MDR-EU-2017-745-欧盟医疗器械法规 第三章

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本文转载自“木之唐咨询”

前言

MDR 推迟一年，原计划于2020年5月26日强制实施，推迟至2021年5月26日，由欧盟委员会2020年4月17日投票决议。

对各企业对个人都是好消息，时间又充分了，加油吧！

本周我们将分享MDR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

按我们读完整部MDR法规计划，已分享了：

法规综述

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

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CHAPTER III

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
IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS,SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
Article 25 供应链中标识 Identification within the supply chain

1. 经销商和进口商应与制造商或授权代表合作，以实现器械适当水平的可追溯性。

Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.

2. 在第10（8）条所述期限，经济运营商应能够向主管机构确定以下内容：

Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8):

其直接提供器械的任何经济运营商；

any economic operator to whom they have directly supplied a device;

直接向其提供器械的任何经济运营商；

any economic operator who has directly supplied them with a device;

其直接提供器械的任何卫生机构或卫生保健专业人员。

any health institution or healthcare professional to which they have directly supplied a device.

Article 26 医疗器械的命名 Medical devices nomenclature

为协助根据第33条设立的欧洲医疗器械数据库“Eudamed”的运作，委员会应确保国际公认的医疗器械命名应就本法规而言，免费提供给需要使用命名的制造商和其他自然人或法人。委员会还应努力确保在合理可行的情况下免费向其他利益相关方提供这一命名。

To facilitate the functioning of the European database on medical devices(‘Eudamed’) as referred to in Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable.

Article 27 唯一器械标识系统 Unique DeviceIdentification system

1.附录VI第C部分中说明的唯一器械标识系统（‘UDI’系统）应允许标识除定制和研究器械以外的器械并促进该器械的可追溯性，此外还应包括以下内容：

The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:

UDI包括以下几点：

production of a UDI that comprises the following:

特定于某一制造商和器械的UDI器械标识符（‘UDI-DI’），提供附录VI第B部分所述信息访问途径；

a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device,providing access to the information laid down in Part B of Annex VI;

UDI生产标识符（‘UDI-PI’），用于标识所生产的器械单元以及附录VI第C部分中规定的包装后器械（若适用）；

a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI;

将UDI应用于器械的标签或其包装上；

placing of the UDI on the label of the device or on its packaging;

经济运营商、卫生机构和卫生专业人员根据本条第8和9段规定的条件储存UDI；

storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively;

根据第28条为唯一器械标识建立UDI电子系统（“UDI数据库”）。

establishment of an electronic system for Unique Device Identification (‘UDI database’)in accordance with Article 28.

委员会应通过实施细则指定一个或多个实体来根据本法规规定操作一个UDI分配系统（委任实体）。实体应满足以下所有标准：

2.The Commission shall, by means of implementing acts, designate one or several entities to operate a system for assignment of UDIs pursuant to this Regulation (‘issuing entity’). That entity or those entities shall satisfy all of the following criteria:

实体是具有法人资格的组织；

the entity is an organisation with legal personality;

其UDI分配系统足以根据本法规要求，在从分销到使用的整个过程中标识器械；

its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation;

其UDI分配系统符合相关国际标准；

its system for the assignment of UDIs conforms to the relevant international standards;

该实体可根据一组预定的和透明的条款和条件，将UDI分配系统的访问权限提供给所有相关使用者；

the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions;

该实体做出以下几点承诺：the entity undertakes to do the following;

在得到委任后，应能够运作其UDI分配系统至少10年；

operateits system for the assignment of UDIs for at least 10 years after its designation;

提供给委员会和各成员国使用，并应要求，提供UDI分配系统的相关信息；

make available to the Commission and to the Member States, upon request,information concerning its system for the assignment of UDIs;

保持遵守指定标准和指定条款。

remainin compliance with the criteria for designation and the terms of designation.

委任签发实体时，委员会应努力确保无论委任的实体使用何种系统，如附录VI第C部分所定义的UDI载体均能够通过通用方式可读，并可为经济运营商和卫生机构减少财务和行政负担。

When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers,as defined in Part C of Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to minimising financial and administrative burdens for economic operators and health institutions.

3.在将器械（除了定制器械外）投放于市场前，制造商应向该器械和（如适用）所有更大的包装分配一个符合委员会根据第2段委任的签发实体颁布规则所产生的UDI。

Before placing a device, other than a custom-made device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.

