NoC251/40 OfficialJournaloftheEuropeanCommunities 28.9.92
AmendedproposalforaCouncilDirectiverelatingtothemedicaldevices
(92/C251/02
(COM(92)356final—SYN3S3)
(SubmittedbytheCommission ,pursuanttoArticle149(3)oftheEECTreatyon28July1992)
Ontheleftsideyouwillfindtheinitialtextofthe'Whereas'articlesandannexesoftheproposalfora
CouncilDirectiveonmedicaldevicesCOM(91)287finalSYN353(J).
OntherightsideyouwillfindthemodificationsproposedbytheCommission .
(MOJNoC237,12.9.1991,p.3.
INITIALTEXT MODIFIED TEXT
FourthRecital
Whereastheharmonizedprovisionsmustbedistinguished
fromthemeasuresadoptedbytheMemberStatestomanage
thefundingofpublicschemesrelatingdirectlyorindirectlyto
suchdevices;whereas,thereforetheseprovisionsdonot
affecttheabilityoftheMemberStatestoimplementthe
abovementioned measuresprovidedCommunitylawis
compliedwith;FourthRecital
Whereastheharmonizedprovisionsmustbedistinguished
fromthemeasuresadoptedbytheMemberStatestomanage
thefundingofpublichealthandsicknessinsuranceschemes
relatingdirectlyorindirectlytosuchdevices;whereas,
therefore,theseprovisionsdonotaffecttheabilityofthe
MemberStatestoimplementtheabovementioned measures
providedCommunitylawiscompliedwith;whereasthis
means,interalia,thatMemberStatesmaydeterminewhich
categoriesandtypesofdeviceareeligibleforreimbursement
undersuchpublichealthandsicknessinsuranceschemes,but
oncethosecategoriesandtypesofdevicearedetermined,all
deviceswithinthosecategoriesorofthosetypeswhich
complywiththeprovisionsofthispresentDirectiveshouldin
principlebereimbursableundersuchpublichealthand
insuranceschemes;
SixthRecital
Whereascertainmedicaldevicesareintendedtoadminister
medicinalproductswithinthemeaningofCouncilDirective
65/65/EECof26January1965ontheapproximation of
provisionslaiddownbylaw,regulationoradministrative
actionrelatingtoproprietarymedicinalproducts(J),aslast
amendedbyDirective89/381/EEC(2);whereas,insuch
cases,theplacingofthemedicinalproductonthemarketis
governedbyDirective65/65/EEC;whereasadistinction
mustbedrawnbetweentheabovementioneddevicesand
medicaldevicesincorporating ,interalia,substanceswhich,
ifusedseparately,maybeconsideredtobeamedicinal
substancewithinthemeaningofDirective65/65/EEC;
whereasinsuchcases,ifthesubstancesareincorporatedin
themedicaldevicestohelpthemoperate,theplacingofthe
devicesonthemarketisgovernedbythisDirective;whereas
inthiscontext,intheeventofthebioavailability ofsuch
substances,thesafety,qualityandusefulnessofthe
substancesmustbeverifiedbyanalogywiththeappropriate
methodsspecifiedinCouncilDirective75/318/EECofSixthRecital
Whereascertainmedicaldevicesareintendedtoadminister
medicinalproductswithinthemeaningofCouncilDirective
65/65/EECof26January1965ontheapproximation of
provisionslaiddownbylaw,regulationoradministrative
actionrelatingtoproprietarymedicinalproducts(*),aslast
amendedbyDirective92/27/EEC(2);whereas,insuch
cases,theplacingofthemedicinalproductonthemarketis
governedbyDirective65/65/EECandtheplacingofthe
deviceonthemarketbythispresentDirective;whereasa
distinctionmustbedrawnbetweentheabovementioned
devicesandmedicaldevicesincorporatingsubstanceswhich,
whilenotdesignedtobeadministered asamedicinal
product,arebioavailablewithinthemeaningofthis
Directiveandifusedseparately,maybeconsideredtobea
medicinalsubstancewithinthemeaningofDirective
65/65/EEC;whereas,insuchcases,ifsuchsubstancesare
incorporatedinamedicaldevicetoimproveitssafety,quality
orperformance ,theplacingofsuchdevicesonthe
marketisgovernedbythispresentDirective;whereas,inthis

28.9.92 OfficialJournaloftheEuropeanCommunities NoC251/41
INITIALTEXT MODIFIED TEXT
20May1975ontheapproximation ofthelawsofthe
MemberStatesrelatingtoanalytical,pharmaco­
toxicologicalandclinicalstandardsandprotocolsinrespect
ofthetestingofproprietarymedicinalproducts(3),aslast
amendedbyDirective89/341/EEC(4);context,intheeventofthebioavailability ofsuchsubstances,
thesafety,qualityandusefulnessofthesubstancesmustbe
verifiedbymeansofcontrolsystemswhichmaybeanalogous
totheappropriatemethodsspecifiedinCouncilDirective
75/318/EECof20May1975ontheapproximation ofthe
lawsoftheMemberStatesrelatingtoanalytical,
pharmaco-toxicological andclinicalstandardsandprotocols
inrespectofthetestingofproprietarymedicinalproducts(3),
aslastamendedbyDirective91/507/EEC(4);(')OJNo22,9.2.1965,p.369.
