MDR-EU-2017-745-欧盟医疗器械法规-第六章

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本文转载自“木之唐咨询”

前言
本周我们将分享MDR第六章 临床评价和临床研究 CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS

MDR中 主管当局和公告机构加强对临床评价和临床研究评审，加强了对临床数据的要求以及上市后临床跟踪。

整部MDR法规共10个章节，17个附录，按我们读完整部MDR法规计划，已分享了：[color=var(--weui-LINK)]法规综述 (可点击进入各章)第一章 范围及定义第二章 器械的上市供应和投入使用、经济运营商的义务、再处理、CE标识、自由流通第三章 器械的标识和可追溯性、器械和经济运营商的登记、安全和临床性能总结、欧洲医疗器械数据库第四章 公告机构[color=var(--weui-LINK)]第五章 分类和符合性评估欢迎关注我们公众号获取更多。

CHAPTER VI

临床评价和临床研究CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
Article 61临床评价Clinical evaluation1.在达到该器械预期用途的正常条件下，应证明符合附录I所所述的通用安全能要求，且附录I第1节和第8节所所述的不良副作用评估和收益/风险比可接受性，均应依据临床数据所提供的充分的临床证据包含附录III规定的相关数据（如适用）。Confirmation of conformity with relevant general safety and performance requirements set outin Annex I under the normal conditions of the intended use of the device,and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk- ratio referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.制造商应规定并证明临床证据的等级足以证明符合通用安全与性能相关的基本要求。该临床证据等级应适合器械及其预期用途的特性。The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose.为此，制造商应根据本法规及附录XIV第A部分计划、实施并用文件记录临床评价。To that end, manufacturers shall plan, conduct and document a clinical evaluationin accordance with this Article and Part A of Annex XIV.2.     对于第54（1）条（b）点中所述的所有III类和IIb类器械，制造商在临床评价和/或研究前依据第106条所述的程序咨询专家小组，目的旨在审查制造商的预期临床用途和临床研究方案。制造商应适当考虑专家小组发表的意见。此外，这些考虑因素应记录在本条第12段所述的临床评价报告中。Forall class III devices and for the class IIb devices referred to in point (b) of Article 54(1), the manufacturer may, prior to its clinical evaluation and/or investigation, consult an expert panel as referred to in Article 106, with the aim of reviewing the manufacturer's intended clinical development strategy and proposals for clinical investigation. The manufacturer shall give due consideration to the views expressed by the expertpanel. Such consideration shall be documented in the clinical evaluation report referred to in paragraph 12 of this Article.制造商可能无法从专家小组对任何未来符合性评估流程表达意见中取得任何权利。The manufacturer may not invoke any rights to the views expressed by the expertpanel with regard to any future conformity assessment procedure.3.     临床评价应遵循以下明确规定且方法得当的程序：A clinical evaluation shall follow a defined and methodologically sound procedure based on the followinga)目前涉及器械安全性能、设计特点和预期用途的科学文献关键评估如可用，则满足下列条件：acritical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are sat is fied:依据附录XIV第3节，表明用于预期用途临床评价的器械等同于与数据相关的器械，it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relate, in accordance with Section 3 of Annex XIV, and数据充分证明符合相关的通用安全能要求；the data adequately demonstrate compliance with the relevant general safety and performance requirements;(b)所有可用的临床研究结果的关键评估应依据第62条至80条、依据第81条和附录XV所采用的法案规定适当考虑是否进行研究。acritical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and(c)    为上述目的考虑替代当前可用的治疗方案（如有）。aconsideration of currently available alternative treatment options for that purpose, if any.4.     对于可植入器械和III类器械，应进行临床研究，除非：In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:该器械由同一制造商对已投放市场的器械进行改进，the device has been designed by modifications of a device already marketed by the same manufacturer,依据附录XIV第3节规定，已改进的器械经制造商证明后等同于投放市场的器械，且此证明已得到公告机构认可，及the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV andthis demonstration has been endorsed by the notified body, and对投放市场的器械进行临床评价以证明已改进的器械符合相关的安全性能要求。the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.在这种情况下，公告机构检查发现PMCF计划很合适且其中包括上市后研究，以证明器械的安全性能。此外，临床研究无需在第6段所所述的情况下执行。In this case, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.5.     依据第4段规定，制造商生产出的器械经证实等同于已投放市场的器械（不属于同一制造商生产），除此条所要求的内容外，若以下条件均满足，则无需进行临床研究：A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him, may alsorely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:在这两个制造商拟定合同的适当位置明确允许第二种器械制造商在现有基础上全权使用技术文件。the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full accessto the technical documentation on an ongoing basis, and原始临床评价已依照本法规要求完成，the original clinical evaluation has been performed in compliance with the requirements of this Regulation,且第二种器械制造商向公告机构提供其明确证据and the manufacturer of the second deviceprovides clear evidence thereof to the notified body.6.     依据第4段执行临床研究的要求不适用于可植入器械和III类器械： The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and class III devices:此类器械依据第90/385/EEC号指令或第93/42/EEC号指令已合法投放市场或投入使用，其临床评价：which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:基于足够的临床数据is based on sufficient clinical data, and符合此类器械临床评价相关产品CS；或is in compliance with the relevantproduct-specific CS for the clinical evaluation of that kind of device, wheresuch a CS is available; or针对缝线、U形钉、牙齿填充物、牙套、齿冠、螺钉、楔子、牙板、金属丝、针、小夹和连接体而进行的临床评价均应建立在充分的临床数据上且符合相关的特定产品CS。that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such a CS is available.7.     对于因第4段的规定而未适用第6段的情况，在制造商的临床评价临床评价报告和公告机构的临床研究评估报告中可视为合理。 Cases in which paragraph 4 is not applied by virtue of paragraph 6 shall be justified in the clinical evaluation report by the manufacturer and in theclinical evaluation assessment report by the notified body.8.     若理由充分，则对于具有在其他器械中使用与本条第6段（b）点列表中豁免器械所用技术类似技术，或出于保障患者、使用者或其他个人的健康和安全或公众健康其他方面的考虑，委员会有权根据第115条，授权将其他类型的可植入器械或III类器械添加到列表中或从中移除，并修订第52（4）第二子段和本条第6段（b）点中所述的豁免器械列表。Where justified in view of well-established technologies, similar to those used in the exempted devices listed in point (b) of paragraph 6 of this Article, being used in other devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list of exempted devices referredto in the second subparagraph of Article 52(4) and in point (b)of paragraph 6 of this Article, by adding other types of implantable orclass III devices to that list or removing devices therefrom.9.     对于附录XVI所列不带有医学目的产品，本章和附录XIV和附录XV中要求说明的临床疗效应理解为说明该器械性能的要求。有关安全性相关数据的临床评价，包括来自上市后的监管、PMCF和具体的临床研究数据（适用时）的数据。应对这些产品进行临床研究，除非其具有能够使用现有类似医疗器械临床数据的正当理由。In the case of the products without an intended medical purpose listed in Annex XVI, the requirement to demonstrate a clinical benefit in accordance with this Chapter and Annexes XIV and XV shall be understood as are quirement to demonstrate the performance of the device. Clinical evaluationsof those products shall be based on relevant data concerning safety, including data from post-market surveillance, PMCF, and, where applicable, specificclinical investigation. Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified.10.   在不影响第4段规定下，若基于临床数据证明其符合通用安全与性能要求的论证不适当，应根据制造商风险管理的结果，考虑该器械与人体间相互影响的具体细节、预期临床性能和制造商要求，为任何此类例外情况给出充分理由。在此情况下，无论是否仅基于非临床研究结果（包括性能评估、台架试验和临床前评估结果）充分论证其符合通用安全与性能要求，制造商应在在附录II所指的技术文件中提供适当证明。Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall begiven based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of them anufacturer. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers ademonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to beadequate.11.   根据附录XIV第B部分计划和第84条所所述的上市后监管计划，在整个器械使用寿命期间，应使用制造商实施PMCF后取得的临床数据对临床评价及其文件进行更新。The clinical evaluation and its documentation shall be updated throughout the lifecycle of the device concerned with clinical data obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.对于III类器械和可植入器械，第32条中所述的PMCF评估报告、安全和临床性能总结（视患者病情）应使用这些数据至少每年更新一次。For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance referred to in Article 32 shall be updated at least annually with such data.12.   从中得出的临床评价、结果和临床证据应记录在附录XIV第4节所述的临床评价临床评价报告中（定制器械除外），并作为附录II规定的有关器械技术文件的一部分。The clinical evaluation, its results and the clinical evidence derived from itshall be documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for custom-made devices, shall be part of the technical documentation referred to in Annex II relating to the device concerned.13.   若有必要确保附录XIV的应用一致性，委员会可充分考虑技术和科学的进展，必要时采取实施细则的措施以解决发生分歧和实际应用中出现的问题。应按照第114(3)条中述及的审查规程实施这些法案。Where necessary to ensure the uniform application of Annex XIV, the Commission may, having due regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3) Article 62执行有关临床研究的一般要求，以证明器械的符合性Generalrequirements regarding clinical investigations conducted to demonstrateconformity of devices1.