Brussels, 24 June 2010. The European Commission has decided to refer Estonia to the EU’s Court of Justice for not implementing the revised Medical Devices Directive (2007/47/EC) within the deadline (December 21, 2008). A referral of the case has been decided today as Estonia failed to notify transposition measures as required by this Directive.
Directive 2007/47/EC enhances the criteria for the conformity assessment of medical devices and strengthens the procedures for such assessment. The Directive aims on the one hand to ensure a high level of protection of human health and safety and on the other hand to ensure that medical devices can circulate freely throughout the Single Market (thereby offering manufacturers economies of scale and users greater choice). Member States were obliged to notify the Commission of measures taken to implement Directive 2007/47/EC by December 21, 2008, but Estonia has so far failed to do so.
Source: European Commission