(2)OJNoL181,28.6.1989,p.44.
(3)OJNoL147,9.6.1975,p.1.
(4)OJNoL142,25.5.1989,p.11.
HOJNo22,9.2.1965,p.369.
(2)OJNoL113,30.4.1992,p.8.
(3)OJNoL147,9.6.1975,p.1.
(4)OJNoL270,26.9.1991,p.1.
Recital7a
(new)
Whereasthe'essentialrequirements'andrequirements set
outintheAnnexestothisDirective,includinganyreference
to'minimising'or'reducing'riskmustlikewisebeinterpreted
andappliedinsuchawayastotakeaccountoftechnology
andpracticeexistingatthetimeofdesignandoftechnical
andeconomicalconsiderations ,bearinginmindthe
relationshipsbetweenriskandcostandwhatmayreasonably
beexpectedinallcircumstances byintendedusersofmedical
devices.
Twenty-Second Recital
WhereastheapplicationofsomeprovisionsofthisDirective
mustbefacilitatedbymeansofguidelinespublishedbythe
Commission ;Twenty-Second Recital
WhereastheapplicationofsomeprovisionsofthisDirective
mustbefacilitatedbymeansofguidelinespublishedbythe
Commission ;andbymakingavailableresourcesenabling
theCommission successfullytocarryoutinformation
programmesatnationallevel;
Article1(1)
1.ThisDirectiveshallapplytomedicaldevices.Italso
coverstheaccessoriestowhichtheprovisionsformedical
devicesapply.
Article1(2)Article1(1)
1.ThisDirectiveshallapplytomedicaldevices.Italso
coverstheaccessoriestowhichtheprovisionsformedical
devicesapply,particularlytheprovisionsgoverningtheclass
towhichtheseaccessoriesbelong.
Article1(2)
(a)medicaldevice(hereinafterreferredtoas'devices')(a)unchanged
meansanyinstrument,apparatus,appliance,material
orotherarticle,includingsoftware,whetherusedalone
orincombination ,intendedbythemanufacturertobe
usedforhumanbeingssolelyorprincipallyforthe
purposeof:

NoC251/42OfficialJournaloftheEuropeanCommunities 28.9.92
INITIALTEXT MODIFIEDTEXT
diagnosis,prevention,monitoring,treatmentor—diagnosis,prevention,monitoring,treatmentor
alleviationofdisease,injuryorhandicap, alleviationofdisaese,
—diagnosis,monitoring,treatmentoralleviationof
injuryorhandicap,
—investigation ,replacementormodificationofthe—unchanged
anatomyorofaphysiologicalprocess,
—controlofconception,
andwhichdoesnotachieveitsprincipalintendedaction
inoronthehumanbodybypharmacological ,
immunological ormetabolicmeans,butwhichmaybe
assistedinitsfunctionbysuchmeans;
(b)'accessory'meansanarticlewhich,whilenotadevice,is
required,accordingtotheintendedpurposeattributed
toitbythemanufacturer ,toenablethedevicetobeused
asspecified;b)'accessory'meansanarticlewhich,whilenotbeinga
device,isintendedspecificallybyitsmanufacturertobe
usedtogetherwithadevicetoenableittobeusedin
accordancewiththemanufacturer'sintentions;
(g)'manufacturer 'meansthenaturalorlegalpersonwith
overallresponsibility forthedesign,manufacturing ,
packagingandlabellingofadevicebeforeitisplacedon
themarketonhisownbehalf,regardlessofwhether
theseoperationsarecarriedoutbythatpersonhimself
oronhisbehalfbyathirdparty.