临床研究应根据第本条和第63 - 80条和根据第81条采用的法案和附录XV进行设计、授权、执行、记录和报告，前提是其出于以下一个或多个目的，为临床评价的符合性评估而执行：Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted pursuant to Article 81, and Annex XV, where carried out as part of the clinical evaluation for conformity assessment purposes, for one or more of the following purposes:建立和验证设计、生产和组装的器械在正常使用条件下适用于第2条（1）点编号（1）中所指的一个或多个特定目的，并能够实现制造商规定的预期性能；to establish and verify that, under normal conditions of use, a device is designed, manufactured and packaged in such away that it is suitable for one or more of the specific purposes listed inpoint (1) of Article 2, and achieves the performance intended as specified byits manufacturer;建立和验证制造商规定的器械临床益处；to establish and verify the clinical benefits of a device as specified by its manufacturer;建立和验证器械的临床安全性，确定器械在正常使用状态下是否存在任何不良的副作用，并在权衡器械取得的疗效时评估其所构成的风险是否可接受。to establish and verify the clinicalsafety of the device and to determine any undesirable side-effects, undernormal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device.2.若临床研究的申办方不是在欧盟境内成立的，该申办方应当确保有一个在欧盟依法登记成立的自然人或法人作为法定代理人。该法定代理人应负责确保申办方遵守本法规规定的义务，并应成为本法规规定的申办方的所有通信的收件人。任何与法定代理人的通信均应视为是与申办方的通信。Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that anatural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor.成员国在其领土或第三国领土上单独进行临床研究时可选择不遵循第一子段，只要其保证申办方在其领土上至少设立一个联络人，该联络人应作为本法规规定的申办方的所有通信收件人。Member Statesmay choose not to apply the first subparagraph to clinical investigations to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical investigation who shall be the addressee for all communications withthe sponsor provided for in this Regulation.3.临床研究的设计和实施必须在受试者权利、安全、尊严和福祉得到保护并且优先于所有其他利益的基础上开展，并且产生的临床数据必须是科学有效、可靠、可信的。Clinicali nvestigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in a clinical investigation are protected and prevail over all other interests and the clinical data generated are scientifically valid, reliable and robust.临床研究应获得科学和伦理审查。伦理审查应当由伦理委员会根据国家法律规定执行。各成员国应确保由伦理委员会进行的审查程序与列于本法规的对临床研究授权申请的评估流程是一致的。至少有一个非专业人士参加伦理审查。Clinical investigations shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethicscommittees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a clinical investigation. At least one lay person shall participate in the ethical review.4.     需在满足以下所有条件的情况下开展第1段所述临床研究：Aclinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met:根据本法规规定，临床研究需受进行临床研究的成员国的主管机构监管，除非另有说明；the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, inaccordance with this Regulation, unless otherwise stated;一个依据国家法律成立的独立的伦理委员会，不能依据国家法律发布对有关整个成员国有效的有关临床研究的负面评价；an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the clinical investigation, which is valid for that entire Member State under its national law;依据第2段，申办方或其法定代理人或联系人应在欧盟境内依法成立；the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the Union;按照第64至68条弱势群体和受试者应得到适当保护；vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68;对受试者或公众健康的预期利益超过其可预见的风险和不便，并将监控其是否持续符合本条件；the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;根据第63条，受试者或其法定代理人（在受试者不能给与知情同意书时）已给出知情同意书。the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent in accordance with Article 63;向受试者或其法定代理人（在受试者不能给与知情同意书时）提供在需要时可接收更多信息的实体联系方式；the subject or, where the subject is not able to give informed consent, his or herlegally designated representative, has been provided with the contact details of an entity where further information can be received in case of need;根据第95/46/EC号指令，保障受试者身心健全的权利、隐私权以及保护自身有关信息权利；the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning himor her in accordance with Directive 95/46/EC are safe guarded;临床研究应尽可能减少受试者的伴随疼痛、不适、恐惧及其他可预见风险，在临床研究计划中风险阈值和压力水平均经过具体确定并对其进行持续监控；the clinical investigation has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the clinical investigation plan and constantly monitored;具有资质的医生有责任为受试者提供医疗护理，在适当情况下，合资格的牙医或其他任何个人应依法在临床研究情况下提供相关的患者护理；提供给受试者的医疗服务是一个合格的医生的责任，或者在适当的情况下，一个合格的牙科医生或由国家法律授权的任何其他人有权在临床研究条件下提供相关的患者护理；the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner or any other person entitled by national law to provide the relevant patientcare under clinical investigation conditions;受试者或其法定代理人在参与临床研究时，不会受到不良影响（包括财务方面）；noundue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the clinical investigation;所述研究器械应符合适用的附录I中规定的通用安全与性能要求，临床研究所涉及的方面除外，而对于这些方面，应采取各种预防措施以保障受试者的健康和安全。其中包括在适当情况下的技术和生物安全检测和临床前评估，以及职业安全和事故预防领域中的规定，这些应考虑目前最先进的技术；the investigational device(s) in question conform(s) to the applicable general safety and performance requirements set out in Annex I apart from theaspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, technical and biological safety testing and pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art;符合附录XV的要求。the requirements of Annex XV are fulfilled.5.     任何受试者或其法定代理人（当受试者无法签署知情同意书时）可在未造成任何损伤且无需提供任何理由的情况下，通过撤销其知情同意书，随时退出该临床研究。在不违反第95/46/EC号指令情况下，撤回知情同意书不得影响已经开展的活动以及在撤离知情同意书前已经获得的数据。Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the clinical investigation at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal. 6.     研究人员应从事相关成员国承认的职业，并将其在患者护理方面具有必要的科学知识和经验考虑认定为其是否具有作为研究人员的资格。为执行任务，应参与临床研究的其他人员，应当在教育、培训或相关医疗领域和临床研究方法的经验方面具有相应资格。The investigator shall be a person exercising a profession which is recognised in the Member State concerned as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patientcare. Other personnel involved in conducting a clinical investigation shall besuitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.7.     临床研究使用的器械应适用于临床研究，并具备相似预期用途。The facilities where the clinical investigation is to be conducted shall be suitable for the clinical investigation and shall be similar to the facilities where the device is intended to be used.Article 63知情同意Informed consent1.知情同意书须由第2段（c）点所述的面试的受试者编写，注明日期并签名，或根据第2段，在已正式通知后，受试者或其法定代理人（不能够给出知情同意书时）签署。当受试者不能编写时，可在至少有一个公正见证人在场的情况下，使用适当的替代方法记录，以予以同意。在这种情况下，见证人应在知情同意书上签名并注明日期。应当向受试者或其法定代理人（在受试者不能给与知情同意书时）提供该文件的副本或备案（如适用）已表示给与知情同意书。知情同意书应记录在案。应当给与受试者或其法定代理人充足的时间，来考虑其是否决议参与临床研究。Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subjector, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2. Where the subject is unable to write, consent may be givenand recorded through appropriate alternative means in the presence of at least one impartial witness. In that case, the witness shall sign and date the informed consent document. The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall beprovided with a copy of the document or the record, as appropriate, by which informed consent has been given. The informed consent shall be documented. Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the clinical investigation.2.为获得知情同意书，提供给与受试者或其法定代理人（在受试者不能给与知情同意书时）的信息应至少包括：Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall:使受试者或其法定代理人理解：enable the subject or his or her legallydesignated representative to understand:临床研究的性质、目的、疗效、影响、风险和困难；the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigations;受试者有权利对个人进行保护，特别是在不产生任何损害的情况下，可拒绝参与并随时从临床研究中退出而无需提供任何理由；the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the clinical investigation at anytime without any resulting detriment and without having to provide any justification;临床研究的实施条件包括临床研究中受试者参与的预期持续时间；和the conditions under which the clinical investigations is to be conducted, including the expected duration of the subject's participation in the clinical investigation; and可能的治疗替代方案，包括受试者中止参与临床研究时的后续措施；the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical investigation is discontinued;保持受试者或她和其指定合法代表全面性、简洁性、清晰性、相关性和理解性；be kept comprehensive, concise, clear, relevant, and understandable to the subjector his or her legally designated representative;在事先面试中须提供一位根据国家法律具有合适资格的研究小组成员；be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law;包括在第69条中所述的适用的损伤赔偿制度的信息；include information about the applicable damage compensation system referred to inArticle 69; and包括临床研究在欧盟范围内第70（1）条中所述的唯一标识号以及依据本条第6段有关临床研究结果可用性的信息。