TUV培训教材（MDD修改）

NewDirective2007/47/ECamendingcurrentMedicalDirectives

Directive2007/47/ECamendingMDD,AIMDandBPD

Website:

Directive2007/47/ECamendingMDD,AIMDandBPD

2007/47/ECMDDAIMDBPD

Overview___

IssueDate(OJ):5September2007

200795

EnforcementDate:25September2007

2007925

Structure:

•Whereas'sectiondescribingthe32rationalforthechanges

implementedwiththisdirective

•6Articles6

2Annexes2

0、△TUVRheiniand'

.I^irsaMhfftapl*

Directive2007/47/ECamendingMDD,AIMDandBPD

Directive2007/47/ECamendingMDD,AIMDandBPD

2007/47/ECMDDAIMDBPD

Overview____

•Article44

—>establishesthetransitionperiods

•Article55

establishesthedatewhenthisdirectiveentersintoforce

•Article66

♦addressesthisdirectivetotheMemberStatesoftheEU

算△TUVAheinland*

Directive2007/47/ECamendingMDD,AIMDandBPD

Directive2007/47/ECamendingMDD,AIMDandBPD

2007/47/ECMDDAIMDBPD

Overview____

MainAreasofChange:

•DefinitionofMedicalDevice(Software)

•RetentionTimeofRecords

•ConformityAssessment(Applicability,lmple«nentation,etc.)

・ClinicalData>'ClinicalEvaluation

/

•OutsourcingControl(Virtualmanufacturer)

・EURepresentative

•CombinationDevices(MedicinalproductsandHumanbloodderivatives)

•TechnicalFileReview

△TUVRheinland'

IUQIM

Directive2007/47/ECamendingMDD,AIMDandBPD

Directive2007/47/ECamendingMDD,AIMDandBPD

thelaws,egulationsandadministrativeprovisionsnecessarytocomplywiththis

Directive.

TheyshallforthwithcommunicatetotheCommissionthetextofthosemeasures.

MDD

Directive2007/47/ECamendingMDD,AIMDandBPD

MedicalDeviceswhicharealsoconsideredMachineryhavetomeetthe

essentialhealthandsafetyrequirementsoftheMachineryDirectiveaswell.

e.g.X-Raysystems,CTScannerSystems,RoboticEquipment

Directive2007/47/ECamendingMDD,AIMDandBPD

2007/47/ECMDDAIMDBPD

Software____

•Whereas(6),:Softwareformedicalpurposesisamedicaldevice

•Whereas(20)':Validationofsoftware(standaloneor

incorporated)needstobevalidated.

Note:

However,Softwareforgeneralpurposeswhenusedina

healthcaresettingisnotamedicaldevices.

TUVRheinland

Directive2007/47/ECamendingMDD,AIMDandBPD

Softwareformedicalpurposesisamedicaldevice

Directive2007/47/ECamendingMDD,AIMDandBPD

2007/47/ECMDDAIMDBPD

DocumentRetentionTime___________

•Whereas(12)':

-Increaseofretentiontimetoatleast15years,inthecaseofImplants

15

Note:

Thisismoreinlinewithothercountriesregulations(e.g.JPAL

requiresalso15yearsretentiontimeforanumberofmedical

devicecategories).

15

区TUVRheiNand*

Directive2007/47/ECamendingMDD,AIMDandBPD

inthecaseofImplants

Directive2007/47/ECamendingMDD,AIMDandBPD

2007/47/ECMDDAIMDBPD

BorderlineProducts________

•Whereas(13)w:

-Whetherornotaproductfallsunderthedefinitionofamedical

device,itisintheinterestofnationalmarketsurveillanceandthe

healthandsafetyofhumanstoestablishaprocedurefor

decisiononwhetherornotaproductfallsunderthemedical

devicedefinition.

