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.
Medical devices and healthcare auto
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.
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.
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.