Changes to the Medical Devices Directive: 93/42/EEC

You might be interested in knowing that the European Commission has finally released a consolidated version of the revised Medical Devices Directive. The original Directive 93/42/EEC (published in 1993) was amended in late 2007 with the publication of Directive 2007/47/EC, but a combined version of those two Directives was not published at that time, making it difficult to interpret the changes Directive 2007/47/EC had on the original MDD. Originally created July 12, 1993 and mandatory since June 14, 1998, the Directive requires that companies wishing to sell medical devices within the EU must meet the requirements under the directive. The regulations under this mandate can vary from member country to member country concerning translation of key documents to other regulatory laws specific to that region. These additions supplement the set of harmonized standards put in place by the European Commission. These harmonized standards serve to free the flow of goods from one market to another within the EU Medical Device industry. Today, all medical devices sold in the EU must have the CE marking affixed to demonstrate compliance to this directive. If your device falls within the scope of the Medical Devices Directive, then you must meet the essential requirements of that law.

Areas Covered in the seminar:

• Learn about the latest changes to the directive and impact on medical device manufacturers.
• Understand how to apply and use the Conformity Assessment Procedure.
• How to classify your medical device correctly.
• Learn how to use the Technical File correctly.
• How to apply the Declaration of Conformity and why this is critical for success.
• How ISO 13485 fits in with this process as a device company.
• Learn and understand the expectations for the Essential Requirements and the Certification Process.
• How is the Authorized Representative involved and why and the ramifications of not meeting the requirements for CE Mark and 93/42/EEC for your company.

Who Will Benefit:

This webinar will provide valuable assistance and guidance to medical device companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC. The employees who will benefit include:

• All levels of Management for all departments and those who desire a better understanding or a "refresh" overview.
• QA/QC
• Marketing & Sales
• Engineering/Technical Services/Operations
• Consultants
• Operations and Manufacturing

Instructor Profile:

David R. Dills, Industry Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change within SCOPE (Strategic Compliance & Operational Excellence). Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Mr. Dills also served as Director of Publications, Regulatory & Compliance for the Institute of Validation Technology. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA, Quality Engineering, Validation, RA/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers in conjunction with marketing and business development responsibilities.

Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company

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