Course code RA3

CE Marking of Medical Devices Conform the European Medical Device Directive(s) (one day)

Course description:

This course has is intended to provide a basic overview of all the Medical Device Directives, the AIMD, MDD and IVD. It systematically examines Medical Device Directives in the EU and the “New Approach”. Global Harmonization as related to the Medical Device Directives discussed. Each Directive is considered in more detail including: the Definition of a medical device; the Roles of the Notified Body and Competent Authorities; the Classification rules and criteria; the Conformity Assessment Route; Quality Management System requirements; Post Marketing Surveillance and Vigilance requirements; Technical Documentation; Standards and Essential Requirements; Labeling; and Clinical Data.

Participants will be informed about any changes to the MDD and about the likely consequences of such changes for their product.

Practical examples are used to interactively demonstrate various aspects of the Directive

Course objectives:

• To provide participants with a general overview of the Directives and their requirements
• To clarify the structure of the Medical Device Directives
• To understand the EU classification of Medical Devices
• To provide participants with a basic understanding of the European CE Marking Approach
• To examine the roles of the Notified Body and Competent Authority
• To identify Quality Assurance requirements and other requirements as specified above.

Who should attend:

There are no prerequisites for this course. The course is aimed at:

• Start-up Medical Device Companies
• Medical Device Companies new to the EU market
• QA/RA Managers
• Senior and Executive Management

Course materials:

Participants will receive a comprehensive course manual with reference materials, and upon successful completion of the course, a “certificate of attendance”

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