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

Instructor: Trevor Lewis
Product ID: 700136
Training Level: Advanced
  • Duration: 60 Min

recorded version

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Training CD

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Read Frequently Asked Questions

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.

Instructor Profile:

Trevor Lewis BSc(Hons), CEng, CPhys, MIEE, MInstP, MCIM, MInstD practices in his own specialist consultancy that he founded during 1995. This provides medical device, in vitro diagnostic and closely related companies with a diverse range of business development advice and services for new product development strategy, quality systems, regulatory affairs (both US and EU), marketing, market research and partner search. Medical Device Consultancy clients range from start-ups to multi-nationals, based in the UK, Europe, North America and internationally. Trevor has written and presented on many aspects of medical device business development both nationally and internationally, this has included two major management reports for the Financial Times:

  • European Medical Devices Directives - a guide to beneficial implementation; and
  • Self Diagnostics and Home Monitoring Products - strategies for success

In more than 30 years of varied experience Trevor has previously been General Manager of Ferraris Medical; Director, Corporate and New Business Development of Huntleigh Healthcare, the core business of Huntleigh Technology plc; Marketing Manager, Infant Care for Air-Shields Vickers; High Technology Securities Analyst (North American) for stockbrokers Grieveson & Grant and a Development Engineer at Smiths Industries. He spent his early career in the Royal Air Force.

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