European Update: CE Labeling Directive Formalizes Requirements
Since the implementation of the “New Approach” and the CE Marking in the European Union, the requirements for device labeling have evolved, been reviewed, variously implemented and not uniformly enforced. A closer look at post-market compliance is an evolving trend across many economies. Discussions in the European Union, North America and the Asia-Pacific Economic Cooperation (APEC) continue to focus on post-market surveillance and enforcement. One area of scrutiny, particularly in Europe is device labeling.