CE Marking Medical Devices: New Approach Directives (NAD) To Consider for Full Compliance

In this Medical device training will provide an explanation of what a New Approach Directive is and what they all have in common from a compliance perspective. The placing of a CE mark on a medical device implies compliance with all European 'New Approach' directives that apply and typically three or four directives will have to be considered.

The webinair will provide an explanation of what a New Approach Directive is and what they all have in common from a compliance perspective. This will include a discussion about the European 'Blue Book' that is vital to understand for those companies wanting to exploit the large and wealthy European medical device market. The simultaneous application of directives, exceptions and a risk based approach that is necessary to understand will be covered.

What the European regulators require and the important things you must do well to gain the CE marking will be included. The most likely directives to consider will be presented with useful links and tips to help those new to the topic so they can start to implement their compliance program following the webinair.

The presentation will finish with a summary of CE marking medical devices.

Areas Covered in the seminar:

• An explanation of what a New Approach Directive is and the importance of the European 'Blue Book'; simultaneous application of directives and exceptions.
• What New Approach Directives have in common, especially the scope and importance of the Essential Requirements.
• Classification, documentation and consumer protection.
• Conformity assessment procedure choices and recommendations.
• Technical documentation required.
• Must have procedures.
• Simultaneous application of directives - a risk based approach.
• Directives to consider with useful links and tips.
• Summary of steps to acquiring the CE marking for complete compliance.

Who Will Benefit:

• Senior management responsible for success in the European marketplace.
• QA, RA and other compliance managers and personnel wanting to learn how to comply with European regulatory requirements for medical devices.
• R&D managers and engineers.
• Manufacturing managers.
• Marketing and business development managers.
• Legal counsel wanting a non-legal explanation of European requirements for medical devices.
• Anyone wanting to really understand the fundamentals of the European New Approach and what must be covered for full compliance with European regulatory environment.