MDR-EU-2017-745-欧盟医疗器械法规 第四章

admin

本文转载自“木之唐咨询”

前言

本周我们将分享MDR第四章 公告机构 NOTIFIED BODIES

MDR对公告机构的要求更加严格

公告机构的授权和监管由多个国家主管当局联合组成的审核小组进行审核；

公告机构必须要有自己的审核专家团队，新法规下对外聘专家的做法将有所限制；

公告机构必须要有自己的临床专家，而不能仅靠外部临床专家进行相关审核。

新法规生效后，公告机构将按照新的资质要求重新授权，不符合要求的公告机构将会被淘汰。

对于已经取得CE证的企业，应密切关注您的公告机构的新授权以及授权范围！

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：

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

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

欢迎关注我们公众号获取更多。

CHAPTER IV 公告机构 Article 35 负责公告机构的主管机构 Authorities responsiblefor notified bodies1.任何成员国如指定符合性评估机构作为公告机构，或已指定一家公告机构根据本法规开展符合性评估活动，则应根据国家法律任命一个由单独实体组成的主管机构（负责公告机构的主管机构），负责建立和开展评估、指定符合性评估机构和符合性评估公告的必要流程，以及公告机构（包括其分包商和分支机构）的监管。Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority(‘authority responsible for notified bodies’), which may consist of separate constituent entities under national law and shall be responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors and subsidiaries of those bodies.2.负责公告机构的主管机构应当妥善建立、组织和运作，以保障其活动的客观性和公正性，并避免与符合性评估机构的任何利益冲突。The authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with conformity assessment bodies.3.负责公告机构的主管机构应当妥善组织，使指定或公告相关的每个决议均由未参与评估的人员做出。The authority responsible for notified bodies shall be organised in a manner such that each decision relating to designation or notification is taken by personnel different from those who carried out the assessment.4.负责公告机构的主管机构不得参与由公告机构组织的商业或竞争性活动。 The authority responsible for notified bodies shall not perform any activities that notified bodies perform on a commercial or competitive basis.5.负责公告机构的主管机构应当保护其获得信息的保密性。但是，可与其他成员国、委员会及其他法规机构（在需要时）交换有关公告机构的信息。The authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains. However, it shall exchange information on notified bodies with other Member States, the Commission and, when required,with other regulatory authorities.6.负责公告机构的主管机构应拥有足够数量的永久供其履行任务的合资格人员。The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently available for the proper performance of its tasks.在负责公告机构的主管机构与负责医疗器械的主管机构是另一家时，应确向负责医疗器械的国家主管机构就相关问题展开咨询。Where the authority responsible for notified bodies is a different authority from the national competent authority for medical devices, it shall ensure that the national authority responsible for medical devices is consulted on relevant matters.7.成员国可公开获得一般资料，包括对符合性评估机构的评估、指定、公告和对公告机构监管的规定，以及对这些任务有重大影响的变化。Member States shall make publicly available general information on their measures governing the assessment, designation and notification of conformity assessment bodiesand for the monitoring of notified bodies, and on changes which have a significant impact on such tasks.8.负责公告机构的主管机构应参与第48条规定的同行审查活动。The authority responsible for notified bodies shall participate in the peer-review activities provided for in Article 48. Article 36公告机构的相关要求 Requirements relating to notified bodies1.公告机构应根据本法规实现指定给其任务，且应满足组织和总体要求以及必需的质量管理、资源和流程要求，以使其具备履行本法规指定任务的资格。尤其是，该公告机构须符合附录VII的要求。Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation. They shall satisfy the organisational and general requirement sand the quality management, resource and process requirements that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex VII.为满足这些在第一子段中所述的要求，公告机构应按照附录VII第3.1.1节可永久获得充足的行政、技术和科研人员，按照附录VII第3.2.4条永久获得相关临床专业人员，如有可能，可由公告机构自行聘用。In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient adminis

