30.3.92 OfficialJournaloftheEuropeanCommunities NoC79/1
II
(PreparatoryActs)
ECONOMIC ANDSOCIALCOMMITTEE
OpinionontheproposalforaCouncilDirectiveconcerningMedicalDevices(')
(92/C79/01)
On12September1991theCouncildecidedtoconsulttheEconomicandSocialCommittee,
underArticle100AoftheTreatyestablishingtheEuropeanEconomicCommunity ,onthe
abovementioned proposal.
TheSectionforIndustry,Commerce,CraftsandServices,whichwasresponsibleforpreparing
theCommittee'sworkonthesubject,adopteditsOpinionon8January1992.TheRapporteur
wasMrFlum.
Atits293rdplenarysession(meetingof29January1992)theEconomicandSocialCommittee
adoptedthefollowingOpinionunanimously .
basicrequirements ,classifications ,etc.iswelcomedin
principle.ItwillbenecessaryfortheCommissionto
undertakeadivisionofmedicaldevicesaccordingto
typeofuser,i.e.distinguishing betweendevicesused
bythedoctororotherpractitioner,andthoseusedby
thepatienthim(her)self.
1.4.TheCommitteealsonotesthatnoethicalprin­
ciplescanorshouldbelaiddownbythisdirective.1.Generalcomments
1.1.TheEconomicandSocialCommitteestrongly
welcomestheproposalandendorsesitsprovisionssub­
jecttothecommentsinthefollowingparagraphs .The
proposeddirectivewouldguaranteethefree,un­
impededmovementofgoodsintheCommunityand
shouldensurethesupplyofmedicaldeviceswhich
providepatientswithahighlevelofprotection.
1.2.Itisassumedthatthedirectivecoversonlyput­
tingthegoodsonthemarketandbringingtheminto
service.IndividualStates'regulationsonthepro­
fessionalqualificationsofusersandoperatorsandpro­
visionsonqualityrequirementsandqualitycontrol
remainunchangedonthe'userside'.Thisshouldbean
additionalprovisioninArticle2orapreambleclause.
1.3.Particularattentionshouldbepaidtothefact
thatthemarketinmedicaldevicesissubjecttoconstant
change,sothattheproposeddirectivemustensurethat
neworimprovedmedicaldevicesarecoveredbythe
wordingofthedirectiveandparticularlybytheclassifi­
cationcriteriaused.SincetheCommission statesthat
thedirectivecoversmorethan400000medicaldevices,
itseemspracticallyimpossibletocataloguetheseprod­
ucts.TheCommissionproposaltolaydownonlythe1.5.Thedirectiveshouldalsopointoutthatpro­
visionsonproductliabilityremainunaffected.This
appliesmutatismutandistothecustomerservicesector.
Itseemsappropriatetoaddsuchaprovisionto
Article2.
1.6.Thecostsarisingfromtheuseofmedicaldevices
areusuallybornebythestatutoryhealthinsurance
schemes.Hencenationallegalprovisionsprovidefor
thecooperationofthecostbearingbodies,suchas
healthinsuranceschemes,inqualitycontroland
demandplanning(planningofthelocationoflarge
medicaldevices).TheMemberStates'healthinsurance
schemesmustbeinvolvedintheimplementation ofthe
directive.However,apreconditionwouldbeforthe
healthinsurancebodiestosetupaCommunity-wide
organizational structuretoenablethemtoassumetheir
responsibilities vis-a-vistheCommunityauthorities . (»)OJNoC237,12.9.1991,p.3.

NoC79/2 OfficialJournaloftheEuropeanCommunities 30.3.92
2.4.Article6
2.4.1.TheEconomicandSocialCommitteepoints
outthattheeconomicandsocialinterestgroupsaffected
bythisdirectiveshouldhaveanopportunitytomake
proposalsandsuggestionstothecommitteereferredto
inArticle6.1.7.Itwillneedtobeassessedlaterwhetherthe
detailedrulescontainedintheannexestothisdirective
areultimatelygearedtotheneedsandrequirementsof
theMemberStates.Itshouldthereforebelaiddownin
thedirectivethatwithinfiveyearsfromthedirective
comingintoforcetheCommissionshallreportonits
applicationandifnecessarysubmitproposalsfor
improvement .Thisprovisioncouldtaketheformofan
additionalArticle.
1.8.TheCommitteenotesthatthisdraftdirective
followsonfromtheCouncilDirective90/385/EECof
20June1990ontheharmonizationofthelawsofthe
MemberStatesrelatingtoactiveimplantablemedical
devices.TheCommittee'sgeneralviewsonthemain
thrustofthatDirectivealsoapplytothepresentpro­
posal.2.5.Article7
2.5.1.TheEconomicandSocialCommitteewel­
comesthefactthatparagraph2describesamoredetail­
edprocedurefortheissuingofthecommittee'sopinion.
WhileunderArticle6ofDirective90/385/EECthe
committeehastherightonlytoadopt,ifnecessaryby
voting,anopiniononproposedmeasures,thepresent
draftdirectiveattachesmoreimportancetothecom­
mittee'sopinion.ThustheCommissionwillbeableto
adoptthemeasuresinquestiononlyiftheyaccordwith
thecommittee'sopinion.
2.5.2.ThecommitteeprovidedforunderArticle7
shouldbegiventherighttobeconsultedondrawing
uptheguidelinesmentionedinArticle21.Thesame
committeeshouldallowthecostbearinginstitutions
(suchasthemanufacturers ofmedicaldevicesandthe
healthinsurancebodies)therighttobeheardinthe
courseofconsultations .Aprovisioncoveringthese
pointsshouldbeaddedasaparagraph (4).
