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surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.
(35)
对于欧盟以外的制造商，授权代表在确保此类制造商生产的器械符合性，以及作为其在欧盟建立的联系人方面发挥关键作用。鉴于这种关键作用，若欧盟以外的制造商未遵守其一般义务，出于执法目的，其授权代表依然应当对有缺陷的器械负法律责任。本法规规定的授权代表的法律责任并不影响第85/374/EEC号指令的规定，因此授权代表应对进口商和制造商承担连带责任。应在书面指令中确定授权代表的职责。鉴于授权代表的角色，应明确规定其应满足的最低要求，包括提供满足最低资格条件的人员的要求，此类资格条件应与制造商处负责法规符合性的人员的资格条件类似。
For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a written mandate. Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance.
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（1） 欧盟委员会于1985年7月25日签发的关于其在涉及缺陷产品责任的成员国相似法律、法规和管理规定的第85/374/EEC号指令
(OJL210, 7.8.1985, p. 29)。
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(36) 为确保经济运营商义务的法律确定性，有必要说明何时将经销商、进口商或其他人视为器械制造商。 To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to clarify when a distributor, importer or other person is to be considered the manufacturer of a device.
(37) 根据“欧盟运作条约（TFEU）”第34条的规定，（该规定以TFEU第36条规定的健康和安全保护需求以及知识产权保护需求带来的限制性规定为准）已经投放市场的产品的平行贸易是内部市场的一种合法贸易形式。但这一平行贸易原则的适用性受成员国的不同解释的制约。因此，应在本法规中特别规定重贴标和重包装的要求，同时考虑到其他相关行业的法院案例法（1）和医疗器械领域的现有良好实践。
Parallel trade in products already placed on the market is a lawful form of trade within the internal market on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of health and safety and from the need for protection of intellectual property rights provided for under Article 36 TFEU. Application of the principle of parallel trade is, however, subject to different interpretations in the Member States. The conditions, in particular the requirements for relabelling and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the Court of Justice (20) in other relevant sectors and existing good practice in the field of medical devices.
(38)
一次性使用器械的再加工和进一步使用仅可在国家法律允许的情况下以及遵守本法规中规定的相关要求下进行。一次性使用器械的再加工者应视为再加工器械的制造商，并应承担本法规规定的制造商义不容辞的义务。尽管有上述规定，成员国有责任决议卫生机构内或通过代表该机构的外部再加工者对一次性使用器械再加工和再利用的义务可能与本法规中所述的制造商义务不同。原则上，仅当在机构内或通过代表该机构的外部再加工者对一次性器械再加工和重新利用符合已通过的CS，或在缺乏CS时，符合相关协调标准和国家法规，才允许该偏差的存在。再加工此类器械应确保与相应未使用的一次性器械相同的安全和性能水平。
The reprocessing and further use of single-use devices should only take place where permitted by national law and while complying with the requirements laid down in this Regulation. The reprocessor of a single-use device should be considered to be the manufacturer of the reprocessed device and should assume the
obligations incumbent on manufacturers under this Regulation. Nevertheless, Member States should have the possibility of deciding that the obligations relating to reprocessing and re-use of single-use devices within a health institution or by an external reprocessor acting on its behalf may differ from the obligations on a manufacturer described in this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of single-use devices within a health institution or by an external reprocessor are compliant with CS that have been adopted, or, in the absence of such CS, with relevant harmonised
standards and national provisions. The reprocessing of such devices should ensure an equivalent level of safety and performance to that of the corresponding initial single-use device.
（39） 应给予植入器械患者以明确且容易获得的，足够识别所植入器械的基本信息，以及关于该器械的其他信息，包
括任何必要的健康风险警戒或需采取的预防措施，例如关于其是否与某些诊断器械或用于安全控制的扫描仪兼容的指示。
Patients who are implanted with a device should be given clear and easily accessible essential information allowing the implanted device to be identified and other relevant information about the device, including any necessary health risk warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.
（40） 一般来说，器械应具有CE标识，表明其符合本法规，以便其在欧盟内自由流通并根据其预期目的投入使用。成
员国不得对符合本法规规定要求的器械，在其投放市场或投入使用方面制造障碍。不过，应允许成员国决定是否限制使用本法规未涵盖的任何特定类型的器械。
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Devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose. Member States should not create obstacles to the placing on the market or putting into service of devices that comply with the requirements laid down in this Regulation. However, Member States should be allowed to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.
（41） 由于改进的事故报告、有针对性的现场安全纠正措施以及主管机构更好的监督机制，通过基于国际指导的唯一
器械标识系统（UDI系统）实现的器械的可追踪性，应显著提高器械上市后安全相关活动的有效性。这归功于减少的医疗失误，以及对虚假器械的打击。UDI系统的应用还应改善卫生机构和其他经济运营商的采购和废物处置政策以及库存管理，并在可能的情况下，与这些设置中存在的其他验证系统兼容。
The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should significantly enhance the effectiveness of the post-market safety-related
activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against falsified devices. Use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators and, where possible, be compatible with other authentication systems already in place in those settings.
（42） UDI系统应适用于除定制器械以外的投放于市场的所有器械，并基于国际公认的原则，包括与主要贸易伙伴相
一致的定义。为使UDI系统及时起作用，以免影响本法规生效，应在本法规中做出详细规定。
The UDI system should apply to all devices placed on the market except custom-made devices, and be based on internationally recognised principles including definitions that are compatible with those used by major trade partners. In order for the UDI system to become functional in time for the application of this Regulation, detailed rules should be laid down in this Regulation.
