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

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

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

Risk management in medical device Degree of risk Risk assessment of devices Risk management

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

The different phases of medical device From Conception to disposal

Life Cycle of a Medical Device Conception and Design ManufacturePackaging Labelling AdvertisingSaleUseDisposal

Life Cycle of a Medical Device Conception and Design ManufacturePackaging Labelling AdvertisingSaleUseDisposal Pre-market On-market Post-market

Life Cycle of a Medical Device Conception and Design ManufacturePackaging Labelling AdvertisingSaleUseDisposal Pre-Market

Life Cycle of a Medical Device Conception and Design ManufacturePackaging Labelling AdvertisingSaleUseDisposal On-Market

Life Cycle of a Medical Device Conception and Design ManufacturePackaging Labelling AdvertisingSaleUseDisposal Post-Market

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

Life Cycle of a Medical Device Conception and Design ManufacturePackaging Labelling AdvertisingSaleUseDisposal MANUFACTURER VENDOR USER

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

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

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