Person Responsible for Regulatory compliance according to MDR and IVDR
This one day course will provide a background on Personal Responsible for Regulatory Compliance duties and how this concept is translated into the Medical Device and IVD world, and will cover some of the practical aspects of the implementation of this new requirement.
Outcome
The MDR and also the IVDR introduce the new concept of Personal Responsible for Regulatory Compliance (PRRC).
This one day course will provide a background on Personal Responsible for Regulatory Compliance duties and how this concept is translated into the Medical Device and IVD world, and will cover some of the practical aspects of the implementation of this new requirement for manufacturers.
“Manufacturers shall have available within their organisation at least one person responsible who possesses expert knowledge in the field of medical devices.” Or: “five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.”
Sign up for this course regarding the ”Role of the Personal Responsible for the Regulatory Compliance” and learn about the concept and how to implement the requirements in your organisation.
Content
- Review of requirements
- Review of the role of person responsible for regulatory compliance for devices, including the personal responsibility associated with documentation review and the skills required to approve devices
- Tasks associated with the role of person responsible for regulatory compliance:
- QMS compliance
- Technical documentation – preparation and maintenance
- Post-Market Surveillance obligations
- Reporting
- Personal responsiblity – independence
- How to implement the new requirements in your organisation
Who should attend
Manufacturers, distributors and importers including:
- Regulatory Managers
- Quality Managers
- General Management
Trainers
Pernille Veje
CEO, Mayday Solution ApS
Pernille Veje brings extensive experience in quality assurance, regulatory affairs and quality management for medical devices. On this course, she focuses on the regulatory requirements for the Person Responsible for Regulatory Compliance under the MDR and IVDR, including the PRRC’s responsibilities, organisational position and interaction with management and the quality management system.
Søren Lyngsø-Petersen
Senior Consultant, Pharma4ever A/S
Søren Lyngsø-Petersen has extensive experience with quality management, auditing and regulatory compliance within the medical device industry. On this course, he translates the MDR and IVDR requirements for the PRRC into practical processes and responsibilities, with particular focus on documentation, compliance oversight, internal collaboration and the challenges organisations may face when implementing the role.
What previous participants said
Contact
Select date
25 November 202622 February 2027
27 September 2027
25 November 2026 - at 09:00 - 16:00
Price ex. VATLatest Registration
22 November 2026
Latest Cancellation
4 November 2026
Bøge Allé 5, 2. th
2970 Hørsholm
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Terms
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