MDR-EU-2017-745-欧盟医疗器械法规 -附录 11

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本文转载自“木之唐咨询”

ANNEX XI
ANNEX XI  基于产品合规性验证的符合性评估 CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION


1.    基于产品合规性验证的符合性评估的目的是确保器械符合已发布EC型式检验证书中所说明的形式，并满足本法规中的适用规定要求。The objective of the conformity assessment based on product conformity verificationis to ensure that devices conform to the type for which an EU type-examination certificate has been issued, and that they meet the provisions of this Regulation which apply to them.

2.    如已根据附录X颁发EC型式检验证书，制造商可申请表第A部分所述流程（生产质量保证），或本附录第B部分所述流程（产品验证）。Where an EU type-examination certificate has been issued in accordance with Annex X, the manufacturer may either apply the procedure set out in Part A (production quality assurance) or the procedure set out in Part B (product verification)of this Annex.

3.    通过豁免上述第1节和第2节，本附录所述程序加上附录II和III所述技术文件也可适用于IIa类器械制造商。By way of derogation from Sections 1 and 2 above, the procedures in this Annex coupled with the drawing up of technical documentation as set out in Annexes II and III may also be applied by manufacturers of class IIa devices.

第A部分：PART A生产质量保证  PRODUCTION QUALITY ASSURANCE

4.    制造商应确保实施批准的相关器械生产质量管理体系，并按照第6节的规定进行最终验证，且接受第7节所述的监管。The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out a final verification, as specified in Section 6, and shall be subject to the surveillance referred to in Section 7.

5.   制造商应履行第4节所规定的义务，并根据第19条和附录IV起草并保存符合性评估流程所涵盖器械型号的EU符合性声明。通过发布EC符合性声明，制造商应确定并声明有关器械是否符合EC型式检验证书中所说明的型式，以及是否满足本法规中的适用规定要求。When the manufacturer fulfils the obligations laid down in Section 4, it shall draw up and keep an EU declaration of conformity in accordance with Article 19 and Annex IV for the device covered by the conformity assessment procedure. By issuing an EU declaration of conformity, the manufacturer shall be deemed to ensure and to declare that the device concerned conforms to the type described in the EU type-examination certificate and meets the requirements of this Regulation which apply to the device.

6.    质量管理体系 Quality management system
6.1    制造商应向公告机构提出申请表，评估自己的质量管理体系。申请表应当包括： The manufacturer shall lodge an application for assessment of its quality management system with a notified body. The application shall include:附录IX第2.1节所列的所有要素；all elements listed in Section 2.1 of Annex IX,附录II和III所述批准型式的技术文件；the technical documentation referred to in Annexes II and III for the types approved, and附录X第4节所述EC型式检验证书副本；若提出申请表后，EC型式检验证书由同一公告机构颁发，则技术文件及其更新信息和所颁发证书的参考资料应包含在申请中。a copy of the EU type-examination certificates referred to in Section 4 of Annex X; if the EU type-examination certificates have been issued by the same notified body with which the application is lodged, a reference to the technical documentation and its updates and the certificates issued shall also be included in the application.
6.2    质量管理体系的实施应确保器械是否符合EC型式检验证书中所说明的型式，以及是否满足本法规中的适用于各阶段器械的规定要求。制造商为其质量管理体系而采用的所有要素、要求和规定，必须以系统和有序的方式记录在质量手册、书面政策和程序之中，例如质量程序、质量计划和质量记录。Implementation of the quality management system shall be such as to ensure that there is compliance with the type described in the EU type-examination certificate and with the provisions of this Regulation which apply to the devices at each stage. All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures, such as quality programmes, quality plans and quality records.该文件尤其应包括对附录IX第2.2节（a）、（b）、（d）和（e）所列所有要素的适当说明。That documentation shall, in particular, include an adequate description of all elements listed in points (a), (b), (d) and (e) of Section 2.2 of Annex IX.
6.3     附录IX第2.3节第一和第二段的规定适用。The first and second paragraph of Section 2.3 of Annex IX shall apply.若质量管理体系可确保器械符合EC型式检验证书中所说明的形式，并满足本法规中的适用规定要求，则欧盟公告机构应出具欧盟质量保证证书。公告机构应将该决议通知制造商。该决议应包含公告机构审核和合理评估的结论。If the quality management system is such that it ensures that the devices conform to the type described in the EU type-examination certificate and that it conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality assurance certificate. The notified body shall notify the manufacturer of its decision to issue the certificate. That decision shall contain the conclusions of the notified body's audit and a reasoned assessment.
6.4     附录IX第2.4节规定应适用。 Section 2.4 of Annex IX shall apply.

7.     监测 Surveillance附录IX第3.1节、第3.2节第一段、第二段和第四段、第3.3节、第3.4节、第3.6节和第4.7节的规定适用。对于III类器械，监管还应包括检查生产或购买原材料或批准用于该类型的关键部件的数量，且应与成品器械数量相对应。Section 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and 3.7 of Annex IX shall apply.In the case of class III devices, surveillance shall also include a check that the quantities of produced or purchased rawmaterial or crucial components approved for the type and correspond to the quantities of finished devices.

