European Commission issues important guidance document on 2007/47/EC

The EU has just released an important guidance document that should be read by every company selling medical devices in Europe. It provides guidance on an amendment to the original Medical Devices and Active Implantable Medical Devices Directives. Probably the most important part of the 2007/47/EC guidance for medical device companies is that the amended directive goes into effect on 21 March 2010 and there will be no transitional period. This means that companies must comply by March 21. There are other points you should read about as well. You can download the entire read our analysis of the changes made by 2007/47/EC to 93/42/EEC on our website.