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presents
UniqueDeviceIdentification(UDI):What&HowwithinoverallMedicalWhat&HowwithinoverallMedical
DeviceValueChain
ByJimPetragnani
PlanningandImplementationoftheMedicalDeviceRegulation(UDI)
2015MakroCare.AllRightsReserved. www.makrocare.com
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AboutMakroCare
AwardsYear
Established
Over15yearsofLifeSciencesCoreConsultingexperience
GlobalAccess ClientsEmployeesProprietary
Frameworks/Tools
1996(HQ:NJ USA)
p y
650+FTEs140+ C lt t
Frameworks/Tools
NAVAVistaar
(HQ:NJ,USA)Privatelyheld
14Global Offices 8 of Global Top 20
140+ Consultants RIMtrackjarTreeTULAClinMetanoiamNAAMGlobalOffices 8 ofGlobalTop20
150+Small/MidlevelmNAAMmEDCmIRT
22015MakroCare.AllRightsReserved. www.makrocare.com
ISO 9001 ISO 14155ISO 27001 ISO 20000
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AboutMakroCare
MedicalDevicePractice
Regulatory Compliance
RegulatoryIntel&RegulatoryStrategyDevelopment
AdvisorySupportandRoadmapConsulting Biocompatibility Assurance cases Testing
Qualitymanagementsystemconsultingandimplementation
SOPsandQualityManualDevelopmenth d d d h Biocompatibility,Assurancecases,Testing
requirements
RegulatoryWritingandSubmissionsDevelopment(510k,PMA,,TechnicalFiles,DHF,etc.)
EstablishmentRegistrationandProductListing
ThirdPartyAuditsandOversight SystemsandUtilitiesValidation DesignControl RiskManagement
ClinicalDevelopment PostMarketSupport
ClinicalStrategy,StudyDesigningandmanagement
Monitoring(Central/Onsite) Clinical Data Management, Stat, Analysis,
PostmarketFollowUpStudies(RegulatoryandMarketing)
Scientific/Medicaladvisory MDR / Annual Reports / Supplements
32015MakroCare.AllRightsReserved. www.makrocare.com
ClinicalDataManagement,Stat,Analysis,Writing
eClinical technology
MDR/AnnualReports/Supplements
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MakroCares Approach
Design>Implement>Train>Transferg p
UDIComplianceSolution
C lti d Ad i
Phase1:Design
Phase2:Implement
Phase3:Report
ConsultingandAdvisorySupportfromSerialization,SupplyChainandComplianceExperts
SourceDataIdentification
DataMappingSOPandProcedure
PlanDevelopment Implementation
Guidance
Implementation
DatabaseSetupMigration/Integration Initial work volume Initialworkvolumemanagement
DataQualityandComplianceteam
42015MakroCare.AllRightsReserved. www.makrocare.com
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MakroCares Approach
Design>Implement>Train>Transferg p
UDIComplianceSolutionPhase3:Phase1: Phase2:
l ReportDesign Implement
HL7SPLUDIxmltoolWebBased/OnpremiseGenerateXMLFDASubmissions
ManageSubmissionLifecycle
EasytoUse IntegrateddashboardPayasperuseOngoing development forOngoingdevelopmentforglobalcompliancerequirements
Part11Compliant
52015MakroCare.AllRightsReserved. www.makrocare.com
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presents
UniqueDeviceIdentification(UDI):What&HowwithinoverallMedicalWhat&HowwithinoverallMedical
DeviceValueChain
ByJimPetragnani
PlanningandImplementationoftheMedicalDeviceRegulation(UDI)
2015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
St 1 D l i th UDI li lStep1.DevelopingtheUDIcomplianceplan
1. Briefseniormanagementonprojectscopeandprovideresourcerequirementswithcost
2. Receiveseniormanagementprojectapproval
3. Buildtherightteammemberswhoarededicatedandhavetherightcomplementof
product/processknowledge
4. Defineclearroles,accountabilitiesandresponsibilities
5. UnderstandtherequirementsoftheMedicalDeviceRegulation
