MDR法规说明书要求:
说明书应同时满足以下要求：
a. 符合医疗器械CE认证新MDR法规附录I中第3章的要求；
b. 符合产品标准中有关说明书和标签的要求；
c. 符合标准EN ISO 15223-1:2016， EN 1041:2008+A1:2013等相关标准要求。
说明书包含但不限于以下信息
产品名称，产品预期用途，适用症，预期使用人群，规格型号，禁忌症，任何副反应和剩余风险，注意事项，是否灭菌/灭菌方式，产品使用方法，器械连用说明，一次性使用，有效期或者使用寿命，贮藏条件，CE标识，标识及标识解释，制造商信息，欧代信息，说明书版本。对于植入和III类器械，应在说明书列出SSCP的获得地址。
Re of MDR regulation specification:
The instructions shall also meet the following re:
a. Conform to the re of Chapter 3 in Appendix I of thenew MDR regulations for CE certification of medical devices;
b. Comply with the re of relevant instructions andlabels in product standards;
c. Comply with EN ISO 15223-1:2016, EN 1041:2008+A1:2013 andother relevant standards.
The instructions include but are not limited to the followinginformation
Product name, intended use of the product, applicableconditions, intended users, specifications and models,contraindications, any side effects and residual risks,precautions, whether or not sterilization/sterilization methods,product use methods, instructions for continuous use of devices,one-time use, expiry date or service life, storage conditions, CElogo, logo and logo interpretation, manufacturer information,European information, and manual version. For implanted and ClassIII devices, the address of SSCP ac shall be listed in theinstruction manual.
