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Medical Devices: EU Regulations

Medical device manufacturers face global economic challenges in an ever-changing regulatory environment. These changes come in the form of more stringent and complex regulations, higher patient expectations and commercial pressures. As the regulatory profession continues to grow in importance and prominence, regulatory professionals have become key contributors to a company’s ability to devise successful business strategies and execute these strategies effectively. Therefore, they need to build robust regulatory expertise by continuously sharpening, maintaining and expanding their skills, knowledge and understanding of relevant and applicable regulations and emerging technologies.

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 in the key elements of the EU directives governing medical devices, including the Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and In Vitro Diagnostic Devices Directive (IVDD), and the 2007/47/EC amendments to the AIMDD and MDD. Examine how devices are classified and the effect classification has on labeling, registration, marketing and postmarketing requirements.

Course Details

 At A Glance
  • Target Audience: This program is designed for new regulatory professionals and others in related departments interested in understanding the basics of the regulation of medical devices in the EU.
  • Learning Level: Basic
  • Total Length of Course: 5 Hours
  • RAC Points: 5
  • Formats: Web and iPad
  • Cost: Member $500; Nonmember $700
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 Learning Objectives

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

  • Explain the differences among the scopes of the three EU device directives
  • Outline how medical devices are classified using the European regulatory framework
  • Identify the important elements 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: