Online CourseOnline Course Medical Device Certificate ElectiveMedical Device Certificate Elective

Medical Devices: EU Regulations [5.0 RAC]

5.0 RAC Credits Member: $545.00 Nonmember: $745
Medical Devices: EU Regulations [5.0 RAC]
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 and regulations 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. This course examines how devices are classified, and the effect classification has on labeling, registration, marketing and post-marketing requirements. The major updates to the newly published Medical Devices Regulation (EU) 2017/745 and the In Vitro Medical Device Diagnostic Regulation (EU) 2017/746, which will replace the directives, will be discussed in detail.

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 Hours
  • RAC Points: 5

Learning Objectives

Upon completion of this course, participants should 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

Enrollment Period: 12 months
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