Gain market access in Europe with a CE mark: Sell your medical devices in Europe with advice and a free e-update service from BSI.
Before theCE Markmay be affixed to a medical device and legally sold within the European Union, the manufacturer or exporter must complete the following: Prepare Technical Documentation (Technical File) to show the product’s compliance with applicable essential requirements and conformity assessment pro...
RoHS2 is now a CE Marking Directive. In plain English, what this means is that if you manufacture an electrical/electronic product, device or equipment, you can no longer CE mark in accordance with just the Medical Device, Machinery, EMC or Low Voltage Directive. Compliance with the RoHS Di...
Learn more about GMED's CE Mark Certification and how they serve the medical device industry worldwide to meet the new requirements of European medical device regulations.
Solar KeyMark认证 SNI认证-印尼 SRCC认证-美国 ENEC标志-欧洲 AGA认证-澳洲 ATEX认证-防爆 ASTA认证 API认证 CE认证-欧盟 SABS认证-南非 E/e-mark认证 FCC认证-美国 VDE认证-德国 GS认证-德国 UL认证-美国 RCM认证-澳洲 CCC认证-中国 FDA认证-美国 ...
网址:camd-europe.eu/ 简介:CAMD的全称是Competent authorities for medical devices,翻译成中文叫做医疗器械监管机构,实际上它指的是欧盟成员国医疗器械监管机构的联盟,毫无疑问,联盟的主要工作是推动医疗器械法规在欧盟的实施。截止到目前并在之后的相当长一段时间内,联盟的主要工作会是和MDR/IVDR的实施相关的。这不...
To put it simply, obtaining your CE Mark is the first step to selling your medical device in the EU. All manufacturers in Europe and abroad must establish CE marking to market and sell their devices in participating member countries successfully and legally. The new directives focus on the tra...
事实上,CE还是欧共体许多国家语种中的"欧共体"这一词组的缩写,原来用英语词组EUROPEANCOMMUNITY缩写为EC,后因欧共体在法文是COMMUNATEEUROPEIA,意大利文为COMUNITAEUROPEA,葡萄牙文为COMUNIDADEEUROPEIA,西班牙文为COMUNIDADEEUROPE等,故改EC为CE。当然,也不妨把CE视为CONFORMITYWITHEUROPEAN(DEMAND)符合欧洲要求。 “CE”标...
The article repots on the granting of Communaut Europenne (CE)-mark certification to Live Tissue Connect Technologies (LTC) for its Bipolar Forceps by its Notified Body, BSI Product Services. The move will allow LTC to...
Comprehensive guide on Class I (Is/Im) - Medical Devices CE marking (mark): European (EU) Authorized Representative service at www.CE-marking.com