The proposed new EU medicines and medical device vigilance portal – EUDAMED – aims to increase oversight and incident reporting systems throughout Europe.
News
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.
Sun Protection Factor Determination Guidelines
More insight on the factors determining sun production factor (SPF) of sunscreens as laid down by EU cosmetics regulation 1223/2009/EC.
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.
Cosmetic Notification between January 2012 to July 2013
More information on cosmetics notification and compliance issues in the transition period from Cosmetics Direction 76/768 to EU Regulation 1223/2009.
Safe Cosmetics Act of 2011 in the USA
Learn about the 2011 Safe Cosmetics Act and what implications it may have for the registration, labelling, and compliance of your products on the US market.
New package of measures for marketing of products
The EU Commission has published a new legislative framework package for the marketing and advertising of CE marked products on the European market.
Initial Cosmetic Webinar to Indie Beauty Members
The Obelis cosmetic regulatory team will present an introduction to the new EU cosmetics regulation at the Indie Beauty Network event in October 2011.
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.