Obelis announce Tel-Aviv workshop to prepare manufacturers for new EU cosmetics regulation and safety assessment reporting system (toxicological assessment).
News
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.
Obelis International Offices Convention
The 2010 Obelis International Offices Convention was held in November to discuss a range of EU-wide compliance and regulatory topics.
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.
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.
Medical Devices to Comply with the PPE 89/686/EEC
Under EU directive 2007/47/EC, PPE (such as masks and other safety equipment) must comply with medical device directive 93/42/EEC and PPE directive 89/686/EEC.
New Guidance on classification has been published
A new guidance document (MEDDEV) has been published on the classification of medical devices in Europe. Talk to Obelis' experts about your device's compliance.
EUCORE Workshop: GMP – EN/ ISO 22716
Obelis to host EUCORE workshop in Israel on good manufacturing processes for cosmetics manufacturers looking to access the EU market.