EUs MDD Mod 5 Changes due March 2010 - Impact on CE-mark Compliance

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Mar 03, 2010 End Date/Time: Mar 03, 2010
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Why Should You Attend:

The EU Medical Device Directive (MDD) classifications are based on Annexes to the MDD and are determined by the manufacturer and notified body, and explained in the product's Technical File or Design Dossier. The MDD classification system is somewhat different from the classification of medical devices in the U.S., which are defined by information in the Code of Federal Regulation, by law, and are not left up to the manufacturer.

The European Union has mandated changes to the Medical Device Directive 93/42/EEC, by the M5 Directive 2007/47/EC. The Mod 5 changes to the MDD become operative in March 2010, requiring the product's Essential Requirements to be reevaluated, updated, which may include additional testing, and the Technical File or Design Dossier updated accordingly. Any such changes must be audited by the company's notified body, prior to the affixing of the CE-mark and sale in Europe.

Attend this Webinar to understand What are the key changes required for CE-marked product? Why are they modified? How should they be implemented? What documents are affected? And the steps to comply with it.

Areas Covered in the Seminar :

  • Relevent sections of the basic MDD.

  • Steps to comply.

  • Testing Requirements.

  • Clinical Issues.

  • Documentation.

  • Audit.