Course Description

RoHS Directive 2011/65/EU & WEEE Directive 2012/19/EU

Course Description:

This course provides an overview of the requirements of the RoHS and WEEE Directives for medical devices (enforced in 2014).

Both directives have caused major implications for manufacturers of electric and electronic medical devices. This course explains what these changes mean for manufacturers, sub-contract manufacturers, and national distributors.

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Learning Objectives:

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

  • Distinguish which types of devices fall under the RoHS and WEEE Directives
  • Identify certain material restrictions that must be addressed before the design and validation process of electric and electronic medical devices
  • Apply the appropriate directive requirements and standards to the quality assurance process
  • Acknowledge the need for setting up waste disposal systems

Who Should Enroll:

Regulatory affairs associates and managers; quality assurance associates, managers, and engineers; supply, purchasing, export, clinical project, and pre-clinical study managers; manufacturing, design, validation, electrical safety, and R&D engineers; notified body, internal, and lead auditors; regulators, and clinical affairs directors are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

There is no prerequisite knowledge required for this course; all areas of expertise are welcome.

Subject Matter Expert:
Jan-Paul Van Loon

33 min

Release date:

Related resources:

Case studies:

Basic Account: € 101.00
Premium Account: € 75.00

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