Regulation 2016/425 (Personnel Protective Equipment)

Personal protective equipment (PPE) are products that the user can wear or hold, to be protected against risks either at work, at home or whilst engaging in leisure activities. the PPE regulation covers the design, manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation.

The PPE regulation guidelines (3rd edition – October 2023) aim to facilitate a common understanding and implementation of the PPE regulation.

Regulation 2023/1230/EU (Machinery)

This Regulation lays down health and safety requirements for the design and construction of machinery, placed on the European market.

Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery replaces Directive 2006/42/EC on machinery. The regulation – as did the 2006 directive – defines the mandatory essential health and safety requirements that machinery products must fulfil to be placed on the European market, as well as the procedures for assessing their conformity, while the technical details are mainly provided through European harmonised standards elaborated by European standards organisations. The requirements of the Regulation are aimed at machinery manufacturers and other economic operators such as importers. The CE marking indicates that the machinery product meets the health and safety requirements in place and can be traded without restriction in the internal market.

Directive 2006/66/EU (Battery Directive)

To combat the Battery Safety issues the European Union (EU) published the EU New Battery Regulation (EU) 2023/1542 on July 28, 2023, in the Official Journal of the European Union. Just weeks later on August 17, 2023, the Regulation was officially put into effect. It covers all batteries available on the EU market and aims to improve sustainability, safety labeling, and waste management. The Regulation supports the shift to a circular economy and increases the security of supply for raw materials.

The EU New Battery Regulation includes both rechargeable and non-rechargeable batteries. It is relevant for manufacturers of cells, modules, battery packs, energy storage systems, EV battery systems, and end products utilizing batteries. The regulation itself casts a broad net, encompassing battery categories such as waste portable batteries, electric vehicle batteries, industrial batteries, starting, lightning, and ignition batteries, and batteries for light means of transportation such as e-bikes, mopeds, and e-scooters. While specific rules within the regulation place stricter requirements on larger batteries exceeding 2 kWh, batteries of all sizes are affected.

An NB list is maintained by searching on the internet, as EC does not provide an official list yet.

Directive 2014/53/EU (RED)

The Radio Equipment Directive (RED) established a regulatory framework for placing radio equipment on the market in the EU. All radio equipment within the scope of this directive that are placed on the EU market must have been compliant with the directive from 13 June 2017. The delay of the publication and approval of the details of this directive has led to difficulties for companies attempting to comply with the directive.

Commission Implementing Decision (EU) 2022/2191 of 8 November 2022 on the harmonised standards for radio equipment drafted in support of Directive 2014/53/EU of the European Parliament and of the Council (Text with EEA relevance)

Directive 2012/19/EU (WEEE)

The WEEE Directive and the RoHS Directive tackle the issue of the growing amount of WEEE.

The WEEE Directive:

• requires the separate collection and proper treatment of WEEE and sets targets for their collection, recovery and recycling
• helps European countries fight illegal waste exports more effectively by making it harder for exporters to disguise illegal shipments of WEEE
• reduces the administrative burden by calling for the harmonisation of national EEE registers and of the reporting format

Regulation 1907/2006 (REACH)

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.

REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. 

In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.

Directive 2011/65/EU (ROHS)

EU laws restrict the use of certain hazardous substances in electrical and electronic equipment through the RoHS Directive. In parallel, the WEEE Directive promotes the collection and recycling of such equipment.

The RoHS Directive currently restricts the use of ten substances: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).

All products with an electrical and electronic component, unless specifically excluded, have to comply with these restrictions.

In 2017, the Commission adopted a legislative proposal adjusting the scope of the RoHS Directive.

The European Artificial Intelligence Act

The European Commission has published the finalized text of the Artificial Intelligence Act (AIA) which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The Act also sets harmonized rules for placing products on the market.

The AIA was published in the Official Journal on 12 July and will go into effect on 2 August, while the requirements for high-risk devices will go into effect one year later, on 2 August 2026.

A risk-based approach is taken to classify AI systems and GPAI models. AI systems are classified according to four categories. Medical devices including IVDs that incorporate AI/ML-enabled device functions will likely be classified as high-risk AI systems. The requirements for high-risk AI systems include: (1) Data governance; (2) Quality Management System (QMS); (3) Technical documentation; (4) Record keeping; (5) Transparency; (6) Human oversight; (7) Accuracy, robustness and cybersecurity; (8) Conformity assessment based on either internal controls (self-declaration) or Notified Body involvement.

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Other Statements to be considered in EU MDR Technical Documentation

Materials of Animal Origin

Detailed description of materials of animal origin used in the device, including the animal species and tissue used. Assessment of risks associated with transmissible spongiform encephalopathies (TSEs) and other zoonoses. This includes a description of the measures taken to reduce these risks. Demonstration of compliance with relevant EU directives and standards, such as those related to TSEs (e.g., Regulation (EU) No 722/2012).

