Authorized Representative Training that provides learners with clarity on the role and responsibilities of the Authorized Representative under Article 11 and Article 12 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

Our training is for anyone that wants to understand the Authorized Representative role under the MDR and IVDR and it can be completed in-person or virtually.

Why Comply Guru?

  • Highly Interactive, Engaging Experience
  • Industry-leading Accelerated Learning Methodology
  • Delivered by Experts with Proven Expertise
Choose Your Preferred Format
Virtual Learning

Virtual Learning

1 day

In-Person Learning

In-Person Learning

1 day

Course Snapshot
Comply Guru
Available Format
Virtual or In-Person Learning
In-Company Groups

Course Overview

Authorized Representative Training

What Will I Learn?

On completion of this course, successful Learners will have the knowledge needed to:

  1. Understand the function and the role of the Authorized Representative
  2. Identify the relationship between the Authorized Representative and the Manufacturers QMS and Documentation (Technical File and Declaration of Conformity)
  3. Recognize the requirements of Registration Obligations
  4. Understand the responsibilities of the Authorized Representative in respect of Post Market Surveillance and Vigilance
  5. Understand the relationship between the Authorized Representative, Competent Authorities, and the Manufacturer
  6. Understand the Liability of the Authorized Representative
  7. Understand the process of Changing the Authorized Representative

A summary of learning topics within this course include:

  • The Role of the Authorized Representative in the context of Article 11 and Article 12 MDR/IVDR
  • Economic Operators of (EU) 2017/745 MDR
  • The role of the Authorized Representative with the Competent Authorities
  • Responsibilities of the Authorized Representative
  • The Authorized Representative, Post Market Surveillance and Vigilance
  • Liability for the Authorized Representative
  • The Mandate between the Authorized Representative and the Manufacturer
  • Obligations of the Authorized Representative in respect of the PRRC
  • Task of the PRRC of an Authorized Representative
  • EUDAMED Registration Obligations
  • Documentation and the Authorized Representative
  • Document Retention Periods for the Authorized Representative
Who Should Attend?
  • Quality Assurance Professionals
  • Quality Engineers
  • Regulatory Professionals
  • Internal Auditors
  • Lead Auditors
  • Management Representatives
  • Top Management
Will I Get A Certificate?

Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.

How Will I Be Assessed?

In order to successfully complete this course, each Learner will need to:

  • Fully attend the Live Instructor Workshop as 100% attendance is required
  • Pass the end of course final assessment.
What Are the Entry Requirements?

Prior to attending this course, learners must be informed that they are expected to have the following prior knowledge:


  • A good understanding of the EU MDR (2017/745) and/or EU IVDR (2017/746) requirements and their application.

ISO 13485

  • Must have experience of working with ISO 13485

Medical device management systems

Knowledge of the following quality management principles and concepts:

  • The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
What Are The Technology Requirements?

If you are completing this training virtually, the following applies:

For the live workshops during a virtual delivery, we utilize both Zoom and Microsoft Teams.

Learners need to individually have:

  • PC or MAC Computer
  • Reliable Internet
  • Video Webcam
  • Headset or Earbuds
  • Quiet Setting

In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

About our Training

Learn about the benefits and key features of Comply Guru’s Instructor led Learning.

Why Choose Instructor led Learning

Frequently Asked Questions

Yes, we offer in-house training and if you have 5 or more learners that can be trained together, we strongly recommend arranging for in-house training. With this option, there is the possibility of customizing some elements of the training to your organization. Please request a quote and a member of our team will be in touch to discuss this further with you.
We keep our classes to 10 or 12 maximum depending on the blended course, to ensure you can enjoy breakout rooms, activities and Q&As with the Instructor and other participants.
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020