include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and information about the availability of the clinical investigation results in accordance with paragraph 6 of this Article3.在第2段所指的信息应书面编写并提供给受试者或其法定代理人（当受试者不能够给出知情同意书时）。The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.4.在第2段（c）中所述的面试期间，应当特别注意具体患者人群及个别受试者的信息需求，以及提供信息的方式。In the interview referred to in point (c) of paragraph 2, special attention shall bepaid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information.5.在第2段（c）中所述的面试期间，应确保受试者已充分理解相关信息。Inthe interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information.6.受试者应知晓临床研究报告，并且无论临床研究结果如何，应尽可能在提供总结报告时，提供方便预期使用者理解的总结报告。第77（5）条关于第73条所指的临床研究电子系统中，不论临床研究的结果如何，在有可能的情况下，应尽可能通知其.The subject shall be informed that a clinical investigation report and a summary presented in terms understandable to the intended user will be made available pursuant to Article 77(5) in the electronic system on clinical investigations referred to in Article 73 irrespective of the outcome ofthe clinical investigation, and shall be informed, to the extent possible, whenthey have become available.7.     在不违背国家法律的前提下，本法规要求，若要参与临床研究，除了法定代理人给与的知情同意书，也需要取得能够得出意见并对给与的信息进行评估的未成年人的同意。This Regulation is without prejudice to national law requiring that, in addition tothe informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to himor her, shall also assent in order to participate in a clinical investigation.Article 64针对无行为能力受试者的临床研究Clinicalinvestigations on incapacitated subjects1.对于无行为能力的受试者，在其无行为能力发生前未给出或拒绝给出知情同意书的情况下，除第62（4）条的规定的条件，临床研究只有在符合以下所有条件的前提下进行： In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical investigation may be conducted only where, in addition to the conditions setout in Article 62(4), all of the following conditions are met:已获得了其法定代理人的知情同意书；the informed consent of their legally designated representative has been obtained;鉴于其理解能力，无行为能力受试者以合适的方式接收第63（2）条中所述的信息；the incapacitated subjects have received the information referred to in Article 63(2) in a way that is adequate in view of their capacity to understand it;研究员应当尊重一个能够形成观点并对第63（2）条的信息进行评估的无行为能力受试者明确拒绝参与或在任何时候退出临床研究的意愿；the explicit wish of an in capacitated subject who is capable of forming an opinionand assessing the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation at any time,is respected by the investigator;不得对受试者和其法定代理人使用激励措施或财务利诱，除了对参与临床研究而直接造成的费用和收入损失提出的补偿。no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss ofearnings directly related to the participation in the clinical investigation;临床研究对于无行为能力受试者是必不可少的，同等有效性数据不能通过对能够给出知情同意个人的临床研究或其他研究方式获得；the clinical investigation is essential with respect to incapacitated subjects anddata of comparable validity cannot be obtained in clinical investigations onpersons able to give informed consent, or by other research methods;临床研究与受试者所患疾病直接相关；the clinical investigation relates directly to a medical condition from which the subject suffers有科学依据表明，无行为能力受试者参与临床研究时产生的直接利益将多于其所涉及的风险和负担。there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the incapacitated subject out weighing the risks and burdens involved.2.受试者应尽可能参与知情同意过程。The subject shall as far as possible take part in the informed consent procedure.Article 65 针对未成年人的临床研究 Clinical investigations on minors除了第 62（4）条设定的条件外，对未成年人的临床研究必须满足以下所有条件时方可开展：Aclinical investigation on minors may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:已获得了其法定代理人的知情同意；the informed consent of their legally designated representative has been obtained;未成年人以适应其年龄和心智成熟度的方式接收第63（2）条所述的信息，由经过培训或对儿童工作有经验的研究人员或研究小组提供；the minors have received the information referred to in Article 63(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;研究员应当尊重一个能够形成观点并对第63（2）条的信息进行评估的未成年人明确拒绝参与或在任何时候退出临床研究的意愿；the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) to refuse participation in, or towithdraw from, the clinical investigation at any time, is respected by the investigator;不得对受试者和其法定代理人使用激励措施或财务利诱，除了对参与临床研究而直接造成的费用和收入损失提出的补偿。no incentives or financial inducements are given to the subject or his or her legally designated representative except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation;临床研究旨在考察未成年人的某种身体状况下的治疗结果，或者临床研究对于未成年人是否为必需，以验证在能够给出知情同意个体的临床研究中获得的数据；the clinical investigation is intended to investigate treatments for a medical condition that only occurs in minors or the clinical investigation is essential with respect to minors to validate data obtained in clinical investigations on persons able to give informed consent or by other research methods;临床研究与涉及的未成年人的身体状况条件直接有关，或本质上，仅能在未成年人身上进行；the clinical investigation either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors;有科学依据表明，未成年人参与临床研究时产生的直接利益将多于其所涉及的风险和负担。there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the minor subject out weighing the risks and burdens involved;未成年人应以适应其年龄和心理成熟度的方式参与知情同意过程；the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity;若临床研究期间，未成年人达到国家法律规定的法定行为能力年龄，能够给予知情同意书，应当在受试者可继续参加临床研究前取得其明确的知情同意书。if during a clinical investigation theminor reaches the age of legal competence to give informed consent as defined in national law, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical investigation.Article 66 针对孕妇或哺乳期妇女的临床研究 Clinicalinvestigations on pregnant or breastfeeding women除满足第62（4）条中规定的条件外，还应满足以下所有条件，孕妇或哺乳期的妇女才能参与临床研究：A clinical investigation on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are meta)  临床研究可能对有关孕妇或哺乳妇女及其胎儿或新生儿产生直接益处，超过其所承担的风险和负担；the clinical investigation has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;（b）        对进行研究的哺乳期妇女进行特殊照顾以避免对孩子的健康造成任何不利影响；和where research is undertaken on breastfeeding women, particular care is taken toavoid any adverse impact on the health of the child;（c）不得对受试者使用激励措施或金钱利诱，除了对参与临床研究而直接造成的费用和收入损失提出的补偿；no incentives or financial inducements are given to the subject except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation.Article 67补充国家措施Additional national measures成员国可为强制性兵役的服役人员、因司法判决被剥夺自由而不能参加临床研究的人员或由社区福利院机构收容的人员规定额外措施。Member Statesmay maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical investigations, or persons in residential care institutionsArticle 68紧急情况下的临床研究Clinicalinvestigations in emergency situations1.通过豁免第62（4）条（f）点，第64(1)条(a)和(b)一级第65条(a)和(b)，在做出受试者入选临床研究的决议后，即可获得参加临床研究的知情同意书，并可给出临床研究信息，前提是根据该临床研究的临床研究计划，该决议是在受试者接受首次干预治疗时做出的，并且须满足以下所有条件：By way of derogation from point (f) of Article 62(4), from points (a)and (b) of Article 64(1) and from points (a) and (b) of Article 65,informed consent to participate in a clinical investigation may be obtained,and information on the clinical investigation may be given, after the decision to include the subject in the clinical investigation, provided that that decision is taken at the time of the first intervention on the subject, in accordance with the clinical investigation plan for that clinical investigation and that all of the following conditions are fulfilled:因突然的危及生命或其他突发性严重身体状况造成的紧急性情况，受试者不能够提供事先知情同意书也不能收到对于临床研究的事先信息；due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide priorinformed consent and to receive prior information on the clinical investigation;参与临床研究对受试者可能产生直接临床益处的期望是具有科学依据，可提高健康质量，缓解遭受的痛苦，或者提高受试者的健康水平，或提高身体状况的诊断水平；there are scientific grounds to expect that participation of the subject in the clinical investigation will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition;在治疗窗口期间，向其法定代理人提供所有的事先信息，并获取事先知情同意是不可能的；it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative;研究者保证其不知道前受试者拒绝参与临床研究；the investigator certifies that he or she is not aware of any objections to participate in the clinical investigation previously expressed by the subject;临床研究直接关系到受试者的健康状况，因此在治疗窗口期内得到受试者或其法定代理人的事先知情同意并提供先验信息是不可能，而且临床研究还具有可在紧急情况下单独进行的特性；the clinical investigation relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtainpri or informed consent from the subject or from his or her legally designated representative and to supply prior information, and the clinical investigationis of such a nature that it may be conducted exclusively in emergency situations与受试者条件的标准治疗相比，临床研究可将风险和受试者身上的负担降至最低。