医疗器械分类指南

Foreword 前言

If you are a manufacturer of medical devices and plan to market your product in either the US or EU markets, you must classify your medical device according to the edicts of the respective regulatory agency.

如果您是医疗设备制造商，并计划在美国或欧盟市场推广您的产品，您必须根据各自监管机构的法令对您的医疗设备进行分类。

The purpose of classifying your medical device is to determine the applications and type of premarket submissions that are required.

对医疗设备进行分类的目的是确定所需的申请和预市场提交的类型。

In this article, we will look at the differences between the FDA medical device classes, and EU MDR medical device classes. We will also discuss different approaches for determining how your medical device will be classified by the US FDA and European Commission and get a basic understanding of regulatory product classification.

在本文中，我们将介绍 FDA 医疗设备类别和欧盟 MDR 医疗设备类别之间的区别。我们还将讨论确定您的医疗设备将如何被美国 FDA 和欧洲委员会分类的不同方法，并对监管产品分类有一个基本的了解。

Note

This post is not a comprehensive guide to medical device classification but a simplified, introductory guide to the classification of medical devices in the US and the EU. Always follow the standards applicable to you and your company!

这篇文章不是关于医疗器械分类的全面指南，而是关于美国和欧盟医疗器械分类的简化入门指南。始终遵循适用于您和您的公司的标准！

What Is Medical Device Classification? 医疗器械分类是什么？

The classification of medical devices is to determine the level of harm they can pose to the end-users, namely patients. In general, Class I includes all medical devices that have the lowest risk and Class III has those medical devices with the highest risk.

医疗器械的分类是为了确定它们对最终用户，即患者可能造成的伤害程度。一般来说，I 类包括所有风险最低的医疗器械，而 III 类则包括风险最高的医疗器械。

For instance, your medical devices company is dealing with handheld surgical instruments, deep-brain stimulators, and computed tomography (CT) scanners, amongst others. When you market these in the US market, you will realize that you need to classify handheld surgical instruments as Class I, deep-brain stimulators as Class III, and CT scanners as Class II.

例如，您的医疗器械公司正在处理手持式外科器械、深脑刺激器和计算机断层扫描（CT）仪等产品。当您在美国市场推广这些产品时，您会意识到您需要将手持式外科器械分类为 I 类，将深脑刺激器分类为 III 类，将 CT 扫描仪分类为 II 类。

Why Medical Device Classification Is Important? 为什么医疗器械分类很重要？

Classifying the medical devices produced by your company is important for the following reasons:

对于以下原因，对您公司生产的医疗器械进行分类很重要：

Classification will help you determine what must be done before selling your product. 分类将帮助您确定在销售产品之前必须完成的工作。
Classifying your medical devices will help you in establishing requirements during the development phase of the product, primarily Design-Controls-for-Medical-Devices. 对医疗器械进行分类将有助于在产品开发阶段建立要求，主要是设计控制。
A crucial point for medical device companies is the costs involved and the timeframe for launching their product in a given market. With product classification, you will get an estimate of the overall costs and time required to bring a medical device to the market. 对于医疗器械公司来说，一个关键点是涉及的成本和在特定市场推出产品的时间框架。通过产品分类，您将获得将医疗器械推向市场所需的总成本和时间的估计。

Classification Strategy: Where to Get Approved First? 分类策略：首先在哪里获得批准？

As a medical device manufacturer, you need to decide whether to seek US FDA approval or EU Medical Device Regulation (MDR) first. Resource constraints may not permit a simultaneous approval process.

作为医疗设备制造商，您需要决定是首先寻求美国 FDA 批准还是欧盟医疗器械法规（MDR）批准。资源限制可能不允许同时进行批准过程。

Before May 26, 2021, the European Union’s Conformité Européenne (CE) mark was easier to obtain compared to the US FDA approval for medical devices. Since the CE mark had limitations, even within some of the EU nations, it was considered less influential.

