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IVDR指令

201755日,欧盟通过其官方渠道Official Journal正式发布IVDRREGULATION (EU) 2017/746)体外诊断设备新法规,将取代现行的IVD 98/79/EEC旧指令。由指令Directive)升级为法规(Regulation),提高了文件的约束力;IVDR(EU) 2017/746是由欧盟委员会拟议并经欧洲议会和理事会认可的法律,将从根本上改变CE标志的机制和欧盟监管体外诊断设备的方式。IVDR(EU) 2017/746法规过渡期为5年,202254日起强制实行;包含了无特定医疗用途的产品,例如彩色隐形眼镜等。

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体外诊断设备的定义:

“体外诊断医疗设备”是指制造商预定用于体外检查从人体取得的样品,包括血液和组织供体的,无论单独使用或是组合使用的任何医疗器械,包括试剂,试剂产品,校准材料,控制材料,成套工具,仪表,装置,设备或系统,其唯一或主要目的是提供以下信息:

(a)关于生理学或病理学状态;

(b)有关先性异常;

(c)用于确定安全性以及与可能接受治疗者的相容性;或

(d)用于检查治疗措施

标本容器也应被视为体外诊断医疗器械;

 

体外诊断设备的分类:

体外诊断产品可分成类,List AList B、自我检测器材(血糖检测除外)、其他类产品、性能评价器材,每一类的符合性评价途径(也就是获得CE认证的途径)各不相同。

 

指令相关的协调标准

EN 375

Information supplied by the manufacturer with in vitro   diagnostic reagents for professional use

EN 376

Information supplied by the manufacturer with in vitro   diagnostic reagents for self-testing

EN 591

Instructions for use in vitro diagnostic instruments for   professional use

EN 592

Instructions for use for in vitro diagnostic instruments for   self-testing

EN 928

In vitro diagnostic systems – Guidance on the application of   EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic   medical devices

EN 980

Graphical symbols for use in the labelling of medical devices

EN 1658 

Requirements for marking of in vitro diagnostic instruments

EN 12286

In vitro diagnostic medical devices – Measurement of   quantities in samples of biological origin – Presentation of reference   measurement procedures

EN 12287 

In vitro diagnostic medical devices – Measurement of   quantities in samples of biological origin – Description of reference   materials

EN 12322

In vitro diagnostic medical devices – Culture media for   microbiology – Performance criteria for culture media

EN 13532

General requirements for in vitro diagnostic medical devices   for self-testing

EN 13640

Stability testing of in vitro diagnostic medical devices

EN 13641

Elimination or reduction of risk of infection related to in   vitro diagnostic reagents

EN 13975

Sampling procedures used for acceptance testing of in vitro   diagnostic medical devices - Statistical aspects

EN ISO 14971

Medical devices – Application of risk management to medical   devices

EN ISO 18153

In vitro diagnostic medical devices - Measurement of   quantities in biological samples - Metrological traceability of values for   catalytic concentration of enzymes assigned to calibrators and control   materials

EN 61010-2-101

Safety requirements for electrical equipment for measurement,   control, and laboratory use - Part 2­101: Particular requirements for in   vitro diagnostic (IVD) medical equipment Reference document: IEC 61010-2-101

EN ISO 18153

In vitro diagnostic medical devices - Measurement of quantities in   biological samples – Metrological traceability of values for catalytic   concentration of

enzymes assigned to calibrators and control materials

EN 61010-2-101

Safety requirements for electrical equipment for measurement, control,   and laboratory use - Part 2- 101: Particular requirements for in vitro   diagnostic(IVD) medical equipment

 

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