Medical Devices: EU Regulations

This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product lifecycle. You will gain a strong foundation of the key elements of the EU directives governing medical devices. These include: Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, Medical Devices Directive (MDD) 93/42/EEC and In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC in their latest revision, including the 2007/47/EC amendments to AIMDD and MDD. This course examines how devices are classified, and the effect classification has on labeling, registration, marketing and postmarketing requirements.

  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Registration Options

At A Glance

  • Target Audience: This program is designed for new regulatory professionals and others in related departments interested in understanding the basics of EU regulation of medical devices.
  • Learning Level: Basic
  • Total Length of Course: 5–10 Hours
  • RAC Credits: 5
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $535; List $735
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Learning Objectives

Upon completion of this course, participants will be able to:

  • Explain and differentiate between the scope of the three EU device directives
  • Outline how medical devices are classified using the European regulatory framework
  • Identify the important contents of each EU directive
  • Discuss the general requirements of preclinical and clinical testing in Europe
  • Describe the conformity assessment pathways for obtaining CE marking
  • Cite the key requirements for postmarketing surveillance
  • Explain the overall regulatory requirements for medical devices in the EU

Lesson Titles

  • Lesson 1: History of Medical Devices in EU
  • Lesson 2: The Medical Device Directive (MDD)
  • Lesson 3: The IVDD, AIMDD plus Other Directives and Guidance Documents
  • Lesson 4: Standards, Quality Assurance and Risk Management
  • Lesson 5: Postmarketing Requirements

Registration Options

This course is available for purchase as follows: