Program Overview
This intensive program unpacks the legal and regulatory framework for economic operators—with a specific focus on importer and distributor obligations under EU MDR/IVDR. Delivered by an industry expert with over 25 years of experience, the workshop blends conceptual understanding, situational awareness, real-world case studies, and interactive simulations. Participants will explore key compliance areas such as CE marking verification, documentation control, post-market surveillance, vigilance reporting, and supply chain risks. With practical exercises and real-life examples, the program ensures participants leave with actionable strategies to strengthen compliance and mitigate risks in corporate environments.
Features
- Understand the legal framework and obligations for importers and distributors under EU MDR/IVDR.
- Identify compliance gaps and risks in documentation, vigilance, and supply chain activities.
- Apply real-world case insights to strengthen corporate compliance frameworks.
- Develop a practical compliance monitoring roadmap for importer and distributor operations.
Target audiences
- Regulatory Affairs and Quality Assurance Teams
- Supply Chain Professionals
- Operations and Compliance Teams
Curriculum
- 4 Sections
- 16 Lessons
- 1 Day
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- Who Are Economic Operators?4
- 1.1Defining economic operators under EU MDR/IVDR: Manufacturer, Authorized Representative, Importer, Distributor
- 1.2Legal basis: Articles 13 & 14 of MDR/IVDR
- 1.3Obligations: Verification of CE Marking & EU Declaration of Conformity, Storage, transport, traceability, Complaint handling & vigilance obligations
- 1.4Key concepts: UDI, EUDAMED, Market Surveillance, PMS, SSCP, PRRC (Person Responsible for Regulatory Compliance)
- Challenges & Compliance Risks in Practice4
- 2.1Practical challenges for importers: Ensuring conformity documentation availability, Managing supply chain transparency, Communication with Notified Bodies & Competent Authorities
- 2.2Distributor realities: Handling storage/transport deviations, Grey market and parallel imports risks, Dealing with non-conforming devices in the supply chain
- 2.3Situational Mapping: Risks of non-compliance penalties, product recalls, reputational loss
- 2.4Key concepts: Vigilance Reporting, Market Withdrawal, Corrective Actions, CAPA
- Lessons from the Field4
- 3.1Case Study 1: Importer fined for inadequate documentation checks
- 3.2Case Study 2: Distributor liability in post-market surveillance failure
- 3.3Case Study 3: Successful implementation of a compliance monitoring system across a supply chain
- 3.4Discussion prompts: Where did things go wrong, what controls could have prevented failure, how can corporations replicate success stories?
- Hands-On Corporate Problem Solving4
- 4.1Exercise 1: Reviewing an importer’s checklist – identify gaps in conformity verification
- 4.2Exercise 2: Distributor compliance role-play – handling a vigilance incident
- 4.3Group Exercise: Designing a compliance monitoring framework for a sample product flow (Manufacturer → Importer → Distributor → Market)
- 4.4Debrief: Expert-led insights & recommendations
Instructor
