分析和临床性能的收益风险比的可接受性，制定判定指标。
1.3. Clinical evidence and performance evaluation report
要求和Article 56中一致。
5.2. The PMPF plan shall include at least:
(f) an evaluation of the performance data relating to equivalentor similar devices, and the current state of the art;
上市后性能跟踪方案应该包括：
(f) 对等效或类似器械性能数据的评价，以及当前。
小结：
1，依据Article 56和ANNEX XIII, PartA，性能评价中的核心内容：器械的分析性能、临床诊断性能、科学有效性，以及使用安全，都需要站在的维度上进行判定是否可接受。
2，对于IVDR下的Class D类产品，是需要送参考实验室实施测试，分析的重点放在分析和诊断灵敏度上。Article100对参考实验室的要求表明，对器械性能测试的接受标准是依据制定和变更的。