IVDR将于2022年5月26日强制执行，很多体外诊断试剂厂商觉得时间还早，IVDEAR却深深觉得已经不早了，因为相比较MDR对于医疗器械企业的影响，IVDR对于体外诊断试剂的厂商影响更大。为什么呢?
IVDD时代只有20%左右的体外诊断试剂是需要公告机构发证的，还有80%企业可以自我声明。到了IVDR这两个比例会倒过来，也就是80%左右的体外诊断试剂需要公告机构发证，20%左右企业自我声明。
体外诊断医疗器械新定义
那么作为医疗器械一部分的体外诊断医疗器械（IVD）呢？一项新的体外诊断医疗器械法规（IVDR）已经被提议用来取代现行的体外诊断医疗器械指令。该拟议法规可以在欧盟法规索引Eur-Lex上搜索并阅读。在这次扩展的法规中，IVDR被定义为：
是指制造商预期用于体外检查从人体提取的样本，包括捐献的血液及组织，单独使用或组合使用的试剂、试剂产品、校准物品、控制材料、成套工具、仪器、器具、设备、软件或系统，其唯一目的或主要目的是提供以下信息：
·有关生理学或病理学状态；
·有关先天性异常；
·有关健康状况或疾病的易感性；
·确定安全性以及与可能接受治疗者的相容性；
·预测治疗效果或反应；
·明确或监控治疗措施。
IVDR将如何影响器械的分类
IVDR将从根本上改变CE标志的机制。这个机制将决定哪些IVD能够加贴CE标志。首先从一个基于风险的新分类机制开始，这种机制将“普通体外诊断试剂”这一分类替换为四种新的器械类别：A、B、C和D类（分别对应最低级风险到最高级风险）。B类到D类产品的技术文档要经过公告机构的评估。技术文档必须包括三种类型的临床证据：
1.科学有效性：一个分析物与一种临床疾病或生理状态相关联
2.分析性能：IVD器械正确检测和测量分析物（检测限（LOD）、定量限（LOQ）、准确度、精确度和可复制性）的能力
3.临床性能：器械依据目标人群产生与预期用途特定的临床疾病相关和与预期用户（若适用）相关的结果的能力
2.1. Rule 1 规则1
Devices intended to be used for the following purposes are classified as class D:
拟用于下列用途的设备被归类为D类:
— detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration;
检测血液、血液成分、细胞、组织或器官或其衍生物中存在或接触可传播媒介，以评估其是否适合输血、移植或细胞给药;
— detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation;
发现或接触到一种可传播媒介的存在，这种媒介引起一种具有高度或疑似高度传播危险的危及生命的疾病;
— determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.
确定危及生命的疾病的感染负荷，在病人管理过程中监测是至关重要的。
2.2. Rule 2 规则2
►C2 Devices intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or for tissue typing to ensure the immunological compatibility of blood,
拟用于血型分组，或确定胎母血型不相容性，或用于组织分型以确保血液免疫相容性的设备，◄ blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as class C, except when intended to determine any of the following markers: 用于输血、移植或细胞给药的血液成分、细胞、组织或器官归为C类，用于确定下列任何一种标志物的除外:
— ABO system [A (ABO1), B (ABO2), AB (ABO3)];
— Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
— Kell system [Kel1 (K)];
— Kidd system [JK1 (Jka), JK2 (Jkb)];
— Duffy system [FY1 (Fya), FY2 (Fyb)];
in which case they are classified as class D. 在这种情况下，他们被归为D类。
2.3. Rule 3 规则3
Devices are classified as class C if they are intended: 设备被归类为C类，如果它们的用途是:
- for detecting the presence of, or exposure to, a sexually transmitted agent;
检测性传播媒介的存在或接触;
- for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation;
检测脑脊液或血液中是否存在传播风险高或疑似高的传染因子;
- for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual's offspring;
如果错误的结果有可能导致被检测的个人、胎儿或胚胎或其后代死亡或严重残疾，则检测感染原的存在;
- for pre-natal screening of women in order to determine their immune status towards transmissible agents;
对妇女进行产前筛查，以确定其对传染性病原体的免疫状况;
- for determining infective disease status or immune status, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;
确定传染病状态或免疫状态，如果错误的结果有可能导致患者管理决定对患者或患者后代造成生命危险;
(f) to be used as companion diagnostics; 用作伴生诊断;
(g) to be used for disease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life- threatening situation for the patient or for the patient's offspring;
用于疾病分期，在这种情况下，错误的结果有可能导致患者管理决定，对患者或患者后代造成生命威胁;
(h) to be used in screening, diagnosis, or staging of cancer;
用于癌症的筛选、诊断或分期;
(i) for human genetic testing; 用于人类基因检测;
(j) for monitoring of levels of medicinal products, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;
对于药品、物质或生物成分水平的监测，当错误的结果有可能导致患者管理决定对患者或患者后代造成生命威胁时;
(k) for management of patients suffering from a life-threatening disease or condition;
管理患有危及生命的疾病或状况的病人;
(l) for screening for congenital disorders in the embryo or foetus;
筛查胚胎或胎儿的先天性疾病;
(m) for screening for congenital disorders in new-born babies where fAIlure to detect and treat such disorders could lead to life-threatening situations or severe disabilities.
用于新生儿先天性疾病筛查，如果不能发现和治疗这种疾病，可能会导致危及生命的情况或严重的残疾。
2.4. Rule 4 规则4
(a) Devices intended for self-testing are classified as class C, except for devices for the detection of pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of glucose, erythrocytes, leucocytes and bacteria in urine, which are classified as class B.
用于自我检测的仪器归为C类，但用于妊娠检测、生育检测和确定胆固醇水平的仪器，以及用于检测尿液中葡萄糖、红细胞、白细胞和细菌的仪器归为B类。
(b) Devices intended for near-patient testing are classified in their own right.
用于近病人检测的设备可自行分类。
2.5. Rule 5 规则5
The following devices are classified as class A: 以下设备被归类为A类:
- products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination;
一般实验室使用的产品、不具有关键特性的附件、缓冲液、洗涤液以及一般培养基和组织学染色剂，制造商打算使其适合于与特定检查有关的体外诊断程序;
- instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures;
制造商打算专门用于体外诊断程序的仪器;
标本容器。
2.6. Rule 6 规则6
Devices not covered by the above-mentioned classification rules are classified as class B.
不符合上述分类规则的设备分类为B类。
2.7. Rule 7 规则7
Devices which are controls without a quantitative or qualitative assigned value are classified as class B.
没有定量或定性赋值的控制装置被归类为B类。
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