Note:

Furtherrevisionofguidancedocumentsexpected(e.g.MEDDEV)

MEDDEV

Ay△TUVRheinland'

Directive2007/47/ECamendingMDD,AIMDandBPD

Whetherornotaproductfallsunderthedefinitionofamedicaldevice,itisinthe

interestofnationalmarketsurveillanceandthe

establishaprocedurefor

Directive2007/47/EC,Art2&AnnexIIamendingMDD

2007/47/EC2IIMDD

Software____

Article1—Definitions-Added:

1

"medicaldevice**means...softwareincludingthesoftware

intendedbyitsmanufacturertobeusedspecificallyfor

diagnosticand/ortherapeuticpurposes...andnecessaryfor

itsproperapplication,...

△TUVRheinland,

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

includingthesoftware

Directive2007/47/EC,Art,2&AnnexIIamendingMDD

2007/47/EC2IIMDD

Software___

Summary:

Softwareisnowclearlydefinedasanactivemedicaldevice.

Interpretation:

Itdoesnotmatterwhetherthesoftwareisintegralwiththe

deviceorisastandaloneproduct.Softwarevalidationwill

alsobecomeanEssentialRequirement.

△TUVRhelnland,

Directive2007/47/EC,Art.2&AnnexIIamendingMDDSoftwareisnowclearly

definedasanactivemedicaldevice.

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

RetentiontimeofRecords_________

Summary：

♦Recordsmustberetainedfor5*years

•ButRecordsofImplantsmustberetainedfor154years

515

Interpr❷tatlon:

RecordsmustnowbemaintainedforInspectionbytheCompetent

AuthoritiesfortheLifetimeoftheproductor5yearsfromthelastdate

ofmanufacture,whicheverIslonger.

Forimplantabledevices,recordsneedtobekeptforatleast15years

fromthetimethelastproductwasmanufactured.

5

5

15

△TUVRheintend,

Directive2007/47/EC,Art.2&AnnexIIamendingMDDButRecordsofImplants

mustberetainedfor15+years

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

Outsourcina(controlofthirdparties)

Summary;

Outsourcedactivitieswithinscopeofthequalitymanagementsystemmust

bemorecloselymonitored

Interpretation:

tftheDesign,ManufacturingorFinalInspectionandTestingofadeviceisdone

byathirdparly,themanufacturermustdemonstratetoh・品adequatecontrolsIn

placetoensurethecontinuedefficientoperationofthesupplier'squalitysystem.

Note:ReferalsotoguidancedocumentsZLG3.9B16andB17.

TUVRheinland,

Pr«aM»vlU9*«

Directive2007/47/EC,Art.2&AnnexIIamendingMDDOutsourcedactivities

withinthescopeofthequalitymanagementsystemmust

Directive2007/47/EC,Art2&AnnexIIamendingMDD

2007/47/EC2IIMDD

Deuigndocumentation________

Summary;

CloserInspectionofdesigndocumentationduringaudits

Int❷rprohtlon:

NotifiedBodieswillberequiredtoperformaninspectionofdesign

documentationforarepresentativesampleofdevicesusingIndustry

standardstatisticaltechniquesandcommensuratewiththeriskofthe

device.

TUVRheinland

PvaoMfyfkglK

Directive2007/47/EC,Art.2&AnnexIIamendingMDDCloserinspectionof

designdocumentationduringaudits

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

Transparency-ReprocesslnaofMechcalDevics

Article12■-Reprocessing-New:

-12a^

ThecommissionshallsubmitareporttotheEuropeanParliamentand

totheCouncilontheIssueofreprocessingofmedicaldevicesinthe

Community,nolaterthan5September2010

201095

Thisreportmayincludeadditionalproposalstoensureahighlevelof

healthprotection.

△TUVRheinland,

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

ThecommissionshallsubmitareporttotheEuropeanParliamentand

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

Trwparency-R❷proc❷olMedicalDevic-

Article14-Registrationpersonsresponslblnforplacing

devl8sonth・market-P・mar»ph1・Amended:

14

ForallmedicaldevicesofclassesIla,libandIII.MemberStatesmay

requesttobeInformedofalldataallowingforIdentificationofsuch

devicestogetherwiththelabelandtheinstructionsforusewhensuch

devicesareputIntoservicewithintheirterritory.

