Course Description

Labeling Requirements for Medical Devices in Europe

Course Description:

This course provides a comprehensive review of the European labeling requirements outlined in directives 93/42/EEC (Medical Device Directive [MDD]) and 90/385/EEC (Active Implantable Medical Device Directive [AIMDD]), as well as the requirements in harmonized standards EN 980, EN 1041, and ISO 15223.

This course also offers detailed guidance on how to apply regulations and requirements, as supported by examples of labeling development for medical devices in the European market.

Learning Objectives:

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

  • Plan labeling activities for target markets
  • Apply MDD and AIMDD definitions and requirements
  • Implement MDD- and AIMDD-specific requirements for labeling
  • Employ EN 980, EN 1041, and ISO 15223 requirements
  • Maintain an overview of the development process for instructions for use
  • Support and drive the labeling process in compliance with change control
  • Use guidance from applicable standards outlined in the course
  • Assess and coordinate national language requirements

Who Should Enroll:

Quality Assurance Associate, Quality Assurance Engineer, Manufacturing Engineer, Design Engineer, Validation Engineer, Electrical Safety Engineer, Pre-Clinical Study Manager, R&D Engineer, Regulatory Affairs Associate, Regulatory Affairs Manager, Notified Body Auditor, Regulator, Internal Auditor, R&D Engineer, Clinical Affairs Director, Clinical Project Manager  whose responsibilities include contributing to the medical device labeling process, quality managers are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

A strong grasp of the CE-marking process, essential requirements, the principles of the risk management process, and the logical links between essential requirements, risk management, clinical evaluation, and the outcome for labeling are all requirements for this course.

Subject Matter Expert:

87 min

Related resources:

Case studies:

Basic Account: € 283.00
Premium Account: € 212.00

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