Medicinal Product

Information on any medicinal substances incorporated into the device, including their function, dosage, and method of release. Evidence of compliance with relevant medicinal product regulations, such as Directive 2001/83/EC. Data on the interaction between the device and the medicinal substance, including stability, compatibility, and pharmacokinetics.

Materials of Human Origin

Documentation on the source of human-derived materials, ensuring traceability and screening for infectious agents. Compliance with ethical and legal requirements related to the use of human-derived materials, including donor consent. Measures taken to minimize the risk of disease transmission and ensure safety.

Substances

Detailed information on all substances used in the device, including their chemical names, CAS numbers, and concentrations. Toxicological data and safety assessments for all substances, including potential risks of exposure during normal use. Evidence of compliance with [[#[Regulation 1907/2006 (REACH)](https //eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1907-20231201)]].

Substances which are Carcinogenic, Mutagenic or Toxic to Reproduction (CMR)

Identification of any CMR substances used in the device, including their classification and labelling according to CLP (Classification, Labelling and Packaging) regulation. Justification for the use of CMR substances, demonstrating that safer alternatives are not available. Measures taken to minimize exposure to CMR substances and ensure user safety.

Endocrine-Disrupting Substances

Identification of any endocrine-disrupting substances used in the device, along with their potential effects on the endocrine system. Justification for the use of such substances, supported by a risk-benefit analysis. Measures taken to mitigate risks associated with endocrine-disrupting substances.

Devices Placed on the Market with a Measuring Function

Information on the accuracy, precision, and stability of the measuring function. Details on the calibration procedures and standards used to ensure the reliability of measurements. Evidence of compliance with relevant metrological standards and regulations.

Latex

Identification of any natural rubber latex (NRL) used in the device, including the percentage composition. Assessment of the risk of allergic reactions associated with latex, supported by appropriate testing. Clear labelling indicating the presence of latex to inform users and healthcare professionals.

Phthalates

Identification of any phthalates used in the device, including their chemical names and concentrations. Assessment of the potential health risks associated with phthalate exposure, particularly for vulnerable populations (e.g., pregnant women, children). Justification for the use of phthalates, demonstrating that safer alternatives are not available. Clear labelling indicating the presence of phthalates and the associated risks.

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中文翻译

法规2016/425（个人防护设备）

个人防护设备（PPE）是使用者可以穿戴或持有的产品，用于在工作、家庭或休闲活动中防护风险。PPE法规涵盖了个人防护设备的设计、制造和营销 。它规定了法律义务，以确保欧盟内部市场上的PPE提供最高级别的风险防护。附加在PPE上的CE标志证明产品符合适用的欧盟法规。 PPE法规指南（第3版 – 2023年10月）旨在促进对PPE法规的共同理解和实施。

法规2023/1230/EU（机械）

本法规规定了投放欧洲市场的机械设计和制造的健康和安全要求。 _2023年6月14日欧洲议会和理事会关于机械的法规(EU) 2023/1230_取代了2006/42/EC机械指令。该法规 – 如同2006年指令一样 – 规定了机械产品投放欧洲市场必须满足的强制性基本健康和安全要求，以及其合格性评估程序，而技术细节主要通过欧洲标准化组织制定的欧洲协调标准提供。该法规的要求针对机械制造商和进口商等其他经济运营者。CE标志表明机械产品符合现行的健康和安全要求，可以在内部市场自由交易。

指令2006/66/EU（电池指令）

为解决电池安全问题，欧盟于2023年7月28日在欧盟官方公报上发布了欧盟新电池法规(EU) 2023/1542。几周后的2023年8月17日，该法规正式生效。它涵盖了欧盟市场上所有可用的电池，旨在改善可持续性、安全标签和废物管理。该法规支持向循环经济转型，并增加原材料供应的安全性。

欧盟新电池法规包括可充电和不可充电电池。它与电池芯、模块、电池组、能源存储系统、电动车电池系统和使用电池的终端产品的制造商相关。该法规范围广泛，包括便携式废电池、电动车电池、工业电池、起动、照明和点火电池，以及用于轻型交通工具（如电动自行车、助力车和电动滑板车）的电池。虽然法规中的具体规则对超过2千瓦时的大型电池提出了更严格的要求，但所有规格的电池都受到影响。

由于欧盟委员会尚未提供官方名单，需要通过互联网搜索来维护公告机构清单。

指令2014/53/EU（无线电设备指令）

无线电设备指令 （RED ）为在欧盟市场投放无线电设备建立了监管框架。自2017年6月13日起，该指令范围内的所有投放欧盟市场的无线电设备必须符合该指令。该指令细节的发布和批准延迟导致企业在遵守指令时遇到困难。 2022年11月8日欧盟委员会实施决定(EU) 2022/2191关于支持指令2014/53/EU的无线电设备协调标准（EEA相关文本）。