在 2021 年 5 月 26 日之前，欧盟的欧洲符合性（CE）标志相对于美国 FDA 对医疗设备的批准更容易获得。由于 CE 标志存在一些限制，甚至在一些欧盟国家内部，它被认为影响力较小。

The new EU MDR guidelines are significantly closer to FDA requirements concerning the following:

新的欧盟 MDR 指南与 FDA 要求在以下方面有显著接近：

Preconditions for conformity assessment 符合评估的前提条件
QMS compliance QMS 合规性

Let us take a look at key differences between these two regulatory approvals – classification of devices and risk process.

让我们来看看这两种监管批准之间的关键差异 — 设备分类和风险过程。

The US FDA’s classification of a medical device is based on its risk. Low and moderate-risk devices are classified as either Class I or Class II medical devices. These are regulated by the 510(K) regulation. You must demonstrate that your device has a similar function to a previously approved device. Class III devices are high-risk devices that need far more validations.

美国 FDA 对医疗器械的分类是基于其风险。低风险和中等风险的设备被分类为 I 类或 II 类医疗器械。这些受到 510(K)法规的监管。您必须证明您的设备与先前批准的设备具有类似的功能。III 类设备是高风险设备，需要更多的验证。

The EU MDR has 4 categories of devices:

欧盟 MDR 有 4 个设备类别：

Non-invasive medical devices 非侵入性医疗设备
Invasive medical devices 侵入性医疗设备
Active medical devices 主动医疗设备
Special category 特殊类别

The medical devices are also classified based on risk, which will give a measure of the data and the type of evaluation required by the manufacturer. Based on risk management, medical devices are grouped in one of the following five different risk-based classes:

医疗设备还根据风险进行分类，这将为制造商提供数据和所需评估类型的度量。根据风险管理，医疗设备分为以下五个不同的基于风险的类别之一：

Class I (Basic): Non-sterile or no measuring function (i.e. low risk) I 类（基本）：非无菌或无测量功能（即低风险）
Class I (Special Function): Sterile and a measuring function (i.e. low to medium risk) I 类（特殊功能）：无菌且具有测量功能（即低至中风险）
Class IIa: Medium risk IIa 类：中风险
Class IIb: Medium to high risk IIb 类：中至高风险
Class III: High-risk Risk process III 类：高风险风险过程

According to the US FDA requirements, Class II devices onwards need to be audited with various evaluations. Under EU MDR, auditing requires wide-ranging technical documentation and risk evaluation. This documentation can efficiently be managed in an Electronic Quality Management System (eQMS).

根据美国 FDA 的要求，从 II 类设备开始需要进行各种评估的审核。根据欧盟 MDR，审核需要广泛的技术文件和风险评估。这些文件可以在电子质量管理系统（eQMS）中高效管理。

A cursory glance at the details given will indicate that it is easier to get approval for your medical device first in the USA.

对给定的细节进行粗略查看将表明，首先在美国获得医疗设备的批准更容易。

FDA Medical Device Classification FDA 医疗器械分类

If you wish to market your medical devices in the US market, you need to know that medical devices are classified as Class I, Class II, or Class III. This classification is based on the risk your medical device has for the end-user, namely patients.

如果您希望在美国市场销售您的医疗器械，您需要知道医疗器械被分为 I 类、II 类或 III 类。这个分类是基于您的医疗器械对最终用户（即患者）的风险。

This classification is tied to the intended use and indication for use of the medical device.

这个分类与医疗器械的预期用途和适应症相关。

The definitions are as follows:

定义如下：

Intended use: This term describes your claim what the medical device does. It means the general purpose/function of the medical device. 预期用途：这个术语描述了您的医疗器械的功能。它指的是医疗器械的一般目的/功能。
Indications of use: This term describes what disease your medical device is to diagnose, prevent, cure, treat, or alleviate. It also includes the target population of patients. 使用指示：这个术语描述了您的医疗器械用于诊断、预防、治愈、治疗或缓解的疾病。它还包括患者的目标人群。

FDA Class I Medical Devices FDA I 类医疗器械

Class I medical devices are defined by the FDA as follows:

FDA 将 I 类医疗器械定义如下：

“not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”

“不用于支持或维持生命，对预防人类健康损害具有重要性，且不会带来潜在的不合理风险。”

Class I medical devices have a low to moderate risk for the patient.

