This document was replaced by:

N15 September, 15, 2005

SG1/N015R22
R!!S"# #!$%&"NT
Global 'armoni(ation Tas) *orce
Title: Principles of Medical Devices Classification
+uthorin, Group: Study Group 1 of the Global Harmonization Task orce
#ate: !ovember 1"# $%%&
Principles of Medical Devices Classification
Study Group 1 Proposed Document SG1'!%1()$$
Table o- $ontents
Preface**********************************************************************************************************************************&
+ntroduction**************************************************************************************************************************************,
Scope************************************************************************************************************************************************(
)eferences****************************************************************************************************************************************(
GHT final documents********************************************************************************************************(
GHT documents proposed for public comment*****************************************************************(
GHT -orkin. draft document not yet available for public comment*******************************(
Definitions****************************************************************************************************************************************(
General Principles****************************************************************************************************************************/
)ecommendations****************************************************************************************************************************0
1*1 Primary )ecommendations****************************************************************************************************0
1*$ actors +nfluencin. Device Classification*****************************************************************************0
1*& Proposed General Classification System for Medical Devices********************************************11
The Determination of Device Class usin. this )ules1based System*********************************************1$
+nitial Classification )ules*************************************************************************************************************1&
1*, )ationale for the inclusion of the 2dditional )ules into this document******************************$1
2ppendices*************************************************************************************************************************$&
2ppendi3 24 Decision trees to demonstrate ho- the rules may be used to classify specific
devices* ******************************************************************************************************************************$,
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Principles of Medical Devices Classification
Study Group 1 Proposed Document SG1'!%1()$$
re-ace
The document herein -as produced by the Global Harmonization Task orce# a voluntary
.roup of representatives from medical device re.ulatory authorities and the re.ulated industry*
The document is intended to provide non1bindin. .uidance for use in the re.ulation of medical
devices# and has been sub5ect to consultation throu.hout its development*
There are no restrictions on the reproduction# distribution# translation or use of this
document ho-ever# incorporation of this document# in part or in -hole# into any other document
does not convey or represent an endorsement of any kind by the Global Harmonization Task
orce*
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Principles of Medical Devices Classification
Study Group 1 Proposed Document SG1'!%1()$$
.ntroduction
The primary -ay in -hich the Global Harmonization Task orce 6GHT7 achieves its
.oals is throu.h the production of harmonized .uidance documents suitable for implementation
or adoption by member )e.ulatory 2uthorities# as appropriate takin. into account their e3istin.
le.al frame-ork# or by nations -ith developin. re.ulatory pro.rammes*
This .uidance document is one of a series that to.ether describe a .lobal re.ulatory
model for medical devices* +ts purpose is to assist a manufacturer to allocate its medical device
to an appropriate risk class usin. a set of harmonized principles* )e.ulatory 2uthorities have the
responsibility of rulin. upon matters of interpretation for a particular medical device* 8nce
assi.ned# such classification -ill prescribe ho- the manufacturer -ill demonstrate that its device
complies -ith other documents in the series and# in particular# -ith those entitled Essential
Principles of Safety and Performance of Medical Devices and Labelling for Medical Devices
should it be re9uired or re9uested so to do by a )e.ulatory 2uthority# Conformity 2ssessment
:ody# user or third party*
This document should be read in con5unction -ith the GHT document on Principles of
Conformity Assessment for Medical Devices that recommends conformity assessment
re9uirements appropriate to each of the four risk classes proposed herein* The linked
development of documents on classification and conformity assessment are important to ensure a
consistent approach across all countries're.ions adoptin. the .lobal re.ulatory model
recommended by the GHT# so that premarket approval for a particular device may become
acceptable .lobally* )e.ulatory 2uthorities -ho may have different classification procedures
are encoura.ed to adopt this GHT .uidance as the opportunity permits*
This document has been developed to encoura.e and support .lobal conver.ence of
re.ulatory systems* +t is intended for use by )e.ulatory 2uthorities# Conformity 2ssessment
:odies and industry# and -ill provide benefits in establishin.# in a consistent -ay# an economic
and effective approach to the control of medical devices in the interest of public health*
)e.ulatory 2uthorities that are developin. classification schemes or amendin. e3istin.
