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...
(New) Publication ofMDCG 2024-4- Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. Update ofMDCG 2022-9 (rev.1)- Summary of safety and performance template. March 2024: (New) Publication ofMDCG 2024-3- Guidance on content of ...
This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same ...
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...
This study evaluates the efficacy and safety of a single intra-articular hyaluronic acid injection in knee osteoarthritis in real-world conditions, over a six-month period, aligning with the summary of safety and clinical performance (SSCP) required by the new regulation. Patients and Methods...
This course aims to help you to perform audits of the medical device quality management systems against the relevant requirements of the European Medical Device Regulations (EU MDR 2017/245).
Regulation (EU) 2017_745 – Questions & Answers regarding clinical investigation(MDCG2021-6)关于临床研究的问题.pdf,Medical Devices Medical Device Coordination Group Document MDCG 2021-6 MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regard
Today, he is back at Medical Health Services managing cosmetic products. Related Services:Medical Device Regulation (MDR)|EU In Vitro Diagnostic Medical Device Regulation (IVDR)|Medical Device Single Audit Program (MDSAP)
If you have downloaded the 175-page European Medical Device Regulation PDF but are frustrated that it does not contain a Table of Contents, Oriel STAT A MATRIX has come to your rescue. We have taken the official MDR regulation as published on May 5, 2017 and added a very easy-to-navigate...
(b) its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation; (b)其UDI的分配系统足以根据本条例的要求,在其整个分配和使用过程中识别一个器械; ...