trative, technical and scientific personnel in accordance with Section 3.1.1

of Annex VII and personnel with relevant clinical expertise in

accordance with Section 3.2.4 of Annex VII, where possible employed by the notified body itself.附录VII第3.2.3及3.2.7条所述的人员应由公告机构自行聘用，聘用人员不得为外部专家或分包商。The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors.2. 公告机构应按要求编制并提交所有可获得的相关文件（包括制造商文件）至负责公告机构的主管机构，使其能够开展评估、指定、公告、监督及监管活动，以促进本章节内所述的评估。Notified bodies shall make available and submit upon request all relevant documentation, including the manufacturer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment, designation, notification,monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter.3. 为确保附录VII要求的统一应用，委员会应按照第114(3)条中所述的检查程序采取实施细则，并在必要情况下解决分歧和实际应用中的问题。In order to ensure the uniform application of the requirements set out in Annex VII, 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 accordance with the examination procedure referred to in Article 114(3).Article 37分支机构和分包 Subsidiaries and subcontracting1.若公告机构将与符合性评估相关的特定任务分包，或分派给分支机构，则应确认分包商或分支机构符合附录VII中规定的适用要求，并通知负责公告机构的主管机构。Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified bodies accordingly2.公告机构应对分包商或分支机构代表其履行任务承担全部责任。Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries.3.  公告机构应公开其分支机构名单。Notified bodies shall make publicly available a list of their subsidiaries.4. 在告知申请符合性评估的法人或自然人后，符合性评估活动可转包或由分支机构开展。Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that the legal or natural person that applied for conformity assessment has been informed accordingly.5.公告机构应保证负责公告机构的主管机构拥有关于分包商或分支机构资格鉴定及其根据本法规开展工作的所有相关文件的处置权。Notified bodies shall keep at the disposal of the authority responsible for notified bodies all relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation. Article 38符合性评估机构的提交的委任申请 Application byconformity assessment bodies for designation1.符合性评估机构应向负责公告机构的主管机构提交委任申请。Conformity assessment bodies shall submit an application for designation to the authority responsible for notified bodies.2.申请应明确本法规中规定的符合性评估活动，以及申请委任的器械类型，并有附录VII中证明符合性文件的支持。The application shall specify the conformity assessment activities as defined in this Regulation, and the types of devices for which the body is applying to be designated, and shall be supported by documentation demonstrating compliance with Annex VII.关于附录VII第1节和第2节所规定的组织和一般要求以及质量管理要求，国家委任机构根据欧盟第765/2008号法规提交的有效认证证书和相应的评估报告，并在第39条所述的评估中予以考虑。但申请机构应准备第一子段提及的所有文件以证明符合这些要求。In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VII, avalid accreditation certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described in Article 39. However,the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate compliance with those requirements upon request.3.为确保负责公告机构的主管机构对是否符合附录VII的所有要求进行持续监督和确认，如有任何相关变化，公告机构应更新第2段中所述的文件。The notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monit or and verify continuous compliance with all the requirements set out in Annex VII.Article 39申请评估 Assessment of the application1.负责公告机构的主管机构应在30天内检查第38条所述的申请是否完成，并要求申请机构提供缺失信息。一旦申请完成，主管机构应将其交送委员会。The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 38 is complete and shall request the applicant to provide any missing information. Once the application is complete that authority shall send it to the Commission.负责公告机构的主管机构应按照自己的程序审查申请和支持文件，并起草一份初步评估报告。The authority responsible for notified bodies shall review the application and supporting documentation in accordance with its own procedures and shall drawup a preliminary assessment report.2.负责公告机构的主管机构应向委员会提交初步评估报告，委员会应立即将报告转交至MDCG。The authority responsible for notified bodies shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the MDCG.3.在本条第2段所述的递交后14天内，委员会和MDCG从第40（2）条的名单中选出三个专家组成联合评估小组，如遇特殊情况可改变专家人数。其中一位专家应为委员会的代表，负责协调联合评估小组的活动。另外两个专家应分别来自不同于申请机构符合性评估的两个成员国。Within14 days of the submission referred to in paragraph 2 of this Article, the Commission, in conjunction with the MDCG, shall appoint a joint assessment team made up of three experts, unless the specific circumstances require a different number of experts, chosen from the list referred to in Article 40(2). One of the experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team. The other two experts shall comefrom Member States other than the one in which the applicant conformity assessment body is established.联合评估小组应由合格的专家组成，能评定符合性评估活动和该申请中的器械类型，特别是在根据第47（3）条启动该评估流程后，确保特定关注点可得到正确评估。The joint assessment team shall be comprised of experts who are competent to assess the conformity assessment activities and the types of devices which are the subject of the application or, in particular when the assessment procedure is initiated in accordance with Article 47(3), to ensure that the specific concern can be appropriately assessed.4.联合评估小组应在委任后的90天内，审核根据第38条提交的申请文件。联合评估小组可向负责公告机构的主管机构提供关于申请和计划现场评估的反馈，或要求其澄清。Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 38. The joint assessment team may provide feedback to, or require clarification from, the authority responsible for notified bodies on the application and on the planned on-site assessment负责公告机构的主管机构以及联合评估小组，应计划并实施对符合性评估申请机构以及欧盟内外参与符合性评估过程的分支机构或分包商进行现场评估。The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor,located inside or outside the Union, to be involved in the conformity assessment process.申请机构的现场评估应由负责公告机构的主管机构领导。The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.5. 如发现申请符合性评估机构的申请人不符合附录VII要求时，应在评估过程中提出，并经负责公告机构的主管机构和联合评估小组讨论，以对该申请的评估达成共识和消除分歧。Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in Annex VII shall be raised during the assessment process and discussed between the authority responsible for notified bodies and the joint assessment team with a view to reaching consensus and resolving any diverging opinions, with respect to the assessment of the application. 在现场评估结束时，负责公告机构的主管机构将向申请符合性评估机构提供因联合评估小组提供的评估和评价总结产生的不符合项清单。At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant conformity assessment body the non-compliances resulting from the assessment and summarise the assessment by the joint assessment team.在规定的时间内，符合性评估机构申请人应向国家主管机构提交纠正和预防措施计划，以解决不符合项。Within a specified time frame, the applicant conformity assessment body shall submit to the national authority a corrective and preventive action plan to address the non-compliances.6. 联合评估小组应在完成现场评估后的30天内记录有关评估的剩余分歧意见，并将这些意见提交给负责公告机构的主管机构。 The joint assessment team shall document any remaining diverging opinions with respect to the assessment within 30 days of completion of the on-sit eassessment and send them to the authority responsible for notified bodies.7. 负责公告机构的主管机构应当在收到申请机构提供的纠正和预防措施计划后，判断评估过程中发现的不符合项是否已经合理解决。该计划应说明所识别不符合项问题的根本原因并应包括执行操作的时间表。The authority responsible for notified bodies shall following receipt of acorrective and preventive action plan from the applicant body assess whether non-compliances identified during the assessment have been appropriately addressed. This plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein.负责认证机构的主管机构在确认纠正和预防措施计划后，应将该计划及其对该计划的意见转交给联合评估小组。可要求负责认证机构的主管机构的联合评估小组进一步澄清和修改。The authority responsible for notified bodies shall having confirmed the corrective and preventive action plan forward it and its opinion there on to the joint assessment team. The joint assessment team may request of the authority responsible for notified bodies further clarification and modifications. 负责公告机构的主管机构应拟定其最终的评估报告，包括：The authority responsible for notified bodies shall draw up its final assessment report which shall include:评估结果，the result of the assessment,确认已采取纠正和预防措施，并在需要时实施confirmation that the corrective and preventive actions have been appropriately addressed and, where required, implemented,与联合评估小组的剩余分歧意见，和（如适用）any remaining diverging opinion with the joint assessment team, and, where applicable,建议的委任范围。the recommended scope of designation.8. 负责公告机构的主管机构应向委员会、MDCG和联合评估小组提交最终评估报告和委任草案（如适用）。The authority responsible for notified bodies shall submit its final assessment report and, if applicable, the draft designation to the Commission, the MDCG and the joint assessment team.9. 联合评估小组应在收到由负责公告机构的主管机构准备的评估报告和委任草案（如适用）后21天内，向委员会提供关于这些文件的最终意见，且委员会应立即将此最终意见提交给MDCG。在收到联合评估小组意见后42天内，MDCG应就委任草案提出建议，负责公告机构的主管机构应在其做出委任公告机构的决议时充分考虑该建议。The joint assessment team shall provide a final opinion regarding the assessment report prepared by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those documents to the Commission, which shall immediately submit that final opinion to the MDCG.Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft designation, which the authority responsible for notified bodies shall duly take into consideration for its decision on the designation of the notified body.10.  委员会可通过实施细则，采取措施设定第38条规定的申请委任和本条规定的申请评估的流程和报告的详细协议。按照第114(3)条的审查流程采用这些实施细则。 The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements specifying procedures and reports for the application for designation referred to in Article 38 and the assessment of the application set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).Article 40公告申请联合评估专家的提名Nominationof experts for joint assessment of applications for notification

