Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes

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. Medical devices sold into the European Union (EU) must comply with the applicable medical device directives and EU laws similar to FDA’s regulations.

Why Should You Attend:

Medical devices sold into the European Union (EU) must comply with the applicable medical device directives, EU laws similar to FDA’s regulations.

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 Webinar:

• New approach directives & background
• IVD, MDD & Active Implantable Directive
• Impact of significant recent & proposed changes
• Competent Authorities & Notified Bodies
• Medical Device Directive vs. Regulation vs. ISO 13485
• Device classification
• Routes to CE marking under various MDD annexes
• Technical files vs. Guidance Documents
• Essential requirements
• Significant Changes Coming

Who Will Benefit:

Companies wishing to penetrate the EU market for medical devices or sharpen their skills will receive practical guidance on achieving the CE mark. Employees who will benefit include:

• Quality & Regulatory Professionals
• Manufacturing & Design Engineers
• Marketing Product Managers
• Program Managers