How to Select and Change a Notified Body in Europe
有任何问题？向我们的专家获取相关信息
联系我们
Selecting a Notified Body (NB) is an important (and required) step for obtaining CE Marking and registering your medical device for sale in the European Union. Your Notified Body audits your quality management system and reviews your Technical File to ensure it complies with the appropriate EU Directive.- What is the difference between a Notified Body and a Registrar?
- What should we consider during our search?
- What should we consider when reviewing proposals from Notified Bodies?
- What are reasons we might need to switch Notified Bodies?
- What are the logistics of switching Notified Bodies?
We answer all these questions and more in this 5-page white paper.
About the Author
Jaap Laufer, MD, PharmD is Vice President of Regulatory & Clinical Affairs at Emergo. Dr. Laufer has over 30 years of experience in the medical device and pharmaceuticals industries. He previously held executive and senior regulatory positions at Pfizer, Abbott Laboratories, LipoMatrix, and others. His areas of expertise include a vast array of mostly implant and higher classed products, ISO and FDA QSR audits, and clinical study approvals and compliance. He holds a PharmD in Pharmacy from the University of Groningen and is an MD from the Medical School of the University of Nijmegen, both in The Netherlands. Dr. Laufer is a member of the Medical Devices Expert Group to the EU Commission and teaches at the University of Southern California in Los Angeles, USA.
相关
-
韩国医疗器械法规框架及注册路径解读
我们的专家将详细解读2023年韩国食品药品安全部（MFDS）指导文件草案更新下韩国医疗器械注册监管要求、分类标准、韩国良好生产规范（KGMP）等相关要求，并将依据多年韩国本地注册经验提供注册案例分享。此外，您还将了解到制造商在面对MFDS监管时需要关注的核心要点，相关研讨会内容包括：
阅读更多 -
墨西哥医疗器械注册和COFEPRIS认证合规审批流程
医疗器械和体外诊断（IVD）器械制造商需要在COFEPRIS注册他们的产品，COFEPRIS是墨西哥卫生部（Secretaría de Salud）的一个机构。器械在上市前需要上市前审批，豁免的器械除外。
阅读更多