Advice and information on how to bring medical devices in a distribution channel into full compliance with the new 3rd edition of IEC 60601-1.
Medical devices and healthcare auto
Registration TAX on Medical Devices Cancelled by Italian MoH
From January 2012, the Italian Ministry of Health has cancelled the registration tax fee for medical devices seeking to enter the Italian market.
Code of Conduct for Notified Bodies?
The European Association of Notified Bodies for Medical Devices has published a new code of conduct in response to new EU medical device regulations.
EU Regulation & CE Marking Workshop in Sao Paulo, BRAZIL
Obelis and EG MONT announce new CE marking and EU regulatory workshop in Sao Paulo to discuss medical and in-vitro devices, cosmetics, and the WEEE directive.
Italy Registration Update: Class I Medical Devices
Following a new decree, all Class I medical devices must be registered with the Italian Ministry of Health. This will not apply to manufacturers with an EC rep.
Animal by-products EU regulation on Medical and Cosmetic products
Find out the definition of an animal by-product and what EU legislative guidelines apply to medical and cosmetic products containing them within the EU market.
EROMED Workshop in Sao Paulo a Success!
The two-day EU regulatory workshop included sessions on developments in medical device legislation and manufacturer obligations for the European market.
Obelis International Offices Convention
Obelis has launched its new International Offices and will be hosting EROMED at its home offices in Brussels, Belgium.
Commission Decision on the European Databank on Medical Devices
The EU decision on a medical device databank has been issued. Competent authorities must enter all manufacturer, AR, and device information before April 2012.
New Portuguese National Law Transposing the 2007/47/EC announced
As of March 2010, Portuguese national decree-law 145/2009 entered into effect, calling for the mandatory transposing of EU medical directives.