MEDICAL DEVICE CLASSIFICATION

IDAMAZURA IDRIS @ HARUN

MEDICAL DEVICE CONTROL DIVISION, MINISTRY OF HEALTH
LEVEL 5, MENARA PRISMA, PERSIARAN PERDANA PRECINCT 3, PUTRAJAYA
CONTENT Background
Introduction to medical device
General principles of device classification
Factors influencing device classification
Notes to be considered
General classification of medical device
Determination of device class using rules-based system
Classification rules of medical device
Decision Tree
The additional rules
Rationale
Matters to consider
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 BACKGROUND
Guidance Document on The Classification of Medical
Device is prepared by MDCD.
The document is based on *GHTF Guidance
Document (SG1-N15:2006).
The purpose of this document is to provide
guidance on how to determine the classification of
medical device.
This GD applicable to all medical device EXCLUDING
IVD medical device.
*GHTF Global Harmonization Task Force
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 INTRODUCTION TO MEDICAL
DEVICE CLASSIFICATION
Regulatory controls are intended to safeguard
the health and safety of patients, users and
others.
The level of controls will depend on the
identified risks associated with devices.
The level of premarket intervention by the
regulator is proportional to the level of
potential risk and established through a
classification system.

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 INTRODUCTION TO MEDICAL
DEVICE CLASSIFICATION
The classification of risk is determined from:
The manufacturers intended purpose for the
medical device,
A set of classification rules.

These rules will classify medical devices into one of

4 classes of medical devices.

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 INTRODUCTION TO MEDICAL
DEVICE CLASSIFICATION
The purpose of risk based classification:
To make sure that the regulatory controls
applied to a medical device are proportionate to
risk.
To assist a manufacturer to allocate its medical
device to an appropriate risk class.
Regulatory authorities have the responsibility of
ruling upon matters of interpretation for a
particular medical device.

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 GENERAL PRINCIPLES OF DEVICE
CLASSIFICATION
i. Regulatory control is proportional
to the level of risk associated with Risk-based
a medical device. classification &
regulatory control
ii. The level of regulatory control
increases with the increasing

Regulatory requirements
degree of risk, taking into account
of the benefits offered by use of

D
the device.

C
B
iii. The classification of the device is

A
based on the risk associated to it Device
at the point of usage. risk

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 GENERAL PRINCIPLES OF DEVICE
CLASSIFICATION
iv. The risk presented by a particular device depends on
Its intended purpose,
The effectiveness of the risk management
techniques applied during design, manufacture
and use,
Its intended user(s),
Its mode of operation,
Technologies.

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 FACTORS INFLUENCING DEVICE
CLASSIFICATION
a) The duration of contact of the device
with the body.
b) The degree of, and site of,
invasiveness into the body.
c) Whether the device deliver
medicines or energy to the patient.
d) Whether the device is intended to
have a biological effect on the body.
e) Intended action on the human body.
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 FACTORS INFLUENCING DEVICE
CLASSIFICATION
f) Local versus systemic effects.
g) Whether the device comes into contact with
injured skin.
h) Whether for diagnosis or treatment,
i) The ability to be re-used or not, and
j) Combination of devices.

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 NOTES TO BE CONSIDERED
Classification of an assemblage of medical devices:
One or more individual medical device in assemblage
comply with the relevant regulatory requirements,
classification depends on the Manufacturers purpose in
packaging and marketing such devices.
One or more individual medical device in assemblage has
yet to comply with the relevant regulatory requirements,
the combination should be classified as a whole according
to its intended use.

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 NOTES TO BE CONSIDERED
Accessories to be used together with a
parent medical device to achieve its
intended purpose should be classified as
medical device in its own right and should be
assigned a risk-based classification according
to CLASSIFICATION RULES.