the clinical investigation poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition.2.按照本条第1段开展干预治疗后，应根据第63条获得知情同意以便受试者能继续参与临床研究，并且应按照下列规定提供临床研究的相关信息：Following an intervention pursuant to paragraph 1 of this Article, informed consentin accordance with Article 63 shall be sought to continue the participation of the subject in the clinical investigation, and information on the clinical investigation shall be given, in accordance with the following requirements:对无行为能力的受试者及未成年人，研究者应获得其法定代理人的知情同意，且不得无故拖延，并应尽快向受试者及其法定代理人提供第63（2）条中所述的信息；regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 63(2) shall be given assoon as possible to the subject and to his or her legally designated representative;对于其他受试者，研究者应获得受试者或其法定代理人（以较快者为准）的知情同意，不得无故拖延，同时还应尽快向受试者或其法定代理人（以较快者为准）提供第63（2）条中所述的信息。regarding other subjects, the informed consent shall be sought by the investigat or without undue delay from the subject or his or her legally designated representative, which ever can be done sooner, and the information referred toin Article 63(2) shall be given as soon as possible to the subject or his or her legally designated representative, as applicable.在根据（b）点规定获得法定代理人知情同意书的情况下，一旦受试者能够自主提供知情同意书，则应获得其对继续参与临床研究的知情同意书。For the purposes of point (b) where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the clinical investigation shall be obtained from the subjectas soon as he or she is capable of giving informed consent.3.如受试者或其法定代理人（如有）未同意，则应告知其具有反对使用临床研究所得数据的权利。 If the subject or, where applicable, his or her legally designated representative does not give consent, he or she shall be informed of the right to object tothe use of data obtained from the clinical investigation.Article 69损害赔偿 Damage compensation1.各成员国应确保受试者在其领土上因参与临床研究而受到损害时有完善系统对其进行补偿，该系统的形式应为保险、担保或具有相同功效并且与风险性质及程度相符的类似安排。Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical investigation conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriateto the nature and the extent of the risk.2.申办方和研究者必须在其开展临床研究的成员国中以适用于该国的形式使用第一段中所述的系统。The sponsor and the investigator shall make use of the system referred to inparagraph 1 in the form appropriate for the Member State in which theclinical investigation is conducted.Article 70申请临床研究 Application for clinicalinvestigations1.     临床研究的申办方应向将进行临床研究的成员国（为本条目的，以下简称为“相关成员国”）提交申请书，并随附附录XV第II章中所述的文件。The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the clinical investigation is to be conducted (referred to for the purposes of this Article as ‘Member State concerned’) accompanied by the documentation referred to in Chapter II of Annex XV.申请应通过第73条所指的电子系统提交，该电子系统应为该临床研究产生一个唯一标识号，其将用于相应临床研究的所有相关沟通中。收到申请之日起10天内，相关成员国应按照附录XV第II章的要求告知申办方该临床研究是否处于本法规范围内，以及申请档案是否完整。The application shall be submitted by means of the electronic system referred to in Article 73, which shall generate a Union-wide unique single identification number for the clinical investigation, which shall be used for all relevant communication in relation to that clinical investigation. Within 10 days of it receiving the application,the Member State concerned shall notify the sponsor as to whether the clinical investigation falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter II of Annex XV.2.     对附录XV第II章所指的相关文件进行任何修改后的一周内，申办方应在第73条所指的电子系统中更新相关数据并使更改的文件清晰可辨。应通过电子系统告知有关成员国数据已更新。Within one week of any change occurring in relation to the documentation referred to in Chapter II of Annex XV, the sponsor shall update the relevant data inthe electronic system referred to in Article 73 and make that change to the documentation clearly identifiable. The Member State concerned shall be notified of the update by means of that electronic system.3.   当成员国发现提出申请的临床研究未处于本法规范围内或申请未完成，应当通过第73条中所述的电子系统通知其申办方，并给出最多十天的时间限制，供申办方表达其意见或完成申请。具有合理理由的情况下，成员国最多可将这一期限延长为20天。Where the Member State concerned finds that the clinical investigation applied for does not fall within the scope of this Regulation or that the application dossier is not complete, it shall inform the sponsor thereof and shall set atime limit of maximum 10 days for the sponsor to comment or to complete the application by means of the electronic system referred to in Article 73.The Member State concerned may extend this period by a maximum of 20 days where appropriate.若申办方在第一子段中所述的期限内未发表意见或完成申请，则该申请将视为失效。若申办方认为申请处于本法规范围内和/或已完成，但相关成员国不同意，则视为申请被拒绝。相关成员国应提供有关此类拒绝申请拒绝申请的上诉程序。Where the sponsor has not provided comments nor completed the application within the time limit referred to in the first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers the application does fallunder the scope of this Regulation and/or is complete but the Member State concerned does not, the application shall be considered to have been rejected.The Member State concerned shall provide for an appeal procedure inrespect of such refusal.不管临床研究是否处于本法规范围内、申请是否完整，相关成员国均应在收到申办方的意见或所要求的额外信息后五天内通知申办方。The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested additional information, whether the clinical investigation is considered as falling within the scope of this Regulation and the application is complete.4.     有关成员国还可将第1和第3段中所述的期限再延长5天。The Member State concerned may also extend the period referred to in paragraph 1 and 3 each by a further five days.5.     根据本章规定，按照第1或第3段的要求通知申办方的日期应为申请的确认日期。若申办方未收到通知，则确认日期应分别为第1、3和4段中所所述时间段的最后一天。For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall bethe last day of the periods referred to in paragraphs 1, 3 and 4 respectively.6.     在此期间，申请处于评估状态，成员国可要求申办方提供额外的信息。应当从第一次请求之日起暂停第7段（b）点规定到期日期，直至收到相关附加信息。During the period when the application is being assessed, the Member State may request additional information from the sponsor. The expiry of the period laid down in point (b) of paragraph 7 shall be suspended from the date ofthe first request until such time as the additional information has been received.7.     申办方可在下列情况下进行临床研究：The sponsor may start the clinical investigation in the following circumstances:对于分类为I类的研究型器械或分类为IIa和IIb的非侵入式器械，除非国家法律另有说明，否则应在第5段所述申请验证日期到期后立即执行，但前提是相关成员国伦理委员会未公布根据国家法律对整个成员国的有效的关于临床研究负面评价；in the case of investigational class Idevices or in the case of non-invasive class IIa and class IIb devices, unless otherwise stated by national law, immediately after the validation date of the application pursuant to paragraph 5, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation;对于除（a）所所述外的其他研究型器械，只需相关成员国通知其授权的申办方，但前提是相关成员国伦理委员会未公布根据国家法律对整个成员国的有效的有关临床研究的负面评价；且成员国应在第5段中所述的确认日期后45天内向申办方发出授权通知。成员国可将此期限延长20天以便进行专家咨询。in the case of investigational devices, other than those referred to inpoint (a), as soon as the Member State concerned has notified the sponsor of its authorisation, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date referred to inparagraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts.8.     委员会有权按照第115条的规定，根据技术进步和全球的监管发展动态，获得授权以修订或补充附录XV第II章中规定的要求。The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress and global regulatory developments, the requirements laid down in Chapter II ofAnnex XV.9.     为确保附录XV第II章中规定要求的统一适用，委员会可批准实施细则，这在某种程度上解决了发生分歧和实际应用中出现的问题。这些实施细则应当根据第114(3)中的所述的检查程序予以通过。In order to ensure the uniform application of the requirements laid down in Chapter II of Annex XV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordancewith the examination procedure referred to in Article 114(3).Article 71成员国评估Assessment by Member States1.各成员国应确保人员核实和评估流程，或对其进行确定，不得有任何利益冲突，独立于申办方、相关研究者和为临床研究提供资金的自然人或法人，并应免除其他任何不适当的影响。Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not have conflicts of interest, are independent of the sponsor,the investigators involved and of natural or legal persons financing the clinical investigation, as well as free of any other undue influence.2.