Course Description

Demarcation of Medical Devices to Other Products

Course Description:

This course features two parts. The first part concentrates on defining various types of medical devices based on standard European definitions. The second part explains how to differentiate medical devices from other medicinal products, and also provides a review of products that share similar components to medical devices, such as cosmetics, biocides, food supplements, and more.

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Define medical devices in accordance with Directive 93/42/EEC
  • Distinguish active implantable medical devices in compliance with Directive 90/385/EEC
  • Determine in vitro diagnostic medical devices under Directive 98/79/EC
  • Differentiate medical devices from other related products, such as cosmetics, medicinal products, and more

Who Should Enroll:

Regulatory Affairs Associate, Quality Assurance Associate, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Notified Body Auditor, Regulator, Electrical Safety Engineer, Internal Auditor, R&D Engineer, Clinical Affairs Director, Clinical Project Manager, and Human Resource Manager are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

Learners who enroll in this course should have a standard knowledge of medical devices and be familiar with the Council Directive 93/42/EEC

The following MEDDEV documents and definitions are also recommended as a reference for this course:

  • Definitions of "medical device," "accessory," and "manufacturer" (2.1/1)
  • Field of application of directive concerning active implantable medical devices (2.1/2 ))
  • Interface with directives including medical devices and other medicinal products (2.1/3)

Subject Matter Expert:

60 min

Related resources:

Case studies:

Basic Account: € 195.00
Premium Account: € 146.00

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