A new EU Commission recommendation, in line with 2006/647/EC) mandates the standardization of claims and labelling for sunscreen products on the EU market.
News
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.
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.
Obelis presenting at US Commercial Services Webinar
Obelis COO Doram Elkayam will join the 2013 US Commercial Services webinar to talk about EU cosmetic regulations and compliance obligations.
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.
Obelis Featured on Important US Community of Cosmetics Manufacturers
Obelis listed as a trusted EU regulatory and compliance service provider by indiebeauty.com, an online community for small cosmetics manufacturers in the USA.
Indie Beauty Network (IBN) Tele-Seminar a Great Success
Find out more about the recent tele-seminar hosted by Indie Beauty Network (IBN) and Obelis. The seminar covered a range of EU cosmetics compliance issues.