Quality Training

Online Overview of EU Medical Device Regulation (MDR)

Objectives

The Irish Medtech Skillnet is delighted to join Comply Guru™ and Meddev Solutions in bringing to market this exciting new online self-paced general overview of the EU MDR course.

Content includes

Module 1:
Introduction to the EU-MDR (Online & Self-Paced)
  • History of MD scandals
  • Purpose of EU-MDR
  • Structure of EU-MDR
  • Definitions
  • Medical devices covered by EU-MDR
  • Key changes introduced by EU-MDR
  • Timelines for transition
Module 2:
Placing on the market (Online & Self-Paced)
  • Overview of articles 10, 11, 13-15
  • Role of the Manufacturer, Authorised Representative, Importer, Distributer and Person Responsible for Regulatory Compliance
  • Overview of articles 5, 19, 20
  • Brief overview of Classification, Conformity assessment, EU declaration of conformity and CE Marking

Who should attend

Anyone interested in a general overview of the EU MDR.
  • Anyone working in the Medical Device Industry
  • Quality assurance professionals
  • Quality Engineers
  • Research and design Engineers
  • Internal Auditors
  • Quality Managers
  • Manufacturing Engineers
  • Regulatory professionals

    Qualification

    Successful completion will entitle each Learner to receive a certificate of completion.
    In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination.

    Upcoming dates:

    No training dates available at the moment.

Register your interest

Course

Online Overview of EU Medical Device Regulation (MDR)

Training Days

Online Platform

Training Location

Available nationally, based on demand

Course Cost

IMDA Skillnet Member: €150
Non-member rate: €195
* Cost quoted per person

Register your interest