I 类医疗器械对患者的风险较低至中等。

Around 47 percent of all medical devices are in this category and 95 percent of these are exempt from the regulatory process.

大约 47% 的医疗器械属于此类别，其中 95% 免于监管程序。

You should note that Class I medical devices have minimal contact with the patient. They do not come in contact with the patient’s cardiovascular system, the central nervous system, or internal organs.

您应该注意到，I 类医疗器械与患者的接触很少。它们不与患者的心血管系统、中枢神经系统或内脏器官接触。

When a device is in a generic category of exempted class I medical devices, there is no requirement for a premarket notification application or FDA clearance before marketing the device in the US market. However, you are required to register your company and list the generic devices with the FDA.

当设备属于豁免的 I 类医疗器械的通用类别时，在美国市场上销售该设备之前，不需要进行预市场通知申请或 FDA 许可。然而，您需要向 FDA 注册您的公司并列出通用设备。

Examples of Class I medical devices:

I 类医疗器械的例子：

Plasters 创可贴
Electric toothbrushes 电动牙刷
Enema kits 灌肠套件
Bedpans 便盆
Manual stethoscopes 手动听诊器
Tongue depressor 舌压板
Oxygen mask 氧气面罩
Hospital beds 医院床

The Path to Market for Class I Medical Devices in the US 美国市场 I 类医疗器械的准入路径

When marketing Class I medical devices in the US, you must note the following.

在美国市场销售 I 类医疗器械时，您必须注意以下事项。

Class I medical devices are the quickest to bring to the US market because they present the lowest risk to the patient.

I 类医疗器械是最快进入美国市场的，因为它们对患者的风险最低。

The majority of Class I medical devices are exempt from the FDA’s requirements for Premarket Approval (PMA) and Premarket Notification (PMN) or 510(k).

大多数 I 类医疗器械不需要符合 FDA 的预市批准（PMA）和预市通知（PMN）或 510(k)的要求。

Class I medical devices are subject to the FDA’s general controls. These are a series of controls that apply to all medical devices (i.e., Class I, II, and III). They address device registration, adulteration, misbranding, record maintenance, and good manufacturing practices.

I 类医疗器械受到 FDA 的一般控制。这些控制适用于所有医疗器械（即 I 类、II 类和 II 类）。它们涉及设备注册、掺假、虚假标识、记录维护和良好的生产规范。

FDA Class II Medical Devices FDA II 类医疗器械

Class II medical devices are defined by the FDA as follows:

FDA 将 II 类医疗器械定义如下：

“devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.”

“一般控制措施无法提供对设备安全性和有效性的合理保证。”

Class II medical devices have a moderate to high risk for the patient. They present a greater risk to the patient because of sustained contact. These medical devices usually come in contact with the patient’s internal organs or cardiovascular system, and various diagnostic tools. Around 43 percent of all medical devices are in this category.

II 类医疗器械对患者有中高风险。它们对患者的风险更大，因为与患者的内脏器官或心血管系统以及各种诊断工具有持续接触。约 43％的医疗器械属于此类别。

Examples of Class II medical devices:

II 类医疗器械的例子：

Powered wheelchairs 动力轮椅
Pregnancy test kits 孕妇试纸
Catheters 导管
Blood pressure cuffs 血压袖带
Blood transfusion kits 输血套装
Surgical gloves 手术手套
Absorbable sutures 可吸收缝线
Syringes 注射器
Contact lenses 隐形眼镜

The Path to Market for Class II Medical Devices in the US 美国市场 II 类医疗器械的准入路径

When marketing Class II medical devices in the US, you must note the following.

在美国市场 II 类医疗器械时，您必须注意以下事项。

Premarket Notification (PMN) or 510(k) process: You need to demonstrate that your Class II medical device is safe and effective. How do you do this?

预市通知（PMN）或 510（k）流程：您需要证明您的 II 类医疗器械是安全有效的。您如何做到这一点？

By showing ‘substantial equivalence’ with another device (called ‘predicate’ device) that is already in the market. The devices need not be identical. But, there must be substantial similarities in design, materials, use, labeling, standards, etc.

