可穿戴手表,帮助消费者更好地了解他们的饮食模式;向治疗医生发送信号的可穿戴衣服;smart watches: they are but a few examples of the increasingly available and increasingly sophisticated "wearables" on the EU market.These technologies are an integrated part of many people's lives,and in some cases allow healthcare professionals to follow-up on the condition or habits of their patients,通常是实时的。制造商如何确定哪些可穿戴设备符合医疗器械的资格?他们如何评估他们的设备是否需要CE标志?Must they differentiate between the actual "wearable" and the hardware or software that accompanies them?在这个简短的贡献中,we briefly analyze some of these questions.文章首先分析了“可穿戴”是什么,当它们符合当前和未来欧盟规则的医疗器械资格时。然后讨论了欧盟医疗器械规则适用于这些产品的相关性。这些规则的应用通常很复杂,而且非常具体。

什么是“可穿戴设备”?

欧盟没有对“可穿戴设备”的法律定义,但欧盟委员会在其智能穿戴式反光定位纸.文章指出,“智能穿戴设备是人体携带的计算和感知设备,能够感知佩戴者和/或其环境。可穿戴设备可以通过嵌入式无线连接或其他设备(例如a smartphone).(…)智能穿戴设备可以控制,交流,存储和驱动能力。”

因此,“可穿戴物品”一词有效地涵盖了非常广泛的物品和技术,市场不断发展。The list of wearables is indeed quite long.一些例子包括:智能手表,健身追踪器,手镯,智能补丁body-worn smart clothes and smart fabrics,smart shoes,smart glasses with sensors,虚拟现实耳机,外骨骼(可穿戴机器人)智能珠宝(例如耳环监测睡眠质量)等。的确,the term could also cover implantable items,但这篇文章并没有涉及欧盟对植入式医疗器械的具体法律要求。

可穿戴医疗设备是否符合欧盟医疗设备规则?

现行医疗器械指令下的分析

对于一个看似简单的问题的答案是相当复杂的,主要是因为欧盟相关立法和指导的应用具有高度的事实特异性。Under theMedical Devices Directive 93/42/EEC(“MDD”)医疗器械被定义为“任何仪器,装置,appliance,软件,material or other article,whether used alone or in combination" and "intended by the manufacturer to be used for human beings" for purposes of (among other things) "diagnosis,预防,monitoring,疾病的治疗或缓解,[或]受伤或残疾“,或者“调查,解剖学或生理过程的替换或修改。

一般来说,当设备拟用于医疗目的时,they qualify as a medical device.术语“医疗用途”是指:然而,not defined and subject to interpretation.

下面,我们将简要评估该定义的关键组成部分,以及它们如何适用于可穿戴设备:

1。"Intended by the manufacturer to be used" for specific purposes:预期用途是“根据制造商在标签上提供的数据,设备的预期用途,in the instructions and/or in promotional materials" (Article 1(2)(g) of the MDD).欧洲法院(“ECJ”)认为“【其中】产品的制造商未设想用于医疗目的,其作为医疗器械的认证不需要“因为它不属于MDD的范围”(C 219/11Brain Products GmbH V Biosemi VOF and Others).Therefore,how the manufacturer advertises and describes the product may have an important bearing on the classification as a medical device.

Example: a bracelet monitoring heart rate.这个设备可以,depending on the circumstances,不属于医疗器械规则的范围。分析不简单,however.一方面,one might take the view that the bracelet is used for the investigation of a physiological process,which would trigger a classification as a medical device.另一方面,如果心率监测不用于任何医疗目的,但是有意的,例如,对于用户在跑步或其他体育锻炼期间的个人信息,可能不受医疗器械规则的约束。这是由支持的MEDDEV指南2.1/6,它提供了“软件本身的权利,当制造商特别打算用于医疗器械定义中规定的一个或多个医疗用途时,is a medical device.Software for general purposes when used in a healthcare setting is not a medical device." On that basis,心率监测手镯用于一般健身用途时不符合医疗器械的资格,但是,如果其预期用途与医疗器械有关,则可作为医疗器械,监测或预防心脏病。

2。"Whether used alone or in combination":实际可穿戴性(衣服,手表,etc.) will often be accompanied by a processing unit (smartphone,计算机,等等)。在这方面,MDD下的“附件”概念是相关的。该指令将附件定义为“非设备的物品,其制造商专门打算与设备一起使用,以使其能够按照设备制造商打算使用的设备使用”(MDD第1(2)(b)条)。附件也应符合MDD的实质性要求,并要求有CE标志。