6. Engageinanapproachthatwillconfirmassumptionsearlyandallowforjointagreed
adjustmenttotheplan
7. Evaluatethesupplychainbusinessprocesses
8. Producegapassessmentandgenerategapfindingsandconclusions
9. Prepareforinnovativeandsustainablechangetothegoforwardenvironment monitor
publications
10. Planandprovidethatproductexpertsenableknowledgetransfer
11. DevelopaplanforChangeManagement
72015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
St 2 U d t di th M hi R d bl T h lStep2.UnderstandingtheMachineReadableTechnology
1. Thatnumberonthemedicaldevice,It'snotjustanumber....Itmeanssomething
2. Standardproductidentifier
3. Reachouttotheglobalcommunity
4. Benefittothemedicalcommunity
5. Bettertraceability
6. Expediterecalls
82015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
St 3 Ch M tStep3. ChangeManagement
1. Createcompellingstoryorbusinesscase
2. Buildateamwhoarefullycommittedtothechangeinitiative
3. Createthevision
4. Communication,Communication,Communication
5. Startwith"shortterm"wins
92015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
St 4 Ri k A t k i th t il f f t hStep4. RiskAssessmentkeepingthesystemagileforfuturechanges
1. Proactivelyidentifyandmanagerisks
2. AssessLabelingchanges GlobalPackaging
3. SupplyChaincontinuityplanning
102015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
St 5 I l t ti f UDI l th l h iStep5. ImplementationofUDIplanacrossthevaluechain
1. Reviewwithprojectteamkeypointsofrequirement
2. Identifytherepresentativeproductsforassessments
3. Buildimplementationroadmap,resourcingincludingcost
4. Identifylowimpactproductdeviceforimplementationaspilotproject
5. Presentimplementationrecommendationsandvalidatewithstakeholders
6. Parallelprocesslowimpactproductdevice
7. Evaluateandcommunicateresultsof"pilot"product
112015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
St 6 Id tif i th d t f FDA tiStep6. IdentifyingthedatasourcesforFDAreporting
1. DevelopUDIdatasourcemap
2. DevelopUDIdatabaseforFDAReporting
3. SubmitinformationtoFDAwhichwillbeusedtopopulatetheUniqueDevice
IdentificationDatabase(GUDID)
122015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
C li D t
1yearafterpublicationofthefinalrule(September24,2014)
ThelabelsandpackagesofclassIIImedicaldevicesanddeviceslicensedunderthePublicHealthServiceAct(PHSAct)mustbearaUDI. 801.20.Datesonthelabelsofthesedevicesmustbeformattedasrequiredby 801.18.Dataforthesedevices
ComplianceDates
mustbesubmittedtotheGUDIDdatabase. 830.300.A1yearextensionofthiscompliancedatemayberequestedunder 801.55;sucharequestmustbesubmittednolaterthanJune23,2014.ClassIIIstandalonesoftwaremustprovideitsUDIasrequiredby 801.50(b).
2yearsafterpublicationofthefinalrule(September24,2015)
Thelabelsandpackagesof implantable,lifesupporting,andlifesustainingdevices mustbearaUDI. 801.20.Datesonthelabelsofthesedevicesmustbeformattedasrequiredby 801.18.
AdevicethatisalifesupportingorlifesustainingdevicethatisrequiredtobelabeledwithaUDImustabear UDI as a permanent marking on the device itself if the device is intended to be used more than oncebearUDIasapermanentmarkingonthedeviceitselfifthedeviceisintendedtobeusedmorethanonceandintendedtobereprocessedbeforeeachuse. 801.45.StandalonesoftwarethatisalifesupportingorlifesustainingdevicemustprovideitsUDIasrequiredby 801.50(b).
D t f i l t bl lif ti d lif t i i d i th t i d t b l b l d ith UDIDataforimplantable,lifesupporting,andlifesustainingdevicesthatarerequiredtobelabeledwithaUDImustbesubmittedtotheGUDIDdatabase. 830.300.