Thenaturalorlegalpersonwhoassembles,packages,
processesand/orlabelsoneormoreready-made
productsand/orassignsthemtotheirintendedpurpose
asadevicewithaviewtotheirbeingplacedonthe
marketonhisownbehalfisalsoconsideredtobea
manufacturer .Thissub-paragraph doesnotapplytothe
person,who,whilenotamanufacturer withinthe
meaningofthefirstsub-paragraph assemblesoradapts
devicesalreadyonthemarkettotheirintendedpurposes
foranindividualpatient.(g)'manufacturer'meansthenaturalorlegalpersonwith
responsibilityforthedesign,manufacturing ,packaging
andlabellingofadevicebeforeitisplacedonthemarket
onhisownbehalf,regardlessofwhetherthese
operationsarecarriedoutbythatpersonhimselforon
hisbehalfbyathirdparty.
Theobligationsimposedonmanufacturers underthe
termsofthisDirectiveshallalsoapplytothenaturalor
legalpersonwhoassembles,packages,processesand/or
labelsoneormoreready-madeproductsand/orassigns
themtotheirintendedpurposeasadevicewithaviewto
theirbeingplacedonthemarketonhisownbehalf.This
sub-paragraph doesnotapplytotheperson,who,while
notamanufacturerwithinthemeaningofthefirst
sub-paragraph ,assemblesoradaptsdevicesalreadyon
themarkettotheirintendedpurposeforanindividual
patient.
Article1(3) Article1(3)
3.Whereadeviceisintendedtoadministerasubstance
definedasamedicinalproductwithinthemeaningof
Article1ofDirective65/65/EEC,thatsubstanceshallbe
subjecttothemarketingauthorizationsystemprovidedforin
thatDirective .3.Whereadeviceisintendedtoadministerasubstance
definedasamedicinalproductwithinthemeaningof
Article1ofDirective65/65/EEC,thatsubstanceshallbe
subjecttothemarketingauthorizationsystemprovidedforin
thatDirective.
Ifsuchadeviceisplacedonthemarketorputintoserviceby
themanufacturerseparatelyfromthemedicinalproduct,it
shallbegovernedbythispresentDirective.

28.9.92 OfficialJournaloftheEuropeanCommunities NoC251/43
INITIALTEXT MODIFIEDTEXT
If,ontheotherhand,suchadeviceisplacedonthemarketby
themanufacturer insuchawaythatthedeviceandthe
medicinalproductformasingleunit,thecombinedproduct
shallbegovernedbyDirective65/65/EECandthispresent
Directiverespectively .
5a(new)
ThisDirectivedoesnotapplytopersonalprotective
equipmentcoveredbyDirective89/686/EECO).The
assessmentofwhetheraproductfallsundertheaforesaid
DirectiveorunderthisDirectiveshallinparticulartake
accountoftheprincipalintendedpurposeoftheproductand
whereandhowitistobeused.
(»)OJNoL399,30.12.1989,p.18.
Article10
1.unchangedArticle10
1.MemberStatesshalltakethenecessarystepstoensure
thatanyinformationbroughttotheirknowledge,in
accordancewiththeprovisionsofthisDirective,regarding
theincidentsmentionedbelowinvolvingaclassIla,liborIII
deviceisrecordedandevaluatedinacentralizedmanner:
(a)anydeterioration inthecharacteristics and/or
performanceofadevice,aswellasanyinaccuraciesin
thelabellingortheinstructionleafletwhichmightlead
toormighthaveledtothedeathofapatientoruserorto
aseriousdeterioration inhisstateofhealth;(a)anymalfunctionofordeteriorationinthecharacteristics
and/orperformanceofadeviceasspecifiedbythe
manufacturer ,aswellasanyinaccuraciesinthelabelling
ortheinstructionleafletwhichmightleadtoormight
haveledtothedeathofapatientoruserortoaserious
deterioration inhisstateofhealth;
(b)anytechnicalormedicalreasontodowiththe
characteristics orperformanceofadeviceleading,for
thereasonsreferredtoinsubparagraph (a)above,to
systematicrecallofdevicesofthesametypebythe
manufacturer .(b)anytechnicalormedicalreasonconnectedwiththe
deviceleadingtosystematicrecallofdevicesofthesame
typebythemanufacturer .
