東盟MDD注冊法規(guī) ASEAN MEDICAL DEVICE DIRECTIVE

ASEANMEDICAL

DEVICEDIRECTIVE

asean

onevision oneidentityonecommunity

TheAssociationofSoutheastAsianNations(ASEAN)wasestablishedon8August1967.TheMember

StatesoftheAssociationareBruneiDarussalam,Cambodia,Indonesia,LaoPDR,Malaysia,Myanmar,Philippines,Singapore,ThailandandVietNam.TheASEANSecretariatisbasedinJakarta,Indonesia.

Forinquiries,contact:TheASEANSecretariat

PublicOutreachandCivilSocietyDivision70AJalanSisingamangaraja

Jakarta12110Indonesia

Phone:(6221)724-3372,726-2991

Fax:(6221)739-8234,724-3504

E-mail:public@

Catalogue-in-PublicationData

ASEANMedicalDeviceDirective

Jakarta:ASEANSecretariat,September2015

363.1959

1.MedicalInstruments–ProductSafety

2.ASEAN–Standards-Healthcare

ISBN978-602-0980-31-7

GeneralinformationonASEANappearsonlineattheASEANWebsite:

Thetextofthispublicationmaybefreelyquotedorreprinted,providedproperacknowledgementisgivenandacopycontainingthereprintedmaterialissenttoPublicOutreachandCivilSocietyDivisionoftheASEANSecretariat,Jakarta

CopyrightAssociationofSoutheastAsianNations(ASEAN)2015.Allrightsreserved

Coverphotos:

