EC publishes revised Blue Guide on implementation of product rules to reflect modernization and harmonization of legislative framework for product marketing.
EC publishes revised Blue Guide on implementation of product rules to reflect modernization and harmonization of legislative framework for product marketing.
The EU Commission has published a new legislative framework package for the marketing and advertising of CE marked products on the European market.
The two-day EU regulatory workshop included sessions on developments in medical device legislation and manufacturer obligations for the European market.
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.
Obelis to host EROMED workshops in Israel in October 2009 to discuss EU medical device regulations and other EU compliance factors and requirements.