Life cycle of medical devices

1. Life cycle of medical devices Gerald Verollet World Health Organization 3rd SIGN Meeting - New Delhi

2. The risk/benefit nature of medical devices The goal is to maximize benefit and to minimize risk

3. Definition of medical device • Article, instrument, apparatus or machine • for • Diagnosis, treatment or prevention of disease • or for • detecting, measuring, restoring, correcting or modifying

4. Risk management in medical device • Degree of risk • Risk assessment of devices • Risk management

5. PRODUCT Pre-market review USE Post-market surveillance Critical factors for medical device safety and effectiveness • Presentation of product to user

6. The different phases of medical device From Conception to disposal

7. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal • 1 2 3 4 5 6 7

8. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal Pre-market Post-market On-market

9. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal Pre-Market

10. Life Cycle of a Medical Device Conceptionand Design Manufacture Packaging Labelling Advertising Sale Use Disposal On-Market

11. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal Post-Market

12. The role of each participant/stakeholder Manufacturer Importer/ Vendor Government User Public

13. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal MANUFACTURER USER VENDOR

14. The safety and effectiveness of medical devices demands co-operation among stakeholders • The Manufacturer • The vendor • The users • The Public • The Governnent

15. The nature of medical device safety • A risk management issue • tied with device effectiveness/performance • Throughout the life cycle of the device

16. Communication Between the Actors Manufacturer Importer/ Vendor Government • Shared • Responsibility User Public