Article11
9.Decisionstakenbythenotifiedbodiesinaccordance
withAnnexesIIandIIIshallbevalidforamaximumoffive
yearsandmaybeextendedonapplicationforfurtherperiods
offiveyears.Article11
9.Decisionstakenbythenotifiedbodiesinaccordance
withAnnexesIIandIIIshallbevalidforamaximumoffive
yearsandmaybeextendedonapplicationforfurtherperiods
offiveyears.Thesedecisionsmustbeconveyedingood
time.
Article12
1.Anynaturalorlegalpersonwhoassemblesdevices
bearingtheECmarkfortheirintendedpurposeandwithin
thelimitsofusespecifiedbythemanufacturers withregardto
theircompatibilitywithotherdevicesinordertoputthemArticle12
1.Anynaturalorlegalpersonwhoassemblesdevices
bearingtheECmarkfortheirintendedpurposeandwithin
thelimitsofusespecifiedbythemanufacturers withregardto
theircompatibilitywithotherdevicesinordertoputthem

NoC251/44 OfficialJournaloftheEuropeanCommunities 28.9.92
INITIALTEXT MODFIEDTEXT
onthemarketintheformofasystem,kitoroperationpack
shalldrawupadeclarationinwhichhestatesthat:onthemarketintheformoforaspartofasystem,kit
orprocedurepackwith,whenappropriate,anyother
compatibleproductshallinformthecompetentauthority
inaccordancewiththeprovisionsofArticle14thatheis
engagedinsuchanactivityingeneralandshalldrawupa
declarationinwhichhestatesthat:
(a)hehasverifiedthemutualcompatibilityofthedevices
andanyotherproductswhichmakeupthesystem,kitor
procedurepackinaccordancewithanyinstructions
fromthemanufacturers andthatassemblyhasbeen
carriedoutinaccordancewiththeseinstructions ;
(b)thesystem,kitorprocedurepackhas,whereapplicable,
beenpackagedinaccordancewithanyrelevant
instructions fromthemanufacturers orthelimits
applicabletothevariousdevicesorotherproductsasthe
casemaybe;(a)hehasverifiedthemutualcompatibilityofthedevices
whichmakeupthesystem,kitoroperationpackin
accordancewiththemanufacturers 'instructions and
thatassemblyhasbeencarriedoutinaccordancewith
theseinstructions ;
(b)thesystem,kitoroperationpackhas,whereapplicable,
beenpackagedinaccordancewiththemanufacturers '
instructionsorthelimitsapplicabletothevarious
devices;
Article14
1.Anymanufacturerwho,onhisownbehalf,places
devicesonthemarketinaccordancewiththeprocedures
referredtoinArticle11(4)and(5)shallinformthe
competentauthoritiesoftheMemberStateinwhichhehas
hisregisteredplaceofbusinessoftheaddressoftheregistered
placeofbusinessandthecategoryofdevicesconcerned .Article14
1.Anymanufacturer who,onhisownbehalf,places
devicesonthemarketinaccordancewiththeprocedures
referredtoinArticle11(4)and(5)shallinformthe
competentauthoritiesoftheMemberStateinwhichhehas
hisregisteredplaceofbusinessoftheaddressoftheregistered
placeofbusinessandthedesignationofthedevices
concerned .
Article15
1.InthecaseofdevicesfallingwithinclassesI,Ilaand
libwhichareintendedforclinicalinvestigations ,the
manufacturer ,orhisauthorizedrepresentative establishedin
theCommunity ,shallfollowtheprocedurereferredtoin
AnnexVIIIandkeepthestatementconcernedatthedisposal
ofthecompetentauthorities .ArticleIS
1.InthecaseofdevicesfallingwithinclassesI,Ilaand
libwhichareintendedforclinicalinvestigations duly
justifiedinaccordancewiththeprovisionsofAnnexVIII,
point2.2,themanufacturer ,orhisauthorizedrepresentative
establishedintheCommunity ,shallfollowtheprocedure
referredtoinAnnexVIIIandkeepthestatementconcerned
atthedisposalofthecompetentauthorities .