各成员国应确保评估是由适当数量的具有必要资质和经验的人员共同完成。Member Statesshall ensure that the assessment is done jointly by an appropriate number of persons who collectively have the necessary qualifications and experience.3.各成员国应评估临床研究是否已将对受试者或第三人的潜在剩余风险降至最低，并达到风险最小化的标准后，则可权衡其预期的临床益处。此外，审查时应考虑适用的CS或协调标准，特别是检查以下要点时：Member States shall assess whether the clinical investigation is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected. They shall, while taking into account applicable CS or harmonised standards, examine in particular:除了临床研究已覆盖的方面外，还需考虑具有适用的通用安全与性能要求的研究的器械的法规符合性证据，不管在这些方面的问题上是否已采取任何保护受试者健康和安全的预防措施。其中包括，在适当情况下保证技术和生物安全测试以及临床前评估的实施；the demonstration of compliance of the investigational device(s) with the applicable general safety and performance requirements, a part from the aspects covered by the clinical investigation, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, assurance of technical and biological safety testing and pre-clinical evaluation;申办方是否采取了协调标准中说明的风险最小化方案，若申办方未使用协调标准，无论风险最小解决方案是否提供与协调标准一致水平的保护；whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by harmonised standards;制定用于研究型器械安全安装、投入使用和维护的措施的合理性；whether the measures planned for the safe installation, putting into service and maintenance of the investigational device are adequate;临床研究所生成数据的可靠性和稳健性，其应将统计方法、研究和方法的设计考虑在内（包括样本大小、比较产品和指标）；there liability and robustness of the data generated in the clinical investigation, taking account of statistical approaches, design of the investigation and methodological aspects, including sample size, comparator and endpoints;是否满足附录XV的要求。whether the requirements of Annex XV are met;对于无菌操作器械，制造商灭菌程序、相关调整信息或研究现场必须进行的灭菌程序的验证证据；in the case of devices for sterile use,evidence of the validation of the manufacturer's sterilisation procedures or information on the reconditioning and sterilisation procedures which have to beconducted by the investigation site;根据第2001/83/EC号指令来源于动物或人体的物质视为医疗产品，应证明其安全性、质量和有用性。the demonstration of the safety, quality and usefulness of any components of animalor human origin or of substances, which may be considered medicinal products inaccordance with Directive 2001/83/EC.4.各成员国应拒绝同意临床研究，若：Member Statesshall refuse the authorisation of the clinical investigation ifa)    根据第70（1）条递交的申请档案仍不完整；the application dossier submitted pursuantto Article 70(1) remains incomplete;（b）该器械或提交的文件，特别是研究计划或研究者手册，与当前的科学技术水平不一致，尤其是临床研究无法提供该器械对受试者或患者有关安全性、性能特征或疗效的证据。the device or the submitted documents, especially the investigation plan and the investigator's brochure,do not correspond to the state of scientific knowledge, and the clinical investigation, in particular, is not suitable for providing evidence for thesafety, performance characteristics or benefit of the device on subjects orpatients,（c）不满足第62条的要求，或the requirements of Article 62 are not met, or（d）根据第3段进行的某些评估得出负面结果。any assessment under paragraph 3 is negative成员国应根据第一子段提供有关此类拒绝申请的上诉程序。Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph. Article 72床研究的实施Conduct of a clinical investigation1.申办方和研究者应确保该临床研究符合已批准的临床研究计划。The sponsor and the investigator shall ensure that the clinical investigation isconducted in accordance with the approved clinical investigation plan.2.为证明受试者的权利、安全和福利得到保障，所报告数据可靠且完善，以及进行的临床研究符合本法规的要求，申办方应当充分监督整个临床研究过程。申办方应评估临床研究中涉及的所有特征，根据评估结果决议监督的范围和性质，其中包括以下特征：In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical investigation is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of aclinical investigation. The extent and nature of the monitoring shall bedetermined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the clinical investigation including the following:临床研究的目的和方法the objective and methodology of the clinical investigation; and正常临床实践干预的偏离程度。the degree of deviation of the intervention from normal clinical practice.3.申办方或研究员应记录、计算、处理和储存所有临床研究信息，（如适用）根据保护个人资料的相关法律，在保护记录机密性和受试者个人资料的同时，对其进行精确的报告、解释和验证。All clinical investigation information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection.4.应采取适当的技术和组织措施，以保护信息和个人资料免受非法侵入、披露、传播、修改或破坏或意外丢失，尤其是当处理过程需涉及网络传输时。Appropriatete chnical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accident alloss, in particular where the processing involves transmission over a network.5.成员国应在合适水平的研究机构开展审查，以检查是否根据本法规要求及批准的研究计划进行了临床研究。Member States shall inspect, at an appropriate level, investigation site(s) to check that clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.6.申办方应制定紧急情况程序，以便立即识别并在必要时立即召回用于研究的器械。 The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the investigation.Article 73临床研究电子系统 Electronic system onclinical investigations1.委员会应与成员国合作设立、管理和维护电子系统：The Commission shall, in collaboration with the Member States, set up, manageand maintain an electronic system:（a）为临床研究创建第70（1）条中所述的单个识别号；to create the single identification numbers for clinical investigations referredto in Article 70(1);（b）        用作第70、74、75和78条所述临床研究的所有申请或通知提交，以及本文中所有其他数据提交或数据处理的入口位点；to be used as an entry point for the submission of all applications or notifications for clinical investigations referred to in Articles 70, 74,75 and 78 and for all other submission of data, or processing of data in this context;（c）用于按照本法规在成员国之间以及成员国与委员会之间交流有关临床研究的信息，包括第70条和第76条所述的信息交换；for the exchange of information relating to clinical investigations in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in Articles 70and 76;（d）按照第77条由申办方提供信息，包括该条第5段所要求的临床研究报告及其总结；forinformation to be provided by the sponsor in accordance with Article 77,including the clinical investigation report and its summary as required inparagraph 5 of that Article;（e）用于报告第80条所述的严重不良事件和器械缺陷及相关更新。for reporting on serious adverse events and device deficiencies and related updatesreferred to in Article 80.2.     在设立本条第1段所述电子系统时，委员会应确保其与用于根据欧洲议会和理事会第536/2014号法规1涉及将器械临床研究与临床试验相结合的第81条规定的人医疗产品临床试验的欧盟数据库彼此兼容。When setting up the electronic system referred in paragraph 1 of this Article,the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council (37) as concerns combined clinical investigations of devices with a clinical trialunder that Regulation.3.     第1段（c）点所述信息，仅成员国和委员会。该段其他点中所述的信息方可向公众公开，除非所有或部分信息对信息保密以下述任何理由作为正当理由：The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission. The information referred to in the other points of that paragraph shall be accessible tothe public, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds:按照欧洲委员会第45/2001号法规保护个人数据；protection of personal data in accordance with Regulation (EC) No 45/2001;保护商业机密信息，尤其是研究者的资料，特别是考虑到对器械进行符合性评估的状态，除非公开信息中有涉及公共利益的压倒性内容，protection of commercially confidential information, especially in the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there is an over riding public interest in disclosure;有效监督有关成员国进行临床研究的情况；effective supervision of the conduct of the clinical investigation by the Member State(s) concerned.4.     受试者个人资料不得公开。No personal data of subjects shall be publicly available.5.     第1段中所述的电子系统使用者界面应具有欧盟所有官方语言的版本。The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union.________________________（1）   欧洲议会及委员会2014年4月16日签发的关于用于人医疗产品临床试验并废除第2001/20/EC号指令的第536/2014号法规（OJ L 158, 27.5.2014,p. 1）Regulation(EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014on clinical trials on medicinal products for human use, and repealing Directive2001/20/EC (OJ L 158, 27.5.2014, p. 1). Article 74 携带CE标识的器械的临床研究 Clinical investigationsregarding devices bearing the CE marking1.若在其预期范围内准备进行临床研究以进一步评估，根据第20（1）条已携带CE标识并符合相关符合性评估流程（以下称为“PMCF研究”）所述预期目的器械时，若在器械正常使用条件下研究会为受试者引入额外创伤或复杂手术且这些额外程序具有侵入性且难以承受，则申办方应通过第73条所述的电子系统在其开始前至少30天通知相关成员国。申办方应附上附录XV第II章所述文件作为公告的一部分。第62（4）条（b）至（k）和（m）点、第75条、第76条、第77条和第80（5）条及附录XV有关规定均适用PMCF研究。