Your key role for regulatory safety – the PRRC
Welcome to our specialized eLearning program on the Person Responsible for Regulatory Compliance (PRRC).
This training provides you with the essential knowledge to competently fulfill the responsible role of the PRRC in accordance with the requirements of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). With our course, you lay the foundation for confidently managing regulatory requirements and sustainably ensuring compliance within your organization.
Why choose our PRRC eLearning?
- Regulatory expertise at first hand: Our course has been developed by experts with many years of experience in European medical device law. You will gain practical, up-to-date knowledge directly from the industry.
- Flexible learning: Whether you are already working as a PRRC or preparing for this role, our eLearning adapts to your schedule. You determine your learning pace and can access the content anytime, anywhere.
- Practice-oriented content: Complex regulatory requirements are explained in a clear and application-oriented way. Interactive learning modules, case studies, and knowledge checks help deepen your understanding step by step.
- Certificate of expertise: Upon successful completion, you will receive a certificate confirming your qualification as a PRRC, documenting your regulatory expertise and sense of responsibility.
- Content
- Person Responsible (PRRC) – Why, what for, and how?
- Who is the PRRC and who needs one?
- Special provisions for small and micro enterprises
- Legal basis: MDR Article 15 and its relation to ISO 13485:2016
- Tasks and responsibilities of the PRRC
- Challenges for manufacturers and EU Authorized Representatives
- Key terms and definitions
- PRRC-relevant areas
- Product conformity
- Technical documentation
- Post-market surveillance (PMS)
- Vigilance
- Declaration/involvement in clinical investigations
Note on your personal learning environment:
After registration, you will receive access to our LMS platform and can complete the training flexibly over time. Upon completion, you will receive proof of qualification.
- Person Responsible (PRRC) – Why, what for, and how?
- How you benefit
- Gain legal certainty: You will understand the legal requirements for the PRRC according to MDR Article 15 and be able to implement them effectively in your organization.
- Clearly fulfill your role: You will know the tasks, interfaces, and typical pitfalls of the PRRC.
- Efficiency & scalability: You will understand the minimum requirements for small/micro enterprises and how to achieve compliance with reasonable effort.
- Flexible learning: 180 days of access to the eLearning – ideal for balancing learning and professional life.
- Proof of your competence: Final certificate/proof of qualification for internal and external documentation.
- Methods
- Concise trainer inputs
- Interactive elements, examples & decision trees
- Practical checklists & do/don’ts
- Quizzes
- Target Audience
- (Junior) Regulatory Affairs professionals and career starters/changers
- Quality management & Clinical/PMCF responsible persons
- PRRC role holders or their deputies
- Responsible persons at EU Authorized Representatives
- Employees from development, production, and service who want to better understand PRRC interfaces
- Management/executives in small and micro enterprises with MDR obligations
