MDR法规原文中英对照 第51~52条

SECTION 1 Classification

Article 51 Classification  of devices

1. 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. 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.

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 request.

3. At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following:

(a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such  devices;

(b) 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 dero­ gation from Annex VIII.

4. 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. 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. 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).

SECTION 2 Conformity assessment

Article 52  Conformity assessment procedures

1. 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. 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. 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 as specified in Annex X coupled with a conformity assessment as specified in Annex XI.

4. 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  an assessment of the technical  documentation  as  specified  in  Section  4  of that Annex of at least one representative device per generic device group.

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 docu­ mentation as specified in Section 4 of Annex IX shall apply for every device.

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. 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 therefrom.

6. 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  as  specified  in  Section  4  of that Annex  of at least one  representative device for each category     of devices.

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 for each category of devices.

7. Manufacturers of class I devices, other than custom-made or inves­ tigational 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:

(a) in the case of devices placed on the market in  sterile condition,  to the aspects relating to establishing, securing and maintaining sterile conditions;

(b) in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements;

(c) in the case of reusable surgical instruments, to the aspects relating     to the reuse of the device, in particular cleaning, disinfection, ster­ ilization, maintenance and functional testing and the related instructions for use.

8. 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.

In addition to the procedure applicable pursuant to the first subpara­ graph, 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. 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, as applicable, shall also apply.

10. In addition to the procedures applicable pursuant to paragraph 3,  4, 6, or 7 of this Article, in the case of devices that are covered by this Regulation in accordance with point (f) or (g) of Article 1(6) and with  the first subparagraph of Article 1(10), the procedure specified  in  Section 5.3 of Annex IX or  Section  6  of  Annex  X,  as  applicable, shall also apply.

11. 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 orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the procedure specified in Section 5.4 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.

12. The Member State in which the notified body is established may require that all or certain documents, including the technical documen­ tation, 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. Investigational devices shall be subject to the requirements set   out in Articles 62 to 81.

14. 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 aspects:

(a) 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) the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified  bodies  in  accordance  with  Section 3.4 of Annex IX,  taking  into  account  the  risk-class  and the type of device;

(c) 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.

The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).

1.考虑到设备的预期用途及其固有风险，设备应分为I，IIa，IIb和III类。分类应按照附件8进行。

2．由于适用附件八而引起的制造商与公告机构之间的任何争议，应移交给制造商在其注册的营业地点的成员国的主管当局作出决定。如果制造商在联盟中没有注册营业地点并且尚未指定授权代表，则应将此事项提交给最后一个缩进点所提及的授权代表所在的成员国的主管当局（附件IX第2.2节第二段的b）有其注册营业地点。如果在制造商以外的成员国中建立了有关公告机构，则主管当局应在与指定公告机构的成员国的主管当局协商后通过其决定。

制造商在其注册地所在的成员国的主管当局应将其决定通知MDCG和委员会。该决定应应要求提供。

3.应成员国的请求，委员会应在征询MDCG之后，通过采取行动决定以下事项：

（a）将附件8适用于给定的设备，设备类别或设备组，以确定此类设备的分类；

（b）出于公共卫生的考虑，应基于新的科学证据或基于在警戒和市场监督活动过程中可获得的任何信息的一种或一种或一组设备，将其重新分类，从附件八中删除。

4，委员会也可以在与MDCG磋商后，主动采取行动，对第3款（a）和（b）所述的问题作出决定。

5，为确保附件八的统一适用，并考虑到有关科学委员会的有关科学意见，委员会可在必要的范围内采取执行措施，以解决分歧的解释和实际适用的问题。

6，本条第三款，第四款和第五款所指的实施行为，应按照第一百一十四条第三款所述的审查程序通过。

1，在将设备投放市场之前，制造商应根据附件IX至XI中规定的适用的合格评定程序对该设备的合格性进行评估。

2在未投放市场的设备投入使用之前，制造商应根据附件IX至XI中列出的适用的合格评定程序对该设备的合格性进行评估。

3，除定制或研究用设备外，III类设备的制造商应接受附件IX规定的合格评定。或者，制造商可以选择应用附件X中规定的合格性评估以及附件十一中规定的合格性评估。

4，IIb类设备的制造商，除定制或研究性设备外，应接受附件IX第I章和第III章中规定的合格评定，并包括对第4节中规定的技术文件的评定每个通用设备组至少有一个代表性设备的附件。

