MDR-EU-2017-745-欧盟医疗器械法规 -附录 13

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本文转载自“木之唐咨询”

ANNEX XIII 定制器械的步骤

PROCEDURE FOR CUSTOM-MADE DEVICES

1.       对于定制器械，制造商或其授权代表应起草声明，包含以下信息：For custom-made devices, the manufacturer or its authorisedrepresentative shall drawup a statement containing all of the followinginformation:

制造商的名称和地址，以及其他生产场所，the name andaddress of the manufacturer, and of all manufacturing sites,如适用，法定代表的姓名和地址，if applicable, the name and address of the authorisedrepresentative,

标识问题器械的数据，data allowingidentification of the device in question,

声明器械经用于特定患者或使用者，按名称首字母缩写或数字代码标识，astatement that the device is intended for exclusive use by a particularpatientor user, identified by name, an acronym or a numerical code,

由国家法律因其专业资格授权制定规定人士的姓名，及有关医疗机构的名称（如适用），the name of the person who made out the prescription and who isauthorised by national law by virtue of their professional qualifications to doso, and, where applicable,the name of the health institution concerned,

规定中所述产品的具体特征，the specificcharacteristics of the product as indicated by the prescription

声明问题器械符合附录I所述通用安全与性能要求，说明未完全符合的通用安全与性能要求（如适用），及理由，a statement that the device in question conforms to the generalsafety and performance requirements set out in Annex I and, whereapplicable, indicating which general safety and performance requirements havenot been fully met, together with the grounds,

该器械如欧盟委员会第722/2012号法规所述包含药械组合，人血液或血浆的衍生物，人或动物来源的组织或细胞，where applicable, an indication that the device contains orincorporates a medicinal substance, including a human blood or plasmaderivative, or tissues or cells of human origin, or of animal origin as referredto in Regulation (EU) No 722/2012.。

2.       制造商应保证国家主管机构可随时查阅文档，说明生产场所，帮助理解产品的设计、生产和性能（包括预期性能），以便允许评估是否符合本法规要求进行评估。The manufacturer shall undertake to keep available for the competentnational authorities documentation that indicates its manufacturing site orsites and allows an understanding to be formed of the design, manufacture andperformance of the device, including the expected performance, so as to allowassessment of conformity with the requirements of this Regulation.

3.       制造商应采取一切必要的措施，确保依据生产工艺生产出的产品在生产过程中遵守第2节所述文件中的要求；The manufacturer shall take allthe measures necessary to ensure that the manufacturing process producesdevices which are manufactured in accordance with the documentation referred toin Section 2.

4.       本附录有关声明中所含信息应在器械上市后保存至少10年的时间。对于植入性器械，此期限应至少为15年。The statement referred to in the introductory part of Section 1shall be kept for a period of at least 10 years after the device has beenplaced on the market. In the case of implantable devices, the period shall beat least 15 years.附录IX第8节应适用。Section 8 of Annex IX shall apply.

5.       制造商应承诺审查并记录在生产后阶段中获得的经验，包括附录XIV第B部分中所述的PMCF，并采取适当的手段落实任何必要的纠正措施。该承诺应包括制造商在获悉任何严重事件和/或现场安全纠正措施之后，立即根据第87(1)条向主管机构发送通知的义务。The manufacturer shall review and document experience gained in thepost-production phase, including from PMCF as referred to in Part B ofAnnex XIV, and implement appropriate means to apply any necessarycorrective action, In that context, it shall report in accordance withArticle 87(1) to the competent authorities any serious incidents or fieldsafety corrective actions or both as soon as it learns of them.