MDR-EU-2017-745-欧盟医疗器械法规-第五章

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本文转载自“木之唐咨询”

前言本周我们将分享MDR第五章 分类和符合性评估 CLASSIFICATION AND CONFORMITY ASSESSMENTMDR对医疗器械仍分为4类

接触时间 (无变化)

- 暂时< 60 分钟;

- 60分钟 < 短期<30 天;

- 长期 > 30 天

MDR的分类规则比MDD更详细更广泛，由原来的18条变为22条。

规则1~4 非侵入器械

规则5~9 侵入器械

规则10~13 有源器械

规则14~22 特殊规则

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 公告机构欢迎关注我们公众号获取更多。



CHAPTER V
分类和符合性评估 CLASSIFICATION AND CONFORMITY ASSESSMENT

第1节 SECTION1 分类 Classfication 第51条 Article 51器械分类  Classification of devices1.  根据器械的预期用途和其固有风险，医疗器械应分为I、IIa、IIb和III类。分类应按照附录VIII规定进行。Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII.2.  制造商和相关公告机构之间因应用附录VIII而产生的任何争议，应提交至制造商注册营业所在成员国主管机构做出裁定。对于未在欧盟注册营业地址也未指定授权代表的制造商，应提交至附录IX第2.2节（b）点最后一项中所述的授权代表注册营业所在成员国的主管机构。当相关公告机构处于非制造商所在成员国时，主管机构应在与委任该公告机构的成员国主管机构咨询后方可通过其决议。Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body.具有营业注册地的制造商所在成员国的主管机构应将其决议告知MDCG及委员会。该决议可根据要求提供。The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request3.  应成员国要求，委员会应在咨询MDCG后通过实施细则，并就以下项目做出决议： Atthe request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following:对指定器械、类别或器械组使用附录VIII，做出此类器械分类决议；application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices;因公共健康原因，根据新的科学证据、或警戒和市场监管活动中获取的任何信息，通过豁免附录VIII，为器械、类别或器械组进行重新分类。that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII.4.  委员会也可在咨询MDCG后，通过实施细则自行决议第3段（a）和（b）点所述的问题。 The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a)and (b) of paragraph 3.5.  为保证附录VIII的统一适用，并考虑到相关科学委员会的相关科学观点，委员会可采取实施细则，以解决分歧和实际应用的问题。In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application.6.  本条第3、4和5段中所述的实施细则应按照第114(3)条的审查流程予以通过。The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 114(3) 第2节 SECTION 2符合性评估 Conformity assessment第52条 Article 52符合性评估流程 Conformity assessment procedures1.     在器械投放市场之前，制造商应对该器械符合性进行评估。符合性评估流程见附录IX至XI。Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device,in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.2.  在投放使用前，制造商应按照附录IX至XI中的符合性评估流程对未投放市场的器械进行符合性评估。Prior to putting into service a device that is not placed on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI。3.  III类器械（非客户定制器械或研究器械）的制造商应依据附录IX中符合性评估的规定进行符合性评估。另外，制造商也可选择附录X规定的符合性评估联合附录XI规定的符合性评估进行符合性评估。Manufacturers of class III devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment asspecified in Annex X coupled with a conformity assessment as specified in Annex XI.4. IIb类器械（非客户定制器械或研究器械）的制造商应依据附录IX第I章和第III章规定的符合性评估（包括附录第4节中规定的对各同类器械组中至少一个代表性器械的技术文件评估）进行符合性评估。Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including anassessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.然而对于IIb类可植入器械，但不包括缝线、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，附录IX第4节中所规定的技术文件评估应适用于每一器械。However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns,screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.另外，制造商也可选择按照附录X规定的形式审核联合附录XI规定的基于产品符合性验证的符合性评估进行符合性评估。Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.5.  如理由充分，鉴于与本条第4段列表中器械所使用的成熟技术相似，此类技术可用于其他IIb类可植入器械，为保护患者、使用者或其他人员或其他方面的卫生安全，委员会应有权依照第115条以授权法案形式将其他IIb类植入器械添加到列表或从列表中删除，从而达到修订列表的目的。Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable 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 that list by adding other types of class IIb implantable devices to that list or removing devices the refrom.6.  IIa类器械（非客户定制或研究器械）制造商应根据附录IX第I和III章规定的质量管理体系接受符合性评估，并应对各器械类别中至少一个代表性器械的该附录第4节所述技术文件进行评估。Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation asspecified in Section 4 of that Annex of at least one representative device for each category of devices.此外，制造商也可选择根据附录II和III及基于附录XI第10节或第第18节产品符合性验证的符合性评估起草技术文件。该技术文件评估应至少适用各器械类别中至少一个代表性器械。Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI. The assessment of the technical documentation shall apply for at least one representative device fo reach category of devices.7.  