IlalibIII

NEW:ClassIladevicesarecoveredunderthisrule.

Ila

△TUVRhelntend,

'PtrKMiVRiiota.

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

Registrationofpersonsresponsiblefbrplacing

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

Transparency-EuropeanDatabank

Article14-EuropeanDatabank-Paragraph1-Amended

14

DatatobestoredInaEuropeandatabaseaccessibletothe

competentauthoritiesnowalsohastoInclude:

Datarelatingtotheregistrationofauthorizedrepresentatives

•DatarelatingtoclinicalInvestigationsreferredtoInArticle15

-15

ATUVRheintand-

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

AmendedDatatobestoredinaEuropeandatabaseaccessibletothe

s

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

AddedProvisionsofarticle14ashallbeimplementednolaterthan

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

•Transparency-Confidentiality________

Article20-Confidentiality-Section3-Added

203

TheCommissionmay,Inaccordancewtththeprocedure

referredtoInarticle7(2),determinetheconditionsunder

whichotherinformationmaybemadepubliclyavailable,and

inparticularforclasslibandclassIIIdevicesanobligationlor

manufacturerstoprepareandmakeavailableasummaryof

theinformationanddatarelatedtothedevice.

72

libIII

©、△TUVRheinUnd(

Directive2007/47/EC,Art.2&AnnexIIamendingMDDTheCommissionmay,in

accordancewiththeprocedurereferredtoinarticle7(2,determinetheconditionsunder

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

Transparency-Cooperation________

Article20a-Cooperation-New:

20a

•TheCommissionshallprovidefortheorganizationofan

exchangeofexperiencebetweenthecompetentauthorities

responsibleformarketsurveillance…

WithoutprejudicetotheprovisionsofthisDirective,

cooperationmaybepartofinitiativesdevelopedatan

Internationallevel.

△TUVRheintend*

Directive2007/47/EC,Art.2&AnnexIIamendingMDDTheCommissionshall

providefortheorganizationofan

exchangeofexperiencebetweenthecompetentauthorities

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

•U»eError-600nomcF❷帆wes-Usab川tv

♦Whereas(18)':

AsdesignforpatientsafetyInitiativesplayanincreasingroleinpublichealth

policy...

•Needtoconsiderergonomicdesignintheessentialrequirements

•Emphasisontheleveloftrainingandknowledgeo!theuser,(suchasInthe

caseofalayuser)withintheessentialrequirements.

•Emphasisontheconsequencesofmisuseoftheproductand

itsadverseeffectsonthehumanbody.

△TUVRheinland'

&Might

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

initiativesplayanincreasingroleinpublichealth

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

•UseError-ergonomicFeature,-UsablUty

Internationalstandards&HarmonizedEurou❷anStandards

•EN60601-1-6:2004(harmonized)

Medicalelectricalequipment-Part1-6:General

requirementsforsafety-Collateralstandard:Usability

•19，

•IEC62366:2007(noharmonizedENstandardIssuedyet)

Medicaldevices-Applicationofusabilityengineeringto

medicaldevices

TUVRheinland,

Directive2007/47/EC,Art.2&AnnexIIamendingMDDInternationalstandards&

HarmonizedEuropeanStandards

Directive2007/47/EC,Art2&AnnexIIamendingMDD

2007/47/EC2IIMDD

TechnicalRie-relatedtoMDDAnnexII,III,V,VI

-MDDM,HLV,VI

Summnry:

TheTechnicalFilemustbeassessed.Detailsaredescribed

ineachConformityAssessmentProc❷dur・.

Interpretation:

ThenewDirectiveclwdystatesthattheNotifiedBodyhasto

reviewtheTechnicalFileofcertainClassesofMedical

DevicesforcertainConformityAssessmentschemes.

区TUVRhein1and,

Directive2007/47/EC,Art.2&AnnexIIamendingMDDTheTechnicalFilemust

beassessed.Detailsaredescribed

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnn”H-DeclarationofConformity(FullQMS)

MDDAnnexH------()

・Annex*・DeclarationConformity-Section2-Replaced:

...Thisdeclarationmustcoveroneormoremedicaldevicesmanufactured,clearly

Identifiedbymeansofproductname,productcodeorotherunambiguous

referenceandmustbekeptbythemanufacturer.

