The Revision of the Medical Devices Directive 93/42/EEC, Background, Proposal and What It Means

Instructor: Trevor Lewis
Product ID: 700148
Training Level: Advanced
  • Duration: 60 Min

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Key insights to the background of the revision for medical device manufacturers with products in Europe.


The Medical Devices Directive 93/42/EEC (MDD) is the key European Directive for regulatory compliance and placing of a CE mark on a medical device.

Article 11 of the MDD provides for a five year review and this process was effectively started during 2002 with a report by the Medial Devices Expert Group (MDEG). This was eventually followed by an initial draft Public Consultation Text that encouraged all interested parties to comment - such as the European trade association EUCOMED. This extensive review and consultation has culminated in the publishing of a Proposal for a Directive of the European Parliament and of the Council amending the Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives hereafter referred to as the Proposed MDD Revision.

The webinar will provide insights to the background of the revision, how it has developed that is important for compliance professionals to understand and then summarise what is in it and what this means to medical device manufacturers with products in Europe. The webinar ends with a summary, an update on the latest developments and indicates where this might all lead in the future.

There is something for everyone to take away in this webinar and the content is vitally important to understand for full European compliance when placing medical devices on the market.

Areas Covered in the seminar:

  • Why the revision of the Medical Devices Directive 93/42/EEC (MDD) was necessary and what the regulators have looked at changing.
  • Where to find the initial Public Consultation Text, EUCOMED reaction and Proposed MDD Revision.
  • What the Proposed MDD Revision means to medical device manufacturers with each significant change covered point-by-point.
  • When the Proposed MDD Revision is likely to take effect and what may follow it in the near future.
  • This webinar provides insights, tips and suggestions on what is required to achieve and maintain the CE marking for medical devices in Europe now and in the future.

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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Product Reviews Write review

The presentation was very informative and to the point.
- Anonymous

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