Medical Device Consultant According to §83 MPDG: Legal Foundations, Responsibilities, and Practical Application
This seminar offers a structured and practice oriented introduction to the legal responsibilities, qualification criteria, and daily work of Medical Device Consultants under §83 of the German Medical Device Implementation Act (MPDG). Participants receive a clear and comprehensible overview of both the European and German regulatory landscape, including the shift from the former Medical Device Act (MPG) to the MPDG and the key implications of Regulation (EU) 2017/745 (MDR).
Interactive sessions and real world examples illustrate how Medical Device Consultants operate within the vigilance system, manage reporting duties, and ensure compliant behavior in the field. Upon completion, participants receive a certificate recognized as proof of qualification under §83 MPDG.
Seminar Agenda
- Foundations of EU and German medical device legislation
- Detailed MDR and MPDG requirements
- Duties, responsibilities, and qualification requirements under §83 MPDG
- Distinction from the PRRC (Article 15 MDR)
- Vigilance processes and reporting workflows
- Liability exposure, sanctions, and compliance principles
- Practical examples, case studies, and group discussions
- Documentation of qualification
Learning Outcomes
Regulatory Framework
- Understand the structure of EU and German medical device legislation
- Learn how MDR and MPDG requirements impact manufacturers, distributors, and field staff
Role of the Medical Device Consultant
- Legal foundations, essential duties, and qualification expectations under §83 MPDG
- Core responsibilities in day to day practice
- Clear differentiation from the MDR’s Person Responsible for Regulatory Compliance (PRRC, Article 15)
Vigilance and Reporting
- Purpose and structure of the European vigilance system
- Reporting obligations, escalation paths, and required timelines
- Consultant’s involvement in incident communication and feedback loops
Compliance and Liability
- Legal consequences of non compliance with MDR/MPDG
- Liability risks and regulatory sanctions
- Best practices to ensure safe and compliant field activities
Regulatory Changes
- Key differences between MPG and MPDG
- How MDR requirements affect field operations and internal processes
Who Should Attend
This seminar is designed for:
- Medical device manufacturers and distributors
- Medical Device Consultants
- Sales and field representatives
- Regulatory Affairs and Quality professionals
- Vigilance and PMS (Post-Market Surveillance) Managers
- Professionals transitioning into the medical device sector
- Service, maintenance, and technical staff
Why You Should Attend
This seminar equips participants with the regulatory knowledge and practical skills needed to act as a fully qualified Medical Device Consultant according to §83 MPDG. You will gain clarity on your legal obligations, understand your role within the vigilance and reporting system, and learn how to conduct field activities in full compliance with MDR and MPDG requirements. The final certificate serves as documented proof of the required expertise and may be used for internal qualification records.
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