2.InthecaseofdevicesfallingwithinclassIIIand
implantabledevicesfallingwithinclassIlaorlibwhichare
intendedforclinicalinvestigations dulyjustifiedin
accordancewiththeprovisionsofAnnexVIII,point2.2,the
manufacturer ,orhisauthorizedrepresentative establishedin
theCommunity ,shallfollowtheprocedurereferredtoin
AnnexVIIIand,atleast45daysbeforethecommencement
oftheinvestigations ,submitthestatementreferredtointhe
abovementioned Annextothecompetentauthoritiesof
theMemberStateinwhichtheinvestigations aretobe
conducted .2.InthecasesofdevicesfallingwithinclassIIIand
implantabledevicesfallingwithinclassIlaorlibintendedfor
clinicalinvestigations ,themanufacturer ,orhisauthorized
representativeestablishedintheCommunity,shallfollowthe
procedurereferredtoinAnnexVIIIand,atleast45days
beforethecommencement oftheinvestigations ,submitthe
statementreferredtointheabovementioned Annextothe
competentauthoritiesoftheMemberStateinwhichthe
investigations aretobeconducted .
Themanufacturer maycommencetherelevantclinicalunchanged
investigations attheendofaperiodof45daysafter
notification,unlessthecompetentauthoritieshavenotified
himwithinthatperiodofadecisiontothecontrarybasedon
considerations ofpublichealthorpublicorder.

28.9.92 OfficialJournaloftheEuropeanCommunities NoC251/45
INITIALTEXT MODIFEDTEXT
Withoutprejudicetothepowerofthecompetentauthorities
totakethefinaldecision,thereisgenerallynoreasonfor
themtointerveneonthebasisoftheprevioussubparagraph
insofarastheethicscommitteeconcernedhasissueda
favourableopinionoftheprogrammeofinvestigations in
question,referredtoinAnnexX.
Article17
2.unchangedArticle17
2.TheECmarkofconformity ,asshowninAnnexXII,
mustappearinavisible,legibleandindelibleformonthe
device,wherepracticableandappropriate,and/oronthe
salespackagingandtheinstructionleaflet.
Itshallbeaccompanied bytheidentificationnumberof
thenotifiedbodyresponsibleforimplementation ofthe
proceduressetoutinAnnexesII,IV,VandVIandthelast
twodigitsoftheyearinwhichthemarkwasaffixed.Itshallbeaccompanied bytheidentificationnumberof
thenotifiedbodyresponsibleforimplementation ofthe
proceduressetoutinAnnexesII,IV,VandVI.
Article17a
(new)
TheCommissionshalltakethenecessarystepstocreateand
ensuretheoperationofaCommunityregistercontainingthe
necessaryinformationforconsistentimplementation ofthis
Directive.
Article19
2.Intheeventofadecisiontowithdrawdevicesfromthe
market,themanufacturer ,orhisauthorizedrepresentative
establishedintheCommunity ,shallhaveanopportunity
toputforwardhisviewpointinadvance,unlesssuch
consultationisnotpossiblebecauseoftheurgencyofthe
measuretobetaken.Article19
2.Intheeventofadecisionreferredtoinparagraph1,the
manufacturer ,orhisauthorizedrepresentative established
intheCommunity ,shallhaveanopportunitytoputforward
hisviewpointinadvance,unlesssuchconsultation isnqt
possiblebecauseoftheurgencyofthemeasuretobe
taken.
Article22
3.Thefollowingparagraph6isaddedtoArticle1of
Directive90/385/EEC:Article22
3.ThedefinitioninArticle1(2)(a)ofCouncilDirective
90/385/EECshallbereplacedbythedefinitionin
Article1(2)(a)ofthispresentDirective;
Followingparagraph6isaddedtoArticle1ofDirective
90/385/EEC:
'6.ThefollowingprovisionsofCouncilDirective
//EEConmedicaldevicesalsoapplytoactive
implantablemedicaldevices:Article1(2)b),(g)and(i);
Article11(6),(8)ad(9);Article13(1)(c)coupledwith
Article7;Article17(3);Article19(2);Article21
points(a)and(c)ofthefirstparagraph.''6.ThefollowingprovisionsofCouncilDirective
//EEConmedicaldevicesalsoapplytoactive
implantablemedicaldevices:Article1(2)(g)and(i);
Article11(6),(8)and(9);Article13(1)(c)coupledwith
Article7;Article17(3);Article19(2);Article21
points(a)and(c)ofthefirstparagraph.'

