The In Vitro Medical Device Regulation (EU) 2017/746

The aims and learning outcomes of this course are:

•   To understand the In Vitro Medical Devices Regulation.
•   To appreciate the EU IVDR requirements In Vitro Medical Devices.

Following completion of this course, participants should:

•    Understand the EU Medical Device Regulation.
•    Be able to actively participate in preparing documentation for technical files.
•   All participants should have a working knowledge of the requirements.

This course is held live in an online lecture theatre and delivered with a PowerPoint presentation.  All participants will fully engage with the lecturer through both group and individual exercises and direct participation throughout the course.  There are exercises included in order to ensure the course contents are fully understood and the opportunity is always available for participants to ask questions.

This eight module course explores the European In Vitro Medical Device Regulation and is broken down into 8 modules. 

1. Introduction.
2. Other articles.
3. Classification & Conformity.
4. Risk.
5. GSPRs.
6. Clinical Evaluation.
7. Post Market.
8. Compliance.