L117/14 EN 欧盟官方公报
5.5.2017
（53） 为提高国家主管机构监督公告机构的透明度，公告机构的主管机构应公布其用于指定和监测器械公告机构的国家评估监管措施的信息。根据良好的行政实践，主管机构应该及时更新这些信息，特别是反映上述流程的相关、重大或实质性变更。
To increase transparency with regard to the oversight of notified bodies by national authorities, the authorities responsible for notified bodies should publish information on the national measures governing the
assessment, designation and monitoring of notified bodies. In accordance with good administrative practice, this information should be kept up to date by those authorities in particular to reflect relevant, significant or substantive changes to the procedures in question.
（54） 公告机构所在的成员国应负责执行本法规关于该公告机构的要求。
The Member State in which a notified body is established should be responsible for enforcing the requirements of this Regulation with regard to that notified body.
（55） 特别是考虑到成员国组织并提供保健服务和医疗护理的责任，允许其制定有关公告机构的其他要求，此类机构用于器械的符合性评估，并且基于本法规未规定问题的领域。规定的此等额外要求不会影响欧盟针对公告机构更为具体的横向欧盟立法和对公告机构的平等对待。
In view, in particular, of the responsibility of Member States for the organisation and delivery of health services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for the conformity assessment of devices and established on their territory as far as issues that are not regulated in this Regulation are concerned. Any such additional requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal treatment of notified bodies.
（56） 对于旨在施用和/或去除某种医疗产品的III类可植入器械和IIb类有源器械，公告机构应有责任要求专家小组仔细审查其临床评估的评定报告（某些特定情况除外）。并且应当于这一专家小组符合性评估程序之后获得证书的器械通知主管机构。通过分享临床方面的专业知识以及按已完成此咨询程序的器械分类建立CS，临床评估相关专家小组的咨询结果应得出高风险医疗器械的协调评估。
For class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert panels to scrutinise their clinical evaluation assessment report. Competent authorities should be informed about
devices that have been granted a certificate following a conformity assessment procedure involving an expert panel. The consultation of expert panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-risk medical devices by sharing expertise on clinical aspects and developing CS on categories of devices that have undergone that consultation process.
（57） 对于III类和特定IIb类器械，制造商应在其临床评估和/或调查之前，可自愿就其临床开发策略和临床研究提案咨询专家小组。
For class III devices and for certain class IIb devices, a manufacturer should be able to consult voluntarily an expert panel, prior to that manufacturer's clinical evaluation and/or investigation, on its clinical development strategy and on proposals for clinical investigations.
（58） 有必要根据国际惯例将器械划分为四个产品类别，特别是出于符合性评估流程考虑。基于人体脆弱性并考虑到与器械技术设计和制造相关的潜在风险的分类规则。为保持与第90/385/EEC号指令中所规定相同的安全水平，有源植入式器械应属于最高风险类别。
It is necessary, in particular for the purpose of the conformity assessment procedures, to maintain the
division of devices into four product classes in line with international practice. The classification rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices. To maintain the same level of safety as provided by
5.5.2017 EN 欧盟官方公报 L117/15
Directive 90/385/EEC, active implantable devices should be in the highest risk class.
（59）
旧框架下适用于侵入性器械的规则并未充分考虑到引入人体的特定器械侵入性水平和潜在毒性。针对在人体中吸收或局部扩展的物质或物质组合构成的器械，为获得基于风险的适当分类，必须针对此等器械引入特定分类规则。分类规则应当考虑到该器械在人体内或在人体上发挥作用的位置及将其引入或加以应用的位置，以及组成器械的这些物质还是这些物质在人体中的代谢产物是否会发生全身吸收。
Rules under the old regime applied to invasive devices do not sufficiently take account of the level of
invasiveness and potential toxicity of certain devices which are introduced into the human body. In order to obtain a suitable risk-based classification of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body, it is necessary to introduce specific classification rules for such devices. The classification rules should take into account the place where the device performs its action in or on the human body, where it is introduced or applied, and whether a systemic absorption of the substances of which the device is composed, or of the products of metabolism in the human body of those substances occurs.
（60）
考虑到与这些器械有关的低水平脆弱性，作为一般规则，应由制造商单独负责执行有关I类器械的符合性评估程序。对于IIa、IIb和III类医疗器械，应当强制公告机构进行适当程度的参与。
The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.
（61）
应进一步加强和简化器械符合性评估流程，同时应明确规定公告机构对其评估执行情况的要求，以确保公平竞争的环境。
The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field.
(62)
自由销售证书包含的信息，应该有助于使用Eudamed，以便获得器械的信息，无论器械是否上市，从市场撤出或召回，以及具备何种合格证。
It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the market or recalled, and on any certificate on its conformity.
