【奧譯言】歐盟發布基于MDR/IVDR的軟件分類指南

2019-10-17 13:25 ?閱讀數:370 標簽:
歐盟醫療器械協調小組(MDCG)上周五(2019年10月11日)發布了一份指南文件,旨在幫助醫療軟件制造商了解新的歐盟醫療器械法規(MDR)和歐盟體外診斷醫療器械法規(IVDR)下的軟件資格標準。


本指南討論了根據MDR或IVDR分類的某些軟件,例如可以直接控制(硬件)醫療器械的軟件(例如放射治療軟件),可提供即時決策觸發信息(如血糖儀軟件)或為醫護專業人員提供支持的軟件(如心電圖解讀軟件)。

例如,醫療器械軟件可以是獨立軟件,并能夠接收測量結果。針對這一點,該指南中提到了其中一個例子,即可以通過經直腸超聲檢查結果、年齡和體外診斷工具來計算患者患前列腺癌風險的軟件。另一方面,軟件也可能會驅動器械或影響器械使用。對此,該指南文件舉例說明了連接到閉環胰島素輸送系統的軟件。

“該軟件可以,但不限于:a)通過接口(如軟件、硬件)或通過器械操作員操作、修改器械的狀態或控制器械,b)或提供與該器械的(硬件)功能相關的輸出,”該指南文件中提到。軟件還可以定性為“醫療器械軟件”(無論其位置如何,例如,在云端、計算機、手機上運行,或者作為硬件醫療器械上的附加功能)。

這份28頁的指南文件還包含一個涉及醫療器械軟件資格認證五步驟的決策樹,以及另一個涉及將醫療器械軟件視為醫療器械或體外診斷醫療器械三步驟的決策樹。

根據IVDR對醫療器械軟件進行分類的情形舉例如下:

  • “根據規則3(k),預期安裝在全自動酶聯免疫吸附測定(ELISA)分析儀上的軟件、預期通過人類HbA1c ELISA獲得的結果確定血清中人類HbA1c的濃度的軟件,以及預期用于篩查和診斷糖尿病并對糖尿病患者進行監測的軟件,應屬于C類。
  • 根據規則3(h),PAP染色自動宮頸細胞學篩查系統中的軟件(預期用于判定PAP宮頸涂片為正常或可疑)應屬于C類。
  • 根據規則1,預期解釋用于確認和測定人血清和血漿中HIV-1、HIV-1 O組和HIV-2抗體的線性免疫測定自動讀數的軟件,應屬于D類。
  • 根據規則3(l),使用母體參數(如年齡、血清標記物濃度和通過胎兒超聲檢查獲得的信息)評估21-三體綜合征風險的軟件,應屬于C類。


指南中關于執行規則部分進一步指出,根據所實現的預期用途,對既實現了自身預期用途、又驅動(硬件)器械或影響(硬件)器械使用的用于醫療用途的醫療器械軟件進行了分類。然而,在這種情況下,其風險等級不得低于硬件醫療器械的風險等級。
對此,該指南舉例說明了預期與近紅外激光掃描儀同時使用的黑色素瘤圖像分析軟件(IIa類)。

“該軟件用于驅動近紅外激光掃描儀或影響近紅外激光掃描儀的使用,因其旨在通過執行專有多重曝光程序來檢測黑色素瘤來控制掃描儀。因此,執行規則3.3適用。然而,分類規則11也可能適用,這取決于軟件的預期醫療用途(如癌癥診斷)。根據分類規則11和附錄VIII執行規則3.5,該醫療器械軟件將被歸類為III類。

根據MDR的部分內容以及國際醫療器械監管者論壇(IMDRF)的國際指南,MDCG進一步解釋了分類規則11,以及如何處理與有源器械提供的信息有關的風險,并對有源器械提供的信息對醫療決策(患者管理)的重要性(結合醫療狀況(患者病情))進行了描述和分類。

該指南中還包含與IVDR相關的其他分類和執行規則。

英文原文

Classifying Software Under MDR, IVDR: New Guidance From MDCG


The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

The guidance discusses certain types of software that would be classified under MDR or IVDR, such as software that can directly control a (hardware) medical device (e.g. radiotherapy treatment software), can provide immediate decision-triggering information (e.g. blood glucose meter software) or provide support for health professionals (e.g. electrocardiogram interpretation software).

For instance, medical device software (MDSW) may be independent and able to receive measurements. The guidance uses the example of software that can use transrectal ultrasound findings, age and in vitro diagnostic instruments to calculate a patient’s risk of developing prostate cancer. Or the software may “drive or influence” a medical device and the guidance points to software connected to a closed-loop insulin delivery system as an example.

“This software can, but is not limited to: a) operate, modify the state of, or control the device either through an interface (e.g.,software, hardware) or via the operator of this device b) or supply output related to the (hardware) functioning of that device,” the guidance notes. Software also may be qualified as MDSW “regardless of its location (e.g.operating in the cloud, on a computer, on a mobile phone, or as an additional functionality on a hardware medical device)."

The 28-page guidance also features a decision tree with five steps for the qualification of MDSW and another tree with three decisions for the qualification of MDSW as either a medical device or an IVD.

Examples for the classification of MDSW under the IVDR include:

  • "Software intended to be installed on a fully automated enzyme-linked immunosorbent assay (ELISA) analyser, and intended to determine the Human HbA1c concentration in serum from the results obtained with a Human HbA1c ELISA, intended to screen for and diagnose diabetes and monitor diabetic patients, should be in class C per Rule 3(k).
  • Software within a PAP stain automated cervical cytology screening system, intended to classify the PAP cervical smear as either normal or suspicious, should be in class C per Rule 3(h).
  • Software for the interpretation of automated readings of line immunoassay for the confirmation and determination of antibodies to HIV-1, HIV-1 group O and HIV-2 in human serum and plasma, should be in class D per Rule 1.
  • Software that uses maternal parameters such as age, concentration of serum markers and information obtained through foetal ultrasound examination for evaluating the risk of trisomy 21, should be in class C per Rule 3(l)."



The section of the guidance on implementing rules further notes that MDSW “that both achieves its own intended purpose and also drives or influences the use of a (hardware) device for a medical purpose is classified on its own, based on the intended purpose achieved. In such a case, however, the risk class shall not be lower than the risk class of the hardware medical device.”

For an example, the guidance points to melanoma image analysis software intended to be used with a near-infrared laser light scanner, which is considered class IIa.

“The software‘drives or influences the use of’the near-infrared laser light scanner as it is intended to take control of the scanner by letting it execute proprietary multi-exposure programs for the detection of melanoma. As such, implementing rule 3.3 applies. However, Rule 11 would also apply based on the intended medical purpose of the software e.g. cancer diagnosis. The MDSW would be classified as class III based on Rule 11 (see section Classification Rules) and per implementing rule 3.5 of Annex VIII,” the guidance says.

In line with part of MDR and international guidance from the International Medical Device Regulators Forum, the MDCG further explains Rule 11 and how it is intended to address the risks related to the information provided by an active device and that it describes and categorizes the “significance of the information provided by the active device to the healthcare decision (patient management) in combination with the healthcare situation (patient condition).”
Other classification and implementing rules related to IVDR are also included in the guidance.




來源:RAPS
原文鏈接:https://www.raps.org/news-and-articles/news-articles/2019/10/classifying-software-under-mdr-ivdr-new-guidance
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