1.成员国和委员会应提名医疗器械领域内具备符合性评估机构评估资格的专家参与第39条和第48条所述的活动。

The Member States and the Commission shall nominate experts qualified in the assessment of conformity assessment bodies in the field of medical devices to participate in the activities referred to in Articles 39 and 48.

2.委员会应根据本条第1段生成一个提名专家名单，及其具体能力和专业信息领域。该名单应当通过第57条的电子系统向成员国主管机构公布。

The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article, together with information on their specific field of competence and expertise. That list shall be made available to Member States competent authorities through the electronic system referredto in Article 57.

Article 41语言要求 Language requirements第38条和第39条要求的所有文件应以一种或多种相关成员国的语言拟定。All documents required pursuant to Articles 38 and 39 shall be drawn up in alanguage or languages which shall be determined by the Member State concerned.成员国在采用第一子段时应考虑在全部或部分有关文件中使用医学领域通用易懂的语言。Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned.委员会应对第38和39条提供的文件进行必要翻译，或将部分翻译为欧盟官方语言，使按照第39(3)条指派的联合评估小组能够理解文档内容。The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts there of into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 39(3).Article 42委任和公告流程 Designation and notificationprocedure

• 成员国只能指定已完成第39条评估并符合附录VII所列要求的符合性评估机构。
  Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 39 was completed and which comply with Annex VII.
  