通过展示与市场上已有的另一设备（称为“前例”设备）的“实质等同性”。设备不需要完全相同，但在设计、材料、用途、标签、标准等方面必须有实质性的相似之处。

To efficiently manage your PMN or 510(k) submissions, you can consider using QMS software for medical devices.

为了有效管理您的 PMN 或 510（k）提交，您可以考虑使用医疗器械质量管理软件。

Exemption to the 510K filing: Over 800 generic Class I and Class II medical devices have been exempted from the 510K submission process. The list can be accessed in the FDA Product Classification Database.

豁免 510K 申报：超过 800 种通用的 I 类和 II 类医疗器械已被豁免 510K 提交流程。该清单可在 FDA 产品分类数据库中查阅。

General controls: As mentioned above, Class II medical devices are also subject to general controls. However, the FDA adds that these are devices for which general controls are insufficient to give reasonable assurance of safety and effectiveness. It is for this reason that Class II medical devices are further subject to special controls.

一般控制：如上所述，II 类医疗器械也受到一般控制的约束。然而，FDA 补充说，这些器械的一般控制不足以合理保证其安全性和有效性。因此，II 类医疗器械还受到特殊控制的约束。

Special controls: Patient registries, premarket data requirements, post-market surveillance, special labeling requirements.

特殊控制：患者登记册、前市场数据要求、后市场监测、特殊标签要求。

FDA Class III Medical Devices FDA III 类医疗器械

Class III medical devices are defined by the FDA as follows:

FDA 将 III 类医疗器械定义如下：

“usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury.”

“通常维持或支持生命，植入或存在潜在的不合理的疾病或伤害风险。”

Class III medical devices have the highest risk for the patient. They are usually used to sustain or support life, are implanted, and present a potential risk of injury or illness. Around 10 percent of all medical devices belong to this category.

III 类医疗器械对患者风险最高。它们通常用于维持或支持生命，植入，并存在潜在的伤害或疾病风险。大约 10％的医疗器械属于这个类别。

Examples of Class III medical devices:

III 类医疗器械的例子：

Breast implants 乳房植入物
Implantable pacemakers 可植入心脏起搏器
Cochlear implants 人工耳蜗植入物
Defibrillators 除颤器
High-frequency ventilators 高频通气机
Fetal blood sampling monitors 胎儿血液采样监测器
Implanted prosthetics 植入式假肢

The Path to Market for Class III Medical Devices in the US 美国市场 III 类医疗器械的准入路径

When marketing Class III medical devices in the US, you must note the following.

在美国市场上销售 III 类医疗器械时，您必须注意以下事项。

Due to the level of risk associated with Class III medical devices, the FDA has regulated that general and special controls (applicable to Class I and II medical devices) are not sufficient to ensure the safety and efficacy of these devices.

由于 III 类医疗器械所涉及的风险水平，美国食品药品监督管理局（FDA）规定，一般和特殊控制措施（适用于 I 类和 II 类医疗器械）不足以确保这些器械的安全性和有效性。

Premarket Approval (PMA): You need to do a rigorous study of your medical device using a data-driven benefit/risk profile to prove its safety and effectiveness. This will require clinical trial data and considerable time and resources.

预市批准（PMA）：您需要对您的医疗器械进行严格的研究，使用基于数据的效益/风险概况来证明其安全性和有效性。这将需要临床试验数据以及相当长的时间和资源。

Exceptions to the PMA clause are Class III medical devices with a substantial equivalent. You may check whether the Class III medical device can be marketed using the 510(k) process by checking both the FDA Premarket Approval (PMA) database and the FDA 510(k) Premarket Notification Database.

PMA 条款的例外情况是具有实质等效性的 III 类医疗器械。您可以通过查看 Premarket Approval (PMA) 预市批准数据库和 510(k) Premarket Notification 预市通知数据库来检查 III 类医疗器械是否可以使用 510（k）流程进行市场推广。

The summary of FDA medical device classification is illustrated below.

FDA 医疗器械分类的摘要如下所示。

How to Determine Your Medical Device Class in the US 如何确定您在美国的医疗设备类别

There are different ways by which medical device manufacturers can determine the class of their medical devices in the US market.