I类器械（非客户定制或研究器械）制造商在制定附录II和III规定的技术文件后，须通过签发第19条中的EU符合性声明，以声明其产品的符合性。若这些器械在无菌状态下投放市场，具有测定功能或为可重复使用手术器械，制造商应采用附录IX第I章和第III章或附录XI第A部分所述程序。但公告机构的介入应限于：Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited:若此类器械在无菌状态下投放市场，则涉及建立、保障和保持无菌条件。in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions;若此类器械具有测定功能，则涉及器械符合计量要求的情况。in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements;若是可重复使用手术器械，则涉及器械的可重复利用，特别是清洗、消毒、杀菌、维护、功能测试和相关使用说明书。in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.8.  客户定制器械的制造商应遵循附录XIII所述程序并按照该附录第1节规定起草声明后再将该器械投放市场。Manufacturers of custom-made devices shall follow the procedure set out in Annex XIII and draw up the statement set out in Section 1 of that Annex before placing such devices on the market.根据第一子段的适用程序，III类客户定制植入器械的制造商应遵循附录IX第I章规定的符合性评估流程。此外，制造商根据附录XI第A部分规定，可选择应用符合性评估。In addition to the procedure applicable pursuant to the first subparagraph, manufacturers of class III custom-made implantable devices shall be subject to the conformity assessment as specified in Chapter I of Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Part A of Annex XI.9.  除根据本条第3、4、6或7段所适用的程序外，在第1（8）条所指器械的情况下，附录IX第5.2节或附录X第6节所规定的程序应适用。In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article, in the case of devices referred to in the first subparagraph of Article 1(8), the procedure specified in Section 5.2 of Annex IX or Section 6 of Annex X, asapplicable, shall also apply10.  除根据本条第3、4、6或7段所适用的程序外，如根据本法规所涵盖的符合第1（6）条（f）点或（g）点及第1（10）条第一子段的器械，附录IX第5.3节或附录X第6节规定的程序也应当适用（如适当）。In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7of this Article, in the case of devices that are covered by this Regulation inaccordance with point (f) or (g) of Article 1(6) and with the firstsubparagraph of Article 1(10), the procedure specified inSection 5.3 of Annex IX or Section 6 of Annex X, asapplicable, shall also apply.11.  除根据本条第3、4、6或7段所适用的程序外，在器械通过体孔将包含的药物或合成物送入人体或通过涂抹于皮肤后被人体吸收或在局部扩散的情况下，附录IX第5.4节或附录X第6节的规定也应当适用（如适当）。 In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7, in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body or ifice or applied to the skin and that are absorbed by or locally dispersed in the humanbody, the procedure specified in Section 5.4 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.12.  成员国境内的公告机构可决议，与第7和9至11段所述程序相关的所有或某些文件，其中包括技术文件、审计、评估和检验报告，并应当使用相关成员国的欧盟官方语言编写。在无此类要求情况下，这些文件应使用公告机构可接受的欧盟官方语言编写。The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body.13.   研究器械应遵守第62至81条的要求。 Investigational devices shall be subject to the requirements set out in Articles 62 to 81.14.   委员会可通过实施细则，规定详细安排和程序等问题，以确保公告机构在以下方面协调应用符合性评估流程：The Commission may, by means of implementing acts, specify detailed arrangements and procedural aspects with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspectsa)  附录IX第2.3节和第3.5节第三段有关IIa类器械和IIb类器械以及附录XI第10.2节有关IIa类器械代表性技术文件评估频率和抽样评估结果。the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in the third paragraph of Section 2.3 and in Section 3.5 of Annex IX in the case of class IIa and class IIb devices, and in Section 10.2 of Annex XI in the case of class IIa devices;(b) 公告机构按照附录IX第3.4节进行的突击现场审核和抽样测试的最低频率，应考虑风险级别和器械的类型；the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified bodiesin accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device;(c) 公告机构根据附录IX第3.4节和第4.3节、附录X第3节以及附录XI第第15节规定通过抽样测试、技术文件评估和形式检验而进行物理测试、实验室测试或其他测试。the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of the technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX, Section 3 of Annex X and Section 15 of Annex XI.应按照第114(3)条中述及的审查规程通过这些第一子段中所述的实施细则。The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).Article 53公告机构参与符合性评估流程Involvement of notified bodies in conformityassessment procedures1. 