MEPs push for single approval body in reformed medical device regulation

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MEPs push for single approval body in reformed medical device regulation

机译：环保部推动改革医疗器械法规的单一批准机构

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The European Parliament is pushing for a single notified body to be set up to approve all high-risk medical devices in the forthcoming replacement for the Medical Device Directive 93/42/EEC. This places MEPs at loggerheads with the European Commission who drafted the revised legislation and representatives to industry who are keen to keep the existing system and buttress it with additional safeguards.

机译：欧洲议会正在敦促成立一个指定的机构，以批准所有即将取代医疗器械指令93/42 / EEC的高风险医疗器械。这使欧洲议会议员与欧洲委员会对立，后者起草了修订后的法规，并代表了工业界的代表，他们热衷于保留现有系统，并为其提供更多保障。

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《Safety and EMC》 |2013年第128期|共1页
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1. MEPs push for single approval body in reformed medical device regulation [J] . null Safety and EMC . 2013,第128期

机译：环保部推动改革医疗器械法规的单一批准机构
2. Latest Notified Body Approval Helps Brexit-Proof EU Medical Devices Regulation [J] . DAVID RIDLEY The Rose Sheet: Toiletries, Fragrances and Skin Care . 2019,第46期

机译：最新通知机构批准有助于Brexit-Proofe欧盟医疗器件监管
3. Review and approval of medical devices in China: Changes and reform [J] . Liu Wenbo, Shi Xinli, Lu Zhong, Journal of biomedical materials research. Part B, Applied biomaterials. . 2018,第6期

机译：中国医疗器械的审核与批准：变革与改革
4. Medical Device Approval Process: Sponsor Burdens During Regulatory Approval Process (PPT) [C] . Linda Braddon International Conference Exhibit on Molding . 2013

机译：医疗设备批准过程：监管审批过程中的赞助商负担（PPT）
5. Medical Device Recalls: The Need for an Updated Protocol in the 510k Approval Process for Medical Device Safety and Efficacy [D] . Boles, Kelly D. 2020

机译：医疗设备召回：在510K批准过程中需要更新的协议，用于医疗器械安全性和疗效
6. US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety? [O] . Jona A. Hattangadi, James T. OReilly, Abram Recht 2012

机译：美国食品药品监督管理局医疗器械和放射肿瘤学法规：改革能否提高安全性？
7. FDA Approvals of Medical Devices Under the De Novo Automatic Class 3 Regulations: An Opinion [O] . Michael AB Naafs 2018

机译：FDA批准De Novo自动第3类法规：意见
8. Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet MedicalNeed for Life Threatening or Irreversibly Debilitating Diseases or Conditions: Guidance for Industry and Food and Drug Administration Staff. [R] . 2015

机译：快速进入上市前批准和De Novo医疗器械用于未满足医疗需要的生命威胁或不可逆转的衰弱疾病或条件：工业和食品药品管理局工作人员指南。

MEPs push for single approval body in reformed medical device regulation

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