在将器械（除了定制器械或临床研究器械外）投放于市场前, ,放置在市场上制造商应确保信息在附件 VI B部分涉及的设备正确提交并转移到本法第二十八条UDI数据库

Beforea device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28

4.UDI载体应添加在该器械标签和所有更大包装上。较大的包装不包括海运集装箱。

UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers.

5.  根据第87条，UDI应用于报告严重事件和现场安全纠正措施。

The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 87.

6. 第19条所述的欧盟符合性声明应载明该器械的基本UDI-DI（定义见附录VI第C部分）。

The Basic UDI-DI, as defined in Part C of Annex VI, of the device shall appearon the EU declaration of conformity referred to in Article 19.

7.  制造商应及时更新所有应用UDI的清单作为附录II中所述技术文件的一部分。

Aspart of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list of all UDIs that it has assigned.

8.  经济运营商最好应以电子方式存储和保存其所供应或所接受的器械UDI，若这些器械属于：

Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to:

III类植入式器械；class III implantable devices;

由第11段（a）点中所指措施确定的器械、类别或器械组。

the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11.

9. 若这些器械属于III类植入式器械，则医疗机构应优先以电子方式存储和保持其所供应或接受的器械UDI。

Health institutions shall store and keep preferably by electronic means the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to class III implantable devices.

除了III类植入式器械外，成员国应鼓励并可要求医疗机构优先以电子方式储存和保管接受的器械UDI。

For devices other than class III implantable devices, Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.

成员国应鼓励，并可要求健康护理人员优先通过电子手段存放和保管提供给其器械的UDI。

Member States shall encourage, and may require, healthcare professionals to store and keep preferably by electronic means, the UDI of the devices with which they have been supplied with.

10.  委员会应有权根据第115条通过以下授权法案：

The Commission is empowered to adopt delegated acts in accordance with Article 115:

从技术进步的角度修订或补充列于附录VI第B部分的资料清单；及

a mending the list of information set out in Part B of Annex VI in the light of technical progress; and

就唯一器械标识领域的国际发展及技术进步修订或补充附录VI。

a mending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification.

11. 委员会可通过实施细则规定模式及程序，以确保以下任何几个方面的唯一器械标识系统的协调适用：

The Commission may, by means of implementing acts, specify the detailed arrangements and the procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the following:

采用第8段规定的义务确定器械、类别或器械组别。

determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply;

规定包括在器械或器械组别的UDI-PI的数据；

specifying the data to be included in the UDI-PI of specific devices or device groups;

应按照第114(3)条中述及的审查规程通过这些在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).

12. 采用第11段所述措施时，委员会应考虑以下事项：

When adopting the measures referred to in paragraph 11, the Commission shall take into account all of the following:

（a）第109和8110条中所述的保密性和数据保护；

confidentiality and data protection as referred to in Articles 109 and 110 respectively;

（b）基于风险的方法；

the risk-based approach;

（c）措施的成本收益；

the cost-effectiveness of the measures;

（d）以国际水准开发UDI系统；

the convergence of UDI systems developed at international level;

（e）避免UDI系统重复的需要；

the need to avoid duplications in the UDI system;

（f）成员国对医疗卫生系统的需要，及在尽可能的情况下，与利益相关方使用的其他医疗器械的识别系统的兼容性。

the needs of the healthcare systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders.

Article 28 UDI数据库 UDI database

1. 委员会应与MDCG商议后设立和管理一个UDI数据库，以验证、整理、处理附录VI第B部分所述信息，并向公众公布此等信息。

The Commission, after consulting the MDCG shall set up and manage a UDI database to validate, collate, process and make available to the public the information mentioned in Part B of Annex VI.

2. 设计UDI数据库时，委员会应考虑在附录VI第C部分第5节说明的UDI数据库的一般原则。UDI数据库设计应特别满足无UDI-PI且其中无商业机密产品信息。

When designing the UDI database, the Commission shall take into account the general principles set out in Section 5 of Part C of Annex VI. The UDI database shall be designed in particular such that no UDI-PIs and no commercially confidential product information can be included therein.

3. 附录VI第B部分中所述的UDI数据库核心数据元素应免费向公众开放。

The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be accessible to the public free of charge.

