The CE Mark: Understanding the Medical Device Directive

If your organization manufactures and exports medical devices to the European Union, you need to know about the CE Mark and how the Medical Device Directive will affect your organization. The European Union's Medical Device Directive is one of the EU's most frustrating and difficult-to-decipher mandates. Fortunately, author Les Schnoll has taken the mystery out of the directive for medical device manufacturers. Schnoll walks readers through the directive's numerous classes, articles, annexes and requirements. This book is a must read if you're exporting medical devices to the European Union.

Les Schnoll has more than 25 years' experience in quality assurance/quality control, auditing, regulatory compliance, management and microbiology in medical, pharmaceutical, clinical, industrial and food areas. He is knowledgeable in all aspects of medical device and material, pharmaceutical, food, clinical laboratory and chemical industry objectives. Schnoll is authorized by the Medical Device Agency in the United Kingdom to perform assessments to the Medical Device Directive and EN 46000 standards.