Person Responsible for Regulatory Compliance (PRRC) Training will provide learners with clarity on the role and responsibilities of the Person Responsible for Regulatory Compliance (PRRC) introduced under Article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and provide details on the qualifications and liabilities that exist for PRRCs.

Our online training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Why Choose Comply Guru?
Learn Anywhere, Anytime
Course Access for 6 Months
Ask The Instructor
Minimize Downtime at Work
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+
Course Snapshot
Accreditation
Comply Guru
Duration
5hrs
Available Format
eLearning
Price
EUR €  595.00
Why Choose Comply Guru?
Learn Anywhere, Anytime
Course Access for 6 Months
Ask The Instructor
Minimize Downtime at Work
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+

Course Overview

Person Responsible for Regulatory Compliance (PRRC) Training

Learning Objectives

Establish an understanding as to why the role of the PRRC was introduced in the MDR and IVDR

Identify the qualifications and relevant experience required to become a PRRC, how to demonstrate them and document the qualifications and relevant experience

Discuss and implement the elements involved in the appointment of the PRRC (appointment letter, job description)

Recognize the requirements of appointing a PRRC (Internal PRRC vs Outsourced PRRC)

Understand the responsibilities of the PRRC of a manufacturer and the Authorized Representative

Comprehend the requirements of registration of the PRRC on EUDAMED

Understand the integration and interaction of the PRRC into the organization and the impact of the PRRC on the Organization’s Quality Management System (QMS)

Understand the Liability of the PRRC

What Will I Learn?

Module 1: The Introduction of the role of the PRRC in EU-MDR and EU-IVDR

Topics Covered:

  • The Role of the PRRC in the context of Article 15 MDR/IVDR
  • Comparison of the PRRC with their equivalent in other industries/regulations

Module 2: The qualifications and relevant experience required to become a PRRC

Topics Covered:

  • Qualifications required to become a PRRC
  • Demonstration of Qualifications
  • Non-EU Qualifications
  • What is meant by “Relevant Experience”
  • Custom Made Devices and the PRRC

Module 3: The appointment of the PRRC

Topics Covered:

  • Job Description of the PRRC
  • Appointment letter for the PRRC

Module 4: Understand the responsibilities of the PRRC of a Manufacturer and the Authorized Representative

Topics Covered:

  • Task of the PRRC of a Manufacturer
  • Task of the PRRC of an Authorized Representative
  • Delegation of Tasks for PRRCs
  • Outsourcing the role of the PRRC
  • Knowledge management for the PRRC
  • EUDAMED Registration

Module 5: Integration of the PRRC into the organization and the impact of the PRRC on the Organization’s Quality Management System (QMS)

Topics Covered:

  • Impact of the PRRC on the QMS
  • QMS Documentation and the PRRC
  • Interactions of the PRRC with the rest of the organization
  • Auditing the role of the PRRC
  • The Liability of the PRRC
  • PRRC Liability at a National Level
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:

  • Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based) within the 90-day course license
What Are the Entry Requirements?

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

EU MDR or IVDR

  • 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 ISO13485

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.
  • The process approach used in quality management.
What Are The Technology Requirements?

If you are completing this training, the following applies:

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 how our training is leading the industry for innovation through online learning.

 
Why Choose eLearning

Frequently Asked Questions

Yes, we permit transfers to a future date (s) provided the request is made at least 30 days in advance of the live workshops you registered for. No refund is possible if less than 30 days’ notice is given. On a case-by-case basis, if we can accommodate a transfer at less than 30-days notice, we will but this cannot be guaranteed.
For the live workshops, we use Zoom and Microsoft Teams. Full details will be shared with Learners upon registering for the training. 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.  
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.
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.
Once you have completed the full program, including examination (if applicable), your certificate will be available within 30 business days via your Dashboard once all examination grading has been completed & verified. 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