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Life cycle of medical devices
Gerald VerolletWorld 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
Manufacture Packaging Labelling
Advertising Sale Use Disposal
1 2 3 4 5 6 7
Life Cycle of a Medical Device
Conception and Design
Manufacture Packaging Labelling
Advertising Sale Use Disposal
Pre-market On-market Post-market
Life Cycle of a Medical Device
Conception and Design
Manufacture Packaging Labelling
Advertising Sale Use Disposal
Pre-Market
Life Cycle of a Medical Device
Conception and Design
Manufacture Packaging Labelling
Advertising Sale Use Disposal
On-Market
Life Cycle of a Medical Device
Conception and Design
Manufacture Packaging Labelling
Advertising Sale Use Disposal
Post-Market
The role of each participant/stakeholder
Manufacturer
Government
User
Importer/ Vendor
Public
Life Cycle of a Medical Device
Conception and Design
Manufacture Packaging Labelling
Advertising Sale Use Disposal
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 ActorsManufactur
er
Government
User
Importer/ Vendor
Public
Shared Responsibility
