On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. The document refers to all 3 medical device directives including the amendment 2007/47/EC. The 3 medical device directives this
Are You Using The Proper Version of EN 60950-1?
Thank you NEMKO for this article: The standard for IT-equipment, for the EU is EN 60950-1:2006, and it was amended with A11 in 2008, with DOP (Date of Publication) 1 December 2009. The A11 is a European amendment only, with
GHTF Proposal for Unique Device Identification (UDI) System for Medical Devices
The Global Harmonization Task Force Ad Hoc Working Group has drafted a proposal for Unique Device Indentification (UDI). The document is GHTF/AH/(PD2)N2R2 and can be accessed by clicking here. The document was posted on 22 Nov 2010 and comments are
Eucomed requests improvements in EU Notified Body Based System
26 Oct 2010 From ‘MTB europe – Technology for healthcare’ Eucomed calls for improvements in EU Notified Body based system http://www.mtbeurope.info/news/2010/1010051.htm
IEC 62A/726/NP Collateral IEC 60601-1-XX Emergency Med Srvcs Circulated for Vote
The New Work Proposal IEC 62A/726/NP and ISO TC121 SC3 N1534 was circulated on 5-Nov-2010 within IEC TC 62 (Technical Committee on Electrical Equipment in Medical Practice) and its’ subcommittees 62A – 62D, as well as ISO TC 121 (Tech