The New European Medical Device Regulation And The Unique

2.3 General Obligations of Manufacturersand other ActorsBased on article 10, manufacturers of medical devices shallhave systems in place for quality (paragraph 2) and riskmanagement (paragraph 9) as well as systems to cover financialresponsibility for harm which might be caused by defectivedevices (paragraph 16). Manufacturers should also apply aconformity assessment procedure (paragraph 6) and conductclinical evaluations (paragraph 3). The MDR also redefines therequirements for the technical documentation(paragraphs 4 and 8) including the manufacture of custom-builtdevices (paragraph 5) and the manufacturer’s responsibilitiesfor devices in the field (paragraphs 12-14). Necessaryinformation for the identification of suppliers shall also bestated (paragraph 15). In further paragraphs of article 10,additional obligations are defined, like the commitmentsconcerning the UDI- (paragraph 7) or market surveillancesystem (paragraph 10). Also, the need for informationavailability in different languages (paragraph 11) as well asthe compensation in case of damage (paragraph 16) arementioned.6Essential legal acts and documentsfor the implementation of theMDR are still missing.To date, there is no sufficient numberof notified bodies that have successfully completed the necessaryaccreditation.To date, there are no harmonisedEuropean standards against whichnotified bodies can check theconformity of medical devices.Source: egram/76EUR-Lex (05.05.2017): Verordnung (EU) 2017/745. i uriserv:OJ.L .2017.117.01.0001.01.DEU(access on 10.07.2019)

Beyond the obligations listed in article 10, furthercommitments are defined, like the need to assign responsibilityfor regulatory compliance to one person (article 15).Manufacturers of implantable devices shall also providean implant card to patients, containing information aboutimplanted medical devices (article 18). Obligations of thirdparties like authorized representatives (article 11), importers(article 13) and distributors (article 14) are also defined in detail.After fulfilling all the obligations, a declaration of conformityshall be provided by the manufacturer (article 19) and thedevices need to be marked with a CE label (article 20).6As assistance, the European Commission published animplementation model for the medical device regulation. Itserves as a step-by-step guide including 12 steps (see Fig. 2)with further underlaying actions.Fig. 2. Implementation model for the medical device regulation9Pre-assessmentGap Analysis andAction Resultingfrom thisOngoingMonitoringQualityManagementSystem (QMS)Notify BodySubmissionReview Efficiencyand EffectivenessStep-by-Step Guide forImplementationof the MedicalDevices RegulationExecute erImplementationPlanRegulatoryTrainingNotified Bodies Capgemini 20196EUR-Lex (05.05.2017): Verordnung (EU) 2017/745. i uriserv:OJ.L .2017.117.01.0001.01.DEU (access on 10.07.2019)European Commission d (20.07.2018): Step-by-step implementation model for Medical Devices Regulation. ss on 10.07.2019)98

2.4 Changes Made by the New IVDRMost of the requirements listed above also apply to in vitrodiagnostic medical devices e.g. more stringent requirementsfor the designation of notified bodies, involvement of anindependent expert panel for highest risk devices, introductionof UDI or the increased transparency due to usage of theEUDAMED. But there are also regulations that only apply to9in vitro devices. Firstly, IVDR defines rules to assign each invitro device to one risk class between A (lowest risk) and D(highest risk). As a result, more than 85% of all devices have tobe tested by a notified body in future, instead of 15%. The newregulations bring more stringent requirements for conformityassessment and clinical evidence. Devices classified as classD (high risk devices) will require the involvement of an EUreference laboratory (if available for that type of device).1010European Commission e (09.08.2018): Factsheet for manufacturers of in vitro diagnostic medical devices. ss on 10.07.2019)

3.0 Unique Device IdentificationA unique identification system for medical devices is currently a global undertaking that will improve patient safety,facilitate medical device innovation and enhance PMS11.GS1 a: Unique Device Identification (UDI). https://www.gs1.org/industries/healthcare/udi (access on 10.07.2019)1110