ones are encoura.ed to consider the adoption of the system described in this document# as this
-ill help to reduce the diversity of schemes -orld-ide and facilitate the process of
harmonization*
The re.ulatory re9uirements of some countries do not# at this time# ali.n fully -ith this
.uidance*
This .uidance document has been prepared by Study Group 1 of the Global
Harmonization Task orce 6GHT7* Comments or 9uestions about it should be directed to either
the Chairman or Secretary of GHT Study Group 1 -hose contact details may be found on the
GHT -eb pa.e*
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Scope
This document applies to all products that fall -ithin the definition of a medical device
that appears -ithin the GHT document Information Concerning the Definition of the Term
Medical Device! other than those used for the in vitro e3amination of specimens derived
from the human body*
Re-erences
G'T* -inal documents
SG1'!%%0 Labelling for Medical Devices
SG1'!%1$ "ole of Standards in the Assessment of Medical Devices#
SG1'!%$% Essential Principles of Safety and Performance of Medical Devices
G'T* documents proposed -or public comment
SG1'!%11 S$mmary Technical Doc$mentation for Demonstrating Conformity to the Essential
Principles of Safety and Performance of Medical Devices#
SG1'!%$0 Information Doc$ment Concerning the Definition of the Term %Medical Device&#
SG1'!%,1 Essential Principles of Safety and Performance of Medical Devices 'incl$ding In
(itro Diagnostic Devices)#
SG1'!%,& Labelling for Medical Devices 'incl$ding In (itro Diagnostic Devices)#
G'T* wor)in, dra-t document not yet a/ailable -or public comment
SG1'!%,% Principles of Conformity Assessment for Medical Devices#
#e-initions
+cti/e implantable medical de/ice: 2ny active medical device# to.ether -ith any accessories for
its proper functionin.# -hich is intended to be totally or partially introduced# sur.ically or
medically# into the human body or by medical intervention into a natural orifice# and -hich
is intended to remain after the procedure* 6Source 1 ;uropean Directive 0%'&/(';;C < but
modified to include accessories7
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+cti/e medical de/ice: 2ny medical device operation of -hich depends on a source of electrical
ener.y or any source of po-er other than that directly .enerated by the human body or
.ravity and -hich acts by convertin. this ener.y* Medical devices intended to transmit
ener.y# substances or other elements bet-een an active medical device and the patient#
-ithout any si.nificant chan.e# are not considered to be active medical devices* 6Source 1
;uropean Directive 0&',$';;C7
+cti/e therapeutical de/ice: 2ny active medical device# -hether used alone or in combination
-ith other medical devices# to support# modify# replace or restore biolo.ical functions or
structures -ith a vie- to treatment or alleviation of an illness# in5ury or handicap* 6Source 1
;uropean Directive 0&',$';;C7
+cti/e de/ice intended -or dia,nosis: 2ny active medical device# -hether used alone or in
combination -ith other medical devices# to supply information for detectin.# dia.nosin.#
monitorin. or to support in treatin. physiolo.ical conditions# states of health# illnesses or
con.enital deformities* 6Source < based on ;uropean Directive 0&',$';;C7
$entral circulatory system: or the purpose of this document# =central circulatory system>
means the ma5or internal blood vessels includin. the follo-in.4 pulmonary veins#
pulmonary arteries# cardiac veins# coronary arteries# common carotid arteries# cerebral
arteries# brachiocephalic artery# aorta# inferior and superior vena cava# renal arteries and
common iliac arteries*
$entral ner/ous system4 or the purpose of this document# =central nervous system> means brain#
menin.es and spinal cord* 6Source 1 ;uropean Directive 0&',$';;C7
#uration o- use
Transient: !ormally intended for continuous use for less than ?% minutes*
Short term: !ormally intended for continuous use for bet-een ?% minutes and &% days*
0on, term: !ormally intended for continuous use for more than &% days*
!8T;4 or the purpose of this document# continuous use means the uninterrupted actual use
of the device for the purpose intended by the manufacturer# e3cept -here the reason for
interruption is to replace a failin.'failed device -ith one that has the same intended purpose
6e*.* replacement of a urinary catheter7# -here this should be re.arded as an e3tension of
continuous use*
6Source 1 ;uropean Directive 0&',$';;C7
'arm: Physical in5ury or dama.e to the health of people or dama.e to property or the
environment* 6Source < +S8'+;C Guide (1410007
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'a(ard: Potential source of harm* 6Source < +S8'+;C Guide (1410007
.mmediate dan,er: 2 situation -here the patient is at risk of either losin. life or an important
physiolo.ical function if no immediate preventative measure is taken
.ntended use / purpose: @se of a product# process# or service in accordance -ith the
specifications# instructions# and information provided by the manufacturer* 6Source < +S8
1,0"17
.n/asi/e de/ices
.n/asi/e de/ice: 2 device# -hich# in -hole or in part# penetrates inside the body# either
throu.h a body orifice or throu.h the surface of the body*
1ody ori-ice: 2ny natural openin. in the body# as -ell as the e3ternal surface of the
eyeball# or any permanent artificial openin.# such as a stoma or permanent tracheotomy*
Sur,ically in/asi/e de/ice: 2n invasive device -hich penetrates inside the body throu.h
the surface of the body# -ith the aid or in the conte3t of a sur.ical operation*
*+TE, Devices other than those referred to in the previo$s s$bparagraph and
-hich prod$ce penetration other than thro$gh an established body orifice! sho$ld be treated
as s$rgically invasive devices#
.mplantable de/ice: 2ny device# includin. those that are partially or -holly absorbed#
-hich is intended4 1
to be totally introduced into the human body or#
to replace an epithelial surface or the surface of the eye#
by sur.ical intervention -hich is intended to remain in place after the procedure*
2ny device intended to be partially introduced into the human body throu.h sur.ical
intervention and intended to remain in place after the procedure for at least &% days is also
considered an implantable device*
6Source 1 ;uropean Directive 0&',$';;C7
0i-e supportin, or li-e sustainin,: 2 device that is essential to# or that yields information that
is essential to# the restoration or continuation of a bodily function important to the
continuation of human life*
&edical de/ice: See GHT .uidance document4 Information Concerning the Definition of the
Term Medical Device 6SG1'!%$07*
Reusable sur,ical instrument: +nstrument intended for sur.ical use by cuttin.# drillin.# sa-in.#
scratchin.# scrapin.# clampin.# retractin.# clippin. or similar procedures# -ithout
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connection to any active medical device and -hich are intended by the manufacturer to be
reused after appropriate procedures for cleanin. and'or sterilisation have been carried out*
6Source 1 ;uropean Directive 0&',$';;C < minor modifications7
Ris): Combination of the probability of occurrence of harm and the severity of that harm*
6Source < +S8'+;C Guide (1410007
General rinciples
)e.ulatory controls are intended to safe.uard the health and safety of patients# users and
other persons by ensurin. that manufacturers of medical devices follo- specified procedures
durin. desi.n# manufacture and marketin.*
The risk presented by a particular device depends substantially on its intended purpose
and the effectiveness of the risk mana.ement techni9ues applied durin. desi.n# manufacture and
use*
The GHT .uidance documents Essential Principles of Safety and Performance of
Medical Devices and Labelling for Medical Devices apply to all de/ices whate/er their ris)
class*
)e.ulatory controls should be proportional to the level of risk associated -ith a medical
device* The level of re.ulatory control should increase -ith increasin. de.ree of risk# takin.