但是，对于IIb类可植入设备，除了缝线，钉书钉，牙科填充物，牙齿矫正器，牙冠，螺钉，楔形物，板，线，销，夹子和连接器外，应按附件第4节中的规定对技术文档进行评估。 IX适用于所有设备。

或者，制造商可以选择应用基于附件X中规定的类型检查的合格性评估，以及基于附件十一中规定的产品合格性验证的合格性评估。

5，鉴于成熟的技术是合理的，类似于本条第4款第二项所列的豁免设备中使用的技术，或在其他IIb类可植入设备中使用的技术，或为保护健康而合理的技术以及患者，使用者或其他人的安全或公共卫生的其他方面，委员会有权根据第115条采取授权行动，通过在列表中添加其他类型的IIb类可植入设备或从中删除设备来修改该列表。

6，IIa类设备的制造商，除定制或研究性设备外，应接受附件IX第一章和第三章中规定的合格评定，并包括对该书第4节中规定的技术文件的评定每种设备类别至少有一个代表性设备的附件。

或者，制造商可以选择起草附件2和附件3中所列的技术文件，以及附件11第10节或第18节中规定的合格评定。对于每种设备类别，技术文件的评估应至少适用于一个代表性设备。

7，除定制或研究用设备以外的I类设备的制造商应在草拟附件II和III中规定的技术文件后，通过发布第19条所述的欧盟合格声明来声明其产品的合格性。如果这些设备在无菌条件下投放市场，具有测量功能或可重复使用的外科手术器械，则制造商应采用附件IX第I和III章或附件XI A部分规定的程序。但是，公告机构在这些程序中的参与应受到限制：

（a）就以无菌状态投放市场的器械而言，涉及与建立，确保和维持无菌状态有关的方面；

（b）就具有测量功能的设备而言，涉及与设备符合计量要求的方面；

（c）就可重复使用的手术器械而言，涉及与器械的再利用有关的方面，尤其是清洁，消毒，灭菌，维护和功能测试以及相关的使用说明书。

8.定制设备的制造商在将此类设备投放市场之前，应遵循附件XIII中规定的程序并草拟该附件第1节中的声明。

除根据第一小节适用的程序外，III类定制植入式器械的制造商还应接受附件IX第I章中规定的合格评定。或者，制造商可以选择按照附件XI A部分的规定进行合格评定。

9，除适用本条第3、4、6或7款规定的程序外，对于第1条第（8）款第1项所指的设备，还应采用附件IX第5.2节规定的程序或附件X第6节（如适用）也应适用。

10，除了依照本条第3款，第4款，第6款或第7款适用的程序外，对于根据本条例第1条第（6）款（f）或（g）项适用的设备）以及第1条第10款的第一小节，还应适用附件IX第5.3节或附件X第六节中规定的程序。

11，除第3、4、6或7款适用的程序外，如果设备是由旨在通过人体孔口或人体引入人体的物质或物质组合构成的，适用于皮肤并被人体吸收或局部分散在人体上的皮肤，也应适用附件IX第5.4节或附件X第6节规定的程序。

12.设立公告机构的会员国可要求制作与第1至7和9至11段所述程序有关的全部或某些文件，包括技术文件，审计，评估和检查报告。以该成员国确定的官方联盟官方语言提供。在没有此类要求的情况下，应以公告机构可以接受的任何正式联盟语言提供这些文件。

13，调查设备应遵守第62至81条规定的要求。

14.委员会可通过实施法案，规定详细的安排和程序方面，以确保公告机构在下列方面中的任何方面统一适用合格评定程序：

 （a）对于IIa类和IIb类设备，以及在附件IX的第2.3节第3段和附件IX的第3.5节中规定的，以代表性为基础的技术文档评估的频率和抽样基础。对于IIa类设备，附件XI第10.2节；

（b）考虑到风险等级和设备类型，公告机构根据附件IX第3.4节进行的未宣布的现场审核和样品测试的最低频率；

（c）认证机构根据本节规定进行的样品测试，技术文档评估和型式检验的物理，实验室或其他测试

附件IX的3.4和4.3，附件X的第3节和附件XI的第15节。

第一项规定的实施行为，应按照第114条第3款规定的审查程序通过。