European Medical Device Regulatory Basics

European Medical Device Regulatory Basics

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.

A beginner's primer to medical device regulation in Europe.

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What you will learn

• Be able to tell differences between EU and US approach to medical device regulation
• Understand how to begin the regulatory process in EU for your device
• Have a basis for pursuing further information on EU medical device regulation

Rating: 4.4

Level: Beginner Level

Duration: 1.5 hours

Instructor: Josh Simon