4. 电子系统的技术设计应保证存储在UDI数据库信息的最大可用性，并允许多个使用者访问和自动上传和下载信息。委员会应对UDI数据库的制造商和其他使用者提供技术和管理支持。

The technical design of the UDI database shall ensure maximum accessibility to information stored therein, including multi-user access and automatic uploads and downloads of that information. The Commission shall provide for technical and administrative support to manufacturers and other users of the UDIdatabase.

Article 29 器械注册 Registration of devices

1. 在市场上投放一个非定制器械时，制造商应遵守第27（2）条所述的发行实体的规则，向器械分配附录VI第C部分定义的基本UDI – DI并将其与附录VI第B部分中所述的相关器械的其他核心数据要素提交给UDI数据库。

Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI asdefined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.

2.  根据第22(1)和（3）条，在市场投放一个非定制器械的系统或手术包，责任自然人或法人应按照指定发行实体的规则，向系统或手术包分配基本UDI– DI，并将其与在附录VI第B部分中定义的相关系统或手术包的其他核心数据要素一并提交至UDI数据库。

Before placing on the market a system or procedure pack pursuant to Article 22(1) and(3), that is not a custom- made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack.

3.  对于经过第52（3）条或第52（4）条第二和第三子段中符合性评估的器械，在器械投放市场前，制造商应在公告机构运用符合性评估流程前向器械分配基本的UDI– DI前向器械分配一个本条第1段中所述的UDI-DI。

For devices that are the subject of a conformity assessment as referred to in Article 52(3) and in the secondand third subparagraphs of Article 52(4), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment.

对于在第一子段中所述的器械，公告机构应按照附录XII第一章第4节a点包括出具证书上基本UDI-DI的参考并确认附录VI第A部分第2.2节中所述的Eudamed。在出具相关证书及在将器械投放在市场之前，制造商应将基本的UDI-DI及附录VI第B部分中定义的相关系统或手术包的其他核心数据要素。

For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Chapter I of Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.

4. 将非定制器械投放在市场之前，制造商应提交或者若已提交，验证附录VI第A部分第2节（第2..2节除外）中所述的Eudamed资料并应及时更新。

Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if, already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and shall there after keep the information updated.

Article 30 经济营运商注册电子系统 Electronic system forregistration of economic operators

1.  在咨询MDCG后，委员会应建立并管理电子系统以创建第31（2）条所述的单一注册号整理及加工识别制造商及（如适用）授权代表及进口商的必要且相应的资料。有关经济营运商提供至电子系统的资料详情载于附录VI第A部分第1节。

The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 31 (2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative and the importer. The details regarding the information to be provided to that electronic system by the economic operators are laid down in Section 1 ofPart A of Annex VI.

2. 成员国可维持或引用有关其领土范围内允许使用的器械的经销商注册的国家规定。

Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory.

3.  非定制器械投放市场两周内，进口商应核实制造商或授权代表已将第1段中所述的资料提交至电子系统中。

Within two weeks of placing a device, other than a custom-made device, on the market, importers shall verify that the manufacturer or authorised representative has provided to the electronic system the information referred to in paragraph 1.

若第1段中所述的资料未上传或不正确，在适用的情况下，进口商应通知相关授权代表或制造商。进口商应将其详细资料添加到相关条目。

Where applicable, importers shall inform the relevant authorised representative or manufacturer if the information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the relevant entry/entries.

Article 31制造商、授权代表和进口商的注册Registration ofmanufacturers,authorised representatives and importers

1.在非定制器械投放市场前，制造商、授权代表和进口商为实现注册，应当向第30条中所述的电子系统提交附录VI第A部分第1节所述的资料。前提是其并未根据本条进行注册。若根据第52条符合性评估流程需要公告机构参与，应在向公告机构申请前向电子系统提交附录VI第A部分第1节所述的资料。

Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of anotified body pursuant to Article 52, the information referred to in Section 1of Part A of Annex VI shall be provided to that electronic system before applying to the notified body.

2.在核实根据第1段输入的数据后，主管机构应自第30条所述的电子系统取得单一注册号('SRN')並签发给制造商、授权代表或进口商。

After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer.

3.制造商向公告机构申请进行符合性评估和评估Eudamed（为履行第29条项下的义务）时需要用到单一注册号。

The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29.

4.如有关本条第1段所述的资料于一周内发生任何变动，相关经济营运商应当更新第30条中所述电子系统中的数据。

Within one week of any change occurring in relation to the information referred to inparagraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.

