Program Overview
This corporate training program equips participants with a clear understanding of the regulatory requirements for economic operators (EOs), with a sharp focus on importers and distributors under EU MDR/IVDR and related global regulations. Delivered by an industry expert with over 25 years of experience, the program blends conceptual knowledge, situational insights, real-life enforcement case studies, and practical simulations. Participants will learn to differentiate importer vs distributor responsibilities, implement robust compliance systems, and prepare for audits and inspections. With practical tools and actionable strategies, the course enables organizations to mitigate regulatory risks, ensure supply chain integrity, and maintain smooth access to global markets.
Features
- Interpret importer and distributor obligations under EU MDR/IVDR and global regulations.
- Implement verification, documentation, and traceability systems across the supply chain.
- Respond effectively to audits, inspections, and enforcement actions.
- Build compliance checklists and SOPs to reduce risks of non-conformity.
Target audiences
- Regulatory Affairs Professionals
- Operations and Compliance Teams
- Quality Assurance Professionals
- Supply Chain & Distribution Teams
Curriculum
- 5 Sections
- 20 Lessons
- 1 Day
- Who are Economic Operators?4
- 1.1Economic Operators (EOs): Manufacturer, Authorized Representative, Importer, Distributor.
- 1.2Scope under EU MDR 2017/745 & IVDR 2017/746.
- 1.3UDI, CE marking, PMS (Post-Market Surveillance), Vigilance, EUDAMED, GDP (Good Distribution Practice).
- 1.4Distinction between legal liability vs operational responsibility.
- Importer & Distributor Obligations5
- 2.1Importer Obligations: Product Conformity Check & UDI/EUDAMED Registration
- 2.2Importer Obligations: Storage & Handling, Complaint Handling, Cooperation With Competent Authorities.
- 2.3Distributor Obligations: Verification Of CE Marking, Labeling & IFU, Traceability, Complaint Forwarding, Corrective Actions.
- 2.4Global context: FDA (US supply chain requirements), MHRA (UK), WHO GDP standards.
- 2.5Risks of non-compliance: Recalls, Fines, Supply Chain Disruption, Brand Damage.
- Real-Life Case Sharing – Lessons from Enforcement4
- 3.1Case 1: Importer penalized for marketing non-conforming IVD kits in EU.
- 3.2Case 2: Distributor recall due to improper storage & temperature excursions.
- 3.3Case 3: Market disruption caused by incomplete EUDAMED registrations.
- 3.4Case 4: Successful compliance system by a multinational distributor using digital track & trace.
- Interactive Exercises & Simulation3
- 4.1Simulation: Teams analyze a scenario where an importer fails to verify CE marking and identify corrective actions.
- 4.2Group Exercise: Draft an obligations checklist for importers and distributors in line with MDR/IVDR.
- 4.3Role-Play: Regulatory authority inspection → importer/distributor teams must respond with documentation & compliance evidence.
- Wrap-Up & Key Takeaways4
- 5.1Importers and distributors are no longer passive players; they carry legal accountability.
- 5.2Compliance requires traceability systems, proactive verification, and PMS integration.
- 5.3Audit readiness and clear SOPs reduce regulatory risks.
- 5.4Collaboration across manufacturers, ARs, importers, distributors is key to seamless market access.
Instructor