II——2—:

・Ann”M•QualitySystem-Section3-Amended:

QualitysystemshallIncludetypeandextendofcontrolappliedtothirdparties

(OutsourcedProcesses)

Note:ThisIsconsistentwithENISO13485:2003.Section4

:ENISO13485:20034

△TUVRheinland,

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

oneormoremedicaldevicesmanufactured,clearlymeansofproductname,product

codeorotherunambiguous

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnnexII-DeclarationofConformity(FullQMS)

MDDAnnexH------()

•AnnexH-Section4.3-Replaced:

Forcombinationproducts・・.Medicaldevicesincorporatingmedicinal

substances:

•NotifiedbodyhastoconsultoneoftheCompetentAuthoritiesOR

theEMEA(EuropeanMedicinesAgency)

II4.3：

EMEA()

Note:Upto210daystimefortheconsultationprocess.

：210.

△TUVRheiniand'

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

MedicaldevicesincorporatingmedicinalNotifiedbodyhastoconsultoneofthe

CompetentAuthoritiesOR

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnn”II-DeclarationofConformity(FullQMS)

MDDAnnexH------()

•AnrwnH-Section6.1一Replaced:

•ForImplantabledevicestokeeprecords/documentsfor15years

,/15

-Clarifiedwhichdocuments,dataandrecordstoberetained

«*

•AnnexH-Section6.3-Removed:

ConfusingParagraphremoved(termImporter**deleted)

("")

Note:LegalManufacturerorEURepresentativeresponsible.

：EU

&△TUVRheintand'

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

keeprecords/documentsfor15years

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnnexII-DeclarationofConformity(FullQMS)

MDDAnnexII------()

•AnnexII-Section7-ReoScM:

ApplicationtodevicesInclassIlaandlib...NotifiedBodyhasto

documentItsrationalforthesamplestakenandkeepHforCompetent

Authorities.

Ilalib...

Decisionshalltakeintoaccount::

-Noveltyofthetechnology

"Similaritiesindesign,technology,manufacturing,sterilization

，，，

-Intendeduse

-Resultsofpreviousrelevantassessments

Note:TCFreviewispartoftheCertificationAudit.

：TCF.

△TUVRheiniand*

"hreaMivlUgta

Directive2007/47/EC,Art.2&AnnexIIamendingMDDdocumentitsrationalfor

thesamplestakenandkeepitforCompetent

:TCF

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnnexM-ECTyp・Ex・mlnaHon(TypeT”l)EC()

•AnnexIM-Section3-Replaced:

-IntendedUsetobedocumented

-Useofhumanbloodderlvatestobedocumented

-Useoftissuesofanimalorigin(Directive2003/32EC)tobedocumented

(2003/32/EC)

-SolutionstomeetAnnexItobedocumented

I

-Pre-clinicalevaluationandClinicalEvaluationtobedocumented

(Su△TUVRheinUnd,

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

keeprecords/documentsfori5years(after

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnnexIV-ECV,rWiC4BHon(SampleYtHnq)EC(

•AnnexIV-Section7-Replaced:

Forimplantabledevicestokeeprecordsdocumentsfor15years

(afterlastproducthasbeenmanufactured)

/15(

•AnnexIV-Section9-Replaced:

AreferencetothelatestDirective2001/83/ECregardingmedicinal

productsisgiven

2001/S3/EC,.

