Ireland
Finland
United Kingdom
United StatesPerson 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.
Course Overview
PRRC for Medical Devices
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
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
- Quality Assurance Professionals
- Quality Engineers
- Regulatory Professionals
- Internal Auditors
- Lead Auditors
- Management Representatives
- Top Management
Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.
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)
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.
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.
Why Choose Comply Guru
About our Training
Learn about how our training is leading the industry for innovation through online learning.
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.7
Average Rating
6 global ratings
-
Good trainings, well delivered. I will take more in the future
-
Found the course very interesting.
-
Really good for content and execution
Frequently Asked Questions
Related Training Courses