NoC251/46 OfficialJournaloftheEuropeanCommunities 28.9.92
INITIALTEXT MODIFIED TEXT
Article23 Article23
4.Inthecaseofdeviceswhich,forthepurposesofthis
Directive,mustbethesubjectofoneoftheprocedures
referredtoinAnnexesIItoVI,MemberStatesshallaccept
theplacingonthemarketandputtingintoserviceofdevices
whichconformtotherulesinforceintheirterritoryon30
June1994duringtheperiodupto30June1997.Inthecase
ofotherdeviceslawfullyplacedonthemarketbefore30June
1994,MemberStatesshallaccepttheirbeingputintoservice
duringtheperiodupto30June1995.4.Inthecaseofdeviceswhich,forthepurposesofthis
Directive,mustbethesubjectofoneoftheprocedures
referredtoinAnnexesIItoVI,MemberStatesshallaccept
theplacingonthemarketandputtingintoserviceofdevices
whichconformtotherulesinforceintheirterritoryon30
June1994duringtheperiodupto30June1997.Inthecase
ofotherdeviceslawfullyplacedonthemarketbefore30June
1994,MemberStatesshallaccepttheirbeingputintoservice
duringtheperiodupto30June1996.
ANNEXI ANNEXI
ParagraphI .ParagraphI
1.Thedevicesmustbedesignedandmanufactured insuch
awaythat,whenusedundertheconditionsandforthe
purposesintended,theywillnotcompromisetheclinical
conditionsorthesafetyofthepatients,usersand,where
applicable,otherpersons.Therisksassociatedwith
thedevicesmustbereducedtoanacceptablelevel
compatiblewithahighlevelofprotectionofhealthand
safety.1.Thedevicesmustbedesignedandmanufactured insuch
awaythat,whenusedundertheconditionsandforthe
purposesintended,theywillnotcompromisetheclinical
conditionorthesafetyofthepatients,usersand,where
applicable,otherpersons,whenusedunderthe
conditionsandforthepurposesintendedprovidedthat
anyriskswhichmaybeassociatedwiththeiruse
constituteacceptableriskswhenweighedagainstthe
benefitstothepatientandarecompatiblewithahigh
levelofprotectionofhealthandsafety.
5.Thedevicesmustbedesigned,manufacturedandpacked
insuchawaythattheircharacteristics andperformances
duringtheirintendedusearenotadverselyaffectedin
thestorageandtransportconditions (temperature ,
humidity,etc)laiddownbythemanufacturer .5.Thedevicesmustbedesigned,manufacturedandpacked
insuchawaythattheircharacteristics andperformances
duringtheirintendedusewillnotbeadverselyaffected
inthetransportandstoragetakingaccountofthe
instructions andinformation providedbythe
manufacturer .
ANNEXI ANNEXI
ParagraphII
7.5Thedevicesmustbedesignedandmanufactured in
suchawayastominimizethehealthrisksposedby
substancesleakingfromthedeviceduringuse.
8.3Steriledevicesmustbedesigned,manufactured and
packedinanon-reusablepackand/oraccordingto
appropriateprocedurestoensurethattheyaresterileParagraphII
7.5Thedevicesmustbedesignedandmanufactured in
suchawayastominimizerisksposedbysubstances
leakingfromthedeviceduringuse.
8.3Steriledevicesmustbedesigned,manufactured and
packedinanon-reusablepackand/oraccordingto
appropriateprocedurestoensurethattheyaresterile

28.9.92 OfficialJournaloftheEuropeanCommunities NoC251/47
INITIALTEXT MODIFIEDTEXT
whenplacedonthemarketandremainsterile,under
thestorageandtransportconditionslaiddown,until
theprotectivepackagingisdamagedoropened.whenplacedonthemarketandremainsterile,under
normalstorageandtransportconditionsasdescribed
intheinstructionsandinformationsuppliedbythe
manufacturer ,untiltheprotectivepackagingis
damagedoropened.
11.5Instruments,apparatusorappliancesemitting
radiationmustbefittedwithvisualdisplaysand/or
audiblewarningsofradiationemissions.11.5Devicesintendedtoemitinvisible,potentially
hazardousradiationmustbefittedwithvisualdisplays
and/oraudiblewarningsofradiationemissions.
12.1Devicesdependingonsoftwaremustbedesignedin
suchawayastominimizetherisksarisingfromerrors
intheprogrammes .12.1Devicesincorporating programmable electronic
systemsmustbedesignedinsuchawayastoavoidso
farasreasonablypracticablerisksarisingfrom
randomand/orsystematicfailures.