Where a clinical investigation is to be conducted to further assess, within the scopeof its intended purpose, a device which already bears the CE marking in accordancewith Article 20(1), (‘PMCF investigation’), and where the investigation would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional proceduresare invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 73. The sponsor shall include the documentation referred to in Chapter II of Annex XV as part of the notification.Points (b) to (k) and (m) of Article 62(4), Article 75,Article 76, Article 77, Article 80(5) and the relevant provisions of Annex XV shall apply to PMCF investigations.2.若根据第20（1）条、第62条至第81条规定进行临床研究是为评估超出其预期目的范围，则已携带CE标识的器械应适用。Where a clinical investigation is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), Articles 62 to 81 shall apply. Article 75临床研究的实质性修改Substantial modificationsto clinical investigations1.若申办方拟对临床研究提出可能对受试者安全性、健康或权利产生重大影响的修改，或对研究产生的临床数据的稳健性或可靠性进行修改，则其应在一周内通过第73条所述的电子系统，通知相关（正在进行临床研究或将急性临床研究）成员国有关这些修改的理由及性质。申办方应加入附录XV第II章所述相关文件的更新版本作为该公告的一部分。相关文件修改更改应清晰可辨。If a sponsor intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated bythe investigation, it shall notify, within one week, by means of the electronic system referred to in Article 73 the Member State(s) in which the clinical investigation is being or is to be conducted of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Chapter II of Annex XVas part of the notification. Changes to the relevant documentation shall beclearly identifiable.2.     成员国应根据第71条规定程序评估临床研究的任何实质性修改。The Member State shall assess any substantial modification to the clinical investigation in accordance with the procedure laid down in Article 71.3.     申办方可在该段所述的公告后最早38天实施第1段所述修改，除非：The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in that paragraph,unless:（a）正在进行临床研究或将进行临床研究的成员国已根据第71（4）条规定或者公共卫生注意事项、公共政策的受试者和使用者安全或健康通知申办方拒绝该修改，或the Member State in which the clinical investigation is being or is to beconducted has notified the sponsor of its refusal based on the grounds referred to in Article 71(4) or on considerations of public health, subject anduser safety or health, of public policy, or（b）成员国伦理委员会根据国家法律发布对整个成员国有效的有关对临床研究实质性修改的否定意见。an ethics committee in that Member State has issued a negative opinion inrelation to the substantial modification to the clinical investigation, which,in accordance with national law, is valid for that entire Member State.4.     为咨询有关专家，有关成员国可将第3段规定的期限额外延长7天。The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the purpose of consulting with experts.Article 76 成员国纠正措施以及成员国之间的信息交流 Correctivemeasures to be taken by Member States and information exchange between MemberStates1.     若正在进行临床研究或将进行临床研究的成员国有理由认为出现了未满足本法规的情况，其至少应在其领土范围内采取以下任何措施：Where a Member State in which a clinical investigation is being or is to be conducted has grounds for considering that the requirements set out in this Regulation are not met, it may take at least any of the following measures onits territory:撤销临床研究授权；revoke the authorisation for the clinical investigation;暂停或终止临床研究；suspend or terminate the clinical investigation;要求申办方修改临床研究所有方面。require the sponsor to modify any aspect of the clinical investigation.2.     有关成员国采取第1段所述的任何措施之前，除非需要立即采取行动，其应征询申办方或其研究员或两者的意见。应在七日内给出意见。Before the Member State concerned takes any of the measures referred to inparagraph 1 it shall, except where immediate action is required, ask the sponsor or the investigator or both for their opinion. That opinion shall be delivered within seven days.3.     若成员国采取了本条第1段所述措施，或拒绝临床研究，或已收到申办方基于安全理由提前终止临床研究的通知，则该成员国应通过第73条所述的电子系统将相关决议及其理由通知所有成员国和委员会。Where a Member State has taken a measure referred to in paragraph 1 of this Article or has refused a clinical investigation, or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds, that Member State shall communicate the corresponding decisionand the grounds there for to all Member States and the Commission by meansof the electronic system referred to in Article 73.4.     如申办方在成员国做出决议之前撤回申请，则应使用第73条所述的电子系统通知所有成员国和委员会。Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall be made available through the electronic system referred to in Article 73 to all Member States and the Commission.Article 77 在临床研究结束、暂停或提前终止时由申办方提供的信息 Information from thesponsor at the end of a clinical investigation or in the event of a temporaryhalt or early termination1.若申办方临时暂停或提前终止临床研究，则其应在15天内通过第73条所述的电子系统通知正在进行临床研究或将进行临床研究的成员国临时暂停或提前终止的理由。若申办方临时暂停或提前终止临床研究，则其应在24小时内通知正在进行临床研究或将进行临床研究的成员国。If the sponsor has temporarily halted a clinical investigation or has terminated aclinical investigation early, it shall inform within 15 days the Member State in which that clinical investigation has been temporarily halted or terminated early, through the electronic system referred to in Article 73, of the temporary halt or early termination, providing ajustification. In the event that the sponsor has temporarily halted or terminated early the clinical investigation on safety grounds, it shall informall Member States in which that clinical investigation is being conducted thereof within 24 hours.2.临床研究的结束应视为与最后一次研究的最后一次访问一致，除非另一个时间点在临床研究计划中列出。The end of a clinical investigation shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in theclinical investigation plan.3.申办方应通知各正在开展临床研究的各成员国，该成员国已结束临床研究。该通知应在该成员国临床研究结束后15天内给出。The sponsor shall notify each Member State in which a clinical investigation was being conducted of the end of that clinical investigation in that Member State. That notification shall be made within 15 days of the end ofthe clinical investigation in relation to that Member State.4.     若在多个成员国进行该研究，则申办方应通知所有进行临床研究的成员国已全面结束临床研究。该通知应在临床研究全面结束后15天内提出。If an investigation is conducted in more than one Member State, the sponsor shall notify all Member States in which that clinical investigation was conducted of the end of the clinical investigation in all Member States.That notification shall be made within 15 days of that end of the clinical investigation.5.     无论临床研究结果如何，在临床研究结束后一年内或在提前终止或暂停的三个月内，申办方应向进行附录XV第I章第2.8节和第III章第7节所述的临床研究的成员国提交临床研究报告。 Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which aclinical investigation was conducted a clinical investigation report asreferred to in Section 2.8 of Chapter I and Section 7 of Chapter IIIof Annex XV.应提交临床研究报告总结，且措词易于预期使用者理解。报告及总结均应由申办方使用第73条所述的电子系统提交。The clinical investigation report shall be accompanied by a summary presented interms that are easily understandable to the intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 73.若因科学原因不能在研究完成后一年内提交临床研究报告，须尽快提交。在此种情况下，附录XV第II章第3节中所述的临床研究计划应规定何时提交临床研究结果及其理由。Where,for scientific reasons, it is not possible to submit the clinical investigation report within one year of the end of the investigation, it shall be submittedas soon as it is available. In such case, the clinical investigation planreferred to in Section 3 of Chapter II of Annex XV shall specifywhen the results of the clinical investigation are going to be available,together with a justification.6.     委员会应发布关于临床研究报告的总结和概要的指南。 The Commission shall issue guidelines regarding the content and structure of thesummary of the clinical investigation report.此外，委员会可发布设计和共享原始数据及申办方决定是否自愿共享原始数据的准则。这些指南可作为基础，并在可能的情况下适应于临床研究领域共享原始数据的现有准则。In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.7.     本条第5段规定的临床研究总结和报告应通过第73条所述的电子系统，最迟在器械根据第29条规定注册并在投放市场前允许公开访问。在提前终止或暂时停止的情况下，总结和报告提交后，应能立即公开访问。The summary and the clinical investigation report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 73, at the latest when the device isregistered in accordance with Article 29 and before it is placed on themarket. In cases of early termination or temporary halt, the summary and thereport shall become publicly accessible immediately after submission.若根据第29条，器械未在总结和报告根据第5段规定输入电子系统后的一年内注册，则应在该时间点公开访问。If the device is not registered in accordance with Article 29 within one year of the summary and the report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at thatpoint in time.
