The Draft European IVD Regulation
Course Description:
This course is designed to provide manufacturers with an overview of the major changes in concept and legislation of the latest draft proposal for IVD regulations in Europe (published in September 2012).
Watch the Course Trailer:
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Understand the major differences between the current directive and the new regulation proposal
- Know what to expect once the new regulation comes into effect
- Start planning for implementing the new regulation requirements
- Embark on the necessary discussions with notified bodies in advance
Who Should Enroll:
Regulatory associates and managers, quality assurance associates and managers, production managers, design and development engineers, and regulatory body personnel are all encouraged to enroll in this course.
Prerequisite Knowledge/Requirements:
Familiarity with the current IVD Directive and EU regulatory system is required. These topics are outlined in the WMDO course “Pathways to CE-Marking Under the In Vitro Diagnostics Directive” (ID N168).