Principles of Medical Device Classification 031117

 

This document was replaced by: N15 September, 15, 2005 SG1/N015R22

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  Title: Principles of Medical Devices Classification   +uthorin Group: Study Group 1 of the Global Harmonization Task orce   #ate: !ovember 1"# $%%&

 

Principles of Medical Devices Classific Classification ation 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 )ulesbased 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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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 nonbindin. .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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.ntroduction

The primary -ay in -hich the Global Harmonization Task orce 6GHT7 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 ofisatoseries describe a .lobal model for medical devices* +ts purpose assistthat a manufacturer mto.ether anufacturer to allocate its re.ulatory medical medical device to an appropriate risk class class usin. a set of harmonized principles* )e.ulatory 2uthorities have the responsibility of rulin. rulin. upon matters of interpretation interpretation for a particul particular ar 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 entitled Essential  Essential  Principles of Safety and Performance of Medical Devices and and Labelling  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 on Principles of Conformity Assessment for Medical Devices that Devices  that recommends conformity assessment re9uirements appropriate to each of the four risk classes classes proposed herein* The linked development of documents on classification and conformity co nformity assessment are important to ensure a consistent approach allso countries're.ions adoptin.for thea.lobal re.ulatory recommended by theacross GHT# that premarket approval particular device model may become acceptable .lobally* )e.ulatory 2uthorities -ho may have different different classificat classification ion 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 Conformity 2ssessment :odies and industry# and -ill provide benefits ben efits in establishin.# in a consistent -ay# an economic and effective approach to the control of medical devices in the interest of pu public blic 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 6GHT7* Comments or 9uestions about iitt should be directed to ei either ther the Chairman or Secretary of GHT Study Group 1 -hose contact details may be found on the GHT -eb pa.e*  !ovember 1"# $%%& $%%&

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Principles of Medical Devices Classific Classification ation Study Group 1 Proposed Document SG1'!%1()$$

Scope This document applies to all products that fall -ithin the definition of a medical device that appears -ithin the GHT document Information document  Information Concerning the Definition of the Term “Medical Device!  Device! other than those used for the in vitro e3amination vitro e3amination of specimens derived from the human body*

Re-erences G'T* -inal documents SG1'!%%0 Labelling SG1'!%%0  Labelling for Medical Devices SG1'!%1$ "ole SG1'!%1$  "ole of Standards in the Assessment of Medical Devices# SG1'!%$% Essential SG1'!%$%  Essential Principles of Safety and Performance of Medical Devices

G'T* documents proposed -or public comment SG1'!%11 S$mmary SG1'!%11  S$mmary Technical Doc$mentation for Demonstrating Conformity to the Essential  Principles of Safety and Performance of Medical Devices# SG1'!%$0 Information 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$ding SG1'!%,1 Essential 'incl$ding In (itro Diagnostic Devices)# SG1'!%,&   Labelling for Medical Devices 'incl$ding SG1'!%,& 'incl$ding In (itro Diagnostic Devices)#

G'T* wor)in dra-t document not yet aailable -or public comment SG1'!%,% Principles 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 p partially artially 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  ;uropean Directive 0%'&/(';;C < but modified to include accessories7  !ovember 1"# $%%& $%%&

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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* ener.y* Medical devices intended to transm transmit it 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  ;uropean Directive 0&',$';;C7 +ctie therapeutical deice: 2ny active medical device# -hether used alone or in combination -ith other medical devices# to support# modify# replace or restore biolo.ical functions or structures -ith a vie- to treatment or alleviation of an illness# in5ury or handicap* 6Source  ;uropean Directive 0&',$';;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 p hysiolo.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* $entral nerous system4 or the purpose of this document# =central nervous system> means brain# menin.es and spinal cord* 6Source  ;uropean Directive 0&',$';;C7 #uration o- use

 !ormally ally intend intended ed for continuous continuous use use for for less less than than ?% minut minutes* es* Transient:  !orm Short term:  !orm  !ormally ally intend intended ed for continuous continuous use for for bet-een bet-een ?% minutes minutes and and &% days* days*