TABLEOFCONTENTS

ASEANAGREEMENTONMEDICALDEVICEDIRECTIVE

ARTICLE1GENERALPROVISIONS 2

ARTICLE2DEFINITIONSANDSCOPE 3

ARTICLE3ESSENTIALPRINCIPLESOFSAFETYAND

PERFORMANCEOFMEDICALDEVICE 10

ARTICLE4CLASSIFICATIONOFMEDICALDEVICES 10

ARTICLE5CONFORMITYASSESSMENTOF

MEDICALDEVICES 11

ARTICLE6REGISTRATIONAND

PLACEMENTONTHEMARKET 12

ARTICLE7LICENSINGOFPERSONRESPONSIBLE

FORPLACINGMEDICALDEVICE

ONTHEMARKETSOFMEMBERSTATES 13

ARTICLE8TECHNICALDOCUMENTS

FORMEDICALDEVICES 13

ARTICLE9REFERENCETOTECHNICALSTANDARDS 13

ARTICLE10LABELLING 14

ARTICLE11MEDICALDEVICECLAIMS 14

ARTICLE12POST-MARKETINGALERTSYSTEM 15

ARTICLE13CLINICALINVESTIGATION 16

ARTICLE14INSTITUTIONALARRANGEMENTS 17

ARTICLE15SAFEGUARDCLAUSES 18

ARTICLE16CONFIDENTIALITY 19

ARTICLE17SPECIALCASES 20

ARTICLE18IMPLEMENTATION 21

ARTICLE19REVISIONS,MODIFICATIONS

ANDAMENDMENT 21

ARTICLE20DISPUTESETTLEMENT 22

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ARTICLE21RESERVATIONS 22

ARTICLE22ENTRYINTOFORCE 22

ARTICLE23ANNEXES 23

ARTICLE24DEPOSITORY 23

ANNEX1EssentialPrinciplesofSafety

andPerformanceofMedicalDevices 27

ANNEX2RiskClassificationRulesforMedicalDevices

otherthanIVDMedicalDevices 41

ANNEX3RiskClassificationRules

forIVDMedicalDevices 50

ANNEX4ASEANCommonSubmission

DossierTemplate 56

ANNEX5PostMarketingAlertSystem

(PMAS)Requirements 66

ANNEX6ComponentsElementsofa

ProductOwner’sorPhysicalManufacturer’s

DeclarationofConformity(DOC) 78

ANNEX7LabellingRequirements 81

ANNEX8ClinicalInvestigation 88

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ASEANAGREEMENT

ONMEDICALDEVICEDIRECTIVE

TheGovernmentsofBruneiDarussalam,theKingdomofCambodia,theRepublicofIndonesia,theLaoPeople’sDemocraticRepublic,Malaysia,theRepublicoftheUnionofMyanmar,theRepublicofthePhilippines,theRepublicofSingapore,theKingdomofThailandandtheSocialistRepublicofVietNam,MemberStatesoftheAssociationofSoutheastAsianNations(ASEAN),hereinaftercollectivelyreferredtoas“MemberStates”orsingularlyas“MemberState”;

MINDFULthatintheyear1992,theASEANHeadsofGovernmentdeclaredthatanASEANFreeTradeArea(AFTA)shallbeestablishedintheregionandthatin1995,theyagreedtoaccelerateitsimplementationtotheyear2003;

NOTINGtheASEANTradeinGoodsAgreementwhichenteredintoforceon17May2010providesforcooperationtosupplementandcomplementtheliberalisationoftradeincluding,amongothers,theharmonisationofstandards,conformityassessmentproceduresandtechnicalregulationsasameansofreducingtechnicalbarrierstotrade;

MINDFULthattheDeclarationofASEANConcordII(BaliConcordII)adoptedbytheASEANHeadsofGovernmentduringthe9thASEANSummitinBali,Indonesiaon7October2003,commitsASEANtodeepenandbroadenitsinternaleconomic

integrationandlinkages,withtheparticipationoftheprivatesector,soastorealiseanASEANEconomicCommunity;

MINDFULthattheestablishmentoftheASEANEconomicCommunityhasbeenacceleratedfrom2020to2015whichwillcreateASEANasasinglemarketandproductionbase;

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REITERATINGtheircommitmentstotheAgreementonTechnicalBarrierstoTradeoftheWorldTradeOrganization,whichencouragestheContractingPartiestoenterintonegotiationsfortheconclusionofagreementsforthemutualrecognitionofresultsofeachother’sconformityassessmentandmandates,amongothermatters,theeliminationofunnecessaryobstaclestotradeincludingthoserelatingtotechnicalregulations;

RECALLINGtheASEANFrameworkAgreementfortheIntegrationofPrioritySectorsandtheASEANSectoral

IntegrationProtocolforHealthcaresignedon29November

2004inVientiane,LaoPDR;and

HAVINGregardtotheobjectivesofharmonisedmedicaldeviceregulations,commontechnicaldocumentsandtheprogressmadeinimplementation.

HAVEAGREEDasfollows:

ARTICLE1

GENERALPROVISIONS

(1)EachMemberStateshallundertakeallnecessarymeasurestoensurethatonlymedicaldeviceswhichconformtotheprovisionsofthisASEANAgreement

onMedicalDeviceDirective(hereinafterreferredtoas“Agreement”)anditsAnnexesmaybeplacedonthemarketsofthatMemberState.

(2)SubjecttotheprovisionsofthisAgreementeachMemberStateshallrequirethatthepersonresponsibleforplacingthemedicaldeviceinthatMemberStateortheauthorisedrepresentativeshallregisterthemedicaldevicewiththeRegulatoryAuthorityofthatMemberState.

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(3)SubjecttotheprovisionsofthisAgreement,eachMemberStateshallrequirethatthepersonresponsibleforplacingthemedicaldeviceinthatMemberStateortheauthorisedrepresentativeshallbelicensedbytheRegulatoryAuthorityofthatMemberStatebeforeplacingthemedicaldeviceinthatMemberState.