account of the benefits offered by use of the device* 2t the same time# the imposition of
re.ulatory controls should not place an unnecessary burden on re.ulators or manufacturers*
Therefore4
there is a need to classify medical devices based on their risk to patients# users and
other personsA and
there is benefit for manufacturers and )e.ulatory 2uthorities if a .lobally harmonized
classification system is developed*
The risk presented by a device also depends# in part# on the de.ree of innovation in a
device# its intended use# its intended user6s7# its mode of operation# and'or technolo.ies* +n
.eneral# the classification rules are intended to accommodate such innovations* Bithout
pre5udice to these rules# )e.ulatory 2uthorities may -ish to re9uire the notification of ne-
devices bein. placed on the market in their 5urisdictions* Such notification may be used in
assessin. the evidence re9uirements for use in the conformity assessment process* +t may also be
used to consider the need# if any# for possible re1classification and'or chan.es in these
harmonized classification rules*
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Recommendations
121 rimary Recommendations
)e.ulatory 2uthorities should -ork to-ards the establishment of a .lobal
classification system*
Such a system should be based upon common features of e3istin. national
re9uirements -ith the aim of future conver.ence*
This system should consist of four risk classes* :ased on e3perience of GHT
oundin. Members# this is sufficient to accommodate all medical devices and allo-s
an efficient and .raduated system of conformity assessment controls*
The initial determination of class should be based on a set of rules derived from those
features of devices that create risk* +n most cases the initial rules based classification
-ill also be the final classification*
These rules should be sufficiently clear that manufacturers may readily identify the
class of their medical devices# sub5ect# as re9uired# to final classification by the
)e.ulatory 2uthority*
The rules should be capable of accommodatin. future technolo.ical developments*
The manufacturer should document its 5ustification for placin. its product into a
particular risk class# includin. the resolution of any matters of interpretation -here it
has asked a Conformity 2ssessment :ody and'or )e.ulatory 2uthority for a rulin.*
Decisions on final classifications# -hich deviate from the initial rules1based
classification# should be -ei.hed a.ainst the disadvanta.es of disharmonized
international classification*
122 *actors .n-luencin, #e/ice $lassi-ication
2 number of factors# includin. for e3ample the duration of device contact -ith the body#
the de.ree of invasiveness# -hether the device delivers medicines or ener.y to the patient#
-hether they are intended to have a biolo.ical affect on the patient and local vers$s systemic
effects 6e*.* conventional vers$s absorbable sutures7 may# alone or in combination# affect device
classification*
Bhere more than one of the classification rules applies to the medical device# it should be
allocated to the hi.hest class indicated*
Bhere one medical device is intended to be used to.ether -ith another medical device#
that may or may not be from the same manufacturer# 6e*.* a physiolo.ical monitor and a separate
recorder# or a .eneral purpose syrin.e and a syrin.e driver7# the classification rules should apply
separately to each of the devices*
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Classification of an assembla.e of medical devices that individually comply -ith all
re.ulatory re9uirements depends on the manufacturerCs purpose in packa.in. and marketin.
such a combination of separate devices* or e3ample4
+f the combination results in a product that is intended by the manufacturer to meet a
purpose different from that of the individual medical devices that make it up# the
combination is a ne- medical device in its o-n ri.ht and should be classified accordin. to
the ne- intended use*
+f the combination is for the convenience of the user but does not chan.e the intended uses
of the individual medical devices that make it up 6e*.* a customised kit that provides all the
devices necessary to carry out a particular sur.ical procedure7 there is no need to classify the
combination as a -hole althou.h the manufacturer may do so if it -ishes*
+f one or more of the medical devices that is in the assembla.e has yet to comply -ith all the
relevant re.ulatory re9uirements# the combination should be classified as a -hole accordin. to
its intended use*
2ccessories intended specifically by manufacturers to be used to.ether -ith a DparentC
medical device to enable that medical device to achieve its intended purpose# should be sub5ect to
the same GHT .uidance as applies to the medical device itself* or classification purposes an
accessory may be classified as thou.h it is a medical device in its o-n ri.ht*
Bhile most soft-are is incorporated into the medical device itself# some is not* Provided
such standalone soft-are falls -ithin the scope of the definition for a Dmedical deviceC# it should
be classified as follo-s4
Bhere it drives or influences the use of a separate medical device# it -ill have the same class
as the device itself*
Bhere it is independent of any other medical device# it is classified in its o-n ri.ht usin. the
rules in Section /*% of this document*
;very re.ion and country has to evaluate ne- products in the conte3t of their o-n health
care system and e3perience -ith similar products and the conte3t for use* )isk classification
should be based not only on the characteristics of the device and intended use# but also the
conte3t of the use in specific health care systems* or e3ample# introduction of a comple3 novel
technolo.y in a country -ith little prior use of similar products may re9uire hi.her risk
classification*
;3perience .ained from the clinical use of a particular type of medical device may su..est
that the rules appearin. in Section /*% of this document are inappropriate* Current GHT