Article 78 临床研究的协调评估流程 Coordinated assessment procedure for clinicalinvestigations1.在一个以上成员国中进行临床研究的申办方就第70条目的，通过第73条所述的电子系统提交一份单一申请，且一经收到该申请即以电子方式传送至进行临床研究的成员国。By means of the electronic system referred to in Article 73, the sponsor of aclinical investigation to be conducted in more than one Member State may submit, for the purpose of Article 70, a single application that, upon receipt, is transmitted electronically to all Member States in which the clinical investigation is to be conducted.2.进行第1段所指单项申请时，申办方应提议将进行临床研究的成员国之一的身份担任协调成员国。将进行临床研究的成员国应在提交申请后六天内商定任命其中一个成员国担任协调成员国的角色。若各有关成员国未商定协调成员国，则由申办方提议的成员国担任。The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States in which the clinical investigation is to beconducted acts as coordinating Member State. The Member States inwhich the clinical investigation is to be conducted shall, within six days of submission of the application, agree on one of them taking the role of the coordinating Member State. If they do not agree on a coordinating Member State, the coordinating Member State proposed by the sponsor shall assume that role.3.在第2段所述的协调成员国指导下，相关成员国应协调其对申请的评估，尤其是根据附录XV第II章提交的文件，应分别由各有关成员国评估。Under the direction of the coordinating Member State referred to inparagraph 2, the Member States concerned shall coordinate their assessment of the application, in particular of the documentation referred toin Chapter II of Annex XV.但附件XV第II章第1.13、第3.1.3、第4.2、第4.3和第4.4节中所述的文档完整性应根据第70（1）条至第（5）条规定由有关成员国分别评估。However, the completeness of the documentation referred to in Sections 1.13, 3.1.3, 4.2,4.3 and 4.4 of Chapter II of Annex XV shall be assessed separately by each Member State concerned in accordance with Article 70(1) to (5).4.     对于未在第3段第二子段中所述的文件，协调成员国应：With regard to documentation other than that referred to in the secondsub paragraph of paragraph 3, the coordinating Member State shall:在收到单项申请6天内通知申办方其为协调成员国（通知日期）；within six days of receipt of the single application, notify the sponsor that it is the coordinating Member State (‘notification date’);为确认申请，需要考虑到任何相关国在通知日期7天内提交的任何考虑事项；for the purpose of the validation of the application, take into account any considerations submitted within seven days of the notification date by any Member State concerned;在通知日期后10天内，评估临床研究是否属于本法规范围及其申请是否完整并应相应通知申办方。第70(1)和（3）至(5)条规定应适用于该评估协调成员国。within10 days of the notification date, assess whether the clinical investigation falls within the scope of this Regulation and whether the application is complete, and shall notify the sponsor accordingly. Article 70(1) and (3)to (5) shall apply to the coordinating Member State in relation to thatassessment;在评估报告草案中给出其评估结果，并在有关成员国有效期限26日内进行提交。直至有效期限第38日，其他有关成员国可将评估报告草案和基本申请的相关意见和建议提交至协调成员国，且应在最终评估报告最后定稿时充分考虑协调成员国，并在申办方和有关成员国和其他相关成员国有效期限45日内进行提交。establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the validation date to the Member States concerned. By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report and the underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned.其他相关成员国在根据第70(7)条决定是否同意申办方申请时应考虑最终评估报告。The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's application in accordance with Article 70(7).5.     有关第3段第二子段中的文件评估，各相关成员国可一次性请求申办方提供补充资料。申办方应在有关成员国规定的期限内提交要求的额外信息，该日期不得超过收到请求日算起的12天。第4段（d）点规定的最后期限到期应自请求日起至收到补充资料时止。As regards the assessment of the documentation referred to in the secondsub paragraph of paragraph 3, each Member State concerned may request, on a single occasion, additional information from the sponsor. The sponsor shall submit the requested additional information within the period setby the Member State concerned, which shall not exceed 12 days from the receipt of the request. The expiry of the last deadline pursuant to point (d)of paragraph 4 shall be suspended from the date of the request until suchtime as the additional information has been received.6.     对于IIb和III类器械，协调成员国还可将第4段所述期限再延长50天，以便与专家进行商议。For class IIb and class III devices, the coordinating Member Statemay also extend the periods referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts.7.     委员会可通过实施细则，规定由协调成员国指导的协调评估流程和时间表，且相关成员国在决定是是否申办方申请时应考虑这些流程和时间表。此种实施细则还可包括根据本条第12段进行重大修改情况下的协调评估流程，以及根据第80(4)条报告不良事件或在药械组合产品的临床研究，其中药品是根据欧盟第536/2014号法规进行临床试验的并行协调评估。应按照第114(3)条中述及的审查规程通过这些实施细则。The Commission may, by means of implementing acts, further specify the procedures and timescales for coordinated assessments to be taken into account by Member States concerned when deciding on the sponsor's application. Such implementing acts may also set out the procedures and timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of this Article, in the case of reporting of adverse event spursuant to Article 80(4) and in the case of clinical investigations of combination products between medical devices and medicinal products, where thelatter are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No 536/2014. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3)8.     若协调评估成员成员国商定接受或在符合特定条件情况下接受该临床研究，则应将该商定视为所有相关成员国的最终结论。Wherethe conclusion of the coordinating Member State concerning the area of coordinated assessment is that the conduct of the clinical investigation is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member States concerned.尽管第一子段有所规定，有关成员国可对协调成员国在协调评估部分的结论提出异议，但仅限于以下理由：Notwith standing the first subparagraph, a Member State concerned may only disagree with the conclusion of the coordinating Member State concerning the area of coordinated assessment on the following grounds:a.当其认为参与临床研究会导致受试者接受比相关成员国正常临床实践更差的治疗时；when it considers that participation in the clinical investigation would lead to asubject receiving treatment inferior to that received in normal clinical practice in that Member State concerned;b.违反国家法律；或infringement of national law; or关于根据第4段（b）点提交的受试者安全和数据可靠性和稳健性的考虑。considerations as regards subject safety and data reliability and robustness submitted underpoint (b) of paragraph 4.c.在本段第二子段基础上，凡有关成员国对结论持有异议的，应通过第73条所述的电子系统，向委员会、所有其他有关成员国及申办方传达其异议及详细理由。Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this paragraph, it shall communicateits disagreement, together with a detailed justification, through the electronic system referred to in Article 73, to the Commission, to allother Member States concerned and to the sponsor.9.     协调成员国关于协调评估领域的结论为临床研究不使用，则该结论应视为所有有关成员国的结论。Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the clinical investigation is not acceptable,that conclusion shall be deemed to be the conclusion of all Member States concerned.10    若相关成员国不同意协调成员国对第8段第二子段所述理由的商定，或若其有充分理由认为未遵守附录XV第II章第1.13、3.1.3、4.2、4.3和4.4节规定，或道德委员会发布了根据国家法律对整个成员国均有效的有关临床研究否定意见，则相关成员国应拒绝授权进行临床研究。成员国应提供有关此类拒绝申请的上诉程序。A Member State concerned shall refuse to authorise a clinical investigation if it disagrees with the conclusion of the coordinating Member State asregards any of the grounds referred to in the second subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV are not complied with, or where an ethics committee has issued an egative opinion in relation to that clinical investigation, which is valid, inaccordance with national law, for that entire Member State. That Member State shall provide for an appeal procedure in respect of such refusal.11    各相关成员国应通过第73条所述的电子系统通知申办方临床研究是否获得授权、是否获得条件授权或是否拒绝授权。根据第4段（b）规定，应在协调成员国最后评估报告传送后的五天内通过单一决议发出通知。受条件所限的临床研究授权仅限于在授权时无法满足条件的情况。 