2.6.Article8
2.6.1.Thesafeguardclauseisparticularlywelcome
sinceitisintendedtoensurehighqualityandsafety
levelswithinthecommonmarket.2.Specificcomments
2.1.Article1
2.1.1.Articlel(2)(d),lastsub-paragraph ,orthecor­
respondingguidelinesinArticle21,shouldbeillustrated
withoneormoreexamples,inordertoavoidlater
difficultiesofinterpretation intheMemberStates.This
alsoappliestoArticle1(2)(f)(implantabledevice—e.g.
dentalimplants).
2.1.2.Thedefinitionof'puttingintoservice'in
Article1(2)(j)intheotherlanguageversionsshouldbe
alignedontheGermanversion.
2.1.3.IntheCommittee'sview,theaccessoriespro­
ducedforactiveimplantabledevicesarecoveredby
Directive90/385/EECandcannotbecoveredatthe
sametimebythepresentdraftdirective[inArticle1(5)].
2.1.4.InconnectionwithArticle1(8)theCommittee
notesthatthisdraftdirectivedoesnotapplytocosmetic
nortoveterinaryproducts.
2.2.Article4
2.2.1.Theproposalonfreemovementofmedical
devicesinthecommonmarketiswelcomed.Thepre­
sentdirectivecoversonlyfreemovementofgoodsand
isintendedtoeliminatebarrierstotrade.However,
productsbearingtheECmark,whentheyareputon
themarketandbroughtintoservice,canbesubjectto
additionalnationalregulationsregardingprofessional
qualifications andcorresponding rulesonthe'user
side'.
2.3.Article5
2.3.1.Article5(1)divergestextuallyfromArticle5
ofDirective90/385/EECwhichhasasimilarcontent.
Itisnotclearwhetheritisintendedtolowerrelevant
nationalstandardsthereby.Clarification isrequested
onwhytextualdifferencesareregardedbytheCom­
missionasbeingnecessaryhere.2.7.Article10
2.7.1.ThewordingunderArticle10(l)(a)shouldbe
amendedsothatcentralrecordingandevaluationtakes
placeevenonthesuspicionofahealthrisk.Thepresent
wordingappliesonlytoproductswhichmightleadto
ormighthaveledtothedeathofapatientoruseror
toaseriousdeterioration inhisorherstateofhealth.
2.7.2.Paragraph2shouldbesupplemented witha
provisionwherebyhealthinsurancebodiesintheMem­
berStateswouldbeinformedofincidentscoveredby
paragraph1,sothatclaimsfordamagescouldbemade
whereappropriate .
2.7.3.Similarprovisionshouldbeintroducedto
coverClassIproducts.
2.8.Article11
2.8.1.TheEconomicandSocialCommitteewel­
comesthedetailedprovisionsonconformityassess­
ment,designedtoprotectpatientsandusers.

30.3.92 OfficialJournaloftheEuropeanCommunities NoC79/3
2.9.Article12
2.9.1.Inthelastsub-paragraph ofArticle12(1),the
phrase'whereappropriate'shouldbedeleted,since
thereisnoruleonwhodecidesontheobligationto
inform.
2.10.Article15
2.10.1.IntheCommittee'sview,theproceduresfor
theproductsmentionedinparagraph (1)shouldbe
clarifiedinordertofacilitatecheckingbytheauthori­
ties.TheCommission isaskedtoassesswhether
Annex8canbesupplemented withaprovisionon
informingtheauthoritiesofthestartandendofclinical
testing.2.12.Article23
2.12.1.TheCommission isaskedtoassesswhether
thedeadlineof31December1993laiddowninArticle
33forthecomingintoforceofthedirectivecouldnot
beharmonizedwiththedeadlineof31December1992
forDirective90/385/EEC(activeimplantablemedical
devices).
2.13.Annex1
2.13.1.Theobjectionofmanufacturers ofmedical
devicesthattheycanacceptnoliabilityforimproper
useofsuchdevicesisjustified.IntheCommittee'sview,
accounthasalreadybeentakenofthisobjection,in
thatnationallegalprovisionsonprofessionalstandards,
andonrulestosafeguardthem,remainunaffectedby
thedirective.Theessentialpointisthatmanufacturers
ofmedicaldevicesmustprovidetheuserwithdetailed
instructionsforusingtheirproducts.
3.Concludingremarks
3.1.TheEconomicandSocialCommitteestrongly
urgesthatalltheprovisionscontainedinthisproposal
shouldapplybothtomedicaldevicesmanufactured in
theEuropeanCommunityandtothoseimportedfrom
thirdcountries.
3.2.ExaminationshowedthatthePortuguesever­
sionofthedraftdirectiveismisleadinginplaces.A
correctedversionshouldthereforebedrawnup.2.11.Article21
2.11.1.TheCommitteewelcomesthelaying-down
ofsuitableguidelinesfortheuniformapplicationof
thisdirective,asthiswillensuresufficientflexibilityto
allowfornewandimprovedmedicaldevices.However,
sincesuchguidelinesareandmustremainaninalienable
partofthedirectives,itisproposedthattheCommittee
beconsultedineachcaseontheseguidelinesandthat
thisrightbeincorporatedinArticle21.
DoneatBrussels,29January1992.
TheChairman
oftheEconomicandSocialCommittee
MichaelGEUENICH