Background As a consequence of sustained scientific and technological advancements, the directive 98/79/EC is no longer 'fit for purpose.' The agreement reached on the medical device regulation (MDR) and In vitro diagnostic medical devices (IVDR) was jointly announced by the European parliament ...
内容提示: 龙德出品REGULATION (EU) 2017/745 欧盟医疗器械法规龙德医疗器械工具丛书医疗器械法规中英文对照系供内部学习使用欧盟医疗器械法规(Regulation (EU)2017/745) 中英对照版EU Medical Device Regulations(Regulation (EU) 2017/745)法规原文发布日期 2017 年 5 月 5 日第一版(2019 年 7 月)主编:杨龙 赵...
One of the key changes introduced by the MDR is the new classification system for medical devices, which is based on potential risk to patients. The regulation also establishes a Unique Device Identification (UDI) system to improve traceability of devices throughout the supply chain. In addition,...
Publication ofMDCG 2020-3 Rev.1Guidance on significant changes regarding the transitional provision under Article 120 of the MDR. March 2023: Publication ofRegulation (EU) 2023/607amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devi...
of certain products manufactured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered non-viable. Such products should come under the scope of this Regulation, provided they comply with the definition of a medical device or are covered by this Regulation....
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medical devices Regulation. When reprocessing is allowed, the entity that wants to reprocess the device must assume the same obligations as a manufacturer. However, a different regime is applied in the case of reprocessing by health institutions and by third parties on the request of health ...
The Medical Device Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union. As more and more manufacturers now have their MDR Quality Management System (QMS) certificates i...
Comparison of the articles of the European Medical Devices Directive (93/42/EEC) and the Medical Devices Regulation ((EU) 2017/745) Eamonn Hoxey 1 Background to changes The MDR is significantly more comprehensive and detailed compared to the MDD. While the MDD comprises 23 Artic...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) imposes several conditions on pathology departments that develop and use in-house in