指令2012/19/EU（废弃电子电气设备指令）

WEEE指令和RoHS指令共同解决日益增长的废弃电子电气设备问题。 WEEE指令：

• 要求对WEEE进行分类收集和适当处理，并设定收集、回收和再循环的目标
• 通过使出口商更难以伪装非法WEEE货物，帮助欧洲国家更有效地打击非法废物出口
• 通过要求统一国家电子电气设备登记册和报告格式，减少行政负担

法规1907/2006（REACH）

REACH代表化学品的注册、评估、授权和限制。该法规于2007年6月1日生效。 REACH是欧盟的一项法规，旨在加强对人类健康和环境的保护，防范化学品可能带来的风险，同时提升欧盟化工行业的竞争力。它还促进物质危害评估的替代方法，以减少动物实验。 原则上，REACH适用于所有化学物质；不仅包括工业过程中使用的物质，还包括我们日常生活中使用的物质，例如清洁产品、油漆以及衣物、家具和电器等物品中的物质。因此，该法规影响着欧盟大多数企业。

指令2011/65/EU（RoHS）

欧盟法律通过RoHS指令限制电子电气设备中某些有害物质的使用。同时，WEEE指令促进此类设备的收集和回收。 RoHS指令目前限制十种物质的使用：铅、镉、汞、六价铬、多溴联苯（PBB）和多溴二苯醚（PBDE）、邻苯二甲酸二（2-乙基己基）酯（DEHP）、邻苯二甲酸丁苄酯（BBP）、邻苯二甲酸二丁酯（DBP）和邻苯二甲酸二异丁酯（DIBP）。 除非特别排除，所有带有电气和电子组件的产品都必须遵守这些限制。 2017年，欧盟委员会通过了一项立法提案，调整RoHS指令的范围。

欧洲人工智能法案

欧盟委员会已发布《人工智能法案》(AIA)的最终文本，该法案为医疗器械、体外诊断设备(IVDs)和其他产品建立了促进”以人为本和可信赖”人工智能的法律框架。该法案还为产品投放市场制定了统一规则。 AIA于7月12日在《官方公报》上发布，将于8月2日生效，而高风险设备的要求将于一年后的2026年8月2日生效。 该法案采用基于风险的方法来分类AI系统和通用人工智能模型。AI系统分为四个类别。包含AI/ML功能的医疗器械（包括IVDs）可能被归类为高风险AI系统。高风险AI系统的要求包括：(1)数据治理；(2)质量管理体系(QMS)；(3)技术文档；(4)记录保存；(5)透明度；(6)人工监督；(7)准确性、稳健性和网络安全；(8)基于内部控制（自我声明）或公告机构参与的合格性评估。

欧盟MDR技术文档中需要考虑的其他声明

动物源性材料

详细说明设备中使用的动物源性材料，包括使用的动物物种和组织。评估与传染性海绵状脑病(TSEs)和其他人畜共患病相关的风险。这包括描述降低这些风险所采取的措施。证明符合相关欧盟指令和标准，如与TSEs相关的标准（如法规(EU) No 722/2012）。

药品

关于设备中包含的任何药用物质的信息，包括其功能、剂量和释放方法。证明符合相关药品法规，如指令2001/83/EC。关于设备与药用物质之间相互作用的数据，包括稳定性、相容性和药代动力学。

人源性材料

关于人源材料来源的文档，确保可追溯性和传染性病原体筛查。符合与使用人源材料相关的伦理和法律要求，包括捐赠者同意。为最小化疾病传播风险和确保安全所采取的措施。

物质

设备中使用的所有物质的详细信息，包括其化学名称、CAS编号和浓度。所有物质的毒理学数据和安全评估，包括正常使用过程中的潜在暴露风险。证明符合REACH法规。

致癌、致突变或生殖毒性物质(CMR)

识别设备中使用的任何CMR物质，包括根据CLP（分类、标签和包装）法规的分类和标签。使用CMR物质的合理性说明，证明没有更安全的替代品。为最小化CMR物质暴露和确保用户安全所采取的措施。

内分泌干扰物质

识别设备中使用的任何内分泌干扰物质，以及它们对内分泌系统的潜在影响。使用此类物质的合理性说明，并附有风险效益分析。为降低与内分泌干扰物质相关的风险所采取的措施。

具有测量功能的上市设备

关于测量功能的准确度、精密度和稳定性的信息。确保测量可靠性的校准程序和使用的标准详情。证明符合相关计量标准和法规。

乳胶

识别设备中使用的任何天然橡胶乳胶(NRL)，包括成分百分比。评估与乳胶相关的过敏反应风险，并有适当的测试支持。清晰标示乳胶的存在，以告知用户和医疗专业人员。

邻苯二甲酸酯

识别设备中使用的任何邻苯二甲酸酯，包括其化学名称和浓度。评估邻苯二甲酸酯暴露的潜在健康风险，特别是对易受影响人群（如孕妇、儿童）的影响。使用邻苯二甲酸酯的合理性说明，证明没有更安全的替代品。清晰标示邻苯二甲酸酯的存在及相关风险。