凡符合性评估流程需要公告机构的参与，制造商可向其选择的公告机构申请，前提是已委任选定公告机构进行有关类型器械的符合性评估活动。对于同一符合性评估流程，制造商无法向其他公告机构平行提出同一份申请。Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned. The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure.2.  在做出关于符合性评估决议前，有关公告机构应通过第57条中所述的电子系统通知给其他公告机构已撤销申请的制造商。The notified body concerned shall, by means of the electronic system referred to in Article 57, inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body's decision regarding the conformity assessment.3.  根据第1段规定申请公告机构时，制造商在该公告机构决议前应声明其已经撤销了其他公告机构的申请，并提供已被其他公告机构拒绝的同一符合性评估的前申请信息When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn an application with another notified body prior to the decision of that notified body and provide  information about any previous application for the same conformity assessment that has been refused by another notified body.4.  公告机构可要求制造商提供任何信息或数据，以适当开展选定的符合性评估流程。The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure. 5.  公告机构以及公告机构人员必须具备执行符合性评估活动的最高级别职业操守、必备技术及特定领域的科学技能，并且能够抵抗一切压力和诱惑，特别是可能会影响其判断或符合性评估活动结果的资金问题，尤其是对于这些活动的结果有利益关系的个人或集体。Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities. Article 54 特定III类器械和IIb类器械的临床评价咨询流程Clinical evaluation consultation procedure for certainclass III and class IIb devices1. 除了根据第52条的适用程序外，公告机构在执行下列器械的符合性评估时，应遵循附录IX第5.1节或附录X第6节规定的临床评价咨询流序（如适用）：In addition to the procedures applicable pursuant to Article 52, a notified body shall also follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of the following devices:III类可植入器械；和 class III implantable devices, and附录VIII第6.4节（规则12）所述的用于给予和/或清除药品的IIb类有源器械。class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12)2.  第1段中所述的流程不用于以下所述的器械：The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:（a）根据本法规更新颁发证书的情况；in the case of renewal of a certificate issued under this Regulation;（b） 由同一制造商将已投放市场的器械进行改进后设计出的具有相同预期用途的器械，若制造商已证明达到公告机构满意程度，则该改进不得对器械收益/风险比产生不利影响。where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; or（c）有关器械类型或种类的临床评价原则已写入第9条所所述的CS中，且公告机构证实制造商器械临床评价符合其相关的临床评价CS要求。where the principles of the clinical evaluation of the device type or category have been addressed in a CS referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.3.  公告机构应依据第57条（无论本条第1段中所述的程序是否适用）规定系统通知主管机构、负责公告机构的主管机构和委员会。该通知应随附临床评估的评定报告。The notified body shall notify the competent authorities, the authority responsible for notified bodies and the Commission through the electronic system referred to in Article 57 of whether or not the procedure referred to in paragraph 1 of this Article is to be applied. That notification shall be accompanied by the clinical evaluation assessment report.4.  委员会应起草一份符合附录IX第5.1节或附录X第6节程序的器械年度总结。该年度总结应包括本条第3段和附录IX第5.1节（e）点规定的公告决议以及公告机构在未听从专家小组建议情况下而编入的列表。委员会应将该总结提交至欧洲议会、理事会和医疗器械协调小组。The Commission shall draw up an annual overview of devices which have been subject to the procedure specified in Section 5.1 of Annex IX and referred to in Section 6 of Annex X. The annual overview shall include the notifications in accordance with paragraph 3 of this Article and point (e) of Section 5.1 of Annex IX and a listing of the cases where the notified body did not follow the advice from the expert panel. The Commission shall submit this overview to the European Parliament, to the Council and to the MDCG.5.  委员会应2025年5月27日之前起草关于本条实施情况的报告，并将其提交欧洲议会和理事会。提交报告中应包括年度总结和MDCG提出的相关可用建议。根据本报告，委员会应酌情提出修订本法规的建议。The Commission shall by 27 May 2025 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. The report shall take into account the annual overviews and any available relevant recommendations from the MDCG. On the basis of that report the Commission shall, if appropriate, make proposals for amendments to this Regulation.Article 55 特定III类器械和IIb类器械的符合性评估的审查机制 Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices1. 