UDI Compliance Service

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1 UDI Cmpliance Service

2 What is UDI? The US Fd and Drug Administratin (FDA) has issued a ruling that medical devices must cnfrm t a Unique Device Identificatin (UDI) standard. The UK Department f Health (DOH) has als issued a NHS eprcurement strategy mandating that medical devices must cnfrm t a UDI standard. T cmply with UDI manufacturers must apply labels n medical devices that cntain a Unique Device Identifier (UDI) and submit a set f data t a central database. Why d yu need t take actin nw? If yur cmpany manufactures prducts that are sld either int the US Healthcare marketplace and/r the UK NHS, whether directly r via distributin, then achieving cmpliance is crucial t retain yur ability t cntinue selling yur prduct(s). With an average implementatin time f 6 mnths any cmpany nt engaging n UDI at an early stage may fail t meet the cmpliance deadlines set by the FDA and DOH. Hw will UDI affect my business? If yu fail t cmply yu will n lnger be able t sell yur prducts. Hw d I achieve cmpliance? Kdit has designed a cmpliance service that will help yu t: Achieve Initial Cmpliance Help yu Maintain Cmpliance Minimise the Impact n yur Business Minimise the cst t yur business. The Kdit cmpliance service is designed fr any manufacturer with a requirement t cnfrm t either the FDA r the UK UDI rule. We will guide yu thrugh every aspect f UDI cmpliance

3 UDI PROJECT PLAN FDA GUDID The quality f yur data is key Identify Cllect Cleanse Cntrl Submit Maintain UDI Terms FDA UDI FDA UDI Unique Device Identificatin UK NHS UDI GS1 Standards Prduct Identificatin Labeller Brand Owner DI FDA Device Identifier GTIN Glbal Trade Item Number Dynamic Data (PI) FDA Prductin Identifier(s) DI & PI = FDA UDI Dynamic Data (AI) Batch/Lt Number (10) Manufactured Date (11) Expiry Date (17) Serial Number (21) GS1 GTIN r GTIN & AI =UK NHS UDI

4 Identify Data needed fr each element ( aut ppulated) Translate each data element t yur cmpany language What/Where are the Data surces and surce systems If the data is available in an electrnic frmat Grup int level f accessibility Status Cunt Percentage Cmpleted- Knwn surce better specificatin needed. Knwn data surce date cleanup r ppulatin needed. Ptential data identified specificatin and data ppulatin needed N electrnic surce Aut ppulated 7 Ttal FDA GUDID 62 Cllect If data exists in multiple systems chse a unique surce Establish electrnic data surces where missing Make specificatin f data extract methd per data element Cllect data frm surce systems t ne repsitry Get IT resurces t supprt the data cllectin Establish a repsitry Create interface t surce systems Cleanse Identify data accuracy Identify the crrect value where multiple surces exist with different values Clean up redundant data Make sure yur data still supprts ther areas f yur daily business Establish data cmpleteness where data is missing

5 Cntrl Cntrl data by establishing data gvernance Define rules fr each data element Establish quality measurements Mnitr that data is maintained in the right way Incrprate data cntrl in daily peratins Quality cntrl system New prduct develpment prcedures Change cntrl prcedures Ensure knwledge in the rganisatin abut UDI in general Kdit Master Data (KDM) - Hw can it help yu? Establish ne single surce f truth Establish clear respnsibilities Prvide fcus n crrect data in the rganisatin Making data cnsistent Imprving data quality Making data accurate & cmplete Maximising the use f data t make decisins Kdit Master Data & UDI rles Regulatry Affairs Owner f regulatry data elements Develp prcedures & wrk instructins Get UDI int the different peratinal systems & dcuments Training in UDI requirements & data maintenance Verify data befre submissin Submit data t GUDID Supply Chain Management Owner f lgistics data elements Develp prcedures & wrk instructins Data cleansing Train users in data maintenance Establish tls t supprt data maintenance

6 Submit Chse submissin methd Web frm HL7 SPL Fr web frm submissin ensure manpwer fr data entry & validatin Fr HL7 SPL submissin ensure IT resurces & integrate t the system GUDID accunt The rles Labeller rganisatin Regulatry Cntact GUDID Crdinatr Data Entry Users Third-Party Submitters

