The CE Mark: Understanding the Medical Device Directive
by Les Schnoll
The European Unionís Medical Device Directive, formally known as 93/42/EEC, is one of the EUís most frustrating and difficult-to-decipher mandates. Les Schnoll, director of quality at the Southern Research Institute, clearly and thoroughly explains the directive for medical device manufacturers. The book includes an overview of the directive, an in-depth analysis of the articles, a description of the annexes, conformity assessment routes and how to use the CE Mark. The CE Mark: Understanding the Medical Device Directive (Paton Press, 1997) is a must read for anyone exporting medical devices to the European Union.