医疗设备制造商可以通过不同的方式确定其在美国市场上的医疗设备类别。

Firstly, you can check the FDA Medical Device Classification Panels, which is a list of categories for medical devices according to their medical specialization.

首先，您可以查看 FDA 医疗设备分类面板，这是根据医疗专业化对医疗设备进行分类的列表。

Let us look at a Microbiology Anaerobic Chamber as an example. 让我们以微生物学厌氧室 (Microbiology Anaerobic Chamber) 为例。

This device is classified under medical specialty 83: Microbiology.

该设备属于医学专业 83：微生物学 (medical specialty 83: Microbiology)。

The next step after locating the relevant medical specialty is to click on the Regulation Citation (21 CFR) and then navigate the list of devices until you have located an equivalent device and the associated device code.

在找到相关的医学专业后，下一步是点击法规引用（21 CFR），然后浏览设备列表，直到找到一个等效的设备和相关的设备代码。

Once you have clicked on the device code (in this case – § 866.2120 – Anaerobic chamber), you will get the guidelines.

一旦您点击设备代码（在本例中为 § 866.2120 — Anaerobic chamber），您将获得指南。

Under section (b), the classification of the device is mentioned.

根据(b)条款，提及了设备的分类。

Other ways to determine your medical device class in the US are the following:

在美国确定医疗设备类别的其他方法如下：

You can use a free, confidential, and informal device determination service via email: [email protected] 您可以通过电子邮件使用免费、保密和非正式的设备确定服务：[email protected]
You can submit an F13(g) request, this is formal and binding, and requires a fee. 您可以提交 F13(g) 请求，这是正式和有约束力的，需要支付费用。
Hire a medical device consultant who has thorough knowledge about the entire process. 聘请一位对整个过程有深入了解的医疗设备顾问。

EU Medical Device Classification 欧盟医疗器械分类

If you wish to market your medical device in the European market, you must obtain a CE marking, even if you are importing the product from outside the Economic European Area (EEA). With the CE mark, you ensure that your medical device complies with all essential requirements that are stipulated by the European Union’s Medical Device Regulation (EU MDR 2017/745).

如果您希望在欧洲市场销售您的医疗器械，即使您从欧洲经济区（EEA）以外进口产品，您也必须获得 CE 标志。通过 CE 标志，您确保您的医疗器械符合欧盟医疗器械法规（EU MDR 2017/745）规定的所有基本要求。

For this, first, you will need to decide what EU classification your medical device comes under.

为此，首先，您需要确定您的医疗器械属于哪个欧盟分类。

All the required information is provided by the European Union’s Medical Device Regulation (EU MDR 2017/745) that was implemented in May 2021. However, for some Class I medical devices, compliance has been deferred until 2024.

所有必需的信息由欧盟医疗器械法规（EU MDR 2017/745）提供，该法规于 2021 年 5 月实施。然而，对于一些 I 类医疗器械，合规性推迟到 2024 年。

First-of-all, you will need to decide whether your medical device is non-invasive/invasive/active:

首先，您需要确定您的医疗器械是非侵入性/侵入性/主动的：

Non-invasive: The medical device should not penetrate the body through the body’s surface or via an orifice. Such devices are characteristically Class I. Some certain exceptions and rules can make these Class I medical devices Class II or higher. 非侵入性：医疗设备不应通过身体表面或腔道穿透身体。这类设备通常属于 I 类。某些特定的例外和规定可以使这些 I 类医疗设备变为 II 类或更高级别。
Invasive: Any medical device, either in part or whole, penetrates the surface of the body or via an orifice. 侵入性：任何医疗设备，无论是部分还是全部，都会穿透身体表面或通过腔道。
Active: A medical device whose functioning depends on a source of energy other than the energy generated by the human body, or by gravity. When such a device is operated, density is changed or such energy is converted. 主动：一种医疗设备，其功能依赖于除人体产生的能量或重力之外的能源。当操作这样的设备时，密度会发生变化或这种能量会被转换。

Rules 1-4 of Annex VIII are for non-invasive devices; rules 5-8 are for invasive devices and rules 9-13 are for active devices.

