Time is running out – ease your MDD compliance strategy stress with detailed guidance from a leading expert!
The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.
In this audio conference, our speaker provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.
Are You Ready for MDD Amendment Directive 2007/47/EC? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, January 27, 2010. For more details or to register, please visit our site at www.fxconferences.com