Each Member State concerned shall notify the sponsor through the electronic system referred to in Article 73 as to whether the clinical investigationis authorised, whether it is authorised subject to conditions, or whether authorisation has been refused. Notification shall be done by way of one single decision within five days of the transmission, pursuant to point (d) of paragraph 4, by the coordinating Member State of the final assessment report. Where an authorisation of a clinical investigation is subject to conditions, those conditions may only be such that, by their nature, they cannot be fulfilled at the time of that authorisation.12.   第75条所述的实质修改应通过第73条所述的电子系统通知相关成员国。除非对附录XV第II章第1.13.、3.1.3.、4.2.、4.3.和4.4.节作了重大修改，否则关于第本条8段第二子段所述是否有分歧理由的任何评估应在协调成员国的指导下进行，由各有关成员国自行评估。Any substantial modifications as referred to in Article 75 shall be notified to the Member States concerned by means of the electronic system referred to in Article 73. Any assessment as to whether there are grounds for disagreement as referred to in the second subparagraph of paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State, except for substantial modifications concerning Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV, which shall be assessed separately by each Member State concerned.13.   委员会应在协调成员国完成本章规定的任务时向其提供行政支持。The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter.14.   本条规定的程序应在2027年5月27日之前，仅适用于已同意实施临床研究的成员国。在2027年5月27日之后，所有成员国均须申请该程序。The procedure set out in this Article shall, until 27 May 2027, be applied only by those of the Member States in which the clinical investigation is to be conducted which have agreed to apply it. After 27 May 2027, all Member States shall be required to apply that procedure.Article 79审查协调评估流程Review of coordinatedassessment procedure在2026年5月27日前，委员会应向欧洲议会和理事会提交一份关于适用第78条所获经验的报告，并在必要时提出对第78（14）和第123（3）条（h）点的审查。By 27 May 2026, the Commission shall submit to the European Parliament and to the Council a report on experience gained from the application of Article 78 and, if necessary, propose a review of Article 78(14) and point (h)of Article 123(3). Article 80 记录并报告临床研究期间发生的不良事件 Recording andreporting of adverse events that occur during clinical investigations1.申办方应充分记录以下所有情况：The sponsor shall fully record all of the following:在临床研究中确定，对根据临床研究计划的临床研究结果的评估至关重要的不良事件；any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;任何严重不良事件；any serious adverse event;当未能采取适当措施、没有发生干预或情况不利时，可能导致严重不良事件的任何器械缺陷；any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances hadbeen less fortunate;有关（a）至（c）所所述任何事件的新发现。any new findings in relation to any event referred to in points (a) to (c).2.申办方应通过第73条所述的电子系统，向所有进行临床研究的成员国报告以下信息，不得有任何延迟：The sponsor shall report, without delay to all Member States in which the clinical investigation is being conducted, all of the following by means of the electronic system referred to in Article 73:与研究器械、比对产品或研究流程有因果关系的任何严重不良事件，或者这种因果关系是合理的；any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;当未能采取适当措施、没有发生干预或情况不利时，可能导致严重不良事件任何的器械缺陷；any device deficiency that might have led to a serious adverse event if appropriateaction had not been taken, intervention had not occurred, or circumstances had been less fortunate;有关（a）和（b）所所述任何事件的新发现。any new findings in relation to any event referred to in points (a) and (b).报告的时间段应考虑事件的严重性。必要时，为确保及时报告，申办方可先提交初步的不完整报告，后续提交完整报告。The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.根据进行临床研究的成员国要求，申办方应提供第1段中所述的所有信息。Uponrequest by any Member State in which the clinical investigation is being conducted, the sponsor shall provide all information referred to in paragraph 1.3.申办方还应向有关成员国报告发生在第三国本条第2段所述的任何事件，其中临床研究通过第73条所述电子系统，适用于本法规所含临床研究的同一临床研究计划进行。The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a clinical investigation is performed under the same clinical investigation plan as the one applying to a clinical investigation covered by this Regulation by means of the electronic system referred to in Article 73.4.对于申办方使用第78条所述的单一申请的临床研究，申办方应通过第73条所述的电子系统报告本条第2段所述的任何事件。一旦收到后，本报告应以电子方式传送给所有相关成员国。In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 78, the sponsor shall report any eventas referred to in paragraph 2 of this Article by means of the electronic system referred to in Article 73. Upon receipt, this report shall be transmitted electronically to all Member States in which theclinical investigation is being conducted.在第78(2)条所述的协调成员国的指导下，成员国应协调对严重不良事件和器械缺陷的评估，以确定是否需要修改、暂停、或终止临床研究或是否撤销该临床研究授权。Under the direction of the coordinating Member State referred to inArticle 78(2), the Member States shall coordinate their assessment ofserious adverse events and device deficiencies to determine whether to modify,suspend or terminate the clinical investigation or whether to revoke the authorisation for that clinical investigation.本段不得影响其他成员国为确保保护公共卫生和患者安全，根据本法规自己执行评估和采取措施的权利。并应随时通知协调成员国和委员会任何此类评估的结果以及采取的任何此类措施。This paragraph shall not affect the rights of the other Member States to perform their own evaluation and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the adoption of any suchmeasures.5.在第74(1)条所述的PMCF的情况下，应适用第87至90条所列明的关于警戒的规定且根据第91条采用的法案因代替本条。In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance laid down in Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply instead of this Article.6.尽管有第5段规定，若严重不良事件与前述研究流程建立了因果关系，本条将适用。Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding investigational procedurehas been established.Article 81 实施细则  Implementing acts委员会可通过实施细则，采取实施本章所需的详细安排和程序，涉及以下方面：The Commission may, by means of implementing acts, establish the detailed arrangements and procedural aspects necessary for the implementation of this Chapter as regards the following:协调电子表格，用于第70和78条所述的临床研究及其评估申请，并考虑到特定类别或器械组；harmonised electronic forms for the application for clinical investigations and their assessment as referred to in Articles 70 and 78, taking into account specific categories or groups of devices;第73条所所述电子系统的运作；thefunctioning of the electronic system referred to in Article 73;第74(1)条所述的PMCF研究通知的协调电子表格，以及第75条所述的实质性修改；harmonised electronic forms for the notification of PMCF investigations as referred to in Article 74(1), and of substantial modifications as referred to in Article 75;第76条所述成员国之间的信息交流；the exchange of information between Member States as referred to in Article 76;用于报告第80条所述严重不良事件和器械缺陷的协调电子表格；harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 80;考虑到第80条所述报告事件的严重性，用于报告严重不良事件和器械缺陷的时间表；the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in Article 80;需要有关临床证据/数据要求的统一应用，以证明符合附录I所规定的通用安全与性能要求。uniform application of the requirements regarding the clinical evidence or data needed to demonstrate compliance with the general safety and performance requirements set out in Annex I应按照第114(3)条中述及的审查规程通过这些在第1段中实施细则。The implementing acts referred to in the first paragraph shall be adopted inaccordance with the examination procedure referred to in Article 114(3).Article 82关于其他临床研究的要求Requirements regardingother clinical investigations1.未按照第62（1）条任何目的进行的临床研究，应符合本法规第62（2）和（3）条，第62（4）条（b）、(c)、(d)、(f)、（h）和（l）点和和第62（6）条。Clinical investigations, not performed pursuant to any of the purposes listed in Article 62(1), shall comply with the provisions of Article 62 (2) and(3), points (b), (c), (d), (f), (h), and (l) of Article 62(4) andArticle 62(6).2.出于保护受试者的权利、安全、尊严和福祉以及根据第62(1)条所列任何目的未进行的临床研究的科学和伦理完整性，各成员国应明确任何附加要求酌情为各有关成员国进行此类研究。 In order to protect the rights, safety, dignity and well-being of subjects and the scientific and ethical integrity of clinical investigations not performed for any of the purposes listed in Article 62(1), each Member State shalldefine any additional requirements for such investigations, as appropriate for each Member State concerned.