医疗器械在EU MDR的分类可以通过AI 工具来进行，简单快捷并给出相应的解释。

EU MDR Classification Rules

ANNEX VIII. CLASSIFICATION RULES

CHAPTER I. DEFINITIONS SPECIFIC TO CLASSIFICATION RULES

1.   DURATION OF USE

1.1 ‘Transient’ means normally intended for continuous use for less than 60 minutes.

1.2 ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.

1.3 ‘Long term’ means normally intended for continuous use for more than 30 days.

2.   INVASIVE AND ACTIVE DEVICES

2.1 ‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

2.2 ‘Surgically invasive device’ means:
(a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation;
(b) a device which produces penetration other than through a body orifice.

2.3 ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.

2.4 ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.

2.5 ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.

2.6 ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior.

2.7 ‘Central nervous system’ means the brain, meninges and spinal cord.

2.8. ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.

CHAPTER II. IMPLEMENTING RULES

3.1 Application of the classification rules shall be governed by the intended purpose of the devices.

3.2 If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices.  Accessories for a medical device shall be classified in their own right separately from the device with which they are used.

3.3 Software, which drives a device or influences the use of a device, shall fall within the same class as the device.
If the software is independent of any other device, it shall be classified in its own right.

3.4 If the device is not intended to be used solely or principally in a specific part of the body, it shall be considered and classified on the basis of the most critical specified use.

3.5 If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device’s intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply.

3.6 In calculating the duration referred to in Section 1, continuous use shall mean:
(a) the entire duration of use of the same device without regard to temporary interruption of use during a procedure or temporary removal for purposes such as cleaning or disinfection of the device. Whether the interruption of use or the removal is temporary shall be established in relation to the duration of the use prior to and after the period when the use is interrupted or the device removed;
(b) the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type.

3.7 A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question by itself or when it provides decisive information for the diagnosis.

CHAPTER III. CLASSIFICATION RULES

4.   NON-INVASIVE DEVICES

4.1.   Rule 1

All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.

4.2.   Rule 2

All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:

— if they may be connected to a class IIa, class IIb or class III active device; or
— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.

In all other cases, such devices are classified as class I.

4.3.   Rule 3

All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa.

All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.

4.4.   Rule 4

All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:

— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;

— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent;

— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and

— class IIa in all other cases.

This rule applies also to the invasive devices that come into contact with injured mucous membrane.

5.   INVASIVE DEVICES

5.1.   Rule 5

All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:

— class I if they are intended for transient use;

— class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and

— class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.

All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.

5.2.   Rule 6

All surgically invasive devices intended for transient use are classified as class IIa unless they:

— are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;

— are reusable surgical instruments, in which case they are classified as class I;

— are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;

— are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;

— have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or

— are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb.

5.3.   Rule 7

All surgically invasive devices intended for short-term use are classified as class IIa unless they:

— are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;

— are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;

— are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;

— have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;

— are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or

— are intended to administer medicines, in which case they are classified as class IIb.

5.4.   Rule 8

All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:

— are intended to be placed in the teeth, in which case they are classified as class IIa;

— are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III;

— have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;

— are intended to undergo chemical change in the body in which case they are classified as class III, except if the devices are placed in the teeth;

— are intended to administer medicinal products, in which case they are classified as class III;

— are active implantable devices or their accessories, in which cases they are classified as class III;

— are breast implants or surgical meshes, in which cases they are classified as class III;

— are total or partial joint replacements, in which case they are classified as class III, with the exception of ancillary components such as screws, wedges, plates and instruments; or

— are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments.

6.   ACTIVE DEVICES

6.1.   Rule 9

All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.

All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.

All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.

All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III.

6.2.   Rule 10

Active devices intended for diagnosis and monitoring are classified as class IIa:

— if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient’s body, in the visible spectrum, in which case they are classified as class I;

— if they are intended to image in vivo distribution of radiopharmaceuticals; or

— if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.

Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.

6.3.   Rule 11

Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

— death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or

— a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I.

6.4.   Rule 12

All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.

6.5.   Rule 13

All other active devices are classified as class I.

7.   SPECIAL RULES

7.1.   Rule 14

All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III.

7.2.   Rule 15

All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III.

7.3.   Rule 16

All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb.

All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.

This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.

7.4.   Rule 17

Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa.

7.5.   Rule 18

All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.

