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重程度出现显著增加，均应向主管机构报告，以允许其进行评估和采取适当的措施。Any statistically significant increase in the number or severity of incidents that are not serious or in expected side-effects that could have a significant impact on the benefit-risk analysis and which could lead to unacceptable risks should be reported to the competent authorities in order to permit their assessment and the adoption of appropriate measures.
（82）
应当成立一个由成员国指派的专家（根据其在医疗器械（包括体外诊断医疗器械）领域中的职务和专长）组成的专家委员会，即医疗器械协调小组（MDCG），以完成本法规和欧洲议会和理事会第2017/746号法规（2）赋予该小组的使命，向委员会提供建议，以及协助委员会和成员国确保本法规的协调实施。MDCG应当能够建立其分小组，以便在医疗器械（包括体外诊断医疗器械）领域提供必要的、有见地的专门技术知识。在建立分小组时，应适当考虑在医疗器械领域中加入现有欧盟级别团体的可能性。An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States based on their role and expertise in the field of medical devices including in vitro diagnostic medical devices, should be established to fulfil the tasks conferred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (25), to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised
implementation of this Regulation. The MDCG should be able to establish subgroups in order to have
access to necessary in-depth technical expertise in the field of medical devices including in vitro diagnostic medical devices. When establishing subgroups, appropriate consideration should be given to the possibility of involving existing groups at Union level in the field of medical devices.
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（1）欧洲议会和理事会于2010年9月22日签发的关于用于科学目的动物保护的第2010/63/EU号指令(OJL276, 20.10.2010, p. 33)。 （2）欧洲议会和理事会于2017年4月5日签发的关于体外诊断医疗器械第2017/746号（EU）法规，废止了第98/79/EC号指令和委员会第
2010/227/EU号决议（见本“官方公报”第176页）
（83） 应由委员会根据最新的临床、科学或技术专业知识，委任专家委员会和专家实验室，以便向委员会、MDCG、
制造商和与本法规实施有关的公告机构提供科学、技术和临床协助。此外，专家小组应履行对高风险器械的公告机构临床评估的评定报告提出自身意见的义务。Expert panels and expert laboratories should be designated by the Commission on the basis of their up-to-date clinical, scientific or technical expertise, with the aim of providing scientific, technical and clinical assistance to the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this Regulation. Moreover, expert panels should fulfil the tasks of providing an opinion on clinical evaluation assessment reports of notified bodies in the case of certain high-risk devices.
（84） 通过在协调机构的指导下的信息交流和协调评估，国家主管机构之间进行的更密切的协调，对于确保内部市场，
特别是在临床研究和警戒领域的统一高水平的健康和安全保护至关重要。协调交流和评估的原则也应适用于本法规中说明的其他机构活动，例如公告机构名称，并应在器械的市场监管领域中鼓励使用该原则。活动的协作、协调和沟通也应在国家层级上引领更有效地利用资源和专门知识。Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is
essential for ensuring a consistently high level of health and safety protection within the internal market, in particular in the areas of clinical investigations and vigilance. The principle of coordinated exchange and assessment should also apply across other authority activities described in this Regulation, such as the designation of notified bodies and
should be encouraged in the area of market surveillance of devices. Joint working, coordination and communication of activities should also lead to more efficient use of resources and expertise at national level.
（85） 委员会应向协调国家主管机构提供科学、技术和相应的后勤支持，并确保器械的监管制度在欧盟层级基于可
靠的科学证据能够得以有效且统一地实施。The Commission should provide scientific, technical and corresponding logistical support to coordinating national authorities and ensure that the regulatory system for devices is effectively
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and uniformly implemented at Union level based on sound scientific evidence.
（86） 欧盟及成员国应酌情积极参与医疗器械领域的国际监管合作，以促进医疗器械安全相关信息的交流，并促进
国际监管准则的进一步发展，从而推动其他法规司法管辖区采用与本法规所规定卫生与安全保障水平同等的法规。The Union and, where appropriate, the Member States should actively participate in international regulatory cooperation in the field of medical devices to facilitate the exchange of safety-related information regarding medical devices and to foster the further development of international regulatory guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that set by this Regulation.
（87） 成员国应采取一切必要措施，确保本法规的规定得到执行，包括针对违反行为制定有效、相称和劝诫性的处
罚。Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement.
（88） 同时，本法规不得影响成员国对国家一级活动征收费用的权利，但成员国在决定相关费用级别和结构之前应
通知欧盟委员会和其他成员国，以确保透明度。为进一步确保透明度，应根据要求公开费用结构和级别。Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level, Member States should, in order to ensure transparency, inform the Commission and the other
Member States before they decide on the level and structure of such fees. In order to further ensure transparency, the structure and level of the fees should be publicly available on request.
