Refresh your key role
Stay up to date with regulatory requirements:
Our compact PRRC refresher course is designed for Persons Responsible for Regulatory Compliance who want to systematically refresh their knowledge of duties and responsibilities under MDR and IVDR.
Why choose our PRRC Refresher eLearning?
- Deepen and consolidate your knowledge: The course offers the opportunity to systematically review existing knowledge and reflect on key MDR and IVDR topics within the current regulatory context. Complex relationships are explained clearly and in a practical manner.
- Practical and efficient: Key topics are revisited in short, interactive learning modules, and current real-world issues are addressed. This helps you stay confident in your role and implement regulatory requirements effectively.
- Flexible learning: Perfect for working PRRCs – you decide when and where to learn, at your own pace.
- Certificate of knowledge update: Upon completion, you will receive a certificate documenting your participation and updated regulatory expertise.
- Content
- Person Responsible for Regulatory Compliance (PRRC) – Why, what for, and how?
- Legal basis: MDR Article 15
- Tasks and responsibilities of the PRRC
- Challenges for manufacturers and EU authorised representatives
- PRRC-relevant areas
- Product conformity
- Technical documentation
- Post-market surveillance (PMS)
- Vigilance
- Declaration/involvement in clinical investigations
- Person Responsible for Regulatory Compliance (PRRC) – Why, what for, and how?
- How you benefit
- Strengthen legal certainty: Refresh your knowledge of legal requirements for PRRCs under MDR Article 15 and strengthen your understanding of implementation in a corporate context.
- Reflect and sharpen your role: Deepen your understanding of the tasks, responsibilities, and interfaces of the PRRC.
- Focus on regulatory areas: Review and consolidate your knowledge in key PRRC activity areas – from product conformity and technical documentation to PMS, vigilance, and involvement in clinical investigations.
- Flexible learning: 180 days of access to the eLearning – ideal for combining learning with your professional routine.
- Proof of 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 authorised representatives
- Employees from development, production, and service who want to better understand interfaces with the PRRC
- Management/executives in small and micro companies with MDR obligations