7 GUDID accunt Rles & respnsibility Labeller rganisatin Represents the labeller s view f the highest crprate level. Headquarters DUNS Number Name and address must be crrect in the D&B DUNS database Regulatry Cntact Individual respnsible fr management f GUDID submissin requirements fr the labeller rganisatin Will be cntacted by FDA n matter pertaining t GUDID regulatry submissin requirements GUDID Crdinatr Assigned ne r mre labeller DUNS numbers Creates Data Entry user accunts Data Entry Users Respnsible fr data entry Respnsible fr data submissin Respnsible fr management f device identificatin infrmatin Third-Party Submitters Needed if submitting via external cmpany GUDID accunt Setting up the accunt Cmplete shrt frm n FDA UDI site and submit Cmplete lng frm received frm FDA Prvide Device Listing number f ne device Prvide infrmatin abut Regulatry Cntact and GUDID Crdinatr Prvide Labeller DUNS number Submit via UDI helpdesk

8 GUDID accunt - Setting up Data Entry Users Lg n as GUDID Crdinatr Chse Manage Accunts Chse Username Cmplete frm and save autmatically sent t user with lg-n details Maintain Overview f data element changes that triggers a new DI, e.g. Brand name Packing size Ensure knwledge in the rganisatin abut DI triggers Incrprate data maintenance in daily peratins Quality cntrl system New prduct develpment prcedures Change cntrl prcedures Ensure re-submissin when required

9 General Prject Organisatin What is yur charter? Wh are yur stakehlders? What is yur true deadline? What are yur csts? Hw d yu define success? What des being finished lk like? RESOURCES Hw d we identify the resurces? D we have enugh internal resurces? Hw d we secure them? Hw d we educate them? Data What d we need? Wh has it/wns it? What frmat is it in? Hw d we cnvert it? Hw/where will we stre it? Can we trust it? Sme Additinal Questins t Cnsider Is my cmpany already using a data pl t share prduct data cmmercially? What is my cmpany s IT expertise in the UDI requirements? What is my cmpany s expertise in GS1 Standards? Hw will my cmpany respnd t sharing data with third parties? (Legal, purchasing, regulatry, quality, cmmercial, IT) Wh will the FDA call at my cmpany if ur data des nt shw up in the GUDID n time?

10 Lessns Learned frm ur experience: UDI takes lnger than yu expect Start as sn as yu can even if all yu have is Class I devices Need t get yur strategy and apprach defined up frnt but break it int manageable chunks All data attributes will nt be in yur ERP Resurce cnstraints / cmpeting initiatives Building internal awareness is key A variety f functinal areas are invlved Participatin is key t repeatable, accurate prcesses Nt simply assigning a unique number Systems, custmers, publishing cnsideratins Bar cde / labelling requirements Crprate r glbal SOP develpment UDI isn t just a prject Crss functinal business prcess Onging business requirement A clear wner is nt always evident Senir leadership must wn the initiative Spnsrship and management are required Autmate as much as yu can UDI generatin Pulling inf electrnically fr label printing

11 FDA Cnfrming Amendments Part 803 Medical Device Reprting Part 806 Reprts f Crrectins and Remvals Part 810 Medical Device Recall Authrity Part 814 Premarket Apprvals Part 820 Quality System Regulatin Part 821 Medical Device Tracking Requirements Part 822 Pstmarket Surveillance Is There Truly a ROI with UDI? ROI Return n Investment A perfrmance measure used t evaluate the efficiency f an investment r t cmpare the efficiency f a number f different investments. ROI = (Gain frm Investment-Cst f Investment) / Cst f Investment Where is Ptential ROI? UDI creates a mre secure glbal distributin chain t address issues such as: Cunterfeiting Diversin f prduct Tracking - prvides standardized identifiers t better track devices & manage device recalls/adverse events Currently, I can lcate a jar f peanut butter in the supply chain easier than a catheter Efficiencies Where Are They Gained? Custmer Order: Reduce manual data entry time, cst & errrs Imprved data accuracy realizing a reductin in rder errrs

12 Utilizatin f data pls and electrnic transactins (EDI) Payment: Ensures accuracy with data fr AP and simplifies cntract administratin Supply Chain/Distributin Efficiencies: Imprves custmer fulfilment times Makes JIT pssible, resulting in lwer inventry carrying csts Inventry mre accurate as manufacturer and distributrs can ship the right amunt f prduct Accurate prduct identificatin and tracking alng the supply chain Use in distributin/warehuses t decrease lgistics expenses Faster re-labelling f returned/damaged gds Enables Deferment /Pstpnement Als knwn as Late Stage Labelling Perfrmed in multiple places Additinal labelling peratin in separate envirnment in prductin Warehuse either cmpany wned r third party lgistics site (knwn as 3PL) Lcal site labelling peratin Enables easier e-labelling

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