IVDR验证D类DIVDS
This content has guidance for establishing the activities of Notified Bodies for the verification process of class D IVD devices.协议ing to the law on in vitro diagnostic Medical Devices (IVDR), Regulation (European) 2017/746, class D devices need to demonstrate their conformity assessment via the involvement of a notified body. In those terms, manufacturers of class D IVDs should forward to notified bodies a report of tests performed on each batch of devices and make available samples or batches of devices to the notified body. The notified body involved in the conformity assessment of class D IVDs should request one of the European reference laboratories (EURLs), if designated via the European commission, to carry out batch testing on those devices. Only upon verification of conformity, the manufacturer can proceed to place class D IVDs on the market.
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IVDR - 通过通知机构验证DIVDS类别
通过使用该指南提供的要点包括通知的身体流程，合同安排以及在此处审视，索引的总体性能：
Notified body procedures
Appointed by means of the manufacturer, the Notified Body performs conformity assessment activities of manufactured class D devices. The agreement between the notified body and the manufacturer should include all necessary preparations related to the performance of the exams, inclusive of a test plan, the transportation of the samples, and all records related to the batches, e.g., batch release quality control results, and conclusions of the verification of manufactured batches. Furthermore, the manufacturer commits to inform the Notified Body about any changes in the devices that affect the verification of the batches as well as to communicate any relevant scientific, technical, or medical information that comes to his knowledge.
Moreover, the Notified Body has to establish documented processes for:
- 验证过程
- The establishment of a test plan including all relevant and critical parameters which have to be examined for the device
- 与制造商的安排指定将在何处和时间何时执行测试
EURL测试：安排和程序
假设设备希望通过EURL进行进一步检查，通知机构需要为这种测试做出某些安排。同样，它们之间的书面合同应定义尝试的所有必要流程。这包括例如检查计划，样本的运输，批量信息和预测时间帧，用于尝试（通常是30天）。此外，通知机构致力于告诉EURL，据符合其关注的任何适用的科学，技术或临床观察以及谈论符合性检查的所有重要事实。
尝试欧元的频率
通知的机构应将批次的样本发送到EURL，指定所制定的产品，以欧元兑换和退房的频率。测试频率应该基于设备故障的频率和预期用途的相对风险/影响。因此，必须更频繁地测试的批次是具有更高故障，具有或暴露于传染性药剂的设备的装置，以及批次的血液分组装置的装置。通知机构可以与EURL一起降低测试历史的历史，以验证的适当整体性能。
测试批次数量
对于用于诊断的一线测定和设备，必须测试每批批次。对于其他设备，通知主体确定要测试的批次数量。为此，通知机构考虑制造商定义的批量测试制度，欧元的科学意见，可能是进一步专家的额外意见。