Example: a smart watch that is used for various purposes and is marketed with an app.Again,这些物品是否符合医疗器械资格取决于各种因素。第一个问题是,物品是属于自己的设备,还是彼此的附属设备。MHRA“医疗设备独立软件(包括应用程序)”指南例如,规定“移动设备上的软件与监控设备无线连接以记录数据”应被视为附件,因为它是“旨在使医疗设备实现其预期功能的产品”。这取决于手表的功能以及使用它的应用程序,一个确实可以成为另一个的附属品。

第二,much will depend on the intended purpose of the watch or the app.An analogy with an example given in EU-level guidance sheds more light on this.根据Manual on Borderline and Classification in the Community regulatory framework for medical Devices(October 2018),管理鼹鼠图片的移动应用程序将不具备医疗设备软件的资格,而一个科学评估痣的移动应用程序,because it performs an action on data other than just storage,为了个人的医疗利益。此外,based on theMEDDEV guidance 2.1/1,可在医疗环境中偶尔使用的具有多种用途的产品通常不是医疗设备,除非指定了特定的医疗目的。欧洲法院最近证实了这一分析,并认为“软件,of which at least one of the functions makes it possible to use patient-specific data for the purposes,除此之外,检测禁忌症,药物相互作用和过量剂量,是,in respect of that function,a medical device within the meaning of [the MDD],即使该软件不直接作用于人体或人体。法院提到MEDDEV指南2.1/6并明确指出,“对于包含两个模块的医疗软件,符合术语‘医疗设备’的定义,以及不符合该定义的其他模块,且不属于指令93/42第1(2)(b)条所指的附件,只有前者在指令范围内,且必须标记为“CE”。(C-329/16snitem和飞利浦法国诉法国总理Ministre和外交部Sociales et de la Sant_)。This shows that the classification of the smart watch and the app it is meant to be used with largely depends on the intended purposes of both items.

未来医疗器械监管的分析

The MDD will be replaced by the医疗器械条例2017/745从2020年5月26日起(“千年发展目标”)(是否有重要的过渡措施)。MDR对医疗器械的新定义与MDD的定义没有太大的区别。但有些重要的细微差别可能与某些可穿戴物品的分类有关。例如,新医疗器械定义下的预期用途已扩大到包括“预测”和“预后”。这些新的可能性可能带来某些数字医疗技术,capable of predicting the likelihood of people incurring for instance,某些疾病,在医疗器械的定义范围内。On balance,我们没有预见到新医疗设备定义对可穿戴设备的巨大影响。That said,some wearables,例如某些数字健康应用程序,目前不受欧盟医疗器械规则的约束,在不久的将来。

Why Does the Classification of Wearables as Medical Devices Matter?

在MDD下,医疗器械制造商应承担各种监管义务。特别地,the MDD requires (among other things) that a CE-mark be applied to medical devices before they are placed on the EU market and that a Declaration of Conformity be drawn up.只有当设备符合MDD的实质性要求(例如:safety requirements).确定器械是否符合医疗器械规则要求遵守所谓的“合格评定程序”。

实质性要求和合格评定程序在千年发展目标下更加复杂和繁重。其中一个变化,例如,制造商很少被允许自行证明符合医疗器械规则,但需要通知机构对其进行评估。对于一些可穿戴设备,self-certification will continue to suffice;for others,通知机构的参与是必要的。是否需要通知机构参与主要取决于设备的分类。MDD将设备分类为I类至III类设备,depending on the health risks of the device.A large part of the currently marketed wearables in the EU that meet the medical device definition qualify as class I devices under the MDD.大多数软件设备,例如,currently qualify as class I devices,and as a consequence do not need to be certified by a notified body.MDR在软件方面还包含更复杂的分类规则。Annex VIII of the Regulation provides that "software intended to monitor physiological processes is classified as class IIa,except if it is intended for monitoring of vital physiological parameters,如果这些参数变化的性质可能会对患者造成直接危险,in which case it is classified as class IIb." Wearables that are currently class I devices could become class IIa or IIb under the MDR,这有重要的意义,如需要公告机构认证。Therefore,a correct analysis of the classification as a medical device under the EU rules is of paramount importance for players operating in the diverse wearables market.