附录 VIII 的规则 1-4 适用于非侵入性设备；规则 5-8 适用于侵入性设备；规则 9-13 适用于主动设备。

You should be aware that for the above-mentioned categories, specific rules apply. These are highlighted in Annex VIII of the new MDR (refer to Article 2 ‘Definitions’).

您应该知道，对于上述类别，适用特定规则。这些规则在新的 MDR 附录 VIII 中有明确标注（请参阅第 2 条“定义”）。

Classification of your medical device is upfront based on the broad categories combined with the duration of use:

根据广泛类别和使用持续时间，对您的医疗设备进行分类：

If the medical device is continuously used for less than 60 minutes, it is considered transient duration. 如果医疗设备连续使用时间少于 60 分钟，则被视为短暂使用。
If the medical device is used for a duration between 60 minutes to 30 days, it is considered short-term. 如果医疗设备使用时间在 60 分钟至 30 天之间，则被视为短期使用。
If the medical device is used for over 30 days, it is considered long-term. 如果医疗设备使用时间超过 30 天，则被视为长期使用。

The product classification system followed in the EU is similar to that of the US.

欧盟采用的产品分类系统与美国类似。

There are 4 different classes, namely:

有 4 个不同的类别，即：

Class I I 类
Class IIa IIa 类
Class IIb IIb 类
Class III III 类

For all medical devices that will be sold in the EU, a required step for obtaining CE marking is medical device technical documentation. You will also need to work with a Notified Body, except in the case of Class I medical devices.

对于所有将在欧盟销售的医疗器械，获得 CE 标志的必要步骤是医疗器械技术文件。除了 I 类医疗器械的情况外，您还需要与一个指定机构 (Notified Body) 合作。

Additionally, you will need to work with an Authorized Representative who will ensure your product registration.

此外，您还需要与一位授权代表合作，他将确保您的产品注册。

EU Class I Medical Devices 欧盟 I 类医疗器械

These medical devices have the lowest observed risk and they make up about 70 percent of the market.

这些医疗器械风险最低，占市场的约 70％。

Class I has several subclasses.

I 类有几个子类。

Basic Class I: These devices are non-sterile and have no measuring function, for example:

基本 I 类: 这些器械非无菌且没有测量功能，例如：

Bedpans 便盆
Hospital beds 医院床
Plasters 膏药
Manual Wheelchairs 手动轮椅
Corrective glasses and frames 矫正眼镜和镜框

Class Is: These devices are placed in the market in a sterile condition, for example:

Is 类别: 这些设备在市场上以无菌状态放置，例如：

Personal protection kits 个人防护套装
Sterile urine bags 无菌尿袋

Class Im: These devices have a measuring function, for example:

Im 类别: 这些设备具有测量功能，例如：

Weighing scale 体重秤
Thermometers 温度计
Stethoscope 听诊器

Class Ir: This is a new subclass for medical devices that are reprocessed or reused, for example:

Ir 类别: 这是一个新的子类，用于重新处理或重复使用的医疗设备，例如：

Endoscopes 内窥镜
Surgical instruments 手术器械

The Path to Market for Class I Medical Devices in the EU 欧盟市场 I 类医疗器械的准入路径

When marketing Class I medical devices in the EU, note the following.

在欧盟市场上销售 I 类医疗器械时，请注意以下事项。

Basic Class I devices do not need certification from a Notified Body. All you need to do is self-certify it, and formally declare its compliance via a written statement.

基本的 I 类器械不需要获得认证机构的认证。您只需要自我认证，并通过书面声明正式宣布其符合性。

For Class Is, Im, and Ir medical devices: You need a Notified Body assessment.

对于 Is、Im 和 Ir 类医疗器械：您需要进行认证机构评估。

EU Class IIa Medical Devices 欧盟 IIa 类医疗器械

These medical devices exchange energy with the patient in a therapeutic manner. They are used to monitor or diagnose medical conditions.

这些医疗器械以治疗方式与患者交换能量。它们用于监测或诊断医疗状况。

They make up around 20 percent of the market. These devices are generally invasive but limited to the natural orifices of the body.

它们占市场的大约 20％。这些设备通常是侵入性的，但仅限于身体的自然孔口。

Class IIa medical devices usually constitute low to medium risk. Patients use them for a short-term period, namely, usually 60 minutes to less than 30 days.