  

2. 成员国应使用公告机构数据库内委员会开发和管理的电子公告工具（NANDO），将其委任的符合性评估机构通知委员会和其他成员国。Member States shall notify the Commission and the other Member States of the conformity assessment bodies they have designated, using the electronic notification tool within the database of notified bodies developed and managed by the Commission (NANDO).3. 该公告应利用本条第13段中所述的法规明确规定本法规所定义的符合性评估活动的委任范围、授权公告机构评估的器械类型以及不影响第44条的与委任相关的条件。 The notification shall clearly specify, using the codes referred to inparagraph 13 of this Article, the scope of the designation indicating the conformity assessment activities as defined in this Regulation and the types of devices which the notified body is authorised to assess and, without prejudice to Article 44, any conditions associated with the designation.4. 公告应附有负责公告机构的主管机构的最终评估报告、第39（9）条所指联合评估小组的最终意见和MDCG的建议。若通知成员国未遵循MDCG的建议，应提供有充分证据的理由。The notification shall be accompanied by the final assessment report of the authority responsible for notified bodies, the final opinion of the joint assessment team referred to in Article 39(9) and the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly substantiated justification.5.  在不影响第44条的情况下，公告成员国应向委员会和其他成员国通报与委任有关的任何情况，并提供关于现有安排的书面证据，以确保定期监督公告机构并将继续满足附录VII的要求。The notifying Member State shall, without prejudice to Article 44, inform the Commission and the other Member States of any conditions associated with the designation and provide documentary evidence regarding the arrangements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set out in Annex VII.6. 在第2段中所述的公告后28天内，成员国或委员会可书面提出异议，就关于公告机构或负责公告机构的主管机构对其进行的监督进行讨论。若未提出异议，委员会应在42天内在第2段所述的NANDO内发布公告。Within 28 days of the notification referred to in paragraph 2, a Member State or the Commission may raise written objections, setting outits arguments, with regard either to the notified body or to its monitoring by the authority responsible for notified bodies. Where no objection is raised, the Commission shall publish in NANDO the notification within 42 days of its having been notified as referred to in paragraph 2.7. 当成员国或委员会根据第6段提出异议时，委员会应在第6段所述的期限到期后10天内将该事项提交MDCG。经与有关各方协商，MDCG应至少在其收到该事项后40天内给出其意见。若MDCG认为可接受该公告，则委员会应在14天在NANDO公布公告。When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall bring the matter before the MDCG within10 days of the expiry of the period referred to in paragraph 6. After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matter having been brought before it. Where the MDCG is of the opinion that the notification can be accepted, the Commission shall publish in NANDO the notification within 14 days.8.  若MDCG在根据第7段进行磋商后，确认现有异议或提出另一异议，公告成员国应在收到MDCG意见后40天内做出书面答复。其答复应处理意见中提出的异议，并说明公告成员国决议指定或不指定该符合性评估机构的原因。Where the MDCG, after having been consulted in accordance with paragraph 7,confirms the existing objection or raises another objection, the notifying Member State shall provide a written response to the MDCG opinion within 40 days of its receipt. The response shall address the objections raised in the opinion, and set out the reasons for the notifying Member State's decision to designateor not designate the conformity assessment body.9. 若公告成员国在根据第8段给出其说明理由后决议任命符合性评估机构，则委员会应在收到通知后14天内在NANDO中公布该公告。Where the notifying Member State decides to uphold its decision to designate the conformity assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in NANDO the notification within14 days of being informed thereof.10. 当在NANDO中发布公告时，委员会还应在第57条所述的电子系统中增加与该公告机构的通知相关的信息、本条第4段中所述的文件以及该条第7和8段中所述的意见和答复。When publishing the notification in NANDO, the Commission shall also add to the electronic system referred to in Article 57 the information relating to the notification of the notified body along with the documents mentioned inparagraph 4 of this Article and the opinion and responses referred toin paragraphs 7 and 8 of this Article.11. 该委任应在NANDO.发布该公告后生效。公布通知应说明公告机构的合法活动范围。The designation shall become valid the day after the notification is published in NANDO. The published notification shall state the scope of lawful conformity assessment activity of the notified body.12.  有关的符合性评估机构只有在根据第11条委任生效后才能开展公告机构的活动。The conformity assessment body concerned may perform the activities of a notified body only after the designation has become valid in accordance with paragraph 11.13. 委员会应在2017年11月26日，通过实施细则起草一份代码和对应的器械类型清单，以说明公告机构的委任范围。且应按照第114(3)条中述及的审查流程通过这些实施细则。委员会在咨询MDCG后，更新本清单，除此之外可更新根据第48条协调活动提供的信息。The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). The Commission, after consulting the MDCG, may update this list based, inter alia, on information arising from the coordination activities described in Article 48.Article 43 标识号和公告机构名单Identification number and list of notified bodies1.