 !ormally lly intende intended d for continuous continuous use for for more more than than &% days* days* on term:  !orma  !8T;4 or the the purpose purpose of this this document# document# continuo continuous us use means the uninte uninterrupt rrupted ed actual actual use 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* 6Sourcee  ;uropean Directive 0&',$';;C7 6Sourc '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* ody 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 Devices other other than than those those referr referred ed to in the the previo$s previo$s s$bpar s$bparagraph agraph and

-hich prod$ce penetration other than thro$gh an established 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  

to be totally introduced into the human body or#  to replace an epithelial surface or the surface of the eye#  by sur.ica sur.icall interven intervention tion -hich -hich is is intended intended to to remain remain in place after the procedu procedure* re* 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* 6Sourcee  ;uropean Directive 0&',$';;C7 6Sourc i-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 bod ily function important to the continuation of human life*   &edicalTerm deice: See GHT .uidance document4 Information Concerning the Definition of the document4 Information “Medical Device Device 6SG1'!%$07*  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  !ovember 1"# $%%& $%%&

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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 sterilisatio sterilisation n have been carried out* 6Sourcee  ;uropean Directive 0&',$';;C 6Sourc 0& ',$';;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 documents  Essential Principles of Safety and Performance of  Medical Devices and and Labelling  Labelling for Medical Devices  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 co ntrol should increase -ith increasin. de.ree of risk# takin. account of the benefits offered by use u se 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 classification rules are intended to accommodate such iinnovations* nnovations* Bithout  pre5udice to these rules# )e.ulatory 2uthorities may -ish to re9uire re9uire the notification of nedevices bein. placed on the market in their their 5urisdictions* Such notification may be used in assessin. the evidence re9uirements for use in the conform conformity ity assessment process* +t may also be used to consider the need# if any# for possible reclassification and'or chan.es in these harmonized classification rules*

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Recommendations 11 11

rim rimar ary y Reco Recomm mmen enda dati tion onss

•

•

•

•

•

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•

12

)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 consist of four risk 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 classi classification fication -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 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 rulesbased classification# should be -ei.hed a.ainst the disadvanta.es of disharmonized d isharmonized international classification*

*acto *actors rs .n-lu .n-luenc encin in  #eic #eicee $lassi $lassi-ic -icati ation on

2 number of factors# includin. for e3ample the duration of device contact -ith the b body# ody# the de.ree of invasiveness# -hether the device d evice delivers medicines or ener.y to the patient# -hether they are intended to have a biolo.ical affect on the patient and local vers$s vers$s systemic  systemic effects 6e*.* conventional vers$s vers$s absorbable  absorbable sutures7 may# alone or in combination# co mbination# 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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Principles of Medical Devices Classific Classification ation Study Group 1 Proposed Document SG1'!%1()$$

Classification of an assembla.e of medical devices that individually comply -ith all re.ulatory re9uirements depends on the manufacturers purpose in packa.in. and marketin. such a combination of separate devices* or e3ample4 •

+f the combination results product that is medical intendeddevices by the manufacturer to the meet a  purpose different from thatinofa the individual that make it up# 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 parent 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* 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 soft-are is incorporated into the the medical device itself# some is not* Provided such standalone soft-are falls -ithin the scope of the definition for a medical device# 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 classification should be based not only on the characteristics of the device and intended use# but also the conte3t of the use in specific specific health care systems systems** or e3ample# introduction of a com comple3 ple3 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* risk* Statutory conformity asses assessment sment authority provides )e.ulatory 2uthorities methods methods to assure compliance -ith rre.ulatory e.ulatory controls* 2t this time# time# conformity assessment re9uirements and other re.ulatory controls assi.ned to each class of device by different )e.ulatory 2uthorities 2uthorities have yet to be harmonized and m may ay vary* Bhile  !ovember 1"# $%%& $%%&

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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 d ifferent local needs -hen they introduce ne- re.ulations on classification# for e3ample# in the application of devices covered by by the 2dditional )ules 1& to to 1?* Study Group 1 hopes any such differences differences -ill disappear in tthe he course of time*