△TUVRheintend'

4RlQflt

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

keeprecords/documentsfor15years

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnnexV&VI-DOC(Production&ProductQMS)

MDDAnnexV&VI—OOC()

•AnnexV&VI-Section32-IndentAdded:

QualitysystemshallIncludetypeandextendofcontrolappliedtothird

parlies(OutsourcedProcesses)

()

•AnnexV-Section4.2-IndentAdded:

TechnicalDocumentationhastobemadeavailabletotheNotifiedBody

forSurveillanceAssessment

•AnnexV&VI-Section5.1-Replaced:

ForImplantabledevicestokeeprecords/documentsfor15years

(afterlastproducthasbeenmanufactured)

/15(

△TUVRbeinUnd'

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

Qualitysystemshallincludetypeandextendofcontrolappliedtothird

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnn・xVVVI-DOC(Production&ProductQMS)

MDDAnnexV&VI-OOC()

•AnnexV&VI-Section6-Replaced:

ApplicationtodevicesinClassIla...

NotifiedBodyhastodocumentItsrationalforthesamples

takenandkeepItforCompetentAuthorities.

Ila...

DecisionshalltakeIntoaccount:

-Noveltyofthetechnology

"Similaritiesindesign,technology,manufacturing,sterilization

，，，

-Intendeduse

-Resultsofpreviousrelevantassessments

区TUVRheimand*

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnn”VII-DeclarationofConformity__________

•AnrwxVII-Section[&2_Replactd;

ForimplantabledevicestokeepRecordsDocuments/DOC

for15years(afterlastproducthasbeenmanufactured)

15

•AnnexVII-Section3-Amended:

-IntendedUsetobedocumented

•SterilisationValidationReportstobedocumented

-SolutionstomeetAnnexItobedocumented

I

-PrzllnlcalevaluationandCllnlcaiEvaluationtobedocumented

Ai△TUVRheiniand

rnIU0M

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

15

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnn”VII-DeclarationofConformity__________

Summary:

ClassIs(Sterile)andClassIm(Measuring)devicesmaynow

chooseAnnexIIwhichmeansthatmanufacturerwillhavemore

flexibilitytoselect■routetocomplianceastheywillbegiven

theoptiontoselectafullqualityassuranceconformity

assessmentmodule(•speciallyusefulIfmakingmedical

devicesbelongingtodifferentriskclasses).

IImII

△TUVRheinland,

Directive2007/47/EC,Art.2&AnnexIIamendingMDDchooseAnnexIIwhich

meansthatmanufacturerwillhavemore

Directive2007/47/EC,ArtJ&AnnexIIamendingMDD

2007/47/EC2IIMDD

MDDAnnexVIII-Devi8slorSpec间Purppg*________________

AnnexVIM-Section2.2-Amended:

"Theclinicalinvestigationplan

-TheInvestigator'sbrochure

-TheconfirmationofInsuranceofsub|ects

-Thedocumentsusedtoobtainconsent

-AstatementIndicatingifdevicecontainsbloodderivatestissuesof

animalorigin

Note:ApplicablefordevicesintendedforclinicalInvestigation.

•区TUVRheintond'

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

•MDDAnnexVHI-Device，forSoeckUPurposes

•AnnexVIM-Section4-R❷placed:

ForimplantabledevicestokeepDocumentsfor15years

15

•Anne*VIH-Section5-Added:

Reviewofpost-productionphaseandobligationforIncident

reportingadded

Note:Applicableforcustom-madedevices.

△TUVRheinland

PrscatfyRtQht

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

keepDocumentsfor15years

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

•MDDAnnexIX-Clag刖cation__

•Newappllcattonrute(section26):Durationofuse(transient,shortterm,longterm)

hastobecalculatedonthecumulativeuseofthesameoranIdenticaldevice.

Immediatereplacementisseenasextensionofcontinuoususe.

(addedtoChapter2.Section2)

2.6

Rule5_Invasivedevices:

AdditiontoIntroductoryphrase(section2.1):Allinvasivedevices,

...,...orwhichareIntendedforconnectiontoanactivemedical

deviceinClassl:N...

5

鲁、区TUVRheinland*

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

Durationofuse(transient,shortterm,longtermhastobecalculatedonthe

cumulativeuseofthesameoranidenticaldevice.

Immediatereplacementisseenasextensionofcontinuoususe.

Directive2007/47/EC,Art.2&AnnexIIamendingMDD

2007/47/EC2IIMDD

•MDDAnnexIXClass阳"Hon___

Rule13-Combioationde