ARTICLE2

DEFINITIONSANDSCOPE

(1)ThisAgreementshallapplytomedicaldevicesandtheiraccessories.ForthepurposesofthisAgreement,accessoriesshallbetreatedasmedicaldevicesintheirownright.Bothmedicaldevicesandaccessoriesshallhereinafterbereferredtoasdevices.ForthepurposeofthisAgreement,unlessthecontextotherwiserequires,theterms:

(a)“medicaldevice”shallmeananyinstrument,apparatus,implement,machine,appliance,implant,invitroreagentandcalibrator,software,materialorothersimilarorrelatedarticle:

(i)intendedbytheproductownertobeused,aloneorincombination,forhumanbeingsforoneormoreofthespecificpurpose(s)of:

(a)diagnosis,prevention,monitoring,

treatmentoralleviationofdisease;

(b)diagnosis,monitoring,treatment,

alleviationoforcompensationforaninjury;

(c)investigation,replacement,modification,orsupportoftheanatomyorofaphysiologicalprocess;

(d)supportingorsustaininglife;

(e)controlofconception;

(f)disinfectionofmedicaldevices;and

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(g)providinginformationformedicalordiagnosticpurposesbymeansofinvitroexaminationofspecimensderivedfromthehumanbody;

(ii)whichdoesnotachieveitsprimaryintendedactioninoronthehumanbodybypharmacological,immunologicalormetabolicmeans,butwhichmaybeassistedinitsintendedfunctionbysuchmeans.

(b)“accessory”meansanarticlethatisintended

specificallybyitsproductownertobeusedtogetherwithaparticularmedicaldevicetoenableorassistthatdevicetobeusedinaccordancewithitsintendedpurpose.

(c)“adverseevent”meanseitheramalfunctionoradeteriorationinthecharacteristicsorperformanceofasuppliedmedicaldeviceoruseerror,whicheitherhascausedorcouldhavecausedorcontributedtodeath,orinjurytohealthofpatientsorotherpersons.

(d)“authorisedrepresentative”meansanypersoninaMemberStatewho,explicitlydesignatedbytheproductowner,actsandmaybeaddressedbyauthoritiesandbodiesinaMemberStateinsteadoftheproductownerwithregardtothelatter’sobligationsunderthisAgreement,andrelevantlaws

andregulationsoftheMemberState

(e)“authoriseddistributor”,inrelationtotheplacingonthemarketofamedicaldevice,meansanypersonwhohasbeenauthorisedbytheproductownerorauthorisedrepresentativetodistributethemedicaldeviceinthatMemberState.

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(f)“custom-mademedicaldevice”meansanydevicespecificallymadeinaccordancewithadulyqualifiedmedicalpractitioner’swrittenprescriptionwhichgives,underhisresponsibility,specificdesigncharacteristicsandisintendedforthesoleuseofaparticularpatient.Forthepurposesofthisdefinition,adulyqualifiedmedicalpractitionerisdefinedasapersonwhoisdulyqualifiedbytherelevantlawsandregulationsoftheMemberStatewherethecustom-mademedicaldeviceisused.

Forpurposesofclarity,massproduceddeviceswhichneedtobeadaptedtomeetthespecificrequirementsofthemedicalpractitioneroranyotherprofessionalusershallnotbeconsideredtobecustom-mademedicaldevices.

(g)“deviceintendedforclinicalinvestigation”meansanydeviceintendedforusebyadulyqualifiedmedicalpractitionerwhenconductingclinicalinvestigationsasreferredtoinAnnex8(ClinicalInvestigation),inanadequatehumanclinicalenvironment.Forthepurposesofconductingofclinicalinvestigation,adulyqualifiedmedicalpractitionerisdefinedasapersonwhoisdulyqualifiedbytherelevantlawsandregulationsoftheMemberStatewheretheclinicalinvestigationiscarriedout,andbyvirtueofhisprofessionalqualifications,isauthorisedtocarry

outsuchinvestigation

(h)“FieldSafetyCorrectiveAction(FSCA)”meansanyactiontakenbyaproductownertoreduceariskofdeathorseriousdeteriorationinthestateofhealthassociatedwiththeuseofamedicaldevice.Thismayinclude:

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(i)thereturnofamedicaldevicetotheproduct

owneroritsrepresentative;

(ii)devicemodificationwhichmayinclude:

(a)retrofitinaccordancewiththeproductowner’smodificationordesignchange;

(b)permanentortemporarychangestothelabellingorinstructionsforuse;

(c)softwareupgradesincludingthosecarriedoutbyremoteaccess;

(d)modificationtotheclinicalmanagementofpatientstoaddressariskofserious

injuryordeathrelatedspecificallytothecharacteristicsofthedevice.