7.6.   Rule 19

All devices incorporating or consisting of nanomaterial are classified as:

— class III if they present a high or medium potential for internal exposure;

— class IIb if they present a low potential for internal exposure; and

— class IIa if they present a negligible potential for internal exposure.

7.7.   Rule 20

All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life-threatening conditions, in which case they are classified as class IIb.

7.8.   Rule 21

Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:

— class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose;

— class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body;

— class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and

— class IIb in all other cases.

7.9.   Rule 22

Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.

中文翻译

欧盟医疗器械法规分类规则

附件八、分类规则

第一章 分类规则的具体定义

1. 使用时间

1.1 “短暂”是指通常连续使用时间少于60分钟。

1.2 “短期”是指通常连续使用时间在60分钟至30天之间。

1.3 “长期”是指通常连续使用时间超过30天。

2. 侵入性和有源器械

2.1 “体腔”是指人体的任何自然开口，以及眼球的外表面，或任何永久性人工开口，如造口。

2.2 “手术侵入性器械”是指：

(a) 通过体表（包括通过手术操作过程中的体腔黏膜）进入体内的侵入性器械；

(b) 通过非体腔途径产生穿透的器械。

2.3 “可重复使用手术器械”是指用于外科手术中进行切割、钻孔、锯切、刮削、夹持、牵开、夹闭或类似操作的器械，这类器械无需连接到有源器械上，且制造商预期在经过适当的清洁、消毒和灭菌等程序后可以重复使用。

2.4 “有源治疗器械”是指单独使用或与其他器械组合使用的任何有源器械，用于支持、改变、替代或恢复生物功能或结构，以达到治疗或缓解疾病、损伤或残疾的目的。

2.5 “用于诊断和监测的有源器械”是指单独使用或与其他器械组合使用的任何有源器械，用于提供信息以检测、诊断、监测或治疗生理状况、健康状况、疾病或先天性畸形。

2.6 “中央循环系统”是指以下血管：肺动脉、升主动脉、主动脉弓、降主动脉至主动脉分叉、冠状动脉、颈总动脉、颈外动脉、颈内动脉、大脑动脉、头臂干、心静脉、肺静脉、上腔静脉和下腔静脉。

2.7 “中枢神经系统”是指大脑、脑膜和脊髓。

2.8 “受损的皮肤或粘膜”是指由于病理改变、疾病或创伤而发生变化的皮肤或粘膜区域。

第二章 实施规则

3.1 分类规则的应用应当以器械的预期用途为准。

3.2 如果某器械预期与另一器械组合使用，分类规则应当分别适用于每个器械。医疗器械的配件应当独立分类，与其配合使用的器械的分类无关。

3.3 驱动器械或影响器械使用的软件应当与该器械属于相同的分类。 如果软件独立于任何其他器械，则应当独立分类。

3.4 如果器械并非仅用于或主要用于人体的特定部位，则应当根据其最重要的特定用途进行考虑和分类。

3.5 如果基于器械的预期用途，同一器械适用多个规则，或在同一规则中适用多个子规则，则应当采用导致更高分类的最严格规则和子规则。

3.6 在计算第1节所述的使用时间时，连续使用是指： (a) 同一器械的整个使用期间，不考虑在操作过程中的临时中断使用或为清洁或消毒而临时移除器械。中断使用或移除是否为临时性的，应当根据中断或移除前后的使用时间来确定； (b) 制造商预期立即更换为同类型器械的累计使用时间。

3.7 当器械本身能够提供疾病或状况的诊断，或为诊断提供决定性信息时，该器械被视为可进行直接诊断。

第三章 分类规则

4. 非侵入性器械

4.1 规则1 所有非侵入性器械均归类为I类，除非适用以下规则。

4.2 规则2 所有用于输送或储存血液、体液、细胞或组织、液体或气体，以便最终输注、给药或引入人体的非侵入性器械归类为IIa类：

— 如果可以连接到IIa类、IIb类或III类有源器械；或

— 如果用于输送或储存血液或其他体液，或用于储存器官、器官部分或体细胞和组织，但血袋除外；血袋归类为IIb类。

在所有其他情况下，此类器械归类为I类。

4.3 规则3 所有用于改变人体组织或细胞、血液、其他体液或用于植入或施用于人体的其他液体的生物或化学成分的非侵入性器械归类为IIb类，除非该器械的治疗过程仅包括过滤、离心或气体、热交换，在这种情况下归类为IIa类。