132015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
C li D t (C t )
3yearsafterpublicationofthefinalrule(September24,2016)
ClassIIIdevicesrequiredtobelabeledwithaUDImustbearaUDIasapermanentmarkingonthedeviceitselfifthedeviceisadeviceintendedtobeusedmorethanonceandintendedtobereprocessedbeforeeachuse.801.45.
ComplianceDates(Cont.)
ThelabelsandpackagesofclassIImedicaldevicesmustbearaUDI. 801.20.Datesonthelabelsofthesedevicesmustbeformattedasrequiredby 801.18.ClassIIstandalonesoftwaremustprovideitsUDIasrequiredby 801.50(b).
DataforclassIIdevicesthatarerequiredtobelabeledwithaUDImustbesubmittedtotheGUDIDqdatabase. 830.300.
5yearsafterpublicationofthefinalrule(September24,2018)
AclassIIdevicethatisrequiredtobelabeledwithaUDImustbearaUDIasapermanentmarkingonthedeviceitselfifthedeviceisadeviceintendedtobeusedmorethanonceandintendedtobereprocessedbeforeeachuse. 801.45.
The labels and packages of class I medical devices and devices that have not been classified into class I class II orThelabelsandpackagesofclassImedicaldevicesanddevicesthathavenotbeenclassifiedintoclassI,classII,orclassIIImustbearaUDI. 801.20.Datesonthelabelsof all devices,includingdevicesthathavebeenexceptedfromUDIlabelingrequirements,mustbeformattedasrequiredby 801.18.
DataforclassIdevicesanddevicesthathavenotbeenclassifiedintoclassI,classII,orclassIIIthatarerequiredtob l b l d h b b d h d b belabeledwithaUDImustbesubmittedtotheGUDIDdatabase. 830.300.ClassIstandalonesoftwaremustprovideitsUDIasrequiredby 801.50(b).
7yearsafterpublicationofthefinalrule(September24,2020)
ClassIdevices,anddevicesthathavenotbeenclassifiedintoclassI,classII,orclass IIIthatarerequiredtobelabeledwithaUDI,mustabearUDIasapermanentmarkingonthedeviceitselfifthedeviceisadeviceintendedto be used more than once and intended to be reprocessed before each use 801 45
142015MakroCare.AllRightsReserved. www.makrocare.com
2020) tobeusedmorethanonceandintendedtobereprocessedbeforeeachuse. 801.45.
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UDI:PlanningandImplementation
UDI f t b FDA A dit d I i AUDIformatsbyFDAAccreditedIssuingAgency
This document contains information and links related to the format of the unique device identifier (UDI) for each FDAaccredited issuingagency. Each FDAaccredited issuing agency has a unique UDI format that has been approved by FDA during the initial accreditationprocess. Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation. Please contact theissuing agency directly to obtain a UDI and for any additional questions regarding the creation or implementation of the formatsissuing agency directly to obtain a UDI and for any additional questions regarding the creation or implementation of the formats.
