As of March 2010, Portuguese national decree-law 145/2009 entered into effect, calling for the mandatory transposing of EU medical directives.
News
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.
EUCORE Workshop: GMP – EN/ ISO 22716
Obelis to host EUCORE workshop in Israel on good manufacturing processes for cosmetics manufacturers looking to access the EU market.
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.
Obelis launches “EUCORE” Workshop
Obelis to host EUCORE workshops in Israel in October/November 2009 to discuss EU medical device regulations and other EU compliance and regulatory factors.
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.