委员会应根据第42（11）条为各公告机构分配一个有效标识号。即使该机构已在欧盟多个活动中被任命，委员会也应为其指定一个唯一标识号。如根据本法规成功指定后，公告机构应根据第90/385和93/42/EEC号指令保留根据这些指令分配的标识号。The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11). It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them pursuant to those Directives.2.委员会将基于本法规生成机构名单，包括分配的标识号、本法规定义的符合性评估活动以及公告的器械类型，这些在NANDO向公众公开。该清单还应在第57条所述的电子系统中公布。委员会应确保清单实时更新。The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list available on the electronic system referred to in Article 57. The Commission shall ensure that the list is kept up to date.Article 44公告机构的监督和再评估Monitoring and re-assessment of notified bodies1.公告机构应最迟在15天内，尽快向负责公告机构的主管机构通报可能影响其遵守附录VII要求或其进行指定器械相关的符合性评估活动的相关变化。Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated.2.负责公告机构的主管机构应监督其境内的公告机构及其分支机构和分包商，以确保其持续符合本法规要求并履行其义务。此外，公告机构应根据负责公告机构的主管机构的要求，提供使主管机构、委员会和其他成员国能够验证所需的所有相关信息和文件符合性。 The authorities responsible for notified bodies shall monitor the notified bodies established on their territory and their subsidiaries and subcontractors to ensure ongoing compliance with the requirements and the fulfilment of its obligations set out in this Regulation. Notified bodies shall, upon request by their authority responsible for notified bodies, supply all relevant information and documents, required to enable the authority, the Commission and other Member States to verify compliance.3.  若委员会或成员国主管机构向另一成员国（相关由该机构开展的符合性评估）境内设立的公告机构，其应向负责另一成员国公告机构的主管机构发送一份副本将收到一个由委员会或另一成员国主管机构提交的副本，该副本列有对其境内公告机构执行有关符合性认证情况的所有要求。相关的公告机构在收到该要求后应立即回复，最迟不超过15天。成员国负责公告机构的主管机构应确保任一其他成员国主管机构或委员会向其境内设立的公告机构提交的要求得到解决，如有合法理由拒绝，可提交MDCG处理。Where the Commission or the authority of a Member State submits a request to anotified body established on the territory of another Member State relating to a conformity assessment carried out by that notified body, it shall send a copy of that request to the authority responsible for notified bodies ofthat other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The authority responsible for notified bodies of the Member State in which the body is established shall ensure that requests submitted by authorities of any other Member State or by the Commission are resolved by the notified body unless there is a legitimate reason for not doing so in which case the matter may be referred to the MDCG.4. 负责公告机构（无论其是否在其各自领域设立）的主管机构应至少每年一次，重新评审每家公告机构（且在合适时应包含其分支机构及由其负责的分包商）是否仍然符合要求，以及是否履行了附录VII列出的应尽义务。评审应包含对每一家公告机构（必要时，对其分支机构和分包商）的现场审核。At least once a year, the authorities responsible for notified bodies shall re-assess whether the notified bodies established on their respective territory and, where appropriate, the subsidiaries and subcontractors under there sponsibility of those notified bodies still satisfy the requirements and fulfil their obligations set out in Annex VII. That review shall includean on-site audit of each notified body and, where necessary, of its subsidiaries and subcontractors.负责公告机构的主管机构应按照年度评估计划执行监管和评估活动以确保其能有效监督公告机构一直遵守本法规的要求。该计划应确定合理的时间表，特别应对公告机构及相关分支机构和分包商的评估频率做出规定。该主管机构应就其管辖的每家公告机构向MDCG和委员会提交年度监管或评估计划。The authority responsible for notified bodies shall conduct its monitoring and assessment activities according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the notified body with the requirements of this Regulation. That plan shall provide a reasoned schedule for the frequency of assessment of the notified body and, in particular,associated subsidiaries and subcontractors. The authority shall submit its annual plan for monitoring or assessment for each notified body for which it is responsible to the MDCG and to the Commission.5. 负责公告机构的主管机构对公告机构的监管应包括对公告机构员工的证据审核，必要时可在制造商工厂内进行质量管理体系评估时，对分支机构和分包商的员工进行审核。The monitoring of notified bodies by the authority responsible for notified bodies shall include observed audits of notified body personnel, including where necessary any personnel from subsidiaries and subcontractors, as that personnelis in the process of conducting quality management system assessments at a manufacturer's facility.6.  负责公告机构的主管机构对公告机构执行的监管应考虑从市场监管、警戒和上市后监管所获得的数据，以帮助指导其活动。The monitoring of notified bodies conducted by the authority responsible for notified bodies shall consider data arising from market surveillance, vigilanceand post-market surveillance to help guide its activities.负责公告机构的主管机构应提供一个跟踪体系来处理投诉和其他信息，来源包括其他成员国，这些投诉或信息可能显示公告机构没有履行应尽义务或偏离常规或最佳行为准则。