FDA issued a Safety Notification on Dec 16, 2010 that any lasers rated 5 milliwatts (mW) or more can cause temporary or permanent damage to skin or eyes. The full FDA safety notification can be accessed by clicking here.
EU Interpretative Doc on Placing Med Dev’s on Mrkt
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