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Online-Event
Clinical studies for medical devices - Qualification for study management according to MDR / MPDG
13. October 2025 - 23. October 2025
08:45 - 15:05
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Since the amendment of the Medical Devices Act and the MPKPV, proof of qualification has been mandatory for investigators and study personnel. Our course - consisting of a two-day basic and an advanced course - complies with the current recommendations of the German Medical Association and the medical ethics committees. With content in accordance with MDR, MPDG and IVDR, you are well prepared for your role in clinical trials.
Since the amendment of the Medical Devices Act (MPG) and the Ordinance on Clinical Trials of Medical Devices (MPKPV) in 2010, the qualifications of persons involved in clinical trials, in particular investigators and members of a trial group, must be verified and assessed by ethics committees. Since October 2016, the German Medical Association and the Working Group of Medical Ethics Committees have issued recommendations for the framework conditions of the corresponding courses, which were revised in the course of the replacement of MDD / MPG by MDR / MPDG and supplemented with content from the IVDR (March 2021 and April 2022). The content of this course, with a two-day basic course and a two-day advanced course, corresponds to these recommendations.
Objective
The aim of the course is to provide basic ethical, regulatory and methodological knowledge for conducting clinical trials as well as practical aspects for planning and organizing a clinical trial.
Target group
- Registered physicians and non-physician members of a trial group
- Monitors, sponsor representatives and employees of medical technology companies
Ethical principles
- Relevant regulations (Nuremberg Code, Declaration of Helsinki)
- Ethical principles of clinical research
Legal basis
- Medical Device Regulation / Medical Device Law Implementation Act (MDR / MPDG)
- Directives and harmonized standards
- Approval procedure of the higher federal authority, ethics application, role of the DIMDI
Methodological principles
- Definition of medical device
- Conformity assessment procedure
- Risk classification
- Study types and designs
Speaker
Information and consent
- Capacity to consent
- Informed consent discussion and documents
- Consent and documentation
Regular conduct of the study
- Screening, inclusion and exclusion criteria
- Study protocol, protocol
- Documentation (source data, CRF, databases)
- Monitoring (queries, corrections)
Adverse events
- Causality and severity
- Reporting obligations of the investigator and the sponsor
- Corrective measures, unblinding, discontinuation criteria
Learning success control
Legal basis
- Differentiation between MDR / MPDG and AMG
- Special responsibility
- Contracts, insurances, fees
- Medical confidentiality and data protection
Organizational management
- Study infrastructure (premises, equipment, pharmacy, laboratory, archive)
- Standard Operating Procedures (SOP)
- Team building and motivation
Quality assurance
- Basics (PDCA, CAPA)
- Study monitoring: audits and inspections
- Protocol violations
Special tasks of the lead auditor
- Resource and cost planning
- Training, distribution of tasks, delegation list
- Recruitment and patient inclusion
- Patient safety, discontinuation criteria, adverse events
- Investigational medicinal products: labeling, proof of use, storage
- Communication of changes (internal and external)
- Study completion (regular or premature), further treatment
Upon receipt of your registration, you will receive a registration confirmation with further information on how to access the digital event platform and an invoice. The number of participants is limited and depends on the number of registrations received.
Please note the following registration deadlines:
- Registration for the basic course is possible until October 4, 2025.
- Registration for the advanced course is possible until October 15, 2025.
Certificate and training points
The course corresponds to the current version of the curricular training recommended by the German Medical Association and the Working Group of Medical Ethics Committees. Participants will receive a certificate of attendance. The Bavarian Medical Association will apply for 9 continuing education points for the course.
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