MDCG 2020-16 rev.2
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
February 2023
更新屬于輕微修訂，主要涉及到規(guī)則1（Rule 1）的示例、新增伴隨診斷（Companion Diagnostics）CDx分類依據(jù)和分類路徑等。
1. Rule 1 示例
修改前：Highly virulent pandemic influenza virus.
修改后：Highly virulent influenza virus.
刪除“流行性”，將非流行性、高致病性流感病毒也歸類為D類產(chǎn)品。
2. 適用于規(guī)則31(Rule3)一般性意見修訂
修改前：Rule 3 covers a range of devices as reflected in its indents (a)-(m). Devices falling under Rule 3 (when not classified as Class D according to rules 1 & 2) are to be classified in class C,irrespective of the indent applied.
It may be possible for a device to fall under more than one Rule 3 indent.Where this is the case, the most appropriate indent should always be applied, based on the intended purpose of the device.修改后：Rule 3 covers a range of devices as reflected in its indents (a)-(m). Devices falling under Rule 3 (when not classified as Class D according to rules 1 & 2) are to be classified in class C,irrespective of the indent applied.It may be possible for a device to fall under more than one Rule 3 indent.
刪除“在此情況下，應(yīng)始終根據(jù)器械的預(yù)期用途應(yīng)用最合適的詞條”，要求器械預(yù)期用途應(yīng)更清晰、描述準(zhǔn)確。
3. 適用于規(guī)則3(f)(Rule3(f))的內(nèi)容修訂修改前：The identification of patients may comprise a quantitative or qualitative determination of specific markers.Such specific markers can be present in healthy subjects and/or in patients.
The emphasis ‘before and/or during treatment’ implies that CDxs may be intended to be applied before a treatment with a corresponding medicinal product is initiated, or during treatment, to identify if (still) the patient is (a) likely to benefit from the corresponding medicinal product or (b) likely to be at increased risk of serious adverse reactions.
Devices that are intended to be used for monitoring treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be CDxs.
修改后：For a device to be defined as a CDx, there should be a link to a medicinal product with an International Non-proprietary Name (INN) .
The identification of patients may comprise a quantitative or qualitative determination of specific markers.
Such specific markers can be present in healthy subjects and/or in patients.
The emphasis ‘before and/or during treatment’ implies that CDxs may be intended to be applied before a treatment with a corresponding medicinal product is initiated, or during treatment, to identify if (still) the patient is(a)likely to benefit from the corresponding medicinal product or (b)likely to be at increased risk of serious adverse reactions.
Devices that are intended to be used for monitoring treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be CDxs (e.g. devices intended for blood glucose monitoring, devices intended for measurement of cyclosporine concentration in blood, devices intended for measurement of metabolites of a medicinal product).
Devices intended to determine quantitative or qualitative specific marker(s) to establish the dosage of a particular medicinal product, for patients that are already eligible to receive that medicinal product, are not considered to be CDxs. For example, devices intended to measure creatinine concentration can be used for estimating kidney function to determine the optimal dosage of medicinal products with renal elimination. Another example is devices identifying CYP2D6 or CYP2C19 genotypes of a patient to determine the appropriate dosage of an already prescribed medication.
Annex II to this guidance provides a flowchart to help determine whether an IVD is a CDx.
新增：
1) 對于定義為CDx的器械，應(yīng)鏈接到具有國際非專利名稱(INN)的藥品。
2) 用于確定特定藥物劑量的定量或定性特定標(biāo)志物的器械，對于已具備資格接受該藥物的患者，不被視為CDxs。
例如：旨在測量肌酐濃度的器械可用于估計腎功能，以確定具有腎消除功能的藥物的最佳劑量；識別患者CYP2D6或CYP2C19基因型，以確定處方藥物適當(dāng)劑量的器械。
3) 附錄II提供流程圖，幫助確定IVD是否為CDx。
強(qiáng)調(diào)：伴隨診斷器械的分類依據(jù)和分類路徑。
伴隨診斷為醫(yī)療器械,屬于體外診斷范疇,能夠?qū)ο鄳?yīng)藥物或生物制品的安全性、使用效果等重要信息進(jìn)行評價。
Q1：對于安全有效地使用具有INN的醫(yī)療產(chǎn)品，IVD是否至關(guān)重要？
Q2: IVD是否監(jiān)測藥物濃度處于治療窗口期？
Q3：IVD是否確定已有資格接受該藥物的患者的藥物劑量？
Q4：IVD是否在治療前或治療期間確定患者：最大可能受益于該藥物，或使用該藥物治療后發(fā)生嚴(yán)重不良事件的風(fēng)險是否會增加？
Q1不適用的情況下，器械為非伴隨診斷器械。
如適用Q1，則繼續(xù)考慮Q2適用情況
→ 如適用Q1+Q2,器械為非伴隨診斷器械。
→如適用Q1但不適用Q2,繼續(xù)考慮Q3適用情況：
1. 如適用Q3情況,器械為非伴隨診斷器械；
2. 如不適用Q3情況，應(yīng)繼續(xù)考慮Q4情況：
2.1 如適用Q1，不適用Q2和Q3，但適用Q4，器械為伴隨診斷器械；
2.2 如適用Q1，不適用Q2、Q3、Q4情況，器械為非伴隨診斷器械。