公告机构应通知已授予器械证书的主管机构，其中符合性评估已根据第54（1）条执行。应根据第57条所所述的电子系统发出此类通知并包括符合第32条的安全和临床性能信息总结、公告机构的评估报告、附录I第23.4节所所述的使用说明书、附录IX第5.1节或附录X第6节所所述的专家小组科学建议（如适用）以及在公告机构和专家小组产生意见分歧的情况下，应包括充分理由）。 Anotified body shall notify the competent authorities of certificates it has granted to devices for which the conformity assessment has been performed pursuant to Article 54(1). Such notification shall take place through the electronic system referred to in Article 57 and shall include the summary of safety and clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the case of divergent views between the notified body and the expert panels, a full justification shall also be included.2.  主管机构以及委员会（在适当情况下）可根据合理顾虑，根据第44、45、46、47或94条要求开展进一步程序，并在必要时，根据第95和97条采取适当措施。A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessary, take appropriate measures in accordance with Articles 95 and 97.3.  MDCG以及委员会（在适当情况下）可根据合理顾虑，要求专家小组就任何器械的安全性和性能要求给出科学建议。 The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety andperformance of any device.Article 56 符合性证书 Certificates of conformity1.  由公告机构根据附录IX、X和XI所颁发的证书应使用该公告机构所在成员国确定的欧盟官方语言或此公告机构可接受的欧盟官方语言编写。该证书的最低应有内容列于附录XII中。The certificates issued by the notified bodies in accordance with Annexes IX,X and XI shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in anofficial Union language acceptable to the notified body. The minimum content of the certificates shall be as set out in Annex XII.2.  该证书的有效期为其列明的期限，不得超过五年。制造商可申请延长证书的有效期，但每次延期不得超过五年，同时需要按照适用的符合性评估流程重新评估。证书的任何补充内容应与其补充的证书具有相同有效期。The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years,based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid aslong as the certificate which it supplements is valid.3. 公告机构可限制器械应用于某些特定患者的预期用途，或要求制造商承担按照附录XIV第B部分进行的PMCF研究。Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or require manufacturers to undertake specific PMCF studies pursuant to Part B of Annex XIV.4.  若公告机构认定制造商不再满足本法规的要求，需考虑均衡原则，暂停或撤销颁发的证书或对其施加限制，除非制造商在公告机构规定的时间内采取合适的纠正措施保证遵守要求。该公告机构需给出其所作决议的理由。Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on itunless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision.5.  公告机构应将所签发证书的相关信息录入第7条所述电子系统，包括修订和补充以及证书的暂停、恢复、撤销或拒绝，和对证书的限制。此信息应向公众开放。The notified body shall enter in the electronic system referred to in Article 57 any information regarding certificates issued, including amendments and supplements thereto, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. Such information shall be accessible to the public.6.  随着技术进步，委员会应有权按照第115条采取纠正措施或按照附录XII补充证书的最低应有内容。In the light of technical progress, the Commission is empowered to adopt delegatedacts in accordance with Article 115 amending the minimum content of the certificates set out in Annex XII.Article 57公告机构和符合性证书的电子系统 Electronic system on notified bodies and on certificates of conformity1. 在咨询MDCG后，委员会应建立并管理电子系统来整理和处理以下信息；The Commission, after consulting the MDCG, shall set up and manage an electronic system to collate and process the following information:（a）第37（3）条所述分支机构名单；thelist of subsidiaries referred to in Article 37(3);（b）第40（2）条所述专家名单；the list of experts referred to in Article 40(2);（c）第42（10）条所述通知相关信息和第46（2）所述的修订公告；the information relating to the notification referred to in Article 42(10) and the amended notifications referred to in Article 46(2);（d）第43(2)条所述公告机构名单；the list of notified bodies referred to in Article 43(2);（e）第44（12）条所述总结报告；the summary of the report referred to in Article 44(12);（f）第54（3）条和第55(1)条中所述的有关符合性评估和证书的通知；the notifications for conformity assessments and certificates referred to in Articles 54(3) and 55(1);（g）在第53(2)条和附录VII第4.3节中所述证书申请撤回或拒绝；withdrawal or refusals of applications for the certificates as referred to in Article 53(2) and Section 4.3 of Annex VII;(h) 在第56(5)条中所述证书相关信息；the information regarding certificates referred to in Article 56(5);(i)    第32条所述安全和临床性能总结。