Person Responsible for Regulatory Compliance (PRRC) Training

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