Live Seminar on the Medical Device Regulatory Framework (MDR & IVDR)

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Michalopoulou & Associates Lawgroup in cooperation with Pytheia – the Competence Center in Greece in the field of Health – organizes the most valuable official seminar, which provides the knowledge required before any researchor development of Medical Devices and Software

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This course is addressed to all stakeholders in the medical device supply chain, from manufacturers to distributors, as well as medical technology product managers, researchers, start-ups, pharmaceutical companies, IT companies active in the medical applications sector, regardless of department and specialization.

The seminar modules include:
  • Key definitions, re: MDR/IVDR.
  • MDR vs AI Act (AI Act): challenges & contrasts between the MDR and the proposed new AI Regulation.
  • Transitional provisions and validity of certificates.
  • The case of Greece – Legislative framework.
  • Medical Devices Vs Drugs.
  • Medical Device as a Software: Definitions, Characteristics and classification, marketing and conformity assessment of MDSW, MDSW sub-modules, changes in software.
  • Medical Device as a Software: Clinical Documentation and Clinical Evaluation.
  • Cybersecurity and MDR/IVDR issues.
  • Obligations of economic operators under MDR/IVDR and role of PRRC (person responsible for regulatory compliance).
  • Security issues including UDI, EUDAMED.
  • Responsibilities and role of Notified Bodies.
  • Scope, scope of MDR/IVDR → Regulations, purpose, key changes, classification of medical devices.
  • The course will also address the challenges and contrasts between MDR
  • and the proposed new AI regulation, followed by a comprehension quiz and concluding remarks.