5.提交第1段所述的资料后不迟于一年及此后的每两年，相关经济营运商应确认数据的准确性。在六个月到期日内未确认的情况下，任何成员国可于其领土范围内采取适当的纠正措施，直至本段所述义务得到履行。

Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.

6.在不影响经济营运商对数据的责任的情况下，主管机构应核实附录VI第A部分第1节中所述的已确认的数据。

Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.

7.根据本条第1段录入第30条所述的电子系统中的数据应向公众开放。

The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 30 shall be accessible to the public.

8.根据第111条，主管机构可利用这些数据对制造商、授权代表或进口商收费。

The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 111.

Article 32安全和临床性能总结 Summary of safety andclinical performance

1.对于III类器械和植入式器械（非定制或研究器械），制造商应起草一份安全和临床性能总结。

For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.

该安全和临床性能总结应令拟定使用者及（如相关）患者明白，并应通过Eudamed向公众开放。

The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed

本安全和临床性能总结的草案应当是提交予依照第52条所参与符合性评估的公告机构文件的一部分，并由该机构来验证。验证后，公告机构应将该总结报告上传到Eudamed。制造商应在标签或使用说明所述总结报告可获得的地址。

The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed.The manufacturer shall mention on the label or instructions for use where the summary is available.

2.  安全和临床性能总结应至少包括以下方面：

The summary of safety and clinical performance shall include at least the following aspects:

器械和制造商标识，包括基本UDI- DI和SRN（如已发布）；

the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;

该器械的预期用途，包括任何适应症、禁忌症和目标人群；

the intended purpose of the device and any indications,contraindications and target populations

该器械的说明，包括前一代或变体（如存在）的参考文件，和差别说明，以及附件、其他器械和其他产品等与该器械联合使用的产品说明；

a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device;

可能的诊断或治疗替代品；

possible diagnostic or the rapeutic alternatives;

协调标准和CS的参考文件；

reference to any harmonised standards and CS applied;

附录XIV中参考的临床评价总结和上市后临床跟踪的相关信息；

thesummary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up;

为使用者提供的建议简况和培训；

suggested profile and training for users;

有关任何剩余风险和任何不良影响、警戒和预防措施的信息。

information on any residual risks and any undesirable effects, warnings and precautions.

3.  委员会可通过实施细则，载列将纳入安全和临床性能总结的数据元素的形式及声明。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, set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).

Article 33 欧洲医疗器械数据库 European database onmedical devices

1.委员会应出于下列目的，与MDCG商议后，设立、维护和管理欧洲医疗器械数据库（'Eudamed'）：

The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) for the following purposes:

帮助公众对投放于市场的器械、认证机构发出的相应证书及相关经济运营商有充分的了解；

to enable the public to be adequately informed about devices placed on the market,the corresponding certificates issued by notified bodies and about the relevant economic operators;

实现内部市场上器械的唯一标识，并促进可追溯性；

to enable unique identification of devices within the internal market and to facilitate their traceability;

帮助公众充分了解临床研究情况，并要求临床研究申办方遵守第62至80条和82条以及任何根据第81条所采用的法案规定的义务；

to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant toArticle 81;

要求制造商遵守第87至90条或任何根据第91条所采用法案规定的信息义务；

to enable manufacturers to comply with the information obligations laid down in Articles 87 to 90 or in any acts adopted pursuant to Article 91;

使成员国和委员会的主管机构能够在充分知情的基础上执行与本法规有关的任务，并加强它们间的合作。

to enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well-informed basisand to enhance the cooperation between them.

2.Eudamed应包括以下电子系统：

Eudamed shall include the following electronic systems:

(a)    在第29（4）条中所述器械注册电子系统；

the electronic system for registration of devices referred to in Article 29(4);

(b)   第28条所指的UDI数据库；

the UDI-database referred to in Article 28;

(c)    在第30条中所述的经济运营商电子登记系统；

the electronic system on registration of economic operators referred to in Article 30;

(d)   在第57条中所述的认证机构和证书电子系统；

the electronic system on notified bodies and oncertificates referred to in Article 57;

(e)    在第73条中所述的临床研究电子系统；

the electronic system on clinical investigations referred to in Article 73;

(f)    第92条所指的警戒和上市后监管电子系统；

the electronic system on vigilance and post-market surveillance referred to in Article 92;

(g)   第100条所指的市场监管电子系统。

the electronic system on market surveillance referred to in Article 100.