IIa 类医疗器械通常构成低到中等风险。患者使用它们的时间较短，通常为 60 分钟至 30 天以下。

Some examples are:

一些例子包括：

Catheters 导管
Hearing aids 助听器
Ultrasonic diagnostic equipment 超声诊断设备
Surgical clamps 手术夹具

欧盟市场 IIa 类医疗器械的准入路径 The Path to Market for Class IIa Medical Devices in the EU

When marketing Class IIa medical devices in the EU, note that you will need to:

在欧盟市场上销售 IIa 类医疗器械时，请注意您需要：

Prepare a Technical File or Design Dossier and demonstrate conformity with applicable requirements. 准备技术文件或设计档案，并证明符合适用要求
Contact an Authorized Regulatory Representative who is based in the European Community. 联系一个位于欧洲社区的授权监管代表
Complete a Notified Body Audit of a QMS and Technical File or Design Dossier. 完成一个合格的机构对质量管理体系和技术文件或设计档案的审核
Secure the CE mark and obtain a Unique Identifier (UDI) after having registered the manufacturer and device in the EUDAMED database. 在将制造商和设备注册到 EUDAMED 数据库后，获得 CE 标志和唯一标识符（UDI）

To secure a CE mark, you might consider using medical device QMS software for managing your submission documentation in an efficient and compliant way.

为了获得 CE 标志，您可以考虑使用医疗器械质量管理体系软件，以高效和合规的方式管理您的提交文件。

EU Class IIb Medical Devices 欧盟 IIb 类医疗器械

These are medium to high-risk medical devices that patients may use for longer than 30 days. They make up around 8 percent of the market.

这些是患者可能使用超过 30 天的中高风险医疗器械。它们占市场的约 8％。

Some examples of such devices are:

此类器械的一些例子包括：

Long-term corrective contact lenses 长期矫正隐形眼镜
Surgical lasers 手术激光器
Defibrillators 除颤器

The Path to Market for Class IIb Medical Devices in the EU 欧盟市场 IIb 类医疗器械的准入路径

Note that the level of control for Class IIb medical devices is similar to that of Class III medical devices. There is no separate CE certificate issued for assessing the technical documentation. Also, the expert panel participation in the review process is not required, except when the Class IIb medical device is active and the intended use is to administer or remove a medicinal substance.

请注意，IIb 类医疗器械的控制级别与 III 类医疗器械相似。评估技术文件时不会发放单独的 CE 证书。此外，除非 IIb 类医疗器械是活性的并且预期用途是给药或去除药物物质，否则不需要专家小组参与审查过程。

When marketing Class IIb medical devices in the EU, note that you will need to:

在欧盟市场销售 IIb 类医疗器械时，请注意需要：

Prepare a Technical File or Design Dossier and demonstrate conformity with applicable requirements 准备技术文件或设计档案，并证明符合适用要求
Contact an Authorized Regulatory Representative who is based in the European Community 联系一个位于欧洲社区的授权监管代表
Complete a Notified Body Audit of a QMS and Technical File or Design Dossier 完成一个受通知机构审核质量管理体系和技术文件或设计档案
Secure the CE mark and obtain a Unique Identifier (UDI) after having registered the manufacturer and device in the EUDAMED database 在注册制造商和设备于 EUDAMED 数据库后，获得 CE 标志和唯一标识符（UDI）

EU Class III Medical Devices 欧盟 III 类医疗器械

These medical devices have the highest possible risk for the patient. Permanent monitoring is essential during the lifetime of these products.

这些医疗器械对患者的风险最高。在这些产品的使用寿命期间，必须进行持续监测。

To ensure the safety and effectiveness of these devices, pre-market approval is required.

为确保这些器械的安全性和有效性，需要进行市场前批准。

Such medical devices make up around 1.8 percent of the market.