13

ropose roposed d Genera Generall $lassi $lassi-ica -ication tion System System -or -or &edi &edical cal #ei #eices ces

risk classes of devices* The e3amples .iven are for *iure 1 indicates the four risk 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

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Eo- )isk

Sur.ical retractors ' ton.ue depressors

Eo- Eo -m moder oderat atee )is )isk k

Hypo Hypode derm rmic ic !eed !eedle less ' suct suctio ion n e9u e9uip ipme ment nt

Moderatehi.h )isk 

Eun. ventilator ' orthopaedic implants

Hi.h )isk

Heart valves ' implantable defibrillator  

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#

*iure 2 sho-s a conceptual illustration of increasin. levels of re.ulatory re9uirements

as the device risk class class increases* These re.ulatory controls may may include# for e3ample4  • • • • •

•

operation of a 9uality system 6recommended for all devices7A documentation of clinical evidence to support the manufacturers claimsA technical dataA  product testin. usin. inhouse or independent resourcesA the need for and fre9uency of independent e3ternal audit of the manufacturers 9uality systemA and independent e3ternal revie- of the manufacturers technical data*

The concept is e3panded in the GHT .uidance document entitled Principles entitled  Principles of Conformity Assessment for Medical Devices* Devices *

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*iure 2: $onceptual illustration o- reulatory controls increasin with deice ris) class

)e.ulatory re9uirements H+GH;) 

E8B;) 

Device Class4

2

:

C

D

The #etermination o- #eice $lass usin this Rules7based System The manufacturer should4 1* Decide if if the product product concerned concerned is a medical medical device# device# usin. usin. the appropri appropriate ate definiti definition* on* N!T": Medical devices that are used for the in vitro e3amination vitro e3amination of specimens derived from the human body are not covered by the classification rules -ithin this document 6see Scope7*

$* Determ Determine ine the the intende intended d use of the the medical medical devic device* e* &* Take into into considerati consideration on all the rules rules that that follofollo- in order order to establish establish the 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 indicated ,* Determine Determine that the the device device is not sub5ect sub5ect to special special nation national al rules rules that apply apply -ithin -ithin a  particular 5urisdiction* N!T"S: 8nce a rulesbased system has been adopted# adop ted# modifications may occasionally e3perience# a level of risk for a be re8uired* or e3ample# -here throu.h postmarket e3perience#

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Principles of Medical Devices Classific Classification ation Study Group 1 Proposed Document SG1'!%1()$$

type of medical device# classified usin. the criteria found in this .uidance document is no lon.er appropriate# consideration should be .iven to reclassification 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 initial classification* @nlike the principle of reclassification reclassification after  postmarket 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* 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%"

.%STR+T." "6+&"S !* #".$"S T'+T &+9 $!N*!R& .T' + R%"   NON-IN  NON-INVASIV VASIVE E DEVIC DEVICES  ES 

1* 2ll noninvasive 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 noninvasive electrodes# hospital beds* N!T": !oninvasive 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 noninvasive devices intended for Such devices are indirectly invasive in channellin. or storin. blood# body 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# unless they may be connected to an active medical device in Class : or a hi.her class# in -hich case they are Class :A

eventually be delivered into the body 6see comment for )ule 17* ;3amples4 administration sets for .ravity infusionA syrin.es -ithout needles* ;3amples4 syrin.es and administration sets for infusion pumpsA anaesthesia  breathin. circuits* N!T": Connection to an active device

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 :* &* 2ll noninvasive 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#

covers those circumstances -here the safety and performance of the active device is influenced by the nonactive device and vice versa* versa* ;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* 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* purpose of this part of the N!T"4 for the purpose rule# modification does not include simple# mechanical filtration or centrifu.in. -hich are covered belo-* ;3amples4 devices to -arm or cool unless the treatment consists of  bloodA devices to remove carbon dio3ideA filtration# centrifu.in. or e3chan.es of .as or of heat# in -hich case they are in  particulate filters in an e3tracorporial Class :* circulation system* ,* 2ll noninvasive devices -hich come Devices covered by this rule are into contact -ith in5ured skin4 e3tremely claim sensitive* ;3amples4 simple -ound dressin.sA  are in Class 2 if they are intended to cotton -ool*  be used as a mechanical barrier# for compression or for absorption of e3udatesA unless intended to be used principally Devices used to treat -ounds -here the -ith -ounds -hich have breached the subcutaneous tissue is as least partially dermis and can only heal by secondary e3posed and the ed.es of the -ound are intent# in -hich case they are in Class not sufficiently close to be pulled to.ether* The device manufacturer C*  !ovember 1"# $%%& $%%&