The authority responsible for notified bodies shall provide for a systemtic follow-up of complaints and other information, including from other Member States, which may indicate non-fulfilment of the obligations by anotified body or its deviation from common or best practice.7.  负责公告机构的主管机构除了定期监督或现场评估外，如需解决特定问题或查证守法情况，还可采取临时通知、暗访或“有因”核查的行动。The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify compliance.8.  负责公告机构的主管机构将评估公告机构对制造商技术，尤其是临床文档的评估，进一步规定参加第45条。The authority responsible fornotified bodies shall review the assessments by notified bodies of manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in Article 45.9.  负责公告机构的主管机构应记录并存档有关公告机构不符合附录VII要求的发现并监督其及时采取纠正和预防措施。The authority responsible for notified bodies shall document and record any findings regarding non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective and preventive actions.10.  公告机构通告成立后三年以及此后每隔4年，成员国负责公告机构的主管机构应全面重新评估设立于该国境内的公告机构，以确定其是否仍符合附录VII的要求，并按照第38条和39条所述流程指定联合评审小组。Three years after notification of a notified body, and again every fourth year the reafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conductedby the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team appointed for the purpose of the procedure described in Articles 38 and 39.11. 委员会有权按照第115条采纳授权法案以修改第10段，进而修订该段所述的已开展的全面重新评估的频率。 The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend paragraph 10 to modify the frequency atwhich the complete re-assessment referred to in that paragraph is to becarried out.12. 成员国应当至少每年一次向委员会和MDCG报告对其境内公告机构及其分支机构和分包商（如适用）开展的监督行动和现场评估。该报告应该详述这些活动的结果，包括根据第7段进行的活动。该报告应由MDCG和委员会视为机密信息，但其摘要可公开。 The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. The report shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however it shall contain a summary which shallbe made publicly available.报告摘要应上传至第57条所述的电子系统。The summary of the report shall be uploaded to the electronic system referred to in Article 57.Article 45对公告机构所评估的技术文件和性能评估报告的评审Reviewof notified body assessment of technical documentation and clinical evaluationdocumentation1.作为对公告机构现行监管的一部分，负责公告机构的主管机构应审查适当数量的由公告机构评估的制造商技术文件，尤其是附录II第6.1节（c）点和（d）点中所述的临床评价文件，以验证公告机构根据制造商提供的信息得出的结论。这些负责公告机构的主管机构进行的评估包括现场评估和现场外评估。The authority responsible for notified bodies, as part of its ongoing monitoring of notified bodies, shall review an appropriate number of notified body assessments of manufacturers' technical documentation, in particular the clinical evaluation documentation as referred to in points (c) and (d) of Section 6.1 of Annex II to verify the conclusions drawn by the notified body based on the information presented by the manufacturer. The reviews by the authority responsible for notified bodies shall be conducted both off-site andon-site.2.按照第1段进行的文件抽查应按计划进行，并能代表公告机构出具证书器械的类别和风险，尤其是高风险器械，在抽样计划中应有适当的理由和记录，以便在MDCG要求时负责公告机构的主管机构可获得这部分信息。The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and representative of the types and risk of devices certified by the notified body, in particular high-risk devices, and be appropriately justified and documented in a sampling plan, which shall be made available by the authority responsible for notified bodies to the MDCG upon request.3.负责公告机构的主管机构应审查公告机构所做的评估是否适当，并检查所使用的流程、相关文档和公告机构得出的结论。该检查包括公告机构作为评估依据的制造商技术和临床评估文件。并应利用CS进行这些审查。The authority responsible for notified bodies shall review whether the assessmentby the notified body was conducted appropriately and shall check the procedures used, associated documentation and the conclusions drawn by the notified body. Such checking shall include the technical documentation and clinical evaluation documentation of the manufacturer upon which the notified body has based its assessment. Such reviews shall be conducted utilising CS.4.  这些审查也是公告机构根据第44（10）条进行重新评估和根据第47（3）条进行联合评估活动的部分内容。进行这些审查需使用相应的专业知识。 Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 44(10) and the joint assessment activities referred to in Article 47(3). The reviews shall be conducted utilising appropriate expertise.5. MDCG可根据负责公告机构的主管机构或联合评估小组的审查和评估报告，第VII章中所述市场监管、警戒和上市后监管活动获取的信息，对技术进步的连续监测、对公众担忧和器械安全与性能的新问题的识别，建议按照本条规定进行抽样，抽取的样本应包括更大或更小比例的由公告机构评估的技术文件和临床评估文件。Based on the reports of the reviews and assessments by the authority responsible for notified bodies or joint assessment teams, on input from the markets urveillance, vigilance and post-market surveillance activities described in Chapter VII, on the continuous monitoring of technical progress, or on the identification of concerns and emerging issues concerning the safety and performance of devices, the MDCG may recommend that the sampling, carried out under this Article, cover a greater or lesser proportion of the technical documentation and clinical evaluation documentation assessed by a notified body.6. 