the summary of safety and clinical performance referred to in Article 32.2.电子系统整理和处理的信息应由各成员国主管机构、委员会访问，公告机构（适用时）或本法规另有规定或第2017/746号法规应向公众开放。 The information collated and processed by the electronic system shall be accessibleto the competent authorities of the Member States, to the Commission, where appropriate to the notified bodies and where provided else where in this regulation or in Regulation (EU) 2017/746 to the publicArticle 58公告机构的自愿变更 Voluntary change of notified body1. 对于同一器械的符合性评估，若制造商终止与一家公告机构的合同，而与另一家公告机构签订合同，公告机构的详细安排需在制造商与即将达成协议的公告机构以及（如可行）即将终止协议的公告机构间的协议中明确定义。本协议应至少包括以下几个方面：In cases where a manufacturer terminatesits contract with a notified body and enters into a contract with an other notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects:（a）即将终止协议的公告机构颁发的证书失效日期；the date on which the certificates issuedby the outgoing notified body become invalid;（b）在此之前，即将终止协议的公告机构的标识号需要在制造商提供的信息包括任何宣传资料the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material;（c）文件传输，包括机密性方面和产权；the transfer of documents, including confidentiality aspects and property rights;（d）在此之后，即将终止协议的公告机构的符合性评估任务委托给即将达成协议的公告机构的日期；the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body;（e）即将终止协议的公告机构负责的最后一个序号或批号。the last serial number or lot number forwhich the outgoing notified body is responsible.2.在失效日期当日，即将终止协议的公告机构应撤销它为相关器械颁发的证书。The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid.Article 59 符合性评估流程的豁免 Derogation from the conformity assessment procedures1.  通过豁免第52条，任何主管机构在正当理由要求下，可在成员国境内授权将特定器械的投放市场或投入使用，而无需等待该条所述程序的实施，但其使用应有利于公共健康及患者安全和健康。By way of derogation from Article 52, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in that Article have not been carried out but use of which is in the interest of public health or patient safety orhealth.2.  该成员国应通知委员会和其他成员国任何授权器械投放市场和投入运行的决议，此决议按照第1段中此类授权得到批准使用而不是仅供单一患者使用。The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient.3.  在按照本条第2段发布通知后，委员会针对公共健康或患者安全或健康的特殊情况，可通过实施细则，在一定程度上延长成员国根据本条第1段在欧盟境内授权的时限，并设置此器械可投放市场或投入使用的条件。此外，应按照第114(3)条中述及的审查规程通过这些实施细则。Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the Union and set the conditions under which the device may be placed on the market or put intoservice. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).若存在攸关人类健康与安全的紧迫性理由，委员会应按照第114(4)条所述的程序立即采取适用的实施细则。On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing actsin accordance with the procedure referred to in Article 114(4). Article 60 自由销售证书 Certificate of free sale1. 为出口目的，应制造商或授权代表要求，制造商或授权代表注册地点所在成员国，需签发一份自由销售证书，声明制造商或授权代表（视情况而定）在其领域具有营业注册地，并且根据此法规，带有CE标记的上述器械可在欧盟市场上销售。自由销售证书应在第29条规定下的UDI数据库中列明器械的基本UDI-DI。若公告机构颁发了第56条所述证书，则自由销售证书应当依据附录XII第II章第3节列出的公告机构颁发唯一编号标识的此证书。For the purpose of export and upon requestby a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufactureror the authorised representative, as applicable, has its registered place ofbusiness on its territory and that the device in question bearing the CE marking in accordance with this Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device asprovided to the UDI database under Article 29. Where a notified body has issueda certificate pursuant to Article 56, the certificate of free sale shall setout the unique number identifying the certificate issued by the notified body,as referred to in Section 3 of Chapter II of Annex XII.2.  委员会可通过实施细则，建立一个自由销售证书模版，其中考虑到自由销售证书的国际使用惯例。应按照第114(2)条中述及的咨询规程通过这些实施细则。The Commission may, by means of implementing acts, establish a model for certificates of free sale, taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted inaccordance with the advisory procedure referred to in Article 114(2).