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claims that they promote healin. throu.h

 are in Class : in all other cases# includin. devices principally intended to mana.e the microenvironment of a -ound*

 physical methods other than providin. a  barrier are in Class C* ;3amples4 dressin.s for chronic ulcerated -oundsA dressin.s for severe burns* ;3amples4 nonmedicated impre.nated .auze dressin.s*

 INVASIVE IVE DEV DEVICES  ICES    INVAS

(* 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*

 are in Class 2 if they are intended for

;3amples4 dental impression impression materialsA materialsA

transient useA  are in Class : if they are intended for shortterm useA 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#  are in Class C if they are intended for lon.term useA

e3amination .lovesA enema devices* ;3amples4 contact lenses# urinary catheters# tracheal tubes* ;3amples4 dentures intended to be removed by the patientA dressin.s for nose bleeds*

;3ample4 urethral stentA contact lenses for lon.term 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 ;3amples4 orthodontic -ire# fi3ed dental far as the pharyn3# in an ear canal up to  prosthesis* the eardrum or in a nasal cavity and are not liable to be absorbed by the mucous membrane# in -hich case they are in Class :* 2ll invasive devices -ith respect to ;3amples4 tracheal tubes connected to a  body orifices 6other than those -hich ventilatorA suction catheters for stomach are sur.ically invasive7 that are draina.eA dental aspirator tips* intended to be connected to an active N!T": independent of the time for -hich they are invasive* medical device in Class : or a hi.her  !ovember 1"# $%%& $%%&

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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 cond uit throu.h the skin 6e*.* syrin.e needlesA lancets7# sur.ical instruments 6e*.* sin.le use scalpelsA sur.ical staplersA sur.ical

unless they are reusable sur.ical instruments# in -hich case they are in Class 2A unless intended to supply ener.y in the form of ionizin. radiation# in -hich case they are in Class CA unless intended to have a biolo.ical

.lovesA sin.leuse aortic punch7 and various types types of catheter 'sucker etc* etc* N!T"4 a sur.ical instrument 6other 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&* ;3amples4 Manually operated sur.ical drill bits and sa-s* ;3ample4 catheter incorporatin.' containin. sealed radioisotopes* referred to N!T"4 the biolo.ical effect referred

effect or be -holly or mainly in -hich case they are in Classabsorbed# CA

is an intended one than unintentional* Therather term absorption 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 ;3ample4 insulin pen for self  by means of a delivery system# if this is administration* done in a manner that is potentially N!T"4 the term administration of hazardous takin. account of the mode medicines implies stora.e and'or of application# in -hich they are in influencin. the rate'volume of medicine Class C* delivered not 5ust channellin.* The term potentially hazardous manner refers to the characteristics of the device and not 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* "* 2ll sur.ically invasive devices

the competence of the user* ;3amples4 an.ioplasty balloon catheters and related .uide -iresA dedicated disposable cardiovascular sur.ical instruments*

Such devices are mostly used in the

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intended for shortterm use are in Class :#

conte3t of sur.ery or postoperative care# or are infusion devices# or are catheters of various types* ;3amples4 clampsA infusion cannulaeA temporary fillin. materialsA non 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

unless they are intended to administer medicines# in -hich case they are in Class CA 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 unless they are intended to supply ener.y in the form or ionizin. radiation# in -hich case they are in Class CA unless they are intended to have a

medicinal substance in a secondary role refer to )ule 1&* N!T"4 the term administration of medicines implies stora.e and'or influencin. the rate'volume of medicine delivered not 5ust not 5ust channellin.* ;3ample4 sur.ical adhesive*