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 NOTES TO BE CONSIDERED
For software;
Where it drives or influences the use of a separate
medical device, it is classified according to the
intended use of the combination.
Where it is independent of any other medical device,
it is classified in its own right using the classification
rules for medical devices.
Standalone software (to the extent it falls within the
definition of a medical device) is deemed to be an
active device.
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 GENERAL CLASSIFICATION OF
MEDICAL DEVICES
Four risk-based class,
CLASS RISK LEVEL DEVICE EXAMPLES

A Low Surgical retractors/tongue

depressors
B Low-moderate Hypodermic needle/suction
equipment
C Moderate-high Lung ventilator/orthopaedic
implants
D High Heart valves/implantable
defibrillator
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 DETERMINATION OF DEVICE CLASS
USING RULES-BASED SYSTEM
The Manufacturer should:
a) Decide if the product is a medical device, based on the
definition
b) Determine the intended use of the medical device.
c) Consider all the rules in order to establish the proper
classification for the device (if a medical device has features
that place it into more than one class, classification and
conformity assessment should be based on the highest
class indicated).
d) Determine that the device is not subject to special national
rules that apply within a particular jurisdiction.
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 CLASSIFICATION RULES FOR
MEDICAL DEVICES
Total of 16 rules:
12 general rules (1 12),
4 additional rules (13 16).
Rules applicable for
NON-INVASIVE DEVICES: 1 4
INVASIVE DEVICES: 5 8
ACTIVE DEVICES: 9 12
ADDITIONAL RULES: 13 - 16
The general principles and factors influencing the
classification are considered when applying these rules.
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CLASSIFICATION RULES FOR MEDICAL
DEVICES

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DECISION TREE
NON-INVASIVE DEVICES

Rule 1
Rule 2 Rule 3
Are in contact with Rule 4
Channel or store Modify biological or
injured skin and Device or other
liquids/tissues/gas chemical composition
intended as a barrier than those where
es intended for of blood/body
or for compression, rules 1, 2, or 3
eventual infusion liquids/other liquids
or absorption of apply
or administration intended for infusion
exudate

Class A Class A Class C Class A

Unless Unless Unless
Intended principally for May be in contact to an Action is filtration,
wounds which breach active medical device in centrifugation or
the dermis Class B or higher exchange of gas /heat

Class B Class B Class B

Unless Unless
The wound can heal only Used to channel blood or
through secondary store channel other body
intent fluids/store organs & Unless Blood bag
tissues
Class C
Class B Class C
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DECISION TREE
INVASIVE DEVICES

Rule 5
Invasive through body
orifice or stoma (not
surgically

Transient use Short term use Long term use

Class Class Class
A B C
Unless
Unless Intended to
diagnose, monitor or
correct a defect of
heart or CCS and in
direct contact with
Used in oral cavity,
ear canal or nasal Class
cavity only B
Class
A
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 INVASIVE DEVICES
Rule 6
Class
Surgically invasive
transient use B
Unless
A reusable surgical Class
instrument A
Unless
Supplies energy as ionizing Class
radiation C
Unless
Biological effect or Class
mainly absorbed C
Unless
Administer medicinal Class
Class products in a potentially
hazardous manner
C
D
Unless CCS Central
Intended to diagnose, Circulatory System
monitor or correct a For use in direct contact with Class
Unless CNS CNS Central
defect of heart or CCS D
and in direct contact with Nervous System

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 INVASIVE DEVICES

Rule 7
Class B Surgically invasive
short term use
Unless
Administer medicinal Class
products C
Unless
Undergoes chemical change Class
in the body (excluding teeth) C
Unless
Class
Supplies ionizing radiation
Class D C
Unless
Intended to Biological effect or Class
diagnose, mainly absorbed D
monitor or
Unless
correct a defect
of heart or CCS Use in direct contact Class
and in direct Unless with the CNS D
contact with
CCS Central Circulatory System
CNS Central Nervous System
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 INVASIVE DEVICES
Rule 8
Class
Surgically invasive long term
use/ implant C
Unless
Class
Placed in teeth
B
Unless
Used in direct contact with the heart, CCS or CCN
Class
C
Unless
Class
Life supporting or life sustaining
D
Unless
Class
Active implants
Unless D
Class
Biological effect or mainly absorbed
D
CCS Central Circulatory System Unless
CNS Central Nervous System Class
Administer medicines
D
Unless
Class
Class
Breast implant Undergoes chemical change in the body
D Unless (excluding teeth) D
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 ACTIVE DEVICES