procedures re9uire that all GHT documents be revie-ed at re.ular intervals* Such a revie- of
this document -ill provide any participant -ith an opportunity to su..est a chan.e of te3t that#
in their opinion# -ill address any shortcomin.*
The purpose of risk classification is to provide that the re.ulatory controls applied to a
medical device proportionate to risk* Statutory conformity assessment authority provides
)e.ulatory 2uthorities methods to assure compliance -ith re.ulatory controls* 2t this time#
conformity assessment re9uirements and other re.ulatory controls assi.ned to each class of
device by different )e.ulatory 2uthorities have yet to be harmonized and may vary* Bhile
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Study Group 1 of GHT continues to support and encoura.e re.ulatory harmonization# it
reco.nises that some )e.ulatory 2uthorities may have to reflect different local needs -hen they
introduce ne- re.ulations on classification# for e3ample# in the application of devices covered by
the 2dditional )ules 1& to 1?* Study Group 1 hopes any such differences -ill disappear in the
course of time*
123 roposed General $lassi-ication System -or &edical #e/ices
*i,ure 1 indicates the four risk classes of devices* The e3amples .iven are for
illustration only and the manufacturer must apply the classification rules to each medical device
accordin. to its intended purpose*
*i,ure 1: roposed ,eneral classi-ication system -or medical de/ices
$0+SS R.S4 0"5"0 #"5.$" "6+&0"S
+ Eo- )isk Sur.ical retractors ' ton.ue depressors
1
Eo-1moderate )isk Hypodermic !eedles ' suction e9uipment
$
Moderate1hi.h
)isk
Eun. ventilator ' orthopaedic implants
#
Hi.h )isk Heart valves ' implantable defibrillator
*i,ure 2 sho-s a conceptual illustration of increasin. levels of re.ulatory re9uirements
as the device risk class increases* These re.ulatory controls may include# for e3ample4 1
operation of a 9uality system 6recommended for all devices7A
documentation of clinical evidence to support the manufacturerCs claimsA
technical dataA
product testin. usin. in1house or independent resourcesA
the need for and fre9uency of independent e3ternal audit of the manufacturerCs 9uality
systemA and
independent e3ternal revie- of the manufacturerCs technical data*
The concept is e3panded in the GHT .uidance document entitled Principles of
Conformity Assessment for Medical Devices*
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*i,ure 2: $onceptual illustration o- re,ulatory controls increasin, with de/ice ris) class
Device Class4 2 : C D
)e.ulatory
re9uirements
H+GH;)
E8B;)
The #etermination o- #e/ice $lass usin, this Rules7based System
The manufacturer should4
1* Decide if the product concerned is a medical device# usin. the appropriate definition*
N!T": Medical devices that are used for the in vitro e3amination of specimens derived
from the human body are not covered by the classification rules -ithin this document 6see
Scope7*
$* Determine the intended use of the medical device*
&* Take into consideration all the rules that follo- in order to establish the proper
classification for the device# notin. that where a medical de/ice has -eatures that place
it into more than one class, classi-ication and con-ormity assessment should be based
on the hi,hest class indicated2
,* Determine that the device is not sub5ect to special national rules that apply -ithin a
particular 5urisdiction*
N!T"S: 8nce a rules1based system has been adopted# modifications may occasionally
be re8uired* or e3ample# -here throu.h post1market e3perience# a level of risk for a
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type of medical device# classified usin. the criteria found in this .uidance document is no
lon.er appropriate# consideration should be .iven to re1classification by a chan.e to the
rules*
Similarly# the historical kno-led.e of a device may necessitate a different class than the
one assi.ned by the initial classification* @nlike the principle of reclassification after
post1market e3perience -ith a device# this principle of historical kno-led.e should be
applied immediately -hen the initial classification yields an inappropriate result*
Bhere special national rules are applied# resultin. in a device class other than that
su..ested by the present rules# then a different conformity assessment procedure may be
indicated* This may have an effect on the acceptability of such devices for free
movement in countries -here these present rules have been adopted unless other# or
additional# conformity assessment procedures are carried out*
.nitial $lassi-ication Rules
The actual classification of each device depends on the precise claims made by the
manufacturer and on its intended use* Bhile the provision of e3amples in the table that follo-s
is helpful -hen interpretin. the purpose of each rule# it must be emphasised that the actual
classi-ication o- a particular de/ice must be considered individually# takin. account of its
desi.n and intended use*
Bhere a medical device has features that place it into more than one class# conformity
assessment should be based on the hi.hest class indicated*
R%0" .00%STR+T.5" "6+&0"S !*
#"5.$"S T'+T &+9 $!N*!R&
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NON-INVASIVE DEVICES
1* 2ll non1invasive devices are in Class
2# unless )ule $# & or , applies*
These devices either do not touch the
patient or contact intact skin only*
;3amples4 urine collection bottlesA
compression hosieryA non1invasive
electrodes# hospital beds*
N!T": !on1invasive devices that are
indirectly in contact -ith the body F can
influence internal physiolo.ical processes
by storin.# channellin. or treatin. blood#
other body li9uids or li9uids -hich are
returned or infused into the body or by
.eneratin. ener.y that is delivered to the
body are outside the scope of this rule*
$* 2ll non1invasive devices intended for
channellin. or storin. blood# body
Such devices are Dindirectly invasiveC in
that they channel or store li9uids that -ill