（43） 为保护公众健康，赋予患者和医疗保健专业人员自主权以及确保其能够做出明智的决定，为向监管决定制定提
供一个稳妥的基础，确保为预期使用者提供的信息的透明度和充分性对于公众利益至关重要。
Transparency and adequate access to information, appropriately presented for the intended user, are
essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
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（1）2011年7月28日法院对Orifarm和Paranova中案件：C-400/09和C-207/10, ECLI:EU:C:2011:519的判决
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（44） 为达成本法规目标，其中一个关键点是建立欧洲医疗器械数据库（Eudamed），该数据库应整合不同的电子系统，
以核对和处理关于上市的体外诊断医疗器械以及相关经济运营商、符合性评定问题、公告机构、证书、临床研究、警戒和后市场监管等相关信息。数据库的目标是提高总体透明度，包括通过更好地为公众和卫生保健专业人员提供信息，以避免多重报告要求、加强成员国之间的配合、简化和促进经济运营商、公告机构或申办方和成员国之间的信息流通，以及成员国之间和欧盟委员会之间的信息流通。在内部市场中，只能在欧盟级别有效
确保这一点，因此欧盟委员会应进一步开发和管理委员会第2010/227/EU号决议（1）设置的医疗器械数据库。
One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals, to avoid multiple reporting requirements, to enhance coordination between Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission. Within the internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices set up by Commission Decision 2010/227/EU (21).
（45） 为促进欧洲医疗器械数据库（Eudamed）的运作，国际公认的医疗器械命名应免费提供给制造商和其他自然人
或法人，且本法规要求相关人员必须使用该命名。此外，在合理可行的情况下，也应向其他利益相关者免费提
供此类命名。
To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature should be available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. Furthermore, that nomenclature should be available, where reasonably practicable, free of charge also to other stakeholders.
（46） Eudamed关于市场上的器械，相关经济运营商和证书的电子系统应确保公众充分了解欧盟市场上的器械。临床
研究电子系统应作为工具，确保成员国之间合作，以及申办方能够在自愿基础上向若干成员国提交单项申请，并报告严重不良事件、器械缺陷和相关更新。电子警戒系统应确保制造商能够报告严重事件和其他异常事件，并支持主管机构协调此等事故和事件的评估。市场监管相关电子系统应作为主管机构之间进行信息交流的工
具。
Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. The electronic system on clinical investigations should serve as a tool for the cooperation between
Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and to report serious adverse events, device deficiencies and related updates. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of the evaluation of such incidents and events by competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities.
（47） 关于通过Eudamed电子系统核对和处理的数据，欧洲议会和理事会第95/46/EC号指令（2）适用于在成员国主
管机构（特别是成员国指定的公共独立机构）的监督下，由成员国进行个人数据处理。欧洲议会和理事会第45/2001号法规（3）适用于在欧洲数据保护管理程序的监督下，由委员会在本法规框架内处理个人数据。根据第45/2001号指令，应指定委员会作为Eudamed及其电子系统的管理者。
In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the European Parliament and of the Council (22) applies to the processing of personal data carried out in the Member States, under the supervision of the Member States' competent authorities, in particular the public independent authorities designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (23) applies to the processing of personal data carried out by the Commission within the framework of this Regulation, under the supervision of the European Data Protection Supervisor. In
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accordance with Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems.
（48） 对于可植入器械和III类器械，制造商应在公开提供的文件中总结器械的主要安全与性能方面以及临床评估的结果。
For implantable devices and for class III devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.
（49） 器械安全和临床性能总结应特别包括在诊断或治疗选择中器械的地位，并考虑到在与诊断或治疗替代项相比时
的器械临床评价，以及可能考虑该器械及其备选方案的具体条件。
The summary of safety and clinical performance for a device should include in particular the place of the device in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when compared to the diagnostic or therapeutic alternatives and the specific conditions under which that device and its alternatives can be considered.
（50） 公告机构的正常运作对于确保高水平的健康和安全保护以及公民对系统的信心至关重要。因此，成员国根据详细和严格的标准对指定机构进行的指定和监测，应在欧盟级别实行控制。
The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and
citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level.
（51） 公告机构对制造商的技术文件的评估，特别是其临床评估文件，应由负责公告机构的主管机构进行严格评估。此类评估是一种基于风险的手段，用于监督和监测公告机构活动，评估时可采取相关文件抽样的方法。 Notified bodies' assessments of manufacturers' technical documentation, in particular documentation on clinical evaluation, should be critically evaluated by the authority responsible for notified bodies. That evaluation should be part of the risk-based approach to the oversight and monitoring activities of notified bodies and should be based on sampling of the relevant documentation.
（52） 应加强公告机构对制造商的监管，包括其进行突击飞行检查和对器械进行物理或实验室测试的权利和义务，以
确保制造商在收到原始证书后持续合规。
The position of notified bodies vis-à-vis manufacturers should be strengthened, including with regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification.
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（1） 委员会签发的关于设立医疗器械数据库的委员会第2010/227/EU号决议
（2）欧洲议会和理事会于1995年10月24日签发的关于保护个人在处理个人数据和数据自由流通方面的第95/46/EC22号指令(OJ L281,
23.11.1995, p. 31)。
（3）欧洲议会和理事会于2000年12月18日签发的关于保护个人在欧共体机构和机构处理个人数据方面的欧洲理事会第45/2001号指令
24(OJ L8, 12.1.2001, p. 1)。