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.
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Person Responsible for Regulatory Compliance (PRRC) Training
Our training is for anyone that wants to understand the PRRC responsibilities under the MDR and IVDR and it can be completed in-person or virtually.
Face to Face Learning
On completion of this course, successful Learners will have the knowledge needed to:
- 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
A summary of topics within this course include:
- The Role of the PRRC in the context of Article 15 MDR/IVDR
- Comparison of the PRRC with their equivalent in other industries/regulations
- Qualifications required to become a PRRC
- Demonstration of Qualifications
- Non-EU Qualifications
- What is meant by “Relevant Experience”
- Custom Made Devices and the PRRC
- Job Description of the PRRC
- Appointment letter for the PRRC
- 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
- Impact of the PRRC on the QMS
- QMS Documentation and the PRRC
- Interactions of the PRRC with the rest of the organization
- The Liability of the PRRC
- 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:
- Fully attend the Live Instructor Workshop as 100% attendance is required
- Pass the end of course final assessment.
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.
- Must have experience of working with ISO13485:2016 or knowledge of ISO13485:2016
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 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.
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