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li9uids or tissues# li9uids or .ases for
the purpose of eventual infusion#
administration or introduction into the
body are in Class 2#
eventually be delivered into the body 6see
comment for )ule 17*
;3amples4 administration sets for .ravity
infusionA syrin.es -ithout needles*
unless they may be connected to an
active medical device in Class : or a
hi.her class# in -hich case they are
Class :A
;3amples4 syrin.es and administration
sets for infusion pumpsA anaesthesia
breathin. circuits*
N!T": GConnectionH to an active device
covers those circumstances -here the
safety and performance of the active
device is influenced by the non1active
device and vice versa*
unless they are intended for use of
storin. or channelin. blood or other
body li9uids or for storin. or.ans# parts
of or.ans or body tissues# in -hich case
they are Class :*
;3amples4 tubes used for blood
transfusion*
N!T": in some 5urisdictions# blood ba.s
have a special rule that places them
-ithin a hi.her risk class*
&* 2ll non1invasive devices intended for
modifyin. the biolo.ical or chemical
composition of blood# other body
li9uids or other li9uids intended for
infusion into the body are in Class C#
Such devices are indirectly invasive in
that they treat or modify substances that
-ill eventually be delivered into the body
6see comment for )ule 17* They are
normally used in con5unction -ith an
active device -ithin the scope of either
)ule 0 or 11*
;3amples4 haemodializersA devices to
remove -hite blood cells from -hole
blood*
N!T"4 for the purpose of this part of the
rule# DmodificationC does not include
simple# mechanical filtration or
centrifu.in. -hich are covered belo-*
unless the treatment consists of
filtration# centrifu.in. or e3chan.es of
.as or of heat# in -hich case they are in
Class :*
;3amples4 devices to -arm or cool
bloodA devices to remove carbon dio3ideA
particulate filters in an e3tracorporial
circulation system*
,* 2ll non1invasive devices -hich come
into contact -ith in5ured skin4
Devices covered by this rule are
e3tremely claim sensitive*
1 are in Class 2 if they are intended to
be used as a mechanical barrier# for
compression or for absorption of
e3udatesA
;3amples4 simple -ound dressin.sA
cotton -ool*
unless intended to be used principally
-ith -ounds -hich have breached the
dermis and can only heal by secondary
intent# in -hich case they are in Class
C*
Devices used to treat -ounds -here the
subcutaneous tissue is as least partially
e3posed and the ed.es of the -ound are
not sufficiently close to be pulled
to.ether* The device manufacturer
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claims that they promote healin. throu.h
physical methods other than providin. a
barrier are in Class C*
;3amples4 dressin.s for chronic ulcerated
-oundsA dressin.s for severe burns*
1 are in Class : in all other cases#
includin. devices principally intended
to mana.e the microenvironment of a
-ound*
;3amples4 non1medicated impre.nated
.auze dressin.s*
INVASIVE DEVICES
(* 2ll invasive devices -ith respect to
body orifices 6other than those -hich
are sur.ically invasive7 and -hich4
a7 are not intended for connection to an
active medical device or
b7 are intended for connection to a Class
2 medical device
Such devices are invasive in body orifices
6refer to definition7 and are not sur.ically
invasive* Devices tend to be dia.nostic
and therapeutic instruments used in ;!T#
ophthalmolo.y# dentistry# proctolo.y#
urolo.y and .ynaecolo.y* Classification
depends on the time of invasion and the
sensitivity 6or vulnerability7 of the orifice
to such invasion*
1 are in Class 2 if they are intended for
transient useA
;3amples4 dental impression materialsA
e3amination .lovesA enema devices*
1 are in Class : if they are intended for
short1term useA
;3amples4 contact lenses# urinary
catheters# tracheal tubes*
unless they are used in the oral cavity as
far as the pharyn3# in an ear canal up to
the ear drum or in a nasal cavity# in
-hich case they are in Class 2#
;3amples4 dentures intended to be
removed by the patientA dressin.s for
nose bleeds*
1 are in Class C if they are intended for
lon.1term useA
;3ample4 urethral stentA contact lenses for
lon.1term continuous use 6for this device#
removal of the lens for cleanin. or
maintenance is considered as part of the
continuous use7*
unless they are used in the oral cavity as
far as the pharyn3# in an ear canal up to
the ear1drum or in a nasal cavity and are
not liable to be absorbed by the mucous
membrane# in -hich case they are in
Class :*
;3amples4 orthodontic -ire# fi3ed dental
prosthesis*
2ll invasive devices -ith respect to
body orifices 6other than those -hich
are sur.ically invasive7 that are
intended to be connected to an active
medical device in Class : or a hi.her
;3amples4 tracheal tubes connected to a
ventilatorA suction catheters for stomach
draina.eA dental aspirator tips*
N!T": independent of the time for
-hich they are invasive*
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class# are in Class :*
?* 2ll sur.ically invasive devices
intended for transient use are in Class :#
2 ma5ority of such devices fall into three
ma5or .roups4 those that create a conduit
throu.h the skin 6e*.* syrin.e needlesA
lancets7# sur.ical instruments 6e*.* sin.le1
use scalpelsA sur.ical staplersA sur.ical
.lovesA sin.le1use aortic punch7 and
various types of catheter 'sucker etc*
N!T"4 a sur.ical instrument 6other than
those in Class D7 is in Class 2 if reusable
and in Class : if supplied sterile and
intended for sin.le use* 2lso# a sur.ical
instrument connected to an active device
is in a hi.her class than 2*
N!T": if the device incorporates a
medicinal substance in a secondary role
refer to )ule 1&*
unless they are reusable sur.ical
instruments# in -hich case they are in
Class 2A
;3amples4 Manually operated sur.ical
drill bits and sa-s*
unless intended to supply ener.y in the
form of ionizin. radiation# in -hich
case they are in Class CA
;3ample4 catheter incorporatin.'
