European Commission has released a new list of harmonized standards for medical devices on the European market. Learn more about the new important updates.
Notified body
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.
New package of measures for marketing of products
The EU Commission has published a new legislative framework package for the marketing and advertising of CE marked products on the European 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.
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.
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.
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.
New package of measures for marketing of products
EU Commission revises 700 Old Approach directives and 27 New approach Directives. Read about these topics here.