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.

This audio conference covers:

• Major areas of change in the amended Medical Device Directive
• The drivers for this change
• Things your notified body may ask for during an audit
• Determining what areas of your system may be impacted
• The interplay between the revised MDD and other EU directives

About the speaker:

Leo Eisner leads Eisner Safety Consultants in its efforts to help medical device, IVD and high-tech device clients navigate international product safety; medical device quality systems & auditing; regulatory processes such as FDA 510(k)s, IDEs, & PMAs, CE marking and the Canadian Medical Device Regulations; risk management; and development of international product safety standards.

As a registered Professional Engineer in the safety engineering discipline, he has over 24 years experience in product safety. In his nine years with UL, he worked with a variety of product categories and then spent several years with TÜV Product Service, specializing in electrical medical products. He later joined Karl Storz Imaging as a compliance engineer and has been consulting independently for over 10 years. He also is a notified body lead auditor for NSAI.

Leo is a member of RAPS, AAMI, ASQ and IEEE and has co-authored numerous articles on IEC 60601-1 and medical device safety. He is the convener of IEC SC 62D JWG9 (IEC/ISO 80601-2-58) and is a member of several IEC 62 technical advisory groups for the IEC 60601 series of standards.

Who should attend?

• Regulatory Affairs
• Quality Assurance
• Operations/Manufacturing
• Managing Directors
• Senior Management

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.