技術電子報‎ > ‎EU CE Mark‎ > ‎

歐盟IVDR體外診斷醫療器材分類規則

張貼者:2020年5月5日 上午3:14Yuhua Chen   [ 已更新 2020年5月12日 下午10:29 ]

歐盟IVDR(Regulation (EU) 2017/746 In Vitro Diagnostic Medical Device Regulation)2017525日公告後,IVDR對於產品的分類規則將原先在IVDD裡的分類由List A, List B, Others變成Class A, Class B, Class C, Class D其風險等級及管控力道是由ClassAD逐步加強Class A可由廠商符合IVDR相關要求並擬定自我宣告後產品即可上市,而Class B, Class C, Class D則須向公告機構(Notified Body)提出符合性評鑑程序,確認其產品符合IVDR要求後才能上市。

由於原先IVDD只管控了約10-20%IVD產品,其餘IVD產品的廠商可自我宣告後產品即可上市,但IVDR一旦執行,情況將翻轉,80-90%IVD廠商必須提出IVDR符合性評鑑程序,因此這項改變對於廠商而言是一大挑戰,IVDR將於20225月開始執行,廠商可重新評估並確認自家IVD產品的等級(表一)後即可開始規劃如何符合IVDR的要求。

表一 IVDR Annex VIII Classification Rule
 RuleIntended Use  Classification
 



Rule 1
 Devices intended to be used for the following purposes are:
  • 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;
  • 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;
  • determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.
 



Class D
 
Rule 2
Devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as: 
Class C



Rule 2
(cont.)
 Except when intended to determine any of the following markers:
  • 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)]
 


Class D














Rule 3
 Devices are classified as if they are intended:
(a) for detecting the presence of, or exposure to, a sexually transmitted agent;
(b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation;
(c) 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;
(d) for pre-natal screening of women in order to determine their immune status towards transmissible agents;
(e) 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;
(f) to be used as companion diagnostics;
(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;
(h) to be used in screening, diagnosis, or staging of cancer;
(i) for human genetic testing;
(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;
(k) for management of patients suffering from a life-threatening disease or condition;
(l) for screening for congenital disorders in the embryo or foetus; 
(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.
 













Class C
Rule 4Devices intended for self-testing are classified as: Class C
Rule 4
(cont.)
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
Rule 4
(cont.)
Devices intended for near-patient testing are classified in their own right. 



Rule 5 
The following devices are classified as:
(a) 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;
(b) instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures; 
(c) specimen receptacles.
 


Class A
Rule 6Devices not covered by the above-mentioned classification rules (Rule 1 to 5) are classified as: Class B
Rule 7Devices which are controls without a quantitative or qualitative assigned value are classified as: Class B