containin. sealed radioisotopes*
unless intended to have a biolo.ical
effect or be -holly or mainly absorbed#
in -hich case they are in Class CA
N!T"4 the Dbiolo.ical effectC referred to
is an intended one rather than
unintentional* The term DabsorptionC
refers to the de.radation of a material
-ithin the body and the metabolic
elimination of the resultin. de.radation
products from the body*
unless intended to administer medicines
by means of a delivery system# if this is
done in a manner that is potentially
hazardous takin. account of the mode
of application# in -hich they are in
Class C*
;3ample4 insulin pen for self1
administration*
N!T"4 the term Dadministration of
medicinesC implies stora.e and'or
influencin. the rate'volume of medicine
delivered not 5ust channellin.* The term
Dpotentially hazardous mannerC refers to
the characteristics of the device and not
the competence of the user*
unless intended specifically to
dia.nose# monitor or correct a defect of
the heart or of the central circulatory
system throu.h direct contact -ith these
parts of the body# in -hich case they are
in Class D*
;3amples4 an.ioplasty balloon catheters
and related .uide -iresA dedicated
disposable cardiovascular sur.ical
instruments*
"* 2ll sur.ically invasive devices Such devices are mostly used in the
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intended for short1term use are in Class
:#
conte3t of sur.ery or post1operative care#
or are infusion devices# or are catheters of
various types*
;3amples4 clampsA infusion cannulaeA
temporary fillin. materialsA non1
absorbable skin closure devicesA tissue
stabilisers used in cardiac sur.ery*
N!T": includes devices that are used
durin. cardiac sur.ery but do not monitor
or correct a defect*
N!T": if the device incorporates a
medicinal substance in a secondary role
refer to )ule 1&*
unless they are intended to administer
medicines# in -hich case they are in
Class CA
N!T"4 the term Dadministration of
medicinesC implies stora.e and'or
influencin. the rate'volume of medicine
delivered not 5ust channellin.*
unless they are intended to under.o
chemical chan.e in the body 6e3cept if
the devices are placed in the teeth7# in
-hich case they are in Class CA
;3ample4 sur.ical adhesive*
unless they are intended to supply
ener.y in the form or ionizin. radiation#
in -hich case they are in Class CA
;3ample4 brachytherapy device*
unless they are intended to have a
biolo.ical effect or to be -holly or
mainly absorbed# in -hich case they are
in Class DA
;3ample4 absorbable sutureA biolo.ical
adhesive*
N!T"4 the Dbiolo.ical effectC referred to
is an intended one rather than
unintentional* The term DabsorptionC
refers to the de.radation of a material
-ithin the body and the metabolic
elimination of the resultin. de.radation
products from the body*
unless they are intended specifically for
use in direct contact -ith the central
nervous system# in -hich case they are
in Class DA
;3ample4 neurolo.ical catheter*
unless they are intended specifically to
dia.nose# monitor or correct a defect of
the heart or of the central circulatory
system throu.h direct contact -ith these
parts of the body# in -hich case they are
in Class D*
;3amples4 cardiovascular cathetersA
temporary pacemaker leadsA carotid
artery shunts*
/* 2ll implantable devices# and lon.1term
sur.ically invasive devices# are in Class
C#
Most of the devices covered by this rule
are implants used in the orthopaedic#
dental# ophthalmic and cardiovascular
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fields*
;3ample4 ma3illa1facial implantsA
prosthetic 5oint replacementsA bone
cementA non1absorbable internal suturesA
posts to secure teeth to the mandibula
bone 6-ithout a bioactive coatin.7*
N!T": if the device incorporates a
medicinal substance in a secondary role
refer to )ule 1&*
unless they are intended to be placed
into the teeth# in -hich case they are in
Class :A
;3amples4 brid.esA cro-nsA dental fillin.
materials*
unless they are intended to be used in
direct contact -ith the heart# the central
circulatory system or the central
nervous system# in -hich case they are
in Class DA
;3amples4 prosthetic heart valvesA spinal
and vascular stents*
unless they are intended to be life
supportin. or life sustainin.# in -hich
case they are in Class DA
unless they are intended to be active
implantable medical devices# in -hich
case they are Class DA
;3ample4 pacemakers# their electrodes
and their leadsA implantable defibrillators*
unless they are intended to have a
biolo.ical effect or to be -holly or
mainly absorbed# in -hich case they are
in Class DA
;3ample4 implants claimed to be
bioactive*
N!T"4 hydro3y1apatite is considered as
havin. biolo.ical effect only if so
claimed and demonstrated by the
manufacturer*
unless they are intended to administer
medicines# in -hich case they are in
Class DA
;3ample4 rechar.eable non1active dru.
delivery system*
unless they are intended to under.o
chemical chan.e in the body 6e3cept if
the devices are placed in the teeth7# in
-hich case they are in Class D*
N!T"4 bone cement is not -ithin the
scope of the term Dchemical chan.e in the
bodyC since any chan.e takes place in the
short rather than lon. term*
unless they are breast implants# in -hich
case they are in Class D*
ACTIVE DEVICES
0* 2ll active therapeutical devices
intended to administer or e3chan.e
ener.y are in Class :#
Such devices are mostly electrically
po-ered e9uipment used in sur.eryA
devices for specialised treatment and
some stimulators*
;3amples4 muscle stimulatorsA T;!S
devicesA po-ered dental hand piecesA
hearin. aidsA neonatal phototherapy
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e9uipmentA ultrasound e9uipment for
physiotherapy*
unless their characteristics are such that
they may administer or e3chan.e ener.y
to or from the human body in a
potentially hazardous -ay# includin.
ionizin. radiation# takin. account of the
nature# the density and site of application
of the ener.y# in -hich case they are in
Class C*
;3amples4 lun. ventilatorsA baby
incubatorsA electrosur.ical .eneratorsA
e3ternal pacemakers and defibrillatorsA
sur.ical lasersA lithotriptorsA therapeutic
I1ray and other sources of ionizin.
radiation*
N!T"4 the term Dpotentially hazardousC
refers to the type of technolo.y involved
and the intended application*
2ll active devices intended to control or
monitor the performance of active
therapeutical devices in Class C# or
intended directly to influence the
performance of such devices# are in
Class C*
;3amples4 e3ternal feedback systems for
active therapeutical devices*
1%* 2ctive devices intended for dia.nosis
are in Class :4
Such devices include e9uipment for
ultrasonic dia.nosis'ima.in.# capture of
physiolo.ical si.nals# interventional
radiolo.y and dia.nostic radiolo.y*
1 if they are intended to supply ener.y
-hich -ill be absorbed by the human
body 6e3cept for devices used solely to
illuminate the patient>s body# -ith li.ht
in the visible or near infra1red spectrum#
in -hich case they are Class 27# or
;3amples4 ma.netic resonance
e9uipmentA dia.nostic ultrasound in non1
critical applicationsA evoked response
stimulators*
1 if they are intended to ima.e in vivo
distribution of radiopharmaceuticals# or
;3ample4 .amma'nuclear cameras*
1 if they are intended to allo- direct
dia.nosis or monitorin. of vital
physiolo.ical processes#
;3ample4 electronic thermometers#
stethoscopes and blood pressure
monitorsA electrocardio.raphs*
unless they are specifically intended
for4
a7 monitorin. of vital physiolo.ical
parameters# -here the nature of
variations is such that it could result in
immediate dan.er to the patient# for
instance variations in cardiac
performance# respiration# activity of
central nervous system# or
b7 dia.nosin. in clinical situations
-here the patient is in immediate
dan.er#
in -hich case they are in Class C*
;3ample4 monitors'alarms for intensive
careA biolo.ical sensorsA o3y.en
saturation monitorsA apnoea monitors*
;3ample4 ultrasound e9uipment for use in
interventional cardiac procedures*
2ctive devices intended to emit ionizin. ;3ample4 dia.nostic I1ray sourceA
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radiation and intended for dia.nostic
and'or interventional radiolo.y# includin.