;3ample4 brachytherapy device*

;3ample4 absorbable sutureA biolo.ical

 biolo.ical effect or be -holly or are mainly absorbed# into -hich case they in Class DA

adhesive* referred to N!T"4 the biolo.ical effect referred is an intended one rather than unintentional* The term absorption 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 ;3ample4 neurolo.ical catheter* use in direct contact -ith the central nervous system# in -hich case they are in Class DA ;3amples4 cardiovascular cathetersA unless they are intended specifically to temporary pacemaker leadsA carotid 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* /* 2ll implantable devices# and lon.term sur.ically invasive devices# are in Class C#

artery shunts*

Most of the devices covered by b y this rule are implants used in the orthopaedic# dental# ophthalmic and cardiovascular

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unless they are intended to be placed into the teeth# in -hich case they are in Class :A 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

fields* ;3ample4 ma3illafacial implantsA  prosthetic 5oint replacementsA bone cementA nonabsorbable 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&* ;3amples4 brid.esA cro-nsA dental fillin. materials* ;3amples4 prosthetic heart valvesA spinal and vascular stents*

in Class DA unless they are intended to be life supportin. or life sustainin.# in -hich case they are in Class DA ;3ample4 pacemakers# their electrodes unless they are intended to be active and their leadsA implantable defibrillators* implantable medical devices# in -hich case they are Class DA ;3ample4 implants claimed to be unless they are intended to have a  bioactive*  biolo.ical effect or to be -holly or mainly absorbed# in -hich case they are N!T"4 hydro3yapatite is considered as havin. biolo.ical effect only if so in Class DA claimed and demonstrated by the manufacturer* ;3ample4 rechar.eable nonactive dru. unless they are intended to administer delivery system* medicines# in -hich case they are in Class DA N!T"4 bone cement is not -ithin the unless they are intended to under.o scope of the term chemical chan.e in the chemical chan.e in the body 6e3cept if  body since any chan.e takes place in the the devices are placed in the teeth7# in short rather than lon. term* -hich case they are in Class D* unless they are breast implants# in -hich case they are in Class D*   ACTIV  ACTIVE E DEVICE DEVICES  S 

0* 2ll active therapeutical devices

Such devices are mostly electrically

intended to administer or e3chan.e ener.y are in Class :#

 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* ;3amples4 lun. ventilatorsA baby unless their characteristics are such that they may administer or e3chan.e ener.y incubatorsA electrosur.ical .eneratorsA e3ternal pacemakers and defibrillatorsA to or from the human body in a sur.ical lasersA lithotriptorsA therapeutic  potential  poten tially ly haz hazardous ardous -ay# includi includin. n. Iray and other sources of ionizin. ionizin. radiation# takin. account of the nature# the density and site of application radiation* N!T"4 the term potentially hazardous of the ener.y# in -hich case they are in refers to the type of technolo.y involved Class C* and the intended a pplication* 2ll active devices intended to control or o r ;3amples4 e3ternal feedback systems for monitor the performance of active active therapeutical devices* therapeutical devices in Class C# or intended directly to influence the  performance of such devices# are in Class C* 1%* 2ctive devices intended for dia.nosis are in Class :4

 if they are intended to supply ener.y

Such devices include e9uipment for ultrasonic dia.nosis'ima.in.# capture of  physiolo.ical si.nals# interventional radiolo.y and dia.nostic radiolo.y* ;3amples4 ma.netic resonance

-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 infrared spectrum# in -hich case they are Class 27# or   if they are intended to ima.e in  in vivo vivo   distribution of radiopharmaceuticals# or   if they are intended to allo- direct dia.nosis or monitorin. of vital  physiolo.ical processes# 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* 2ctive devices intended to emit ionizin.

e9uipmentA dia.nostic ultrasound in non critical applicationsA evoked response stimulators*

;3ample4 .amma'nuclear cameras* ;3ample4 electronic thermometers# stethoscopes and blood pressure monitorsA electrocardio.raphs*

;3ample4 monitors'alarms for intensive careA biolo.ical sensorsA o3y.en saturation monitorsA apnoea monitors*

