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.
Medical devices and healthcare auto
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.
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.
Obelis launches “EROMED” Workshop
Obelis to host EROMED workshops in Israel in October 2009 to discuss EU medical device regulations and other EU compliance factors and requirements.