(iii)deviceexchange;(iv)devicedestruction;

(v)advicegivenbyproductownerregardingtheuseofthedevice.

(i)“intendedpurpose”meanstheuseforwhichthemedicaldeviceisintendedaccordingtothespecificationsofitsproductownerasstatedonanyorallofthefollowing:

(i)thelabelofthemedicaldevice;

(ii)theinstructionsforuseofthemedicaldevice;(iii)thepromotionalmaterialsinrelationtothe

medicaldevice.

(j)“invitrodiagnostic(IVD)medicaldevice”meansany

reagent,reagentproduct,calibrator,controlmaterial,kit,instrument,apparatus,equipmentorsystem,whetherusedaloneorincombinationwithanyotherreagent,reagentproduct,calibrator,controlmaterial,kit,instrument,apparatus,equipmentorsystem,thatisintendedbyitsproductownertobeusedinvitrofortheexaminationofanyspecimen,includinganybloodortissuedonation,derivedfromthehumanbody,solelyorprincipallyforthepurposeofprovidinginformation:

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(i)concerningaphysiologicalorpathologicalstateoracongenitalabnormality;

(ii)todeterminethesafetyandcompatibilityofanybloodortissuedonationwithapotentialrecipientthereof;or

(iii)tomonitortherapeuticmeasuresandincludesaspecimenreceptacle.

(k)“manufacture”,inrelationtoamedicaldevice,meanstomake,fabricate,produceorprocessthe

medicaldeviceandincludes:

(i)anyprocesscarriedoutinthecourseofsomaking,fabricating,producingorprocessingthemedicaldevice;and/or

(ii)thepackagingandlabellingofthemedicaldevicebeforeitissupplied.

(l)“person”meansanaturalpersonoralegalentityincludingacorporation,apartnershiporassociationdulyestablishedpursuanttotheprevailinglawsandregulationsofMemberStates.

(m)“physicalmanufacturer”,inrelationtoamedicaldevice,meansanypersonwhoperformstheactivityofmanufacture.

(n)“placingonthemarket”meansthemakingavailableinreturnforpaymentorfreeofchargeof

amedicaldeviceotherthanadeviceintendedforclinicalinvestigation,withaviewtodistributionand/oruseonthemarketofaMemberState.

(o)“productowner”,inrelationtoamedicaldevice,meansanypersonwho:

(i)suppliesthemedicaldeviceunderhisownname,orunderanytrademark,design,tradenameorothernameormarkownedorcontrolledbyhim;and

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(ii)isresponsiblefordesigning,manufacturing,assembling,processing,labelling,packaging,refurbishingormodifyingthemedicaldevice,orforassigningtoitapurpose,whetherthosetasksareperformedbyhimoronhisbehalf.

(p)“puttingintoservice”meansthestageatwhichamedicaldevicehasbeenmadeavailabletothefinaluserasbeingreadyforuseonthemarketofaMemberStateforitsintendedpurpose.