3.  设计Eudamed时，委员会应充分考虑国家数据库和国家网络接口的兼容性以允许数据的输入和输出。

When designing Eudamed the Commission shall give due consideration to compatibility with national databases and national web-interfaces to allow for import and export of data.

4.  应由成员国、认证机构、经济运营商和申办方，根据第2段中所述电子系统的规定，将数据录入Eudamed。委员会应向Eudamed使用者提供技术和行政支持。

The data shall be entered into Eudamed by the Member States, notified bodies,economic operators and sponsors as specified in the provisions on the electronic systems referred to in paragraph 2. The Commission shall provide for technical and administrative support to users of Eudamed.

5.  Eudamed整理并加工所有信息，应可供成员国和委员会访问。第2段所述有关电子系统规定中定义的范围内，向认证机构、经济运营商、申办方和公众应可访问该信息。

All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extents pecified in the provisions on the electronic systems referred to in paragraph 2

委员会应确保Eudamed公共部分以使用者友好且易于搜索的形式呈现。

The Commission shall ensure that publicparts of Eudamed are presented in a user-friendly and easily-searchable format.

6. Eudamed所包含的个人数据，应当方便本条第2段中所述电子系统根据本法规规定进行整理和处理。个人数据的保存形式应能够使数据主体标识时间不长于第10（8）条所述期限。

Eudamed shall contain personal data only insofar as necessary for the electronic systems referred to in paragraph 2 of this Article to collate andprocess information in accordance with this Regulation. Personal data shall bekept in a form which permits identification of data subjects for periods nolonger than those referred to in Article 10(8).

7. 委员会和成员国应当确保数据主体可分别按照欧洲委员会第45/2001号法规和第95/46/EC号指令，有效行使其知情权以及获取、纠正和反对的权利。其应确保数据主体能够有效地行使与其有关的数据访问权，并有权纠正或删除不准确或不完整的数据。在各自的职责范围内，委员会和各成员国应确保按照适用的法律删除不准确的和非法处理的数据。应尽快进行更正和删除，但不得迟于数据主体提出请求后60天。

The Commission and the Member States shall ensure that data subjects may effectively exercise their rights to information, of access, to rectificationand to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall also ensure that datasubjects may effectively exercise the right of access to data relating to them,and the right to have inaccurate or incomplete data corrected and erased.Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data are deleted, in accordance with the applicable legislation. Corrections anddeletions shall be carried out as soon as possible, but no later than 60 days after a request is made by a data subject.

8. 委员会应通过实施细则，以制定设立和维护Eudamed所必需的形式。应按照第114（3）条中述及的审查规程通过这些实施细则。当采纳这些实施细则时，委员会应尽可能确保系统的开发能够在同一模块或系统的不同模块内-输入同一资料两次。

The Commission shall, by means of implementing acts, lay down the detailed arrangements necessary for the setting up and maintenance of Eudamed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). When adopting those implementing acts, theCommission shall ensure that, as far as possible, the system is developed insuch a way as to avoid having to enter the same information twice within the samemodule or in different modules of the system.

9.  关于其在本条下的责任和其中所涉及个人数据的处理，应将委员会视为Eudamed及其电子系统的控制者。

Inrelation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered to be the controller of Eudamed and its electronic systems

Article 34 Eudamed的功能 Functionalityof Eudamed

1.委员会应与MDCG协作，为Eudamed制定功能规范。委员会应最迟于2018年5月26日制定实施这些规范的计划。这一计划将寻求确保Eudamed在规定日期完全运转，即该日期允许委员会于2020年3月25日公布第3段中所述通知，且本法规第123条和第2017/746号法规第113条的所有其他相关最后期限都得到满足。

The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. That plan shall seek toensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2020 and that all other relevant deadlines laid down in Article 123of this Regulation and in Article 113 ofRegulation (EU) 2017/746 are met.

2.一旦在UDI上确认Eudamed已实现全部功能，且Eudamed符合根据第1段制定的职能规范，委员会应通过独立审计报告来通知MDCG。

The Commission shall, on the basis of an independent audit report, inform the MDCG when it has verified that Eudamed has achieved full functionality and Eudamed meets the functional specifications drawn up pursuant to paragraph 1.

3.委员会应在咨询MDCG后，在确认第2段中所述条件已得到满足时，在欧盟公报上公布相应通知。

The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled,publish a notice to that effect in the Official Journal of the European Union.