委员会可通过实施细则，采取措施制订本条款所述的技术和临床评估文件模式、相关文档和协调要求。应按照第114(3)条述及的审查流程通过这些实施细则。 The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements, associated documents for, and coordination of, the review of assessments of technical documentation and clinical evaluation documentation, as referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).Article 46委任与公告变更Changes to designations and notifications1.负责公告机构的主管机构应通知委员会和其他成员国有关公告机构委任的任何后续相关变更。The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body.第39条和第42条中所述流程适用于委任范围扩大的变更。The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation.在非委任范围扩大的所有其他情况下，在以下段落中规定的程序应适用。For  changes to the designation other than extensions of its scope, the procedures laiddown in the following paragraphs shall apply.2. 委员会应立即在NANDO在公布修订后的公告。委员会应立即在电子系统输入第57条中所述的公告机构委任变化信息。The Commission shall immediately publish the amended notification in NANDO. The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 57.3. 若公告机构决议停止其符合性评估活动，应尽快告知负责公告机构的主管机构和相关制造商，并且在停止评估活动前一年拟定停止计划。若另一公告机构书面确认为证书所包括的器械承担责任，其证书在停止公告机构活动后九个月内暂时有效。新的公告机构应在上述期限结束前完成对受影响器械的全面评估，方可为给这些器械签发新的证书。若公告机构停止其活动，负责公告机构的主管机构应撤销该委任。Wherea notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation.4. 若负责公告机构的主管机构已确定公告机构不再符合附录VII的要求，或其未能履行自身义务，或未执行必要的纠正措施，主管机构可根据未达要求或不履行义务的严重程度，暂停、限制、全部或部分撤销对该机构的委任。一次暂停不得超过一年，但可追加一次同样期限的暂停。Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period.负责公告机构的主管机构应将任何暂停、限制或撤销委任的情况立即通知委员会和其他成员国。The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation5.  若委任已暂停、限制或全部或部分撤销，公告机构应在最迟10天内告知相关制造商。Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at thelatest within 10 days.6. 若发生限制、暂停或撤销委任的情况，负责公告机构的主管机构应当采取适当步骤以确保公告机构的文件送达其他成员国负责公告机构的主管机构及其要求的负责市场监管的主管机构。 In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request.7. 在限制、暂停或撤销委任的情况下，负责公告机构的主管机构应该：In the event of restriction, suspension or withdrawal of a designation, the authority responsiblefor notified bodies shall:(a) 评估对公告机构所签发证书的影响；assessthe impact on the certificates issued by the notified body;(b) 在发出委任变更通知后3个月内向委员会和其他成员国报告结果；submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;(c)  要求公告机构在主管机构决议的合理期限内暂停或撤销任何不当签发的证书，以确保市场上的器械安全；require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market;(d)   将其要求暂停或撤销的所有证书录入第57条中所述的电子系统。enter into the electronic system referred to in Article 57 information inrelation to certificates of which it has required their suspension or withdrawal;(e) 将其要求暂停或撤销的证书通过第57条所述的电子系统通知制造商或其授权代表经营注册地所在成员国的医疗器械主管机构。该主管机构应采取适当措施，以在必要时避免给患者、使用者或其他人的健康或安全带来潜在风险。inform the competent authority for medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 57 of the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others.8.  除不当签发的证书外，在委任出现暂停或限制时，证书在以下情况下仍然有效：With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances:(a) 负责公告机构的主管机构确认在暂停或限制的一个月内，相关证书的安全问题不受暂停或限制的影响；和负责公告机构的主管机构已制定了纠正暂停或限制的时间表和措施；或the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or(b) 负责公告机构的主管机构已确认在暂停或限制期间将不再签发、修订或重新签发与暂停相关的证书，并指出在暂停或限制期间公告机构是否有能力继续监管并负责现有的已签发证书。若负责公告机构的主管机构认为公告机构无能力支持现有已签发证书，则制造商应在暂停或限制3个月内向证书覆盖的器械制造商（有其自己的商业注册地）所在成员国主管机构书面确认由其他合格公告机构临时承担公告机构的监督职能，并继续负责暂停或限制期间的证书。the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.9.  除不当签发的证书外，在撤销委任时，在以下情况下证书仍有9个月的有效期：With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances:(a)    证书覆盖的器械制造商（有其自己商业注册地）所在成员国的医疗器械主管机构已确认未发生与上述器械相关的安全问题。where the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and（b）其他公告机构书面确认将承担这些器械的直接责任，并在委任撤销起12个月内完成对器械的评估。an other notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation.在第一子段中所述的情况下，证书覆盖的器械制造商（有其自己商业注册地）在成员国的医疗器械主管机构可将证书的临时有效期进一步延长3个月（总共不超过12个月）。In the circumstances referred to in the first subparagraph, the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months.承担受委任变更影响公告机构职能的主管机构或公告机构，应立即通知委员会、其他成员国及其他相关公告机构。The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.Article 47对公告机构资质的挑战 Challenge to thecompetence of notified bodies1.委员会联合MDCG会对引发关注的公告机构或其一个/多个分支机构或分包商连续履行附录VII要求或其应承担义务的情况进行调查。应确保负责公告机构的主管机构接到通知并有合适的机会对关注问题进行调查。The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body, or of one or more of its subsidiaries or subcontractors, of the requirements set out in Annex VII or the obligations to which they are subject. It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns.2.公告成员国应按要求向委员会提供有关委任公告机构所发公告的所有信息。The notifying Member State shall provide the Commission, on request, with all information regarding the designation of the notified body concerned.3.  