8.   结合药物共同使用时，根据第1(8)条器械可被视为整体部分的人血样或血浆源医药产品按批次进行验证结合药物共同使用，根据第1(8)条第一子段可被视为整体部分的人血样或血浆源医药产品的器械生产完成后，制造商应通知欧盟公告机构器械批号，并向欧盟公告机构发送成员国国家实验室或根据第2001/83/EC号指令第114(2)节由成员国指定实验室颁发的使用人血液或血浆衍生物器械的官方证明。Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(8).Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2)of Directive 2001/83/EC

9.   行政管理规定 Administrative provisions制造商或其授权代表（如制造商在成员国内无注册地址）应在最后一个器械上市至少10年内（植入式器械为至少15年内）按照主管机构指示，保管以下文件：The manufacturer or, where the manufacturer does not have a registered place of businessin a Member State, its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:EU符合性声明；the EU declaration of conformity,附录IX第2.1节第五段所述的文件，the documentation referred to in the fifth indent of Section 2.1 of Annex IX,附录IX第2.1节第八段所述的文件，包括附录X所述的EC型式检验证书，the documentation referred to in the eighth indent of Section 2.1 of Annex IX, including the EU type-examination certificate referred to in Annex X,附录IX第2.4节所述的变更信息；以及informationon the changes referred to in Section 2.4 of Annex IX, and附录IX第2.3、3.3和3.4节所述的公告机构决议和报告。the decisions and reports from the notified body as referred to in Sections 2.3,3.3 and 3.4 of Annex IX.附录IX第8节应适用。Section 8 of Annex IX shall apply.

10.    适用于IIa类器械 Application to class IIa devices
1.1       通过豁免第5节，制造商可根据EC符合性，确定并声明相关IIa类器械是否符合附录II和III所述技术文件，以及是否满足本法规中的适用规定要求。By way of derogation from Section 5, by virtue of the EU declaration of conformity the manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are manufactured in conformity with the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them.
1.2       对于IIa类器械，作为第6.3节所述评估的一部分，欧盟公告机构应评估附录II和III所述技术文件中所选器械是否符合本法规规定。For class IIa devices the notified body shall assess, as part of the assessment referred to in Section 6.3, whether the technical documentation as referred to in Annexes II and III for the devices selected on a representative basis is compliant with this Regulation.在选择器械的代表性样品时，欧盟公告机构应考虑到技术的创新性，设计、工艺、生产和灭菌方法的相似性，预期用途和之前根据本法规进行的有关评估结果（如物理、化学、生物或临床特性）。欧盟公告机构应记录其选择器械样品的理由。In choosing a representative sample or samples of devices, the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical, biological or clinical properties) that have been carried out in accordance with this Regulation. The notified body shall document its rationale for the sampleor samples of devices taken.
1.3       如按照第10.2节进行评估，结果确认IIa类器械符合附录II和III所述技术文件，并满足本法规本部分中的适用规定要求，欧盟公告机构应根据本附录该节出具证明。Where the assessment under Section 10.2. confirms that the class IIa devices inquestion conform to the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them, the notified body shall issue a certificate pursuant to this Part of this Annex.
1.4       作为第7节所述监管评估的一部分，欧盟公告机构应对器械进行再次抽样评估。Samples additional to those taken for the initial conformity assessment of devices shall be assessed by the notified body as part of the surveillance assessment referred to in Section 7.
1.5       通过豁免第6节，制造商或其授权代表应在最后一个器械上市至少10年内，按照主管机构指示，保管以下文件：By way of derogation from Section 6, the manufacturer or its authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities:EC符合性声明；the EU declaration of conformity,附录II和III所述技术文件，the technical documentation referred to in Annexes II and III, and第10.3节所述证书。the certificate referred to in Section 10.3.附录IX第8节应适用。Section 8of Annex IX shall apply.

第B部分：PART B产品验证 PRODUCT VERIFICATION

11.    产品验证应理解为指产品经制造商检查后，根据第19条和附录IV出具EC符合性声明，并依据第14节和第15节所述过程确定并声明并器械是否符合EC型式检验证书中所说明的形式，并满足本法规中适用规定要求的过程。Product verification shall be understood to be the procedure where by after examination of every manufactured device, the manufacturer, by issuing an EU declaration of conformity in accordance with Article 19 and Annex IV, shall be deemed to ensure and to declare that the devices which have been subject to the procedureset out in Sections 14 and 15 conform to the type described in the EU type-examination certificate and meet the requirements of this Regulation which apply to them.

