Mar 31, 2014
The European Commission has published its latest “Blue Guide” covering all products subject to the European Union’s New Legislative Framework, including medical devices, IVDs and active implantable devices.
Emergo Group consultants in the US and Europe will be performing an extensive review of the new Blue Guide over the next several days, and will provide additional analysis of how medical device manufacturers will be impacted.
The European Commission has officially adopted a new Directive that is of critical importance to most medical device companies selling and/or conducting clinical trials in Europe.
The European Court has recently ruled to limit member states’ authority to restrict medical