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深圳市寶安區洲石路743號深業U中心A棟7F
2017年5月5日，歐盟通過其官方渠道Official Journal正式發布IVDR（REGULATION (EU) 2017/746）體外診斷設備新法規，將取代現行的IVD 98/79/EEC舊指令。由指令（Directive）升級為法規（Regulation），提高了文件的約束力；IVDR(EU) 2017/746是由歐盟委員會擬議并經歐洲議會和理事會認可的法律，將從根本上改變CE標志的機制和歐盟監管體外診斷設備的方式。IVDR(EU) 2017/746法規過渡期為5年，2022年5月4日起強制實行；包含了無特定醫療用途的產品，例如彩色隱形眼鏡等。
體外診斷設備的定義：
“體外診斷醫療設備”是指制造商預定用于體外檢查從人體取得的樣品，包括血液和組織供體的，無論單獨使用或是組合使用的任何醫療器械，包括試劑，試劑產品，校準材料，控制材料，成套工具，儀表，裝置，設備或系統，其唯一或主要目的是提供以下信息：
(a)關于生理學或病理學狀態;或
(b)有關先性異常;或
(c)用于確定安全性以及與可能接受治療者的相容性；或
(d)用于檢查治療措施
標本容器也應被視為體外診斷醫療器械;
體外診斷設備的分類：
體外診斷產品可分成5 類，List A、List B、自我檢測器材（血糖檢測除外）、其他類產品、性能評價器材，每一類的符合性評價途徑（也就是獲得CE認證的途徑）各不相同。
指令相關的協調標準
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 2-101: 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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