Rule 9(i) Rule 9(ii) Rule 10 (i) Rule 10(ii)

Active therapeutic Intended to Active diagnostic Diagnostic and/or
devices intended to control monitor or devices or supply interventional
administer or directly influence energy that is absorbed radiology devices,
exchange energy the performance or intended to image in including their
of active vivo radio- controls &
therapeutic pharmaceuticals monitor
devices in Class C intended to allow direct
Class B diagnosis/monitoring of
vital physiological
Class A
Unless Class C processes

Used to Class B
administer/exchange
energy (including ionizing Unless
radiation) in a potentially
hazardous way
The absorbed energy is
Class C for illumination only Class A
Unless

DECISION TREE The patient is or could

be in immediate danger Class C

Class C
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DECISION TREE
ACTIVE DEVICES

Rule 11
Rule 12
Active devices to
Active devices
administer or remove
other than those
medicinal products &
where Rules 9, 10
other subtances from
or 11 apply
the body

Class B Class A

Unless

In a potentially hazardous
manner

Class C
Class C

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 ADDITIONAL RULES

Rule 16
Rule 13 Rule 14 Rule 15 Device used for
Device incorporating Device Device intended contraception or
medicinal product manufactured specifically for prevention of
which has ancillary from or sterilisation of medical sexually
action incorporating devices or disinfection transmitted
human or animal as the end point of diseases
tissues, cells or processing
Class D derivatives thereof Class A
Class B
Class C
Unless
Unless Used for disinfecting
Class Unless
medical devices
Non-viable animal prior to end point
sterilisation or
B
tissues or derivatives
thereof & in contact higher level disinfection
with intact skin only
Unless
Implantable or long-term
Class A Specifically for disinfecting, invasive
cleansing,
rinsing or hydrating of contact
lenses
Class C Class D

DECISION TREE Class C

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 THE ADDITIONAL RULES -
RATIONALS
There are a small number of products that
fall within the scope of the definition of a
medical device and which may need to be
classified to take account of factors OTHER
THAN those covered by the general rules
(Rules 1 to 12).

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 ADDITIONAL RULES MATTERS TO
CONSIDER
Rule 13: Devices incorporating a
medicinal product
The regulations applying to medicinal
products require DIFFERENT acceptance
procedures to those for medical devices.
The behavior of a medicinal product
used in conjunction with a medical device
may DIFFER from that covered by its
approved use as a medicinal product
alone.
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 ADDITIONAL RULES MATTERS TO
CONSIDER
Rule 14: Devices incorporating animal or human
tissues
There is an absence of global regulatory controls for
such devices.
Classification needs to acknowledge the diversity of
opinions on such devices, globally.
The possible risks associated with the transmission
of infectious agents through materials used in such
devices (e.g. Bovine Spongiform Encephalopathies (BSE) and
Creutzfeldt-Jacob disease (CJD), demand classification at a higher risk
level).
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ADDITIONAL RULES MATTERS TO
CONSIDER
Rule 15: Disinfectants
The particular concerns
relating to those
disinfectants that are
used with contact lenses,
due to sensitivity and
vulnerability of the eye.

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 ADDITIONAL RULES MATTERS TO
CONSIDER
Rule 16: Contraceptive devices
The risks associated with unwanted
pregnancy if caused by mechanical failure of
the device.
The need to safeguard public health through
the use of condoms to reduce the prevalence
of sexually transmitted diseases.
User expectation that contraceptive devices
are perfectly reliable and safe despite
published data to the contrary.
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 SUMMARY
Classification is intended to determine the
level of regulatory control
There are principles and factors to be
considered before assigning the classification
There are 16 rules of classification with 12
general rules and 4 additional rules.
There are a small number of products that fall
within the scope of the definition of a medical
device need to be classified that is covered by
the general rules
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 MEDICAL DEVICE CONTROL DIVISION, MINISTRY OF HEALTH
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