Requirements of Regulation (EU) 2017/745 (MDR) - Understanding and Implementing the Core Obligations
This seminar provides a structured and practice oriented journey through the essential requirements of Regulation (EU) 2017/745 (MDR). Participants gain a clear understanding of the regulatory framework, transitional provisions, and the significantly expanded obligations for manufacturers and other economic operators.
Throughout the session, participants will explore how to correctly interpret MDR requirements, how to integrate them effectively into existing organizational structures, and how current MDCG guidance influences day‑to‑day implementation. Using real‑world examples, the seminar will illustrate approaches for preparing compliant technical documentation, strengthening quality system processes, managing suppliers, and addressing common OEM/PLM challenges in a sustainable and pragmatic manner.
Seminar Agenda
- The MDR framework: regulatory foundations, definitions, and transitional provisions
- Obligations of manufacturers, importers, distributors, and authorized representatives
- PRRC responsibilities and OEM/PLM considerations
- EUDAMED, UDI systems, and related data requirements
- QMS expectations under MDR and links to ISO 13485
- Technical documentation under Annex II and III
- Supplier management, contractual obligations, and audit strategies
- Liability, sanctions, and national enforcement practices
- Practical case examples and solution focused implementation strategies
Learning Outcomes
Understand the MDR Regulatory Framework
- Regulatory and normative foundations
- Date of application, transitional provisions, and amendments (Articles 120 and 123)
- Definitions and terminology (Article 2)
- Claims, harmonized standards, and Common Specifications (Articles 7–9)
Fulfil Obligations as an Economic Operator
- Responsibilities of manufacturers, authorized representatives, importers, and distributors (Articles 10–14)
- Role and responsibilities of the Person Responsible for Regulatory Compliance (PRRC, Article 15)
- OEM/PLM relationships and associated regulatory considerations
- Requirements for managing suppliers and subcontractors
Implement MDR Requirements in Practice
- EUDAMED and UDI requirements (especially Articles 27, 29–32 and Annex VI)
- Quality management system expectations under MDR and their alignment with ISO 13485
- Technical documentation structure and content according to Annex II and III
- Supplier controls, quality assurance agreements, and audit strategies
- Navigating unresolved challenges and interpreting current MDCG guidance documents
Recognize Risks, Sanctions, and Liability
- Regulatory consequences of non compliance
- National enforcement mechanisms and oversight approaches
Who Should Attend
- Medical device manufacturers
- Importers, distributors, and authorized representatives
- Sales and Supply Chain Managers
- Regulatory Affairs Managers
- Quality and Vigilance Managers
- Market surveillance authorities and Notified Bodies
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