12.7.5Accessiblepartsofthedevicesandtheir
surroundingsmustnotattainpotentiallydangerous
temperaturesundernormaluse.12.7.5Accessiblepartsofthedevices(excludinganyparts
orareasintendedtosupplyheatorattainahigh
temperature )andtheirsurroundingsmustnotattain
potentiallydangeroustemperaturesundernormal
use.
12.8.2Devicesmustbefittedwithmeanstopreventand/or
indicateanyinadequaciesinthecommandedoutput
whichcouldposeadanger.12.8.2Devicesmustbefittedwithaninterlockand/or
alarmsystemtopreventand/orindicateany
inadequaciesintheflowratewhichcouldposea
danger.
12.9Thefunctionofthecontrolsandvisualdisplays12.9Thefunctionofthecontrolsandindicatorsmustbe
mustbeclearlyspecifiedonthedevices. clearlyspecifiedonthedevices.
13.3unchanged
(a)unchanged13.3Thelabelmustbearthefollowingparticulars :
(a)thenameortradenameandaddressofthe
manufacturer :
(b)unchanged (b)thedetailsstrictlynecessaryfortheuserto
identifythedeviceandthecontentsofthe
packaging;
(c)whereappropriate ,theword'STERILE; (c)whereappropriate,thesymboljSTERILE
(d)whereappropriate ,thebatchcode,precededby
theword'LOT',ortheserialnumber;(d)whereappropriate,thebatchcode,preceded
bythesymbol(LOTI,ortheserialnumber;

NoC251/48 OfficialJournaloftheEuropeanCommunities28.9.92
INITIALTEXT MODIFIEDTEXT
13.6a(new)Theinstructionsforuseshallcontainan
explicitrequesttotheuserorpatientto
informhis/herdoctorormedicalinstitution
ofanyside-effectnotreferredtointhe
instructionsforuse.
ANNEXII ANNEXII
2.unchanged 2.Thedeclarationofconformityistheprocedurewhereby
themanufacturerwhofulfilstheobligationsimposed
bySection1ensuresanddeclaresthattheproducts
concernedmeettheprovisionsofthisDirectivewhich
applytothem.
Themanufacturer shallaffixtheECmarkinaccordance
withArticle17andshalldrawupwrittendeclarationof
conformity .Thisdeclarationofconformityshallcovera
givennumberofidentifiedspecimensoftheproducts
manufactured andshallbekeptbythemanufacturer .
TheECmarkshallbeaccompaniedbytheidentification
numberofthenotifiedbodywhichperformsthetasks
referredtointhisAnnex.Themanufacturer shallaffixtheECmarkinaccordance
withArticle17andshalldrawupawrittendeclaration
ofconformity .Thisdeclarationofconformityshallcover
agivennumberofproductsmanufactured onthebasisof
theapprovalofthequalitysystemandshallbekeptby
themanufacturer .
3.1Themanufacturer shalllodgeanapplicationfor3.1unchanged
assessmentofhisqualitysystemwithanotifybody.
unchanged
unchangedTheapplicationshallinclude:
—thenameandaddressofthemanufacturer ,
—alltherelevantinformationontheproductor
productcategorycoveredbytheprocedure,
—awrittendeclarationthatnoapplicationhasbeen
lodgedwithanyothernotifiedbodyforthesame
products,awrittendeclarationthatnosuchapplicationhas
beenlodgedwithanyothernotifiedbodyforthe
sameproducts,
ANNEXV ANNEXV
2.unchanged 2.Thedeclarationofconformityisthepartofthe
procedurewherebythemanufacturerwhofulfilsthe
obligationsimposedbySection1ensuresanddeclares
thattheproductsconcernedconformtothetype
describedintheEC-typeexaminationcertificateand
meettheprovisionsofthisDirectivewhichapplyto
them.
Themanufacturer shallaffixtheECmarkinaccordance Themanufacturer shallaffixtheECmarkinaccordance
withArticle17andshalldrawupawrittendeclaration withArticle17andshalldrawupawrittendeclaration

28.9.92 OfficialJournaloftheEuropeanCommunities NoC251/49
INITIALTEXT MODIFEDTEXT
ofconformity .Thisdeclarationofconformityshallcover
agivennumberofproductsmanufacturedonthebasisof
theapprovalofthequalitysystemandshallbekeptby
themanufacturer .ofconformity .Thisdeclarationofconformityshallcover
agivennumberofidentifiedspecimensoftheproducts
manufactured andshallbekeptbythemanufacturer .