devices -hich control or monitor such
devices# or those -hich directly influence
their performance# are in Class C*
devices for the control# monitorin. or
influencin. of the emission of ionizin.
radiation*
11* 2ll active devices intended to
administer and'or remove medicines#
body li9uids or other substances to or
from the body are in Class :#
Such devices are mostly dru. delivery
systems# or anaesthesia e9uipment*
;3amples4 feedin. pumpsA 5et in5ectors*
unless this is done in a manner that is
potentially hazardous# takin. account of
the nature of the substances involved# of
the part of the body concerned and of the
mode of application# in -hich case they
are in Class C*
;3amples4 infusion pumpsA anaesthesia
e9uipmentA dialysis e9uipmentA
hyperbaric chambers*
1$* 2ll other active devices are in Class
2*
;3amples4 e3amination lampsA sur.ical
microscopesA po-ered hospital beds F
-heelchairsA po-ered e9uipment for the
recordin.# processin.# vie-in. of
dia.nostic ima.esA dental curin. li.hts*
ADDITIONAL RULES
1&* 2ll devices incorporatin.# as an
inte.ral part# a substance -hich# if used
separately# can be considered to be a
medicinal product# and -hich is liable to
act on the human body -ith action
ancillary to that of the devices# are in
Class D*
These devices cover combination devices
that incorporate medicinal substances in a
secondary role*
;3amples4 antibiotic bone cementsA
heparin1coated cathetersA -ound
dressin.s incorporatin. antimicrobial
a.ents to provide ancillary action on the
-ound*
1,* 2ll devices manufactured from or
incorporatin. animal or human
cells'tissues'derivatives thereof#
-hether viable or non1viable#
are Class D#
N!T"4 +n some 5urisdictions such
products4
- are considered to be outside the scope
of the medical device definitionA
- may be sub5ect to different controls*
+t is likely the re.ulations controllin.
these devices -ill be the sub5ect of future
harmonization efforts*
;3amples4 porcine heart valvesA cat.ut
sutures*
unless such devices are manufactured
from or incorporate non1viable animal
tissues or their derivatives that come in
contact -ith intact skin only# -here they
are in Class 2*
;3amples4 leather components of
orthopaedic appliances*
1(* 2ll devices intended specifically to ;3amples4 disinfectants intended to be
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be used for disinfectin. or sterilisin.
medical devices are in Class :#
used -ith medical devicesA -asher
disinfectors*
N!T": This rule does not apply to
products that are intended to clean medical
devices other than contact lenses by means
of physical action e*.* -ashin. machines*
unless they are intended specifically to
be used for disinfectin.# cleanin.# rinsin.
or# -hen appropriate# hydratin. contact
lenses# in -hich case they are in Class C*
;3amples4 contact lens solutions*
N!T"4 +n some 5urisdictions solutions
for use -ith contact lenses4
- are considered to be outside the scope
of the medical devices definitionA
- may be sub5ect to different controls*
1?* 2ll devices used for contraception or
the prevention of the transmission of
se3ually transmitted diseases are in Class
C#
;3amples4 condomsA contraceptive
diaphra.ms*
unless they are implantable or lon.1term
invasive devices# in -hich case they are
in Class D*
;3ample4 intrauterine contraceptive
device*
Decision trees illustratin. ho- these rules may be used to classify specific devices are
sho-n in 2ppendi3 2*
12; Rationale -or the inclusion o- the +dditional Rules into this document
There are a small number of products that fall -ithin the scope of the definition of a
medical device and -hich may need to be classified to take account of factors other than those
covered by the risk1based rules 6)ules 1 to 1$7* or the understandin. of those countries that are
not oundin. Members of GHT# it is felt important to offer .uidance on the classification of
such devices 6see Clause ?*$# above7* Therefore# four 2dditional )ules are provided 6)ules 1& to
1?7*
Matters that may need to be considered are4 1
Rule 13: Devices incorporatin. a medicinal product
The re.ulations applyin. to medicinal products re9uire
different acceptance procedures to those for medical devices*
The behavior of a medicinal product used in con5unction -ith a
medical device may differ from that covered by its approved
use as a medicine alone*
The public perception of possible risks associated -ith such
devices demands a hi.h classification*
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Rule 1;: Devices incorporatin. animal or human tissues
There is an absence of .lobal re.ulatory controls for such
devices*
Classification needs to ackno-led.e the many different ethical
and reli.ious cultures throu.hout the -orld have an opinion on
such devices*
The public perception of possible risks associated -ith such
devices# particularly after the problems caused by :ovine
Spon.iform ;ncephalopathies 6:S;7 and Creutzfeldt1Jacob
disease 6CJD7# demands a hi.h classification*
Rule 15 Disinfectants
The particular concerns relatin. to those disinfectants that are
used -ith contact lenses# due to sensitivity and vulnerability of
the eye*
Rule 1< Contraceptive devices
The risks associated -ith un-anted pre.nancy if caused by