(q)“refurbishedmedicaldevice”meansamedicaldeviceofwhichthewholeoranypartthereofhasbeensubstantiallyrebuilt,whetherornotusingpartsfromoneormoreusedmedicaldevicesofthatsamekind,soastocreateamedicaldevicethatcanbeusedforthepurposeoriginallyintendedbytheproductowneroftheoriginalmedicaldevice,andwhichmayhavehad

thefollowingworkcarriedoutonit:

(i)strippingintocomponentpartsorsub-assemblies;

(ii)checkingtheirsuitabilityforreuse;

(iii)replacementofcomponents/sub-assembliesnotsuitableforreuse;

(iv)assemblyofthereclaimedand/orreplacementcomponents/sub-assemblies;

(v)testingoftheassembleddeviceagainst

eitheroriginalorrevisedreleasecriteria;or

(vi)identifyinganassembledmedicaldeviceasa

refurbishedmedicaldevice.

(r)“register”meanstoobtainmarketingapprovalforamedicaldevicefromtheRegulatoryAuthorityofaMemberStateinordertoplacethemedicaldeviceonthemarketofthatMemberState.

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(s)”RegulatoryAuthority”meanstheregulatoryauthorityorentityofthatMemberStatewhichexercisesalegalrighttocontroltheimport,manufacture,export,distribution,transfer,useandsaleofmedicaldeviceswithinthatMemberState’sjurisdictionandwhichmaytakeregulatoryactiontoensurethattheproductsmarketedwithinitsjurisdictioncomplywithregulatoryrequirements.

(t)“Sponsor”meansanindividualororganisationtakingresponsibilityandliabilityfortheinitiationor

implementationofaclinicalinvestigation.

(2)ThisAgreementshallnotapplytothefollowing:

(a)humanblood,plasmaorbloodcellsofhumanoriginortomedicaldeviceswhichincorporateatthetimeof

placingonthemarketsofMemberStatessuchhuman

blood,plasmaorbloodcellsofhumanorigin,exceptif:(i)itisincorporatedinanIVDmedicaldevice,or(ii)itisincorporatedinamedicaldeviceasa

humanbloodderivativewithanactionancillarytothatofthemedicaldevice.

(b)transplantsortissuesorcellsofhumanoriginnortoproductsincorporatingorderivedfromtissuesorcellsofhumanorigin,exceptifitisincorporatedinanIVDmedicaldevice;or

(c)transplantsortissuesorcellsofanimalorigin,unless:

(i)itisincorporatedinanIVDmedicaldevice,or(ii)itisamedicaldevicemanufacturedutilising

animaltissuewhichisrenderednon-viableornon-viableproductsderivedfromanimaltissuesorcells.“Non-viable”meansinrelationtoabiologicalentity,anentitythatisincapableofgrowth,developmentandreproduction.

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ARTICLE3

ESSENTIALPRINCIPLESOFSAFETYAND

PERFORMANCEOFMEDICALDEVICE

MedicaldevicesshallmeettheessentialprinciplessetoutinAnnex1(EssentialPrinciplesofSafetyandPerformanceofMedicalDevices),asmaybeapplicable,takingaccountoftheintendedpurposeofthemedicaldeviceconcerned.

ARTICLE4

CLASSIFICATIONOFMEDICALDEVICES

(1)Medicaldevicesshallbeclassifiedintothefollowingfourclasses,inaccordancewithriskclassificationrulessetoutinAnnex2(RiskClassificationRulesforMedicalDevicesotherthanIVDDevices)andAnnex3(RiskClassificationRulesforIVDDevices):

ClassRiskLevel

ALowrisk

BLow-moderateriskCModerate-highrisk

DHighrisk

(2)Intheeventthatamedicaldevicemaybeassignedintotwoormoreclassesofmedicaldevices,theRegulatoryAuthorityoftheMemberStateshallassignthemedicaldeviceintosuchofthoseclassesasrepresentsthehighesthealthriskposedtoanend-userofthemedicaldevice.

(3)Intheeventthatamedicaldeviceisdesignedtobeusedincombinationwithanothermedicaldevice,eachofthemedicaldevicesshallbeclassifiedseparately.

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(4)Intheeventthemedicaldevicehastwoormoreintendedpurposes,themedicaldeviceshall,subjecttoparagraph3ofthisArticle,beassignedintoaclassofmedicaldeviceshavingregardtothemostcriticalintendedpurposeofthemedicaldevice.

