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
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.