（63）
为确保具有较高的安全与性能水平，本法规中规定的通用安全与性能要求符合性的证明应基于以下临床数据：作为一般规则，对于III类器械和可植入性器械，此类数据应来自申办方所进行的临床研究。还可以由制造商和另一自然人或法人作为申办方负责开展此类临床研究。
To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical data that, for
class III devices and implantable devices should, as a general rule, be sourced from clinical investigations that have been carried out under the responsibility of a sponsor. It should be possible both for the
manufacturer and for another natural or legal person to be the sponsor taking responsibility for the clinical investigation.
（64） 临床研究的规则应符合该领域成熟的指导原则，例如关于人类受试者医疗器械临床研究的临床试验质量管理
规范（ISO国际标准14155:2011），以促使将在欧盟内进行的临床研究结果成为欧盟境外得到认可的文件规范，并促使根据国际准则在欧盟之外进行的临床研究结果可在欧盟内获得认可。此外，这些规则应符合世界医学协会《赫尔辛基宣言》关于涉及人类受试者医学研究伦理原则的最新版本。
L117/16 EN 欧盟官方公报 5.5.2017
The rules on clinical investigations should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of clinical investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of clinical investigations conducted outside the Union in accordance with international guidelines to be accepted within the Union. In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
（65） 应由开展临床研究的成员国决定参与评估申请进行临床研究的适当管理机构，并组织伦理委员会在本法规设
定的临床研究授权的时间期限内参与。这些决定属于各成员国的内部组织问题。在这种情况下，成员国应确保非专业人员，特别是患者或患者组织的参与。此外，其还应确保提供必要的专门知识。
It should be left to the Member State where a clinical investigation is to be conducted to determine the appropriate authority to be involved in the assessment of the application to conduct a clinical investigation and to organise the involvement of ethics committees within the timelines for the authorisation of that clinical investigation as set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. In that context, Member States should ensure the involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the necessary expertise is available.
（66） 若在临床研究过程中，对受试者造成的伤害导致研究者或申办方承担民事或刑事责任，在这种情况下的法律
责任条件，包括问题的因果关系和损害赔偿和制裁的水平，应该接受国家法律管辖。
Where, in the course of a clinical investigation, harm caused to a subject leads to the civil or criminal liability of the
investigator or the sponsor being invoked, the conditions for liability in such cases, including issues of causality and the level of damages and sanctions, should remain governed by national law.
（67） 应在欧盟层面建立一个电子系统，以确保在可公开访问的数据库中记录和报告每一项临床研究。为保护“欧
盟基本权利宪章”第8条规定的个人资料保护权益，不得在电子系统中记录参与临床研究的受试者的个人资料。为确保与医药产品临床试验领域的协同作用，临床研究的电子系统应与人用药品临床试验的欧洲数据库互通。An electronic system should be set up at Union level to ensure that every clinical investigation is recorded and reported in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use.
（68） 如需在一个以上的成员国进行临床研究，则申办方应提交单独申请，以便减少行政负担。为允许资源共享并
确保用于研究器械以及临床研究的科学设计的卫生安全方面的一致性，这种单项申请的评估流程应便于在协调成员国指导下成员国之间协调。此等协调评估不得包括对临床研究的国家、地域和族群方面的评估，包括知情同意。自本法规施行之日起七年内，成员国应自愿参与协调评估。在这一时期结束后，所有成员国都有义务参与协调评估。委员会根据成员国之间自愿协调所取得的经验，应拟订有关协调评估流程的相关规定应用报告。若报告的结果是否定的，委员会应提交一份建议，延长协调评估流程中自愿参与的时间段。Where a clinical investigation is to be conducted in more than one Member State, the sponsor should have the
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possibility of submitting a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the investigational device and of the scientific design of that clinical investigation, the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State. Such coordinated assessment should not include the
assessment of intrinsically national, local and ethical aspects of a clinical investigation, including informed consent. For an initial period of seven years from the date of application of this Regulation, Member States should be able to participate on a voluntary basis in the coordinated assessment. After that period, all Member States should be obliged to participate in the coordinated assessment. The Commission, based on the experience gained from the voluntary coordination between Member States, should draw up a report on the application of the relevant provisions regarding the coordinated assessment procedure. In the event that the findings of the report are negative, the Commission should submit a proposal to extend the period of participation on a voluntary basis in the coordinated assessment procedure.
