Quality Training

EU Medical Device Regulation (MDR) Online Overview

Objectives

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

This Online & SELF PACED Basic Overview of the EU Medical Device Regulation (MDR 2017/745) Training Course is perfect for anyone working in the medical device industry sector who is looking for a general overview of the EU Medical Device Regulation and it can be completed anytime, anywhere!

This event is also FULLY FUNDED under SKILLS CONNECT for UNEMPLOYED Job seekers who are currently seeking employment, subject to eligibility criteria.

Content includes

Module 1:
Introduction to the EU-MDR (Online & Self Paced)

• Context for revision of MDD/ AIMDD/ IVDMD
• 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, Distributor 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.