所有由物质或物质混合物组成的非侵入性器械，预期在体外与取自人体的人体细胞、组织或器官直接接触，或在植入或施用于人体之前与人体胚胎在体外使用的，归类为III类。

4.4 规则4 所有与受损皮肤或粘膜接触的非侵入性器械归类为：

— 如果预期用作机械屏障、用于压迫或吸收渗出液，归类为I类；

— 如果主要预期用于已破坏真皮的皮肤创伤，且只能通过继发愈合的情况，归类为IIb类；

— 如果主要预期用于管理受损皮肤或粘膜的微环境，归类为IIa类；

— 在所有其他情况下归类为IIa类。 该规则也适用于与受损粘膜接触的侵入性器械。

5. 侵入性器械

5.1 规则5 所有通过体腔的侵入性器械（非手术侵入性器械），且不预期与有源器械连接，或预期与I类有源器械连接的器械归类为：

— 如果预期短暂使用，归类为I类；

— 如果预期短期使用，归类为IIa类，但如果在口腔至咽喉、外耳道至鼓膜或鼻腔内使用，则归类为I类；

— 如果预期长期使用，归类为IIb类，但如果在口腔至咽喉、外耳道至鼓膜或鼻腔内使用且不会被粘膜吸收，则归类为IIa类。

所有通过体腔的非手术侵入性器械，预期与IIa类、IIb类或III类有源器械连接的，归类为IIa类。

5.2 规则6 所有预期短暂使用的手术侵入性器械归类为IIa类，除非：

— 特别预期用于通过直接接触来控制、诊断、监测或纠正心脏或中央循环系统的缺陷，在这种情况下归类为III类；

— 属于可重复使用的手术器械，在这种情况下归类为I类；

— 特别预期直接接触心脏、中央循环系统或中枢神经系统，在这种情况下归类为III类；

— 预期以电离辐射形式提供能量，在这种情况下归类为IIb类；

— 具有生物效应或主要被人体吸收，在这种情况下归类为IIb类；或

— 预期通过给药系统施用药品，如果考虑到使用方式，这种给药方式具有潜在危险性，在这种情况下归类为IIb类。

5.3 规则7 所有预期短期使用的手术侵入性器械归类为IIa类，除非：

— 特别预期用于通过直接接触来控制、诊断、监测或纠正心脏或中央循环系统的缺陷，在这种情况下归类为III类；

— 特别预期直接接触心脏、中央循环系统或中枢神经系统，在这种情况下归类为III类；

— 预期以电离辐射形式提供能量，在这种情况下归类为IIb类；

— 具有生物效应或主要被人体吸收，在这种情况下归类为III类；

— 预期在体内发生化学变化，在这种情况下归类为IIb类，但放置在牙齿中的器械除外；或

— 预期用于给药，在这种情况下归类为IIb类。

5.4 规则8 所有植入性器械和长期手术侵入性器械归类为IIb类，除非：

— 预期放置在牙齿中，在这种情况下归类为IIa类；

— 预期直接接触心脏、中央循环系统或中枢神经系统，在这种情况下归类为III类；

— 具有生物效应或主要被人体吸收，在这种情况下归类为III类；

— 预期在体内发生化学变化，在这种情况下归类为III类，但放置在牙齿中的器械除外；

— 预期用于给药，在这种情况下归类为III类； — 属于有源植入性器械或其配件，在这种情况下归类为III类；

— 属于乳房植入物或手术网片，在这种情况下归类为III类；

— 属于全部或部分关节置换，在这种情况下归类为III类，但辅助部件如螺钉、楔块、钢板和器械除外；或

— 属于脊椎椎间盘置换植入物或接触脊柱的植入性器械，在这种情况下归类为III类，但部件如螺钉、楔块、钢板和器械除外。

6. 有源器械

6.1 规则9 所有用于施用或交换能量的有源治疗器械归类为IIa类，除非考虑到能量的性质、密度和施用部位，其特性可能以潜在危险的方式向人体施用或交换能量，在这种情况下归类为IIb类。