在合理关注公告机构或其分支机构或分包商符合附录VII所列要求的现状和主管机构的调查未能完全解决关注问题时，或应主管机构要求，委员会可联合MDCG启动（如适用）第39(3)和(4)条所述的评估流程。此外，该报告和评估流程的结果应遵循第39条的原则。另外，根据问题的严重程度，委员会和MDCG可要求负责公告机构的主管机构允许来自第40条名单中最多两位专家参与现场评估，作为第44条所述计划检查和评估活动以及第44（4）条所述年度评估计划的一部分。The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described in Article 39(3) and (4), where there is reasonable concern about the ongoing compliance of a notified body or a subsidiary or subcontractor of the notified body with the requirements set outin Annex VII and where the investigation by the authority responsible for notified bodies is not deemed to have fully addressed the concerns or upon request of the authority responsible for notified bodies. The reporting and outcome of that assessment shall follow the principles of Article 39. Alternatively, depending on the severity of the issue, the Commission, inconjunction with the MDCG, may request that the authority responsible fornotified bodies allow the participation of up to two experts from the list established pursuant to Article 40 in an on-site assessment as part of the planned monitoring and assessment activities in accordance with Article 44and as outlined in the annual assessment plan described in Article 44(4).4.  若委员会确定公告机构不再符合其委任要求，应当相应地通知公告成员国，要求其采取必要的纠正措施，包括暂停、限制或必要时撤消委任。Where the Commission ascertains that a notified body no longer meets the requirementsfor its designation, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the designation if necessary.凡成员国未能采取必要的纠正措施，委员会可通过实施细则来暂停、限制或撤销公告。应按照第114(3)条的审查流程通过这些实施细则。应当通知有关成员国相关决议，并更新NANDO和第57条中所述的电子系统。Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdrawthe designation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). It shall notify the Member State concerned of its decision and update NANDO and theelectronic system referred to in Article 57.5.  委员会应确保对调查过程中获得的所有保密信息保密。The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly.Article 48同行评审和负责公告机构的主管机构之间的经验交流Peer review and exchangeof experience between authorities responsible for notified bodies1.委员会应为负责公告机构的主管机构提供经验交流及实践合作的机会。该交流应包括以下内容：The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies. Such exchange shall cover elements including:负责公告机构主管机构活动的最佳实践文件的制定；development of best practice documents relating to the activities of the authorities responsible for notified bodies;与本法规实施相关的公告机构指导性文件的制定；development of guidance documents for notified bodies in relation to the implementation of this Regulation;第40条所述专家的培训和资格认定；training and qualification of the experts referred to in Article 40;监控公告机构委任和公告的变更以及公告机构之间证书撤销和转让的动态；monitoring of trends relating to changes to notified body designations and notifications and trends in certificate withdrawals and transfers between notified bodies;监控第42（13）条所述的范围代码的申请和使用；monitoring of the application and applicability of scope codes referred to in Article 42(13);制定主管机构与委员会之间的同行评审机制；development of a mechanism for peer reviews between authorities and the Commission;向公众传播主管机构和委员会对公告机构的监督和监管活动的方法。methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies.2.负责公告机构的主管机构应根据本条第1段制定的机制每三年参与一次同行评审。该审查通常应在第39条所述的现场联合评估同时进行，另外主管机构可选择进行该审查并作为第44条所述的其监管活动的一部分。 The authorities responsible for notified bodies shall participate in a peer reviewevery third year through the mechanism developed pursuant to paragraph 1of this Article. Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 39. Alternatively, anauthority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 44.3.委员会应参与组织并为同行评审机制的实施提供支持。 The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism.4. 委员会应撰写同行评审活动的年度总结报告并予以公布。The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available.5. 委员会可通过实施细则，采取措施限定本条第1段所述的同行评审机制详细安排和相关文件、培训和资格认定。应按照第114(3)条中所述的审查流程通过这些实施细则。 The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanism and training and qualification as referred to in paragraph 1 of this Article.Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).Article 49公告机构的协调Coordination of notified bodies委员会应确保公告机构之间有适当的协调和合作，并且在医疗器械（包括体外诊断医疗器械）领域内以公告机构协调组的形式进行。该协调组应定期会面，至少每年一次。The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. This group shall meet on a regular basis and atleast annually.根据本法规，公告机构应参与该协调组的工作。The bodies notified under this Regulation shall participate in the work of that group.委员会可建立公告机构协调组的具体安排。The Commission may establish the specific arrangements for the functioning of the coordination group of notified bodies. Article 50收费标准列表 List of standard fees公告机构应制定并公开其所开展的符合性评估活动的收费标准列表。Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available.