This is a bare basics overview of how medical devices are regulated in the European Union (EU). You will learn how the EU government creates laws and regulations that control medical device approvals there.

The course covers three main areas:

1) Governmental structure of the EU

2) The EU Directives that deal with medical devices

3) The structure of a Tech File/Design Dossier which is submitted for a device.

The course is intended for those with no knowledge of device regulation in the EU. After taking this course, you will understand where to go next with your EU device project, from a regulatory standpoint, and you will know how to gain additional learning for your desired device approval.