IVDR - Regulatory Requirements of Regulation (EU) 2017/746 and Practical Implementation
This seminar provides a comprehensive and practice oriented introduction to the regulatory requirements of Regulation (EU) 2017/746 (IVDR) and their practical application in the daily work of IVD manufacturers and related stakeholders. Participants learn how to classify IVDs correctly, select the appropriate conformity assessment pathway, and address the significantly expanded IVDR expectations for technical documentation, QMS processes, performance evaluation, and supplier management.
The seminar also explains the roles and responsibilities of economic operators, the function of the Person Responsible for Regulatory Compliance (PRRC), and how to make effective use of EUDAMED. Real world examples and implementation strategies show how companies can systematically integrate IVDR requirements into existing quality systems and manage the transition from the IVDD to the IVDR efficiently and sustainably.
Seminar Agenda
- IVDR regulatory framework, timelines, and key definitions
- Responsibilities of manufacturers, importers, distributors, and PRRC
- Supplier qualification, monitoring, and contractual controls
- EUDAMED registration, UDI, and traceability obligations
- QMS expectations and IVDR specific processes
- Technical documentation according to Annex II and III
- GSPRs and evidence requirements
- Risk management, performance evaluation, and PMS
- Transitioning from the IVDD to the IVDR
- Practical implementation strategies and case discussions
Learning Outcomes
Regulatory and Normative Foundations
- Understand the structure of the IVDR regulatory framework
- Dates of application, transitional provisions, and implementation timelines
- Essential terms and definitions
- Role of harmonized standards and Common Specifications (CS)
Responsibilities of Economic Operators
- Obligations of manufacturers, importers, distributors, and authorized representatives
- Tasks and responsibilities of the Person Responsible for Regulatory Compliance (PRRC)
- OEM/PLM challenges and related regulatory expectations
Supplier and Subcontractor Requirements
- Qualification, monitoring, and evaluation of suppliers
- Quality assurance agreements and contractual responsibilities
- Managing outsourced processes under IVDR requirements
EUDAMED and Regulatory Data Management
- Structure and function of the European Database for Medical Devices
- Registration requirements and mandatory data elements
- UDI obligations and traceability concepts
Quality Management System Requirements
- QMS expectations under IVDR and ISO 13485
- Integration of IVDR specific processes
- Record keeping and evidence management
Technical Documentation
- Structure and content according to Annex II and III
- General Safety and Performance Requirements (GSPRs)
- Evidence expectations and depth of documentation
- Maintaining and continuously updating technical documentation
Compliance, Liability, and Enforcement
- Legal consequences of non compliance
- Expectations of competent authorities and Notified Bodies
- Practical examples illustrating regulatory and normative requirements
Practical Implementation Examples
- Risk management under IVDR
- Clinical evidence and performance evaluation
- Usability engineering and human factors
- Post Market Surveillance (PMS) and vigilance obligations
Who Should Attend
- Employees of IVD manufacturers and operators (Regulatory Affairs, Medical Affairs, Operations and Manufacturing)
- Quality Managers
- Supply Chain Managers
- Auditors and internal compliance specialists
- R&D Engineers/Scientists
- Product Lifecycle Managers
- Vigilance and PMS Managers
Why You Should Attend
This seminar is designed for professionals who need a clear, structured, and actionable understanding of IVDR requirements. Participants gain the skills to classify IVDs correctly, choose the appropriate conformity assessment procedure, and create robust, compliant technical documentation. The training provides practical strategies for integrating IVDR specific processes into existing QMS structures, managing suppliers and subcontractors in line with regulatory expectations, and ensuring continuous compliance. Real world case studies help participants evaluate necessary organizational changes and implement them effectively.
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