European Commission has released a new list of harmonized standards for medical devices on the European market. Learn more about the new important updates.
Medical devices and healthcare
New WEEE Directive’s Affects on Medical Devices
The updated Waste Electrical & Electronic Equipment directive places new obligations on medical devices in the EU. Find out how to reach compliance with Obelis.
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.
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.
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.