The EC proposed new personal protective equipment (PPE) regulation to replace current EU legislature and harmonize Europe-wide standards and requirements.
Industrial and mechanical
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.
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.
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.
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.