Medical Device CE Mark - Required to Sell in European Union Market

This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. It will provide practical guidance on achieving the CE Mark.

Why Should You Attend:

Medical devices declared compliant must bear a CE mark in order to be admitted into the 29 member countries comprising the EU. The market population of these 29 countries is 450 million people, exceeding the 420 million people served by NAFTA (USA, Canada & Mexico), so many companies have an interest in penetrating this market. This presentation will provide an explanation in layman’s terms of the various routes to CE marking of medical devices, with a focus on the Medical Device Directive, MDD 93/42/EEC.

Areas Covered in the seminar:

• New approach directives & background
• IVD, MDD & Active Implantable Directive
• Competent Authorities & Notified Bodies
• Medical Device Directive
• Device classification
• Routes to CE marking under various MDD annexes
• Technical files
• Essential requirements
• ISO 13485:2003 Quality System Certification