Clinical Investigation of Medical Devices - According to Regulation (EU) 2017/745
This course provides a comprehensive and practice oriented introduction to the clinical investigation of medical devices under Regulation (EU) 2017/745 (MDR). Participants gain a clear understanding of the regulatory requirements for planning, submitting, conducting, and completing clinical investigations in Europe.
The training covers MDR obligations, national requirements under the MPDG (Germany), and the principles of ISO 14155:2020, which defines Good Clinical Practice (GCP) for medical device studies. In addition, the course integrates the most relevant MDCG guidance documents that support the interpretation and practical implementation of MDR requirements in clinical investigations.
Drawing on experience from numerous clinical projects and extensive interactions with ethics committees and competent authorities, this course conveys all concepts through practical examples and real‑world scenarios. This enables participants to confidently navigate ethical considerations, documentation requirements, safety reporting, and communication pathways with regulators and ethics committees.
Course Outline
- MDR, MDCG, MPDG and ISO 14155:2020 requirements for clinical investigations
- Roles and responsibilities of sponsors, investigators, and monitors
- Application processes for authorities and ethics committees
- Informed consent and special population considerations
- Conducting studies: documentation, monitoring, auditing
- Safety reporting and communication pathways
- Managing substantial modifications
- Electronic systems and essential documentation
- Practical examples and implementation strategies
Learning Outcomes
Regulatory Requirements
- MDR requirements for clinical investigations
- National requirements under the MPDG
- International expectations for clinical evidence
- Requirements for CE marked devices undergoing further clinical investigation
Planning and Submitting a Clinical Investigation
- General requirements for clinical investigations used to demonstrate conformity
- Study design and documentation
- Preparing and submitting applications to competent authorities and ethics committees
- Informed consent procedures, including special populations
- Coordinated assessment procedures for multi country studies
Conducting a Clinical Investigation
- Roles and responsibilities of sponsors, investigators, and monitors
- Essential documents and trial master file requirements
- Electronic systems for clinical investigations
- Managing substantial modifications
- Monitoring, auditing, and quality assurance
Safety Reporting
- Recording and reporting adverse events and device deficiencies
- Sponsor and investigator obligations
- Communication with authorities and ethics committees
Who Should Attend
- Medical device manufacturers
- Start-ups and innovators entering the MDR environment
- Regulatory Affairs specialists
- Clinical Affairs professionals
- Quality Management representatives
- Project Managers in Clinical Research
Why You Should Attend
This course is ideal for professionals who need a clear and actionable understanding of clinical investigations under the MDR. It equips participants to plan, submit, and conduct studies in compliance with European and international requirements. The training provides practical insights into GCP principles, safety reporting, documentation expectations, and coordinated assessment procedures, enabling participants to manage clinical investigations confidently and efficiently.
The inclusion of practical examples, insights from numerous real world projects, and our direct experience communicating with ethics committees and authorities makes this training especially valuable for operational implementation.
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