（69） 申办方应向开展临床研究的成员国报告在临床研究期间发生的特定不良事件和器械缺陷。如认为有必要确保
参与临床研究的受试者得到高水平保护，成员国应可以终止或暂停此等研究或撤销此等研究的授权。这些信息应该传达给其他成员国。Sponsors should report certain adverse events and device deficiencies that occur during clinical investigations to the Member States in which those clinical investigations are being conducted. Member States should have the possibility of terminating or suspending the investigations or revoking the authorisation for those investigations, if considered necessary to ensure a high level of protection of the subjects participating in a clinical investigation. Such information should be communicated to the other Member States.
（70） 如适用，临床研究的申办人应在本法规规定的时间期限内编制一份预期使用者容易理解的临床研究研究摘要，
连同临床研究报告一起提交。如因科学原因未能在规定的时间内提交结果摘要，申办人应说明理由，并说明何时提交结果。The sponsor of a clinical investigation should submit a summary of results of the clinical investigation that is easily understandable for the intended user together with the clinical investigation report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results will be submitted.
（71） 本法规应涵盖旨在证明器械符合性，以收集临床证据为目的的临床研究，并应同时规定有关其他类型医疗器
械临床研究的伦理和科学评估的基本要求。This Regulation should cover clinical investigations intended to gather clinical evidence for the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and scientific assessments for other types of clinical investigations of medical devices.
（72） 无行为能力受试者、未成年人、孕妇和哺乳期妇女需要特殊保护措施。但需要由成员国确定无行为能力受试
者和未成年人的法定代表人 ncapacitated subjects, minors, pregnant women and breastfeeding women
require specific protection measures. However, it should be left to Member States to determine the legally designated representatives of incapacitated subjects and minors.
（73） 应遵守欧洲议会和理事会第2010/63/EU号指令（1）中所规定的动物实验领域的替换、减少和完善原则。特
别是，应避免不必要的重复测试和研究。The principles of replacement, reduction and refinement in the area of animal experimentation laid down in the Directive 2010/63/EU of the European Parliament and of the Council (24) should be observed. In particular, the unnecessary duplication of tests and studies should be avoided.
L117/18 EN 欧盟官方公报
5.5.2017
（74） 制造商应在售后阶段发挥积极作用，通过系统和积极地根据其器械售后体验收集信息，以更新其技术文件，
并与负责警戒和市场监管活动的国家主管机构合作。为此，制造商应根据质量管理体系并基于上市后监管计划，建立一个综合的上市后监管体系。且应借助在上市后监管中收集的相关数据和信息，以及从任何执行的预防和/或纠正措施中吸取的经验教训，更新技术文件的任何相关部分，如风险评估相关文件和临床评估，还应确保文件透明度。Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set up
under their quality management system and based on a post-market surveillance plan. Relevant data and information gathered through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the purpose of transparency.
（75） 为更好地保障上市器械相关健康和安全问题，应当通过创建欧盟级别的中央门户网站报告严重事件和现场安
全纠正措施，使得用于器械的电子警戒系统更有效。In order to better protect health and safety regarding devices on the market, the electronic system on vigilance for devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions.
（76）
成员国应采取适当措施，提高医护专业人员、使用者和患者对报告事件的重要性的认识。应该鼓励医护专业人员、使用者和患者使用统一格式在国家级别报告可疑的严重事件。国家主管机构应通知制造商任何疑似严重事件，并且当制造商确认此等事故发生时，相关主管机构应确保采取适当的跟踪措施，以尽量避免此类事件的再次发生。Member States should take appropriate measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be encouraged and enabled to report suspected serious incidents at national level using harmonised formats. The national competent authorities should inform manufacturers of any suspected serious incidents and, where a manufacturer confirms that such an incident has occurred, the authorities concerned should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents.
（77）
应在国家级别评估报告的严重事件和现场安全纠正措施，但应确保在类似事件发生时进行协调，或者必须在多个成员国进行现场安全纠正措施，目的是共享资源并确保纠正措施的一致性。The evaluation of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State, with the objective of sharing resources and ensuring consistency regarding the corrective action.
（78）
在事故调查背景中，主管机构应酌情考虑利益相关者（包括患者和医护专业人员组织和制造商协会）提供的信息和意见。In the context of the investigation of incidents, the competent authorities should take into account, where appropriate, the information provided by and views of relevant stakeholders, including patient and healthcare professionals' organisations and manufacturers' associations.
（79）
应清楚区分临床研究期间的严重不良事件或器械缺陷报告和器械投放市场后发生的严重事件报告，以避免重复报告。The reporting of serious adverse events or device deficiencies during clinical investigations and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.
（80）
本法规应包含市场监管规则，以加强国家主管机构的权利和义务，确保市场监管活动的有效协调，并说明适用的流程。Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures.
（81）
可能对风险利益分析产生重大影响，并且可能导致不可接受风险的，不严重或预期副作用事件，如数量或严