（89） 本法规尊重基本权利，并遵守《宪章》所认可的原则，尤其是人类尊严、人身完整性、个人资料的保护、艺
术和科学自由、开展业务的自由和财产权。成员国应根据这些权利和原则应用本法规。This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property. This Regulation should be applied by the Member States in accordance with those rights and principles.
（90） 根据TFEU第290条，应当授予委员会批准授权法案的权限，以便修订本法规的某些非必要规定。特别重要
的是，委员会在其筹备工作期间，包括在专家层级上进行适当的咨询，且应根据2016年4月13日《改善的立法机构间协议》所规定的原则（1）进行这些咨询。特别是，为确保平等参与制订授权法案，欧洲议会和理事会将与成员国专家同时收到所有文件，并且其专家可系统地参加委员会专家组会议，以讨论授权法案的制订。The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in order to amend certain non-essential provisions of this Regulation. It is of particular
importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (26). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with preparation of delegated acts.
（91） 为确保执行本法规的条件一致，应向委员会授予执行权力。应根据欧洲议会和理事会第182/2011号法规（2）
行使这些权力。In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (27).
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（1） OJ L123, 12.5.2016, p. 1.
L117/21
（2） 欧洲议会和理事会2011年2月16日签发的关于规定行使这些权力及成员国管制委员会行使其执行权力机制的规则和一般原则的第
182/2011号法规(OJ L55, 28.2.2011, p.13)。
（92） 实施细则应借助咨询程序，其中规定了制造商安全与性能总结的数据要素形式，并建立了表述以及自由销售证
书模式的形式与表述，因为实施细则具有程序性，并且不会直接对欧盟层级的卫生与安全产生影响。The advisory
procedure should be used for implementing acts that set out the form and presentation of the data elements of manufacturers' summaries of safety and clinical performance, and that establish the model for certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an impact on health and safety at Union level.
（93） 若存在紧急理由，即涉及到欧盟领土扩张，而相关国家豁免适当符合性评估流程，则委员会应采取立即适用的
实施细则。The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity assessment procedures, imperative grounds of urgency so require.
（94） 为使委员会能任命签发机构、专家小组和专家实验室，应授予委员会实施权限。In order to enable it to designate
issuing entities, expert panels and expert laboratories, implementing powers should be conferred on the
Commission.
（95） 为使经济运营商，特别是中小型企业、指定机构、成员国和委员会能够适应本法规引入的变化并确保其适当的
应用，适当的做法是为这种适应和后期的组织安排提供充分的过渡期。但应当尽快实施法规中直接影响成员国和委员会的特定部分。特别重要的是，在本法规生效之日，根据新的要求指定足够数量的公告机构，以避免市场上医疗器械的任何短缺。尽管如此，在法规生效日期前，有必要根据本法规要求任命一个公告机构，但不得影响这些公告机构按照第98/79/EC号指令任命的有效性，并且不影响其按照该指令继续签发有效证书的权限，直至本法规生效。To allow economic operators, especially SMEs, notified bodies, Member States and the Commission to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements that are to be made. However, certain parts of the Regulation that directly affect
Member States and the Commission should be implemented as soon as possible. It is also particularly important that, by the date of application of this Regulation, a sufficient number of notified bodies be
designated in accordance with the new requirements so as to avoid any shortage of medical devices on the market. Nonetheless, it is necessary that any designation of a notified body in accordance with the
requirements of this Regulation prior to the date of its application be without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and 93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of application of this Regulation.
（96） 为确保顺利过渡至器械和证书注册的新规定，按照本法规，向在欧盟层级别设置的电子系统提交相关信息的义
务（若已根据计划开发了相应的IT系统）应当在本法规适用日期后的18个月内完全有效。在此过渡期内，第90/385/EEC和93/42/EEC号指令的某些条款应继续有效。但根据这两项法规在欧盟层级设立的相关电子系统中注册的经济运营商和指定机构应视为符合成员国根据规定所采取的注册要求，以避免多次注册。In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the obligation to submit the relevant information to the electronic systems set up at Union level pursuant to this Regulation should, in the event that the corresponding IT systems are developed according to plan, only become fully effective from 18 months after the date of application of this Regulation. During this transitional period, certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However, in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic systems set up at Union level pursuant to this Regulation should be considered to be in compliance with the registration requirements adopted by the Member States pursuant to those provisions.
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（97） 为使UDI系统顺利引入，将UDI载体加在器械标签上义务的生效时机还应当在本法规生效日期之后一年至五
年之间完成，具体取决于相关器械的类别。In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned.
