medical device regulationdrug regulationEU and US regulatory frameworksregulatory agenciesThis article provides an overview of the regulation of medical devices and drugs in the European Union and the US. It is important for all stakeholders involved in bringing a medical device or drugs to market to...
devices for the control or support of conception; • products specifically intended for the cleaning,disinfection, or sterilization of devices.” In addition to the definition of a medical device, the European Union In vitro Diagnostic Regulation (EU IVDR),17an in vitro diagnostic (IVD) medical...
龙德出品REGULATIONEU017/745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RegulationEU017/745中英对照版EUMedicalDeviceRegulationsRegulationEU017/745法规原文发布日期017年5月5日第一版(019年7月)主编:杨龙赵肖肖策
EU IVDR Regulation + Table of Contents Overview of the European IVDR (2017/746) Clinical Evaluation Reports 101 Oriel STAT A MATRIX’s Goal Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes ...
一、MDR简介 医疗器械(MDR):法规2017/745 2017年5月5日,欧盟官方期刊(Official Journal of the European Union)正式发布了欧盟医疗器械法规(REGULATION (EU) 2017/745,简称“MDR”)。MDR将取代Directives 90…
So you’ve taken a look at EU MDR transitions for some of your devices and shopped around for quotes on help writing the technical file. One of the more common [...] The DIY Clinical Evaluation Report – Do You Really Need A CER Writer?
On 15 March 2023, the Regulation (EU) 2023/607 was formalised, which provides medical device manufacturers more time to certify medical devices to mitigate the risk of shortages. The amended regulation introduces a longer transition period for products already on...
CIRS Medical Device BU assist domestic and overseas medical device enterprises with a comprehensive service chain and one-stop solution in medical device regulation and technical consulting service, including medical device R&D technical support, medical
For implantable devices, check whether the mandatory information to be supplied to the patient (including the implant card) complies with the MDR and hedges your company sufficiently against product liability risks. For devices that incorporate electronic programmable systems, inc...
Regulation (EU) 2017/745 (EU MDR) The EU MDR entered into application on 26 May 2021 If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to...