MDR-EU-2017-745-欧盟医疗器械法规 -附录 12

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本文转载自“木之唐咨询”

ANNEX XII 由公告机构签发的证书

CERTIFICATES ISSUED BY A NOTIFIED BODY

第I章 CHAPTER I一般要求GENERAL REQUIREMENTS

1.       应用欧盟的其中一种官方语言起草证书；Certificates shall be drawn up in one of the official languages ofthe Union.

2.       各证书均应仅参考一种符合性评估流程；Each certificate shall refer to only one conformity assessmentprocedure.

3.       证书应仅颁发给一家制造商证书中包含的制造商名称和地址应与在第30条中所述的电子系统中注册的信息相同；Certificates shall onlybe issued to one manufacturer. The name and address of the manufacturerincluded in the certificate shall be the same as that registered in theelectronic system referred to in Article 30.

4.       证书适用范围的内容应明确说明所涵盖的器械：The scope of the certificates shall unambiguously identify thedevice or devices covered:

EU技术文件评估证书、EU型式检验证书和EU产品验证证书应包含明确标识，包括器械名称、型号、类型、预期用途（制造商在使用说明中包含的并已通过符合性评估流程进行评定的预期用途）、风险分类以及第27(6)条所述的基本UDI - DI号；EU technical documentation assessment certificates, EU type-examinationcertificates and EU product verification certificates shall include a clearidentification, including the name, model and type, of the device or devices,the intended purpose, as included by the manufacturer in the instructions foruse and in relation to which the device has been assessed in the conformityassessment procedure, risk classification and the Basic UDI-DI as referred toin Article 27(6);

EU质量管理体系证书和EU质量保证证书应包括器械标识或器械组别、风险分类和IIb类器械的预期用途；EU quality management system certificates and EU quality assurancecertificates shall include the identification of the devices or groups ofdevices, the risk classification, and, for class IIb devices, the intendedpurpose.

5.       公告机构应能够应要求说明证书所涵盖的（单一）器械。公告机构应说明能够确定证书所涵盖器械（包括其分类）的方法；The notified body shall be able to demonstrate on request, which(individual) devices are covered by the certificate. The notified body shallset up a system that enables the determination of the devices, including theirclassification, covered by the certificate.

6.       如适用，证书应包含本证书所涵盖器械的上市记录，还需根据本法规颁发的另一证书；Certificates shall contain, if applicable, a note that, for theplacing on the market of the device or devices it covers, another certificateissued in accordance with this Regulation is required.

7.       根据第52(7)条需要涉及公告机构的第I类器械的EU质量管理体系证书和EU质量保证证书应包含一份声明，声明公告机构已审核质量管理体系涉及该段中要求的方面。EU quality management system certificates and EU quality assurancecertificates for class I devices for which the involvement of a notifiedbody is required pursuant to Article 52(7) shall include a statement thatthe audit by the notified body of the quality management system was limited tothe aspects required under that paragraph.

8.       若本证书代替先前证书，即增补、修改或重新颁发证书时，新证书应包含先前证书的参考资料及其颁发日期以及变更标识。Where a certificate is supplemented, modified or re-issued, the newcertificate shallcontain a reference to the preceding certificate and its dateof issue with identification of the changes.

第II章证书的必需内容MINIMUMCONTENT OF THE CERTIFICATES

1.       公告机构名称、地址和标识号；name,address and identification number of the notified body;

2.       制造商和授权代表（如适用）的名称和地址；name and address of the manufacturer and, if applicable, of theauthorised representative;

3.       证书的唯一标识号；unique number identifying the certificate;

4.       第31(2)条所述的制造商单一注册号；if already issued, the SRNof the manufacturer referred to in to Article 31(2);

5.       颁发日期；

6.       date of issue;

7.       失效日期；

8.       date of expiry;

9.       符合第I部分第4节规定的器械明确标识所需数据（如适用）；data needed for the unambiguous identification of the device ordevices where applicableas specified in Section 4 of Part I;

10.   如适用，参照在第I章第8节指定的先前证书；if applicable, reference to anyprevious certificate as specified in Section 8 of Chapter I;

11.    符合所进行符合性评估要求的本法规和相关附录参考资料；reference to this Regulation and the relevant Annex inaccordance with which the conformity assessment has been carried out;

12.    所进行的检验和试验，例如相关CS、协调标准、检验报告和审核报告的参考资料；examinations andtests performed, e.g. reference to relevant CS, harmonised standards, testreports and audit report(s);

13.    涵盖器械上市所需技术文件相关部分或其他证书的参考资料（如适用）；if applicable, reference to the relevant parts of the technicaldocumentation or other certificates required for the placing on the market ofthe device or devices covered;

14.    公告机构的监管信息（如适用）；if applicable, information about the surveillance by the notifiedbody;

15.    公告机构针对相关附录的符合性评估结论；conclusions of the notified body's conformity assessment with regardto the relevant Annex;

16.    证书有效性的条件或限制；conditionsfor or limitations to the validity of the certificate;

17.    符合相关国家法律要求且具有法律约束力的公告机构签名。legally binding signature of the notified body in accordance withthe applicable national law.