mechanical failure of the device*
The need to safe.uard public health throu.h the use of condoms
to reduce the prevalence of se3ually transmitted diseases*
Public e3pectation that contraceptive devices are perfectly
reliable and safe despite published data to the contrary*
Hi.h political profile of these devices in assurin. the protection
of public health
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+ppendices
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+ppendi= +: #ecision trees to demonstrate how the rules may be used to
classi-y speci-ic de/ices2
Rule 1
Non7in/asi/e de/ices
other than those where
Rules 2, 3, or ; apply
$lass
+
Rule 2
$hannellin, or
storin, li8uids
-or e/entual
administration
$lass
+
Rule 3
&odi-y biolo,ical or
chemical composition o- blood
/ body li8uids / other li8uids
intended -or in-usion
$lass
$
Rule ;
.n contact with
in>ured s)in ? act as
a mechanical barrier or
to absorb e=udates only
$lass
+
N!N7.N5+S.5" #"5.$"S
.ntended -or wounds which
breach dermis and heal
by secondary intent only
$lass
$
%N0"SS
!nly -iltration,
centri-u,ation or
e=chan,e o- ,as or heat
$lass
1
%N0"SS
&ay be connected to
an acti/e medical de/ice
in $lass 1 or hi,her
$lass
1
*or use with blood,
other body -luids,
or,ans, tissues
$lass
1
%N0"SS
!T'"R:.S"
+ll other de/ices
includin, mana,ement o-
micro7 en/ironment
o- wound
$lass
1
N!T": this dia,ram and those that -ollow are -or illustrati/e purposes only and the
determination o- ris) class -or a particular de/ice should be made by re-errin, to the rules
themsel/es and not the decision trees2 :here a medical de/ice has -eatures that place it
into more than one class, con-ormity assessment should be based on the hi,hest class
indicated2
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Rule 5
.n/asi/e throu,h body
ori-ice or stoma
@not sur,icallyA
Short term use
$lass
1
.N5+S.5" #"5.$"S
Rule <
Sur,ically in/asi/e
7 transient use
$lass
1
0on, term use
$lass
$
Transient use
$lass
+
$onnected
to an acti/e
medical de/ice
o- $lass 1
or hi,her
$lass
1
.- only in oral
ca/ity, ear canal
or nasal ca/ity
$lass
+
#ia,nose, monitor or correct
7 de-ect o- heart or
central circulatory system
? in direct contact
$lass
#
Reusable
sur,ical instrument
$lass
+
Supplies ener,y as
ioni(in, radiation
$lass
$
%N0"SS
%N0"SS
%N0"SS
1iolo,ical e--ect
or mainly absorbed
$lass
$
+dministers medicines
in a potentially
ha(ardous manner
$lass
$
.- only in oral
ca/ity, ear canal
or nasal ca/ity
? not li)ely to
be absorbed by
mucous
membrane
$lass
1
Principles of Medical Devices Classification
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!ovember 1"# $%%& Pa.e $? of $/
.N5+S.5" #"5.$"S @continuedA
Rule B
Sur,ically in/asi/e
7 lon, term use / implant
$lass
$
%nder,oes chemical chan,e
in the body @e=cludin, teethA
$lass
#
laced in the teeth
$lass
1
#irect contact with the heart,
central ner/ous system or
central circulatory system
$lass
#
0i-e supportin, or
li-e sustainin,
$lass
#
1iolo,ical e--ect
or mainly absorbed
$lass
#
%N0"SS
Rule C
Sur,ically in/asi/e
7 short term use
$lass
1
#ia,nose, monitor or correct
7 de-ect o- heart or
central circulatory system
? in direct contact
$lass
#
+dministers medicines
$lass
$
%nder,oes chemical
chan,e in the body
@e=cludin, teethA
$lass
$
1iolo,ical e--ect
or mainly absorbed
$lass
#
#irect contact
with the central
ner/ous system
$lass
#
%N0"SS
Supplies ioni(in,
radiation
$lass
$
+cti/e implants
$lass
#
+dministers
medicines
$lass
#
1reast implants
$lass
#
Principles of Medical Devices Classification
Study Group 1 Proposed Document SG1'!%1()$$
+$T.5" #"5.$"S
%N0"SS
Rule 12
+cti/e de/ices
other than
those where
Rules D, 10
or 11 apply
$lass
+
Rule 11
+cti/e de/ice to
administer or
remo/e medicines
? other
substances
-rom the body
$lass
1
:here patient is, or could be,
in immediate dan,er
$lass
$
RuleD
+cti/e therapeutic
de/ices intended to
administer or
e=chan,e ener,y
$lass
1
%sed to administer /
e=chan,e ener,y
@includin, ioni(in,
radiationA
in a potentially
ha(ardous way,
includin, acti/e de/ices
to control, monitor
or directly in-luence
their per-ormance
$lass
$
Rule10
+cti/e dia,nostic
de/ices intended
to allow direct
dia,nosis / monitorin,
o- /ital si,ns
$lass
1
Supplies ener,y
that is absorbed
$lass
1
.ntended to ima,e
in vivo radiopharmaceuticals
$lass
1
%N0"SS
#ia,nostic and/or inter/entional
radiolo,y de/ices includin,
their controls ? monitors
$lass
$
.n a
potentially
ha(ardous
manner
$lass
$
%N0"SS
*or illumination only
$lass
+
%N0"SS
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!ovember 1"# $%%& Pa.e $/ of $/
Rule 13
#e/ice incorporatin,
inte,ral medicinal
substance / product
which has
ancillary action
$lass
#
Rule 1;
#e/ice manu-actured
-rom or incorporatin,
human or animal
tissues, cells or
deri/ati/es thereo-
$lass
#
+##.T.!N+0 R%0"S
Rule 15
#e/ice speci-ically
-or disin-ection or
sterilisation o-
medical de/ices
$lass
1
Speci-ically -or
disin-ectin,, cleansin,,
rinsin, or hydratin,
o- contact lenses
$lass
$
%N0"SS
Non7/iable animal
tissues or
deri/ati/es thereo-
? in contact with
intact s)in only
$lass
+
Rule1<
#e/ice used -or
contraception or
pre/ention o-
se=ually
transmitted diseases
$lass
$
.mplantable or
lon,7term in/asi/e
$lass
#
%N0"SS
%N0"SS