Please note that standards development organizations that are helping to promote standard adoption of UDI in electronic health informationare currently working on recommendations for UDI representation and transmission. When available, links to these documents will be availableat the UDI webpage: www.fda.gov/udi
GS1IssuingAgency
IssuingAgency
DataDelimiters
Identifier DatatypeHumanReadable
DatabaseField SizeAgency Delimiters
FieldSizeFieldSize
GS1 (01) DI Numeric 16 14
GS1 (11)Manufacturing/ProductionDate numeric[YYMMDD] 8 6
GS1 (17) ExpirationDate numeric[YYMMDD] 8 6
GS1 (10) Batch/LotNumber alphanumeric 22 20
GS1 (21) SerialNumber alphanumeric 22 20
GS1 MaximumBaseUDI alphanumeric 76 66
152015MakroCare.AllRightsReserved. www.makrocare.com
ex:(01)51022222233336(11)141231(17)150707(10)A213B1(21)1234
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UDI:PlanningandImplementation
H lth I d t B i C i ti C il (HIBCC) I i AHealthIndustryBusinessCommunicationsCouncil(HIBCC)IssuingAgency
IssuingAgencyDataDelimiters
Identifier DatatypeHumanReadableFieldSize
DatabaseFieldsize
HIBCC + DI Alphanumeric 7to24 6to23HIBCC $ LotNumberOnly Alphanumeric 19 18HIBCC $$7 LotNumberOnly(alternativeoption) Alphanumeric 21 18
HIBCC $$ ExpirationDatefollowedbyLotNumber ExpDate:numeric[MMYY] 6 4
LotNumber:alphanumeric 18 18
HIBCC $$2 ExpirationDatefollowedbyLotNumber ExpDate:numeric[MMDDYY] 9 6
LotNumber:alphanumeric 18 18
HIBCC $$3 ExpirationDatefollowedbyLotNumber ExpDate:numeric[YYMMDD] 9 6
LotNumber:alphanumeric 18 18
HIBCC $$4 ExpirationDatefollowedbyLotNumber ExpDate:numeric[YYMMDDHH]
11 8
LotNumber:alphanumeric 18 18
HIBCC $$5 ExpirationDatefollowedbyLotNumber ExpDate:numeric[YYJJJ]JulianDateformat
8 5
b l h i 8 8LotNumber:alphanumeric 18 18
HIBCC $$6 ExpirationDatefollowedbyLotNumber ExpDate:numeric[YYJJJHH]JulianDateformatwithHouroption
10 7
LotNumber:alphanumeric 18 18
$ l b l l h
162015MakroCare.AllRightsReserved. www.makrocare.com
HIBCC $+ SerialNumberonly Alphanumeric 20 18
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UDI:PlanningandImplementation
H lth I d t B i C i ti C il (HIBCC) I i A (C t )
IssuingAgency DataDelimiters Identifier DatatypeHumanReadableFieldSize
DatabaseFieldsize
HealthIndustryBusinessCommunicationsCouncil(HIBCC)IssuingAgency(Cont.)
HIBCC $$+7 SerialNumberonly(alternativeoption) Alphanumeric 22 18
HIBCC $$+ ExpirationDatefollowedbySerialNumber ExpDate:numeric[MMYY] 7 4
SerialNumber:alphanumeric 18 18
HIBCC $$+2 ExpirationDatefollowedbySerialNumber ExpDate:numeric[MMDDYY] 10 6
SerialNumber:alphanumeric 18 18
HIBCC $$+3 ExpirationDatefollowedbySerialNumber ExpDate:numeric[YYMMDD] 10 6
SerialNumber:alphanumeric 18 18
HIBCC $$+4 ExpirationDatefollowedbySerialNumber ExpDate:numeric[YYMMDDHH]
12 8
SerialNumber:alphanumeric 18 18
HIBCC $$+5 ExpirationDatefollowedbySerialNumber ExpDate:numeric[YYJJJ] 9 5
SerialNumber:alphanumeric 18 18
HIBCC $$+6 ExpirationDatefollowedbySerialNumber ExpDate:numeric[YYJJJHH] 11 7
SerialNumber:alphanumeric 18 18
HIBCC /S SupplementalSerialNumber,wherelotnumber Alphanumeric 20 18also requiredandincludedinmainsecondarydatastring
HIBCC /16D ManufacturingDate(supplementaltosecondarybarcode)
numeric[YYYYMMDD] 12 8
HIBCC MaximumBaseUDI Alphanumeric 70to87 58to75Ex of Human Readable Barcode: +H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C
172015MakroCare.AllRightsReserved. www.makrocare.com
ExofHumanReadableBarcode:+H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ456789012345678/16D20130202C
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UDI:PlanningandImplementation
I t ti l C il f C lit i Bl d B ki A t ti (ICCBBA) I iInternationalCouncilforCommonalityinBloodBankingAutomation(ICCBBA)IssuingAgency
HumanReadable Database
IssuingAgency DataDelimiters Identifier DatatypeReadableBarcodeFieldSize
DatabaseFieldSize
ICCBBA =/ DI Alphanumeric 18 16
ICCBBA =, SerialNumber Alphanumeric 8 6
ICCBBA = DonationIdentificationNumber Alphanumeric 16 15
ICCBBA => ExpirationDate numeric[YYYJJJ] 8 6
ICCBBA =} ManufacturingDate numeric[YYYJJJ] 8 6
ICCBBA &,1 MPHOLotNumber Alphanumeric 21 18
ICCBBA MaximumBaseUDIforHCT/Ps Alphanumeric 79 67
ExofHumanReadableBarcode:=/A9999XYZ100T0944=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123
182015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
I t ti l C il f C lit i Bl d B ki A t ti (ICCBBA) I iInternationalCouncilforCommonalityinBloodBankingAutomation(ICCBBA)IssuingAgency(Cont.)
