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European Medical Device Regulatory Basics
Rating: 4.2 out of 5(33 ratings)
63 students

European Medical Device Regulatory Basics

A beginner's primer to medical device regulation in Europe.
Created byJosh Simon
Last updated 2/2019
English

What you'll 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

Course content

1 section • 7 lectures • 1h 25m total length

  • Introduction5:57

    This lecture describes the course and who should take it. By the end, you will understand if you can benefit from the information.

  • EU Regulatory Introduction12:47

    Description of some basic regulatory terms and concepts in the EU:

    * Competent Authority

    * Notified Body

    * Authorized Representative

    * Manufacturer

    * CE Mark

  • EU Government Structure and Legislation Process8:27

    Gain an understanding of the overall structure of the EU Government and how it proposes and adopts legislation. These rules, known as Directives, are then fulfilled by the member states.

  • Medical Device Directives17:45

    Introduction to the "Three Eras" of EU Regulation: Old Approach, New Approach, MDR/IVDR

    Overview of the New Approach and the three different medical device directives:

    93/42/EEC - Medical Device Directive (MDD)

    98/79/EC - In vitro Diagnostic Directive (IVDD)

    90/385/EEC - Active Implantable Medical Device Directive (AIMDD)


  • Tech File and Design Dossier Basics12:33

    Description of content that goes into a Tech File and a Design Dossier. Outlines the structure of the files and how they are used to gain approval (CE Marking) for a device in the EU.

  • Introduction to MDR and IVDR15:18

    Introduction to the EU Medical Device Regulation (MDR) and EU In vitro Devices Regulation (IVDR)

  • Similarities and Differences Between New Approach and MDR/IVDR12:36

    Overview of what new changes the MDR/IVDR bring to EU device regulation, development, and post-market surveillance

Requirements

  • No prior knowledge of medical device regulations is necessary
  • Comparative knowledge of the US FDA would be helpful

Description

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.

Who this course is for:

  • Engineers with medical device experience
  • Medical device project team members
  • Students interested in pursuing device careers
  • Physicians/Professors with device ideas

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