European Commission has released a new list of harmonized standards for medical devices on the European market. Learn more about the new important updates.
Medical devices and healthcare
New Agency for Medical Device Registration in France
In April 2012, the National Agency for the Safety of Medicines and Health Products will replace current medical device regulatory agency, Afssaps, in France.
New WEEE Directive’s Affects on Medical Devices
The updated Waste Electrical & Electronic Equipment directive places new obligations on medical devices in the EU. Find out how to reach compliance with Obelis.
Early Implementation of an EU Vigilance Portal
The proposed new EU medicines and medical device vigilance portal – EUDAMED – aims to increase oversight and incident reporting systems throughout Europe.
Revision of the IEC 60601-1 Regarding Medical Devices, 3rd Edition
The 3rd edition revision of IEC 60601-1 for medical devices in Europe will come into effect in June 2012. Learn more about EU harmonized standards with Obelis.
Medical Devices in Distribution Channel Complying with IEC 60601-1, 3rd edition?
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.
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.