Person Responsible for Regulatory Compliance (PRRC) according to MDR / IVDR Article 15

This course is intended for:

• Persons currently serving as PRRCs
• Individuals preparing to assume the PRRC role
• Regulatory Affairs Managers and Specialists
• Quality Assurance and Quality Management Professionals
• Clinical Affairs Professionals
• Post-Market Surveillance and Vigilance Personnel
• Medical Device and IVD Manufacturers
• EU Authorized Representatives
• Consultants supporting regulatory compliance
• Company Executives and Senior Management
• Individuals responsible for MDR and IVDR implementation

1. Introduction to MDR and IVDR

• Regulatory background and history
• MDR and IVDR overview
• Key regulatory developments
• MDCG guidance documents

2. PRRC Requirements and Proof of Competence

• Article 15 requirements
• Qualification pathways
• Professional experience requirements
• Special provisions for custom-made device manufacturers
• Evidence of competence
• Micro and small enterprise requirements
• Multiple PRRC structures

3. Registration of the PRRC

• EUDAMED overview
• Economic operator registration
• PRRC registration requirements
• Device registration requirements
• National registration systems and DMIDS overview

4. Responsibilities of the PRRC

• Product conformity verification
• Quality management system interactions
• Technical documentation requirements
• EU Declaration of Conformity
• Clinical investigations and performance studies
• PMS obligations
• PMS plans, reports, and PSURs

5. Vigilance and Reporting Obligations

• Vigilance definitions
• Serious incident reporting
• Field Safety Corrective Actions (FSCA)
• Trend reporting
• Reporting timelines
• EUDAMED vigilance reporting

6. PRRC and Authorized Representatives

• PRRC obligations for authorized representatives
• Qualification requirements
• Responsibilities under Article 11
• Manufacturer and AR interactions

7. Liability and Legal Considerations

• Labor law considerations
• Internal and external liability
• Insurance considerations
• Regulatory penalties and enforcement provisions

8. Practical Workshop

• Real-world PRRC scenarios
• Dealing with regulatory nonconformities
• Managing regulatory escalation
• Cooperation with authorities
• Practical implementation strategies

The introduction of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) established the role of the Person Responsible for Regulatory Compliance (PRRC) as a key element of regulatory oversight within medical device and IVD organizations. Manufacturers and authorized representatives must ensure that appropriately qualified individuals are available to oversee compliance with regulatory requirements and quality management system processes.

This comprehensive training provides participants with a detailed understanding of the legal basis, qualification requirements, and practical responsibilities of the PRRC under Article 15 MDR and IVDR. Participants will examine applicable regulatory requirements, including MDCG 2019-07 Rev.1 guidance, and learn how the PRRC contributes to ensuring device conformity, maintenance of technical documentation, declaration of conformity activities, and compliance with quality management system requirements.

The course further explores the PRRC's responsibilities throughout the product lifecycle, including post-market surveillance (PMS), vigilance reporting, trend reporting, field safety corrective actions, and interactions with competent authorities. Participants will also gain insight into registration obligations, including EUDAMED requirements and the registration of economic operators and products.

Special attention is given to the role of the PRRC within manufacturers, micro and small enterprises, authorized representatives, and organizations with multiple PRRCs. Participants will learn how responsibilities may be structured, documented, and integrated into organizational processes while maintaining regulatory compliance.

Through practical examples, discussions, and workshop activities, participants will develop the knowledge needed to perform the PRRC function confidently, understand liability considerations, and support compliance with evolving MDR and IVDR requirements.

After completing this course, you will be able to:

• Understand the legal framework governing the PRRC role under MDR and IVDR.
• Identify qualification and competence requirements for PRRCs.
• Understand the responsibilities and authority associated with the PRRC position.
• Apply practical approaches for ensuring device conformity and regulatory compliance.
• Manage technical documentation and declarations of conformity effectively.
• Understand PRRC involvement in PMS, vigilance, and reporting activities.
• Navigate EUDAMED and registration obligations relevant to the PRRC.
• Understand responsibilities within manufacturers and authorized representatives.
• Recognize liability considerations and risk mitigation strategies.
• Apply regulatory requirements through practical exercises and case-based discussions.

This instructor-led live online training combines:

• Expert presentations
• Interactive discussions
• Case studies
• Practical examples
• Workshop exercises
• Group activities
• Scenario-based learning
• Q&A sessions

Participants benefit from direct interaction with experienced trainers and peer discussions focused on practical implementation challenges.

Participants who attend at least 90% of the total training duration will receive a Certificate of Attendance from TÜV SÜD Academy upon completion of the training.

Participants should have:

• Basic knowledge of medical device regulations.
• Familiarity with MDR and/or IVDR requirements.
• General understanding of quality management systems in the medical device or IVD sector is advantageous.

Laerning Path:

• The training course deals with the requirements of the MDR and IVDR.
• This course is part of a modular training programme. After successful participation in the advanced modules, you can acquire this recognized qualification:
  • MDR Expert – TÜV

What is a PRRC?

A PRRC (Person Responsible for Regulatory Compliance) is a designated individual required under MDR and IVDR Article 15 to oversee regulatory compliance activities within medical device and IVD organizations.

Who is required to have a PRRC?

Manufacturers of medical devices and IVDs, as well as EU Authorized Representatives, are generally required to have a qualified PRRC available.

Does the course cover both MDR and IVDR requirements?

Yes. The course covers PRRC requirements under both Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

Will I learn the qualification requirements for becoming a PRRC?

Yes. The course explains qualification pathways, professional experience requirements, competence expectations, and special cases described in Article 15 and MDCG guidance.

Is EUDAMED registration covered?

Yes. Participants will learn about EUDAMED modules, economic operator registration requirements, and PRRC-related registration obligations.

Does the course discuss PMS and vigilance responsibilities?

Yes. PMS, PSURs, vigilance reporting, trend reporting, serious incident reporting, and Field Safety Corrective Actions are key topics.

Will the course explain the responsibilities of Authorized Representatives?

Yes. The course includes dedicated coverage of PRRC requirements and responsibilities applicable to Authorized Representatives.

Does the course include practical examples?

Yes. Workshop exercises and practical scenarios help participants understand how to apply regulatory requirements in real-world situations.

Is the course suitable for someone newly appointed as a PRRC?

Absolutely. The course is designed both for newly appointed PRRCs and experienced regulatory professionals seeking a deeper understanding of Article 15 responsibilities.

Are liability and legal implications discussed?

Yes. The course addresses labor law considerations, liability risks, enforcement provisions, and practical measures to support compliant execution of the PRRC role.

Is this course relevant for both medical devices and IVDs?

Yes. All core requirements are addressed from both the MDR and IVDR perspectives.

Does completion of the course qualify me to act as a PRRC?

The course provides essential knowledge and understanding of the role. However, appointment as a PRRC remains subject to the qualification and experience requirements defined in MDR/IVDR Article 15 and the organization's own assessment of competence.

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