所有用于控制或监测IIb类有源治疗器械性能，或直接影响此类器械性能的有源器械归类为IIb类。

所有预期用于发射电离辐射进行治疗目的的有源器械，包括控制或监测此类器械，或直接影响其性能的器械，归类为IIb类。

所有预期用于控制、监测或直接影响有源植入性器械性能的有源器械归类为III类。

6.2 规则10 用于诊断和监测的有源器械归类为IIa类：

— 如果预期供给能量被人体吸收，但预期在可见光谱下照明患者体部的器械除外，后者归类为I类；

— 如果预期用于显示放射性药物的体内分布；或

— 如果预期用于直接诊断或监测重要生理过程，除非其特别预期用于监测重要生理参数，且由于这些参数变化的性质可能导致患者即刻危险，例如心脏功能、呼吸、中枢神经系统活动的变化，或预期用于临床情况下对处于即刻危险的患者进行诊断，在这些情况下归类为IIb类。

预期发射电离辐射并用于诊断或治疗性放射学的有源器械，包括介入放射学器械以及控制或监测此类器械或直接影响其性能的器械，归类为IIb类。

6.3 规则11 预期提供用于诊断或治疗决策的信息的软件归类为IIa类，除非此类决策可能造成：

— 死亡或人体状态不可逆恶化，在这种情况下归类为III类；或

— 人体状态严重恶化或需要手术干预，在这种情况下归类为IIb类。

预期用于监测生理过程的软件归类为IIa类，除非其预期用于监测重要生理参数，且由于这些参数变化的性质可能导致患者即刻危险，在这种情况下归类为IIb类。

所有其他软件归类为I类。

6.4 规则12 所有预期用于施用和/或移除药品、体液或其他物质进出人体的有源器械归类为IIa类，除非考虑到所涉及物质的性质、涉及的身体部位和使用方式，这种操作具有潜在危险性，在这种情况下归类为IIb类。

6.5 规则13 所有其他有源器械归类为I类。

7. 特殊规则

7.1 规则14 所有包含作为整体组成部分的物质的器械，如果该物质单独使用时可被视为药品（按照指令2001/83/EC第1条第2点的定义，包括该指令第1条第10点定义的来源于人血或人血浆的药品），且该物质对器械具有辅助作用，则归类为III类。

7.2 规则15 所有用于避孕或预防性传播疾病的器械归类为IIb类，除非是植入性或长期侵入性器械，在这种情况下归类为III类。

7.3 规则16 所有特别预期用于接触镜消毒、清洁、冲洗或适当时水化的器械归类为IIb类。

所有特别预期用于医疗器械消毒或灭菌的器械归类为IIa类，除非其为消毒溶液或作为终末处理步骤专门用于侵入性器械消毒的清洗消毒器，在这种情况下归类为IIb类。

本规则不适用于仅通过物理作用清洁接触镜以外器械的器械。

7.4 规则17 特别预期用于记录X射线辐射产生的诊断图像的器械归类为IIa类。

7.5 规则18 所有使用人源或动物源组织或细胞或其衍生物制造的非活性或经处理成非活性的器械归类为III类，除非此类器械仅预期与完整皮肤接触，且是使用动物源组织或细胞或其衍生物制造的非活性或经处理成非活性的器械。

7.6 规则19 所有包含或由纳米材料组成的器械归类为：

— 如果具有高或中等内部暴露潜力，归类为III类；

— 如果具有低内部暴露潜力，归类为IIb类；

— 如果具有可忽略的内部暴露潜力，归类为IIa类。

7.7 规则20 所有通过体腔给药的非手术侵入性器械，预期通过吸入给药的，归类为IIa类，除非其作用方式对所施用药品的功效和安全性有重要影响，或预期用于治疗危及生命的情况，在这种情况下归类为IIb类。

7.8 规则21 由预期通过体腔引入人体或施用于皮肤并被人体吸收或局部扩散的物质或物质组合组成的器械归类为：

— 如果它们或它们的代谢产物被人体系统性吸收以达到预期目的，归类为III类；

— 如果它们在胃部或更低胃肠道达到预期目的，且它们或它们的代谢产物被人体系统性吸收，归类为III类；

— 如果它们施用于皮肤或在鼻腔或口腔至咽喉腔施用，且在这些腔体达到预期目的，归类为IIa类；

— 在所有其他情况下归类为IIb类。

7.9 规则22 具有集成或整合诊断功能的有源治疗器械，如果该诊断功能显著决定器械对患者的管理，如闭环系统或自动体外除颤器，归类为III类。