(5)IntheeventofadisputebetweenaMemberStateand

anypersonintheclassificationofamedicaldevice,the

RegulatoryAuthorityofthatMemberStateshalldecideontheproperclassificationofthemedicaldeviceconcerned,whosedecisionshallbefinal.

(6)MemberStatethatreclassifiesordiffersinitsapplicationoftheclassificationrulessetoutinAnnex2(RiskClassificationRulesforMedicalDevicesotherthanIVDDevices)andAnnex3(RiskClassificationRulesforIVDDevices)shallnotify,withthereasonsthereof,totheASEANMedicalDeviceCommittee(hereinafterreferredtoas“AMDC”)tobeestablishedpursuanttoArticle14ofthisAgreement,ofsuchmeasurestaken.

ARTICLE5

CONFORMITYASSESSMENTOFMEDICALDEVICES

(1)Amedicaldevice,whichisrequiredtobeassessedbyaMemberStateandintendedtobeplacedonthemarketofthatMemberState,shallbeassessedbytheRegulatory

AuthorityofthatMemberState,oranyappointedbodiesrecognisedbythatMemberState,asthecasemaybe,forconformityandcompliancewithatleasttherequirementslaiddowninthisAgreementunlessthemedicaldevicehasbeenexemptedfromtherequirementforregistrationunderparagraph2ofArticle6.

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(2)MemberStatesshallputinplaceanappropriatesystemfortheconformityassessmentofmedicaldevicesasreferredtoparagraph1ofthisArticle.

ARTICLE6

REGISTRATIONANDPLACEMENTONTHEMARKET

(1)Amedicaldevice,whichisrequiredtobeassessedbyaMemberStateandhasbeenassessedbytheRegulatoryAuthorityofthatMemberStateoranyappointedbodiesrecognisedbythatMemberStatetobeinconformityandincompliancewiththerequirementslaiddowninthisAgreementmaybeplacedonthemarketofthatMemberState.

(2)AmedicaldevicetobeplacedonthemarketofaMemberStateshallberegisteredwiththeRegulatoryAuthorityofthatMemberState.TheRegulatoryAuthorityoftheMemberStatemayexemptcertainmedicaldevicesfromtherequirementforregistrationwhereappropriate.

(3)MemberStatesshallputinplaceanappropriatesystemfortheregistrationofmedicaldeviceswiththeRegulatoryAuthorityofthatMemberState.

(4)Custom-mademedicaldevicesshallnotbesubjectedtoproductregistrationrequirements.

(5)Notwithstandingparagraphs1and2ofthisArticle,theRegulatoryAuthoritiesofaMemberStatemay,pursuanttoadulyjustifiedrequestoronitsowninitiative,authorisetheusewithintheterritoryofthatMemberState,ofmedicaldeviceswhichhavenotundergoneregistrationwiththeRegulatoryAuthorityandwheresuchuseisintheinterestorprotectionofpublichealth.

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ARTICLE7

LICENSINGOFPERSONRESPONSIBLEFORPLACING

MEDICALDEVICESONTHEMARKETSOFMEMBERSTATES

EachMemberStateshallrequireapersonwhoisresponsibleforplacingmedicaldevicesonthemarkettobelicensedbytheRegulatoryAuthorityofthatMemberStatebeforethemedicaldevicesareplacedonthemarketofthatMemberState.MemberStatesshallputinplaceanappropriatesystemforthelicensingofpersonsresponsiblefor

placingmedicaldevicesontheirmarkets.

ARTICLE8

TECHNICALDOCUMENTSFORMEDICALDEVICES

MemberStatesshallundertakeappropriatemeasurestoadoptandimplementthefollowingcommontechnicaldocuments:

(a)Annex4-ASEANCommonSubmissionDossier

Template(CSDT);

(b)Annex5-PostMarketingAlertsSystem(PMAS)Requirements;and

(c)Annex6-HarmonisedsetofelementsforaProductOwner’sorPhysicalManufacturer’sDeclarationofConformity(DoC).