12.    制造商应采取一切必要措施，以确保生产的器械均符合EC型式检验证书中所说明的形式，并满足本法规中适用规定的要求。生产开始前，制造商应规定文档定义生产流程，特别是与必要消毒和所有预先确定的日常规定有关的流程，以保证生产同类产品，并符合EC型式检验证书中所说明的形式，且满足本法规中适用规定的要求（如适用）。The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which conform to the type described in the EU type-examination certificate and to the requirements of the Regulation which apply to them. Prior to the start of manufacture, the manufacturer shall prepare documents defining the manufacturing process, in particular as regards sterilisation where necessary, together with all routine, pre-established procedures to be implemented to ensur ehomogeneous production and, where appropriate, conformity of the devices withthe type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them.此外，对于上市的无菌器械以及用于确保和维护无菌条件的生产过程，制造商应适用第6节和第7节的规定。Inaddition, for devices placed on the market in a sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer shall apply the provisions of Sections 6 and 7.

13.    制造商应组织并不断更新上市后监管计划，其中包括PMCF计划和确保遵守制造商义务的过程，详见第VII章警醒症与上市后监管体系规定。The manufacturer shall undertake to institute and keep up to date a post-market surveillance plan, including a PMCF plan, and the procedures ensuring compliance with the obligations of the manufacturer resulting from the provisions on vigilance and post-market surveillance system set out in Chapter VII.

14.    欧盟公告机构应根据第15条所述方法进行适当的检查和测试，以验证器械符合法规要求。The notified body shall carry out the appropriate examinations and tests in orderto verify the conformity of the device with the requirements of the Regulationby examining and testing every product as specified in Section 15.本节第一段所述的检查和试验不适用于用于确保无菌条件的生产过程。The examinations and tests referred to in the first paragraph of this Section shall not apply to aspects of the manufacturing process designed to secure sterility.

15.    通过检查和测试验证器械的符合性Verification by examination and testing of every product
15.1  对各器械进行单独检查，应进行第8条相关标准中定义的适当物理试验或实验室试验或同等测试和评估，以确定器械符合EC型式检验证书中所说明的形式，且满足本法规中适用规定的要求（如适用）。Every device shall be examined individually and the appropriate physical or laboratory tests as defined in the relevant standard or standards referred to in Article 8, or equivalent tests and assessments, shall be carried out in order to verify, where appropriate, the conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them.
15.2  欧盟公告机构应在每台认可器械上贴上标识号，并根据所进行的测试和评估出具欧盟产品验证证书。The notified body shall affix, or have affixed, its identification number to each approved device and shall draw up an EU product verification certificate relating to the tests and assessments carried out.

16.    结合药物共同使用时，根据第1(8)条器械可被视为作为整体部分的人血样或血浆源医药产品按批次进行验证Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(8).结合药物共同使用，根据第1(8)条第一子段可被视为作为整体部分的人血样或血浆源医药产品的器械生产完成后，制造商应通知欧盟公告机构器械批号，并向欧盟公告机构发送成员国实验室或根据第2001/83/EC号指令第114(2)节由成员国指定实验室颁发的使用人血液或血浆衍生物器械的官方证明。Upon completing the manufacture of each batch of devices that incorporate, as anintegral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it theofficial certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or alaboratory designated for that purpose by a Member State inaccordance with Article 114(2) of Directive 2001/83/EC.

17.    行政管理规定Administrative provisions制造商或其授权代表应在最后一个器械上市至少10年内（植入式器械为至少15年内），按照主管机构指示，保管以下文件：The manufacturer or its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:EU符合性声明；the EU declaration of conformity,第12节所述文件，the documentation referred to in Section 12,第15.2节所述证书，the certificate referred to in Section 15.2, and附录X所述EC型式检验证书。the EU type-examination certificate referred to in Annex X.附录IX第8节应适用。Section 8 of Annex IX shall apply.

18.    适用于IIa类器械Application to class IIa devices
18.1 通过豁免第11节，制造商可根据EC符合性，确定并声明IIa类器械是否符合附录II和III所述技术文件，以及是否满足本法规中的相应规定要求。 By way of derogation from Section 11, by virtue of the EU declaration of conformity the manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are manufactured in conformity with the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them.
18.2 由欧盟公告机构按照第14节进行的器械验证是用于确认IIa类器械是否符合附录II和III所述技术文件，以及是否满足本法规中的相应规定要求。 The verification conducted by the notified body in accordance with Section 14 is intended to confirm the conformity of the class IIa devices in question with the technical documentation referred to in Annexes II and III and with the requirements of this Regulation which apply to them.
18.3 如按照第18.2节进行验证，结果确认IIa类器械是否符合附录II和III所述技术文件，以及是否满足本法规中的相应规定要求，欧盟公告机构应根据本附录该节出具证明。 If the verification referred to in Section 18.2 confirms that the class IIa devices in question conform to the technical documentation referred to in Annexes IIand III and meet the requirements of this Regulation which apply to them, the notified body shall issue a certificate pursuant to this Part of this Annex.
18.4  通过豁免第17节，制造商或其授权代表应在最后一个器械上市至少10年内，按照主管机构指示，保管以下文件：By way of derogation from Section 17, the manufacturer or its authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities:EU符合性声明；the EU declaration of conformity,附录II和III所述技术文件，the technical documentation referred to in Annexes II and III, and第18.3节所述证书。the certificate referred to in Section 18.3.附录IX第8节应适用。Section 8 of Annex IX shall apply.