这类医疗器械占市场的约 1.8％。

Examples are:

例如：

Cardiovascular catheters 心血管导管
Hip-joint implants 人工髋关节植入物
Prosthetic heart valves 人工心脏瓣膜
Aneurysm clips 动脉瘤夹

The Path to Market for Class III Medical Devices in the EU 欧盟市场 III 类医疗器械的准入路径

A viable option for marketing Class III medical devices in the EU is Annexe IX, which included a full QA audit and a full Technical Documentation review. Additionally, Class III devices are assessed by an expert panel.

在欧盟市场上销售 III 类医疗器械的一个可行选择是附录 IX，其中包括全面的质量保证审核和全面的技术文件审查。此外，III 类器械还需要由专家小组进行评估。

When marketing Class III medical devices in the EU, note that you will need to:

在欧盟市场上销售 III 类医疗器械时，请注意以下事项：

Prepare a Technical File or Design Dossier and demonstrate conformity with applicable requirements. 准备技术文件或设计档案，并证明符合适用要求
Contact an Authorized Regulatory Representative who is based in the European Community. 联系一个位于欧洲社区的授权监管代表
Complete a Notified Body Audit of a QMS. 完成质量管理体系的通知机构审核
Complete Design Dossier review by a Notified Body. 通过通知机构完成设计档案审查
Secure the CE mark and obtain a Unique Identifier (UDI) after having registered the manufacturer and device in the EUDAMED database. 在 EUDAMED 数据库中注册制造商和设备后，获得 CE 标志并获得唯一标识符（UDI）

The summary of EU MDR medical device classification is illustrated below.

欧盟 MDR 医疗器械分类的摘要如下所示。

How to Determine Your Medical Device Class in the EU 如何确定您在欧盟的医疗器械类别

As a medical device manufacturer planning to enter the EU market, you will first need to broadly categorize your device into:

作为一家计划进入欧盟市场的医疗器械制造商，您首先需要将您的设备广泛分类为：

Non-invasive 非侵入性
Invasive 侵入性
Active 主动

Next, you will look at all the applicable rules and pick the one with the highest risk, just to be sure, and identify the main intended use of your device.

接下来，您将查看所有适用的规则，并选择风险最高的规则，以确保，并确定您设备的主要预期用途。

Let us take the example of infusion cannulae. It fits into the ‘invasive’ category. Thus, the research is narrowed down to Rules 5,6,7, and 8.

让我们以输液导管为例。它属于“侵入性”类别。因此，研究范围缩小到规则 5、6、7 和 8。

Further, you will see that it is for short-term use (between 60 minutes and 30 days).

此外，您将看到它是用于短期使用（60 分钟至 30 天之间）。

Thus, Rule 7 becomes applicable for classifying this device.

因此，规则 7 适用于对该设备进行分类。

Conclusion 结论

If you are a manufacturer of medical devices and plan to market your products in the US and EU markets, you need to classify these medical devices. You must follow the regulatory requirements in your market as it will also help you market your product quicker.

如果您是医疗设备制造商，并计划在美国和欧盟市场推广您的产品，您需要对这些医疗设备进行分类。您必须遵循市场上的监管要求，因为这也将帮助您更快地推广您的产品。

A crucial aspect of quality management for your company in general, and your medical devices, is to meet compliance.

对于您的公司总体和医疗设备来说，质量管理的一个关键方面是符合规定。

SimplerQMS can help you manage product design control documentation, change control activities, and other quality events. It allows you to interlink documents and store everything in a central system, providing you with cross-functional visibility throughout the lifecycle of your medical device.

SimplerQMS 可以帮助您管理产品设计控制文件、变更控制活动和其他质量事件。它允许您相互链接文档并将所有内容存储在一个中央系统中，为您提供在医疗设备的整个生命周期中的跨职能可见性。

SimplerQMS solution is specifically designed for the Life Science industries, such as the Medical Device industry, and aligned with the relevant regulations and standards.

SimplerQMS 解决方案专门为生命科学行业设计，如医疗器械行业，并与相关法规和标准保持一致。

We recommend you schedule a demo to see SimplerQMS in action and talk to our experts to see how we can help you work more efficiently with your documentation.

我们建议您安排一个演示，以了解 SimplerQMS 的运作方式，并与我们的专家交流，看看我们如何帮助您更高效地处理文档。

References 参考文献

Medical Device Classification (FDA & EU MDR) - SimplerQMS