;3ample4 ultrasound e9uipment for use in interventional cardiac procedures*

;3ample4 ;3ampl e4 dia.nostic dia.no stic Iray sourceA source A

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radiation and intended for dia.nostic

devices for the control# monitorin. or

and'or devicesinterventional -hich controlradiolo.y# or monitorincludin. such devices# or those -hich directly influence their performance# are in Class C* 11* 11* 2ll act active dev devices inte ntended to admini adm iniste sterr and'or and'or remove remove medici medicines nes##  body li9uids li9uids or other substances substances to or from the body are in Class :# unless this is done in a manner that is  potential  poten tially ly haza hazardous rdous## takin. takin. account account of 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*

influencin. radiation* of the emission of ionizin.

1$* 2ll other active devices are in Class 2*

Such devices are mostly dru. delivery systems# or anaesthesia e9uipment* ;3amples4 feedin. pumpsA 5et in5ectors* ;3amples4 infusion pumpsA anaesthesia e9uipmentA dialysis e9uipmentA hyperbaric chambers*

;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*

  ADDIT  ADDITIONAL IONAL R RULES  ULES 

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

These devices cover combination devices that incorporate medicinal substances in a secondary role* ;3amples4 antibiotic bone cementsA cementsA heparincoated cathetersA -ound dressin.s incorporatin. antimicrobial

Class D* 1,* 2ll devices manufactured from or incorporatin. animal or human cells'tissues'derivatives cells'tiss ues'derivatives thereof# -hether viable or nonviable# are Class D#

a.ents to provide ancillary action on the -ound* N!T"4 +n some some 5urisdictions 5urisdictions such  products4 are considered to be outside the scope of the medical device definitionA may be sub5ect to different controls*

unless such devices are manufactured from or incorporate nonviable animal

+t is likely the re.ulations controllin. these devices -ill be the sub5ect of future harmonization efforts* ;3amples4 porcine heart valvesA cat.ut sutures* ;3amples4 leather components of orthopaedic appliances*

tissues their derivatives that-here comethey in contactor -ith intact skin only# are in Class 2* 1(* 2ll devices intended specifically to

;3amples4 disinfectants intended to be

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 be used for disinfectin. or sterilisin. sterilisin. medical devices are in Class :#

used -ith medical devicesA -asher disinfectors* N!T": This rule does not apply to  products  produc ts that that are are intended intended to to clean clean medical medical devices other than contact lenses by means of physical action e*.* -ashin. machines* ;3amples4 contact lens solutions* unless they are intended specifically to some 5urisdictions 5urisdictions solutions solutions  be used used for disinfect disinfectin.# in.# cleani cleanin.# n.# rinsin. rinsin. N!T"4 +n some for use -ith contact lenses4 or# -hen appropriate# hydratin. contact lenses# in -hich case they are in Class C* - 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 ;3amples4 condomsA contraceptive diaphra.ms* the prevention of the transmission of se3ually transmitted diseases are in Class C# unless they are implantable or lon.term 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*

1;

Rational Rationalee -or the the inclus inclusion ion o- the +ddi +ddition tional al Rules Rules into into this this docume document nt

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 riskbased rules 6)ules 1 to 1$7* or the understandin. of those countries that are not oundin. Members of GHT# it is felt important to offer o ffer .uidance on the classification of such devices 6see Clause ?*$# above7* Therefore# four 2dditional )ul )ules es are provided 6)ules 1& to

1?7* Matters that may need to be considered are4  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 b y 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;:

Rule 15

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 device dev ices# s# partic particula ularly rly aft after er the proble problems ms caused caused by :ov :ovine ine Spon.iform Spon.i form ;ncephalopat ;ncephalopathies hies 6:S;7 and Creutzfeldt CreutzfeldtJacob Jacob disease 6CJD7# demands a hi.h classification* Disinfectants The particular concerns relatin. to those disinfectants that are • used -ith contact lenses# due to sensitivity and vulnerability of the eye* Contraceptive devices The risks associated -ith un-anted pre.nancy if caused cau sed by • mechanical failure of the device* The need to safe.uard public health throu.h the use of condoms • to reduce the prevalence of o f 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