ARTICLE9

REFERENCETOTECHNICALSTANDARDS

(1)MedicaldeviceswhichconformtoeithertherelevanttechnicalstandardsrecognisedbytheAMDCorothertechnicalstandardsacceptedbytheRegulatoryAuthorityofaMemberStateforthemedicaldevicetobeplacedinthemarketofthatMemberStateshallbedeemedtocomplywiththeapplicableessentialprinciplesreferredtoinArticle3.

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(2)TheAMDCmayrevisebyconsensus,thelistofrecognisedtechnicalstandardsreferredtoinparagraph1ofthisArticle.

ARTICLE10

LABELLING

(1)AmedicaldeviceshallbelabelledinaccordancewiththerequirementsoftheMemberStatepriortoplacingonthemarketinthatMemberState.

(2)MemberStatesmaysetthelabellingrequirementsforamedicaldeviceinaccordancewithAnnex7(LabellingRequirements)orasdeemedappropriatebytheMemberStates.

(3)MemberStatesmaysettherequirementforhavingthelabelofamedicaldeviceintheirnationallanguages.

ARTICLE11

MEDICALDEVICECLAIMS

(1)MedicaldeviceclaimsshallbesubjecttoregulatorycontrolofMemberStates.

(2)Asageneralrule,claimedbenefitsofamedicaldeviceshallbejustifiedbysubstantialevidenceand/orbythemedicaldevicecomposition/formulation/componentorpreparationitselfinaccordancewiththerequirementsassetoutinAnnex1(EssentialPrinciplesforSafetyandPerformanceofMedicalDevices).

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ARTICLE12

POST-MARKETINGALERTSYSTEM

(1)MemberStatesshalltakethenecessarystepstoensurethatanyinformationbroughttotheirknowledge,inaccordancewiththeprovisionsofthisAgreement,regardingtheincidentsinvolvingamedicaldeviceasmentionedbelowisrecordedandevaluatedwhenappropriate:

(a)anymalfunctionordeteriorationinthe

characteristicsorperformanceofamedicaldevice,aswellasanyinadequacyinthelabellingortheinstructionsforusewhichmightleadtoormighthaveledtothedeathofapatientoruserortoaseriousdeteriorationinhisstateofhealth;

(b)anytechnicalormedicalreasoninrelationtothecharacteristicsorperformanceofamedicaldeviceforthereasonsreferredtoinsubparagraph(a),leadingtoproductrecallofmedicaldevicesofthesametypebytheproductowner,authorisedrepresentative,authoriseddistributororpersonresponsibleforplacingmedicaldeviceintothemarket.

(2)Aftercarryingoutanassessment,ifpossibletogetherwiththeproductowner,aMemberStateshallinformtheotherMemberStatesoftheincidentsreferredtoinparagraph1ofthisArticleforwhichrelevantmeasureshavebeentakenorarecontemplated.

(3)EachMemberStateshallrequirethatanyperson,whoisresponsibleforthemanufactureorplacingthemedicaldevicesonthemarketofthatMemberState,to:

(a)keepallrelevantrecordspertainingtothetraceabilityofthemedicaldevice,forsuchperiodandformatastheRegulatoryAuthorityintheMemberStatemaystipulate;

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(b)producesuchrecordsforinspectionwhenrequired

bytheRegulatoryAuthorityintheMemberState;

(c)informtheRegulatoryAuthority,withinthestatedprescribedtimeandformatoftheRegulatoryAuthorityintheMemberState,wherehebecomesawareofanyadverseeventthathasarisenorcanarisefromtheuseofthemedicaldeviceplacedonthemarketintheMemberState;and

(d)informtheRegulatoryAuthority,withinthestatedprescribedtime