Eye Readable DatabasBloodBagsOnly
IdentifyingSymbol
Identifier DatatypeEyeReadableBarcodeFieldSize
DatabaseFieldSize
ICCBBA =) DIforbloodcontainers(bags) Alphanumeric 12 10
ICCBBA &)LotNumberforbloodcontainers(bags) Alphanumeric 12 10
ICCBBAMaximumBaseUDIforBloodBags Alphanumeric 24 20ICCBBA Bags Alphanumeric 24 20
ExofHumanReadableBarcode:=)1TE123456A&)RZ12345678
192015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
UDI I i A iUDIIssuingAgencies
1.FirmName: GS1Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648Address: PrincetonPikeCorporateCenter,1009LenoxDrive,Suite202,Lawrenceville,NJ08648ContactPerson: SiobhanOBara,SeniorVicePresident IndustryEngagementPhone: (609)6208046Email: [email protected]: http://www.gs1.orgDateofInitialAccreditation: December17,2013Initial Accreditation Granted through: December 17 2016InitialAccreditationGrantedthrough: December17,2016
ApplicationApprovalLetterInformationonUsingtheGS1SystemforUDIRequirements
2.FirmName: HealthIndustryBusinessCommunicationsCouncil(HIBCC)Address: 2525E.ArizonaBiltmoreCircle,Suite127,Phoenix,AZ85016ContactPerson: RobertA.Hankin,PhD.,PresidentandCEOPhone: (602)3811091Email: [email protected] b Sit htt // hib
3.FirmName: ICCBBAAddress: POBox11309,SanBernardino,CA924231309ContactPerson: PatDistler,TechnicalDirectorPhone: (909)7936516Email: [email protected] b Sit htt // i bbWebSite: http://www.hibcc.org
DateofInitialAccreditation: December26,2013InitialAccreditationGrantedthrough: December26,2016
ApplicationApprovalLetter
WebSite: http://www.iccbba.orgDateofInitialAccreditation: February12,2014InitialAccreditationGrantedthrough: February12,2017
ApplicationApprovalLetter
202015MakroCare.AllRightsReserved. www.makrocare.com
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UDI:PlanningandImplementation
P j t Ti liProjectTimeline
Week1
Week2
Week3
Week4
Week5
Week6
Week7
Week8
Week9
Week101 2 3 4 5 6 7 8 9 10
EnterpriseProgramManagementOffice
N R l i C liNewRegulationCompliance
TASKORACTIVITY TIMELINED l i h UDI li Pl W k 1 W k 2DevelopingtheUDIcompliancePlan Week1 Week2
IdentifyingthedatasourcesforFDAReporting Week3 Week4
UnderstandingtheMachineReadableTechnology Week5
Change Management Plan Week 6ChangeManagementPlan Week6
RiskAssessmentRegister Week7
ImplementationofUDI Week7 10
212015MakroCare.AllRightsReserved. www.makrocare.com
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Contact:Contact:
JimPetragnani andAaryak JoshiJ g y J
+19734810100extn 3043
www.makrocare.com
OneWashingtonPark,Suite1303,Newark, 07102,NJ(USA)
2015MakroCare.AllRightsReserved. www.makrocare.com
(USA)