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.
Medical devices and healthcare auto
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.
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.