The latest release of the Manual on Boderline and Classification in the Community Regulatory Framework for Medical Devices Version 1.9 was updated March of 2011. There are 4 new areas that have been incorporated into this version (1.9) of
RoHS EU Directive & the Future of Med Dvcs
Posted 12 May 2011 on the DeviceTalk blog of MD&DI, RoHS Directive and the Future of Medical Devices Thx Heather Thompson, Editor in Chief of MD&DI, for your enlightening post!
COCIR Issues Flowchart to determine if Software = Med Dvc per MDD
COCIR, the European industry association representing the radiological, electromedical and IT industries, issued (on 22 Nov 2010) a decision diagram to determine if software is considered a medical device per the Medical Device Directive (MDD) 93/42/EEC including the amendment. The
UL’s IEC 61010 3rd Ed. Int’l Activities Blog
UL has set up a blog for getting you current information on the IEC 61010-1 3rd edition is titled ‘Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements’. For the Health Care industry
Recasted RoHS Directive will apply to Med Dvcs & IVDs
This article is courtesy from BSI Healthcare eUpdate of 11-APR-2011. We send out thanks to BSI for such an informative and critical article for the medical device and IVD industries selling product in Europe (EU). Medical device manufacturers should be