Medical Device Definition

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MEDICAL DEVICE DEFINITION
What is a Medical Device?
Copyright © Semoegy Advisers & Ventures

COURSE CONTENT
• Basic definition of a medical device
• Key attributes
• Intended purpose
• Brief insight into in vitro diagnostic medical
device

DRUGS /
PHARMACEUTICALS
HEALTHCARE PRODUCTS
MEDICAL
DEVICES
BIOLOGICS

Healthcare is one of the most
regulated industries in the world
HEALTHCARE PRODUCTS
Medical devices are highly
regulated

HEALTH PRODUCTS REGULATION
REVIEW
Approval of
healthcare products
before marketing
RISK OF HARM
Healthcare products
may carry a certain risk
of harm to patients
EVIDENCE-BASED
Associated risks
must be reduced
or eliminated

KEY INFLUENCER REGULATORS
The European
Union Directives
for Medical
Devices and
Medicines
Health
Canada
UNITED STATES
CANADA
The Medicines
and Healthcare
Products
Regulatory
Agency of the UK
US Food & Drug Administration
AUSTRALIA
Therapeutic Goods
Administration
EUROPEAN UNIONUNITED KINGDOM

KEY INFLUENCER REGULATORS
The healthcare products
regulations in the UK,
Canada and Australia use
the European Union
framework as a foundation.
Used as regulatory
benchmarks to develop local
frameworks
UNITED KINGDOM
CANADA
AUSTRALIA
EUROPEAN UNION

MEDICAL DEVICES
Clear definition by regulators
Application of appropriate regulatory
controls
For products that are defined as medical
devices

HEALTH PRODUCT DIFFERENCES
MEDICAL
DEVICE
PHARMACEUTICALS BIOLOGICS
Download this
document at our
Lecture Materials tab.
DOWNLOAD
Differences between
a medical device,
pharmaceutical and
biological product.

KEY MEDICAL DEVICES ATTRIBUTES
PRIMARY MECHANISM
OF ACTION
• PHYSICAL
• STRUCTURAL
• DIAGNOSTIC
• PREVENTIVE
• INFORMATIVE
FORM
• EQUIPMENT
• TOOL
• ENGINEERED OR
CONSTRUCTED
ARTICLE
• SOFTWARE
This includes fluid substances

MEDICAL DEVICE DEFINITION
The FORM of a medical device
How a medical device
FUNCTIONS
The INTENDED PURPOSE
of the medical device
MEDICAL PURPOSE
For human use
The detailed definition of a medical device can be broken down into three
attributes:

FORM OF A MEDICAL DEVICE
SOFTWARE
IMPLANT
IMPLEMENT
MATERIAL
INSTRUMENT APPLIANC
E
MACHINE
IN VITRO
REAGENTAPPARATUS
MOBILE MEDICAL
DEVICES
This includes medical
devices that are
controlled by or run on
mobile platforms.

HOW IS A MEDICAL DEVICE USED
Intended by the Manufacturer
For human
beings
To be used
alone
Or in
combination

INTENDED USE OF A MEDICAL DEVICE
Disease Injury
Anatomy, or
Physiological
Process
Other
Medical
Purposes
DISEASE
• Diagnosis
• Prevention
• Monitoring
• Treatment
• Alleviation
INJURY
• Diagnosis
• Monitoring
• Treatment
• Alleviation
• Compensation
ANATOMY OR
PHYSIOLOGICAL
PROCESS
• Investigation
• Replacement
• Modification
• Support
OTHER MEDICAL
PURPOSES
• Supporting or
sustaining life
• Control of
conception
• Disinfection of
medical devices
• Providing
information by
means of in vitro
examination.
Example
text

WHAT A MEDICAL DEVICE DOES NOT DO
DON’T
x Pharmacologic
x Immunologic
x Metabolic
DO
Does not achieve its
primary intended function
by these means:
May be assisted in its
intended function by such
means

MEDICAL DEVICE EXAMPLES
Wound dressing
Glucometer
Contact Lens
Infusion Set
Eye Drops
X-ray CT scan

Wound dressing
Injury
Treatment & Protection

Glucometer
Disease
Diagnosis & Monitoring

Contact Lens
Anatomy
Modify & Support

Infusion Set
Physiological Process
Support & Sustain

Eye Drops
Anatomy
Support & Sustain

X-ray CT scan
Disease & Anatomy
Diagnosis, Monitoring
& Investigation

The examination of these samples
outside of the human body, for
example in a laboratory or using a
measurement instrument.
Step 2
IN VITRO DIAGNOSTICS
Retrieval of physiological
samples from the human body
Step 1
Provides information on an
individual’s health or disease
condition
Step 3
Helps to monitor treatment
outcomes
Step 4

IN VITRO DIAGNOSTIC MEDICAL DEVICE
In Vitro
Diagnostics
Intended Use
• Diagnosis
• Aid to diagnosis
• Screening
• Monitoring
• Predisposition
• Prognosis
• Prediction
• Determination

IN VITRO DIAGNOSTIC MEDICAL DEVICE
• These devices can be used alone
or in combination.
• Includes self-testing in vitro
diagnostics

IN VITRO DIAGNOSTIC EXAMPLES
Glucometer
HIV & Hepatitis Test Blood Grouping
Cardiac Marker
Genetic Testing

IMPORTANT LEARNING POINTS
Medical devices are highly
regulated
Highly Regulated
Medical devices are
intended for a Medical
Purpose
Medical Purpose
Primary mechanism of
action: physical, structural
or diagnostic
Action
The definition of a medical device will differ
from country to country.
Definition
The appropriate medical device definition and
regulatory controls of that country must be
followed.
Regulations
A medical device does not achieve its primary
intended action by pharmacological,
immunological or metabolic means.
What it does not do
In vitro Diagnostics are Medical Devices
IVDs

DOWNLOAD
Lecture Materials Tab
Slides for
this lecture
Country-specific
medical device
definition
Healthcare product
comparison table

This lecture is part of the introductory course
series for medical devices. For more updates on
upcoming lectures, sign up on our website:
www.semoegy.com.

REFERENCES
• International Medical Device Regulators
Forum (IMDRF) - http://www.imdrf.org/

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Medical Device Definition

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