The MDS-codes are mainly relevant for the allocation of personnel involved in the review of technical documentation. This is because, generally, the auditing aspects linked to MDS codes have their corresponding MDT code for the relevant technology (e.g. MDS 1001 Devices incorporating medicinal substances vs MDT 2007

「6」MDA/MDN,MDS和MDT. 医疗器械协调小组（MDCG）曾发布指南文件《MDCG 2019-14 MDR代码说明》( MDCG 2019-14 Explanatory note on MDR codes)， 指南解释了可分配给不同器械的代码类型。主要分为以下三种类型的代码：

2021年10月22日 · 立即注册 x MDR，IVDR 中需要用到的各种code,大家各取所需，MDA 有源器械，MDN无源器械，MDS特定类别，MDT生产工艺. 您需要 登录 才可以下载或查看，没有帐号？ 立即注册. 非常感谢楼主，真的很有用处。 小新11. 当前离线. 感谢分享。 非常感谢楼主，真的很有帮助。 感谢楼主分享！ 感谢分享！ 1、本站为技术交流论坛，发帖的内容具有互动属性。 您在本站发布的内容： ①在无人回复的情况下，可以通过自助删帖功能随时删除（自助删帖功能关闭 …

2024年9月26日 · MDR codes are essential for any medical device manufacturer aiming for certification under European standards. Codes MDA, MDN, MDS, and MDT make up a classification system that helps to accurately describe each device, select the right Notified Body (NB), and assign qualified auditors.

The following MDT codes should be assigned: • “MDT 2008 Devices manufactured in clean rooms and associated controlled environments”, because the manufacturing of the implant is in a controlled environment, • “MDT 2005 Devices manufactured using bio-technology”, because the main risks in man-ufacturing are related to the production and

The document is intended for information about the preparatory works on the future implementing legislation and it is without prejudice to the final text of such implementing legislation.

Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical de...

2022年7月28日 · mdt一共有13个代码，分别是mdt2001~mdt2013； 随着MDR的正式实施，各医疗器械制造商已开始逐步提交MDR申请，但是在提交过程中难免遇到不少MDR code。 诸多客户问询，均表示：对于纷繁复杂的MDR code很是陌生和无措。

Learn how MDA, MDN, MDS, and MDT codes are used in MDR and IVDR regulatory processes. Understand their role in device classification, Notified Body assessments, and conformity audits to ensure compliance with EU medical device regulations.

2023年3月1日 · MDS 代码反映了设备的特定特性，每个设备有零到几个适应的代码： MDT 代码描述了设备的主要生产技术和工艺，每个设备对应一到几个代码： （全文完）