This post is on the newly published Commission Regulation (EU) No 722/2012 of 8 August 2012 “concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
IEC 60601-1:2012 Consolidated 3.1 Edition Just Published
On August 20, 2012 IEC released the consolidated edition 3.1 of IEC 60601-1:2012 which is a combination of IEC 60601-1:2005 (also known as 3rd ed. of IEC 60601-1) combined with Amendment 1:2012 (A1).
Draft ASEAN Medical Devices Directive (AMDD)
Consultation on AMDD “From the Singapore Health Sciences Authority – Updated 2 August 2012 – As part of efforts to enhance economic integration among ASEAN (Association of Southeast Asian Nations) member states, ASEAN has been working on developing a standardised framework
Impact of WEEE2 on Medical Devices Industry
EUCOMED on 25 July 2012 wrote a nice summary of the Impact on the Medical Devices Industry of the long awaited revision of the Waste Electrical and Electronic Equipment (WEEE2 or WEEE recast) Directive (2012/19/EU) was published in the EU
Eisner Safety Consultants to Restart Monthly Newsletter Service
It has been over 2 years since we sent out our last newsletter. Our apologies. We have decided to send out a monthly update of our blog posts for each month which are all located at www.EisnerSafety.com/Industry_News/. We have been working