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

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.