TheECmarkshallbeaccompaniedbytheidentification
numberofthenotifiedbodywhichperformsthetasks
referredtointhisAnnex.
3.1Themanufacturer shalllodgeanapplicationfor3.1unchanged
assessmentofhisqualitysystemwithanotifybody.
unchanged
unchangedTheapplicationshallinclude:
—thenameandaddressofthemanufacturer ,
—alltherelevantinformationontheproductor
productcategorycoveredbytheprocedure,
—awrittendeclarationthatnoapplicationhasbeen
lodgedwithanyothernotifiedbodyforthesame
products,awrittendeclarationthatnosuchapplicationhas
beenlodgedwithanyothernotifiedbodyforthe
sameproducts,
ANNEXVI ANNEXVI
2.unchanged 2.Thedeclarationofconformityisthepartofthe
procedurewherebythemanufacturerwhofulfilsthe
obligationsimposedbySection1ensuresanddeclares
thattheproductsconcernedconformtothetype
describedintheEC-typeexaminationcertificateand
meettheprovisionsofthisDirectivewhichapplyto
them.
Themanufacturer shallaffixtheECmarkinaccordance
withArticle17andshalldrawupawrittendeclaration
ofconformity .Thisdeclarationofconformityshallcover
agivennumberofidentifiedspecimensoftheproducts
manufactured andshallbekeptbythemanufacturer .
TheECmarkshallbeaccompaniedbytheidentification
numberofthenotifiedbodywhichperformsthetasks
referredtointhisAnnex.Themanufacturer shallaffixtheECmarkinaccordance
withArticle17andshalldrawupawrittendeclaration
ofconformity .Thisdeclarationofconformityshallcover
agivennumberofproductsmanufacturedonthebasisof
theapprovalofthequalitysystemandshallbekeptby
themanufacturer .
3.1Themanufacturer shalllodgeanapplicatonfor3.1unchanged
asessmentofhisqualitysystemwithanotifiedbody.
unchanged
unchangedTheapplicationshallinclude:
—thenameandaddressofthemanufacturer ,
—alltherelevantinformationontheproductor
productcategorycoveredbytheprocedure,
—awrittendeclarationthatnoapplicationhasbeen
lodgedwithanyothernotifiedbodyforthesame
products,awrittendeclarationthatnosuchapplicationhas
beenlodgedwithanyothernotifiedbodyforthe
sameproducts,

NoC251/50 OfficialJournaloftheEuropeanCommunities 28.9.92
INITIALTEXT
ANNEXVIII
2.2Fordevicesintendedfortheclinicalinvestigations
coveredbyAnnexX:
—dataallowingidentification ofthedevicein
question,
—aninvestigationplanstatinginparticularthe
purpose,scopeandnumberofdevicesconcerned,MODIFIEDTEXT
ANNEXVIII
2.2unchanged
—unchanged
—aninvestigationplanstatinginparticularthe
purpose,scientific,technicalormedical
justification ,scopeandnumberofdevices
concerned,
—unchanged
—unchanged
—unchanged
—unchanged—theopinionoftheethicscommitteeconcernedand
detailsoftheaspectscoveredbyitsopinion,
—thenameofthemedicalspecialistorother
authorizedpersonandoftheinstitutionresponsible
fortheinvestigations ,
—theplace,startingdateandscheduleddurationfor
theinvestigations ,
—astatementthatthedeviceinquestionconformsto
theessentialrequirementsapartfromtheaspects
coveredbytheinvestigationsandthat,withregard
tothoseaspects,everyprecautionhasbeentakento
protectthehealthandsafetyofthepatient.
ANNEXIX
ParagraphI
2.4unchanged
—tobeplacedinorontheteethordentalprotheses,in
whichcasetheyareinclassIla,
—unchanged
—unchangedANNEXIX
ParagraphI
2.4Rule8
Allimplantabledevicesandlong-termsurgically
invasivedevicesareinclasslibunlesstheyare
intended:
—tobeplacedintheteeth,inwhichcasetheyarein
classIla,
—tobeusedindirectcontactwiththeheart,the
centralcirculatorysystemorthecentralnervous
system,inwhichcasetheyareinclassIII,
—toundergochemicalchangeinthebody,tobe
biologicallyactive,tobewhollyormainly
absorbed,tosupplyenergyintheformofionizing
radiationortoadministermedicines,inwhichcase
theyareinclassIII,exceptifthedevicesareplaced
intheteeth.