（98） 应废除第90/385/EEC号和第93/42/EEC号指令，以确保只有一套规则适用于医疗器械投放市场及本法规所涉及
相关问题。制造商依然有义务为其投放市场的器械提供相关文件，而制造商和成员国依然有义务按照该指令开展已投放市场器械的监管活动。虽然应当由成员国决定如何组织监管活动，但建议成员国使用与报告依照本法规投放市场之器械相同的工具来报告使用依照该指令投放市场的器械。此外，为确保从旧框架顺利过渡到新框架，恰当的做法是规定欧盟委员会第207/2012号法规（1）和欧盟委员会第722/2012号法规（2）应持续有效并继续适用，除非并直至其被执行委员会根据本法规通过的实施细则废除。Directives 90/385/EEC and
93/42/EEC should be repealed to ensure that only one set of rules applies to the placing of medical devices on the market and the related aspects covered by this Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to those Directives should however continue to apply. While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting incidents related to devices placed on the market pursuant to the Directives using the same tools as those for reporting on
devices placed on the market pursuant to this Regulation. It is furthermore appropriate, in order to ensure a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (28) and Commission Regulation (EU) No 722/2012 (29) should remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation. Decision 2010/227/EU adopted in implementation of those Directives and Directive 98/79/EC should also remain in
force and continue to apply until the date when Eudamed becomes fully functional. Conversely, no such maintenance in force is required for Commission Directives 2003/12/EC (30) and 2005/50/EC (31) and Commission Implementing Regulation (EU) No 920/2013 (32). _____________________
（1）委员会于2012年3月9日签发的关于医疗器械使用电子机构的委员会第207/2012号法规(OJ L72, 10.3.2012, p. 28)。
（2） 委员会于2012年8月8日签发的关于在委员会关于有源植入式医疗器械和医疗器械第90/385/EEC和93/42/EEC指令规定要求特殊要
求的委员会第722/2012号法规。
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在欧洲医疗器械数据库完全启用日之前，在实施这些指令和第98/79/EC号指令时所通过的第2010/227/EU号决议应继续有效并继续适用。相反，委员会第2003/12/EC（1）和2005/50/EC号指令（2）和委员会第920/2013号实施法规（3）无需维持效力。
（99） 本法规的要求应适用于自本法规生效之日起投放市场或投入使用的所有器械。但为提供平稳过渡，应能够允许
器械自该日期起的有限期限内，根据第90/385/EEC或93/42/EEC号指令颁发的有效证书投放市场或投入使用。The requirements of this Regulation should be applicable to all devices placed on the market or put into service from the date of application of this Regulation. However, in order to provide for a smooth transition it should be possible, for a limited period of time from that date, for devices to be placed on the market or put into service by virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) 欧洲数据保护主管根据欧洲委员会第45/2001号法规第28（2）条发表了意见（4）。The European Data Protection
Supervisor has given an opinion (33) pursuant to Article 28(2) of Regulation (EC) No 45/2001.
（101） 出于本法规的目标，即确保医疗器械境内市场的顺利运转并确保医疗器械的高质量和安全性，因此若患者、使
用者及其他人员的卫生与安全得到高水平的保护，无法由成员国充分实现，且由于规模和效果，可更好地在欧盟层级中实现时，欧盟可根据《欧盟条约》第5条规定的辅助性原则采取措施。按照该条款中规定的比例原则，本法规将不会超过实现该目标所需范围。Since the objectives of this Regulation, namely to ensure the
smooth functioning of the internal market as regards medical devices and to ensure high standards of quality and safety for medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the
principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,
已经通过本法规：HAVE ADOPTED THIS REGULATION CHAPTER I
第I章
范围及定义
SCOPE AND DEFINITIONS 第1条 Article 1 主题与范围
Subject matter and scope 1. 本法规规定了有关欧盟境内供人类使用的医疗器械极其附件的市场投放、市场提供或投入使用方面的规则。本
法规也适用于在欧盟进行的有关该医疗器械及其附件临床研究。This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.
2. 本法规还应适用于自根据第9条通过的通用规范适用之日起，附录XVI所列并无预期医疗目的产品组，并考虑
到基于类似技术的目前最高水平，特别是适用于具有医疗目的类似器械的现有协调标准。该附录XVI中所列产品组的通用规范应至少解决适用于如该产品组附录I中所列风险管理应用，及必要时，针对安全性的临床评价。 应在2020年5月26日通过强制性的通用技术规范。此类规范应自其生效日的六个月后或自2020年5月26日起适用，以最迟发布者为准。his Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group