3.1 Background of Unique DeviceIdentificationidentifier allows the grouping of medical devices with similarfeatures within the EU regulatory database. The submissionof a product for market registration and/or approval to thecompetent authority assumes that the assignment was done bythe medical device manufacturer or authorized representative.In 2013, the International Medical Device Regulators Forum(IMDRF) released a guide intended to globally harmonizedevice identification12. The regulatory frameworks of the USand the EU, two of the biggest markets for medical devices,follow these guidelines, although there are some discrepanciesbetween the two systems regarding UDI data submissionrequirements/terminology as well as UDI labeling.3.2 UDI FormatIn order to develop a UDI, device labelers need to contact oneof the issuing agencies accredited by the FDA or the EuropeanUnion. The accredited agencies are GS1, HIBCC (Health IndustryBusiness Communications Council) and ICCBBA (InternationalCouncil for Commonality in Blood Banking Automation).As for the US UDI system, it is currently in the final phase ofimplementation. According to the UDI Rule, the device labelers- typically the manufacturers - are requiredto: A UDI itself is a unique alphanumeric or numeric code(see Fig. 4) that consists of a:include a UDI on device labels andpackages (except where exceptions oralternatives are allowed); in the casethat a device is intended to be usedmore than once and intended to bereprocessed before each use, the devicelabeler is also required to mark the UDIdirectly on the device.submit device information to the GlobalUnique Device Identification Database(GUDID).MDR and IVDR determine the legal requirements for theEuropean UDI system. The UDI data must be provided on theEUDAMED database. The European UDI system will be phasedin successively as scheduled (see Fig.3), in a similar way to theUS approach. Depending on the medical risk class, all marketeddevices shall have a unique identifier by 26 May 2027. device identifier (DI): a mandatory, fixed segment thatidentifies the labeler and the specific model or version of adevice, following an identification standard such as GTIN production identifier (PI): a conditional, variable segmentthat identifies one or more of the following pieces ofinformation when part of the label of a device: lot or batch number serial number expiration date manufacturing date distinct identification code (for a human cell, tissue, orcellular and tissue-based product (HCT/P) regulated asa device)It is the device labeler’s duty to provide the UDI in twoforms on packages and labels. It consists of an easilyreadable plain text format and a machine-readable formatthat uses Automatic Identification and Data Capture (AIDC)technology.Contrary to the US FDA regulation, a new identifier – the BasicUDI-DI - has been introduced by the EU regulations. This new26 SeptClass III201426 SeptClass II20152016IVDRMDREuropeanCommissionFDA 21 CFRFig.3: Timetable of UDI application dates26 MayMD Class III26 MayIVD Class D26 MayIVD Class B&C26 MayMD Class II26 MayMD Class I26 MayIVD Class A26 SepClass I20172018201920202021202220232024202520262027 Capgemini 20191112MedTech Europe b (01.2019): UDI System in the US and in the EU – Mapping of 90128 EU-US Differences-in-the-UDI-requirements.pdf (access on 10.07.2019)

3.3 Capturing of UDI Related DataUDI-related information can be captured in different ways.For small and medium-sized companies with limited numbersof devices that need to be registered, a lightweight solutionmight be sufficient. However, with an increasing number ofitems, software support is advisable. By using a workflowmanagement software, users can be guided through the datacapturing process which usually results in increased efficiencyand productivity. At the same time, software solutions can helpto avoid false data entries by validating the user’s input.3.4 Submission of Device InformationAs for EUDAMED, there are three ways planned to enter anddownload data: manual data entry through the application semiautomatic XML upload/download machine2machineThe last option signifies that data will automatically betransmitted between an external system and EUDAMED.Regarding the most appropriate way to transmit data, theEuropean Commission provides a guideline to consider relevantparameters such as volume of data, frequency of transmissionetc.13In the US, device information needs to be submitted to theGUDID. For that, the FDA provides two options: manual data entry by using the web application HL7 SPL file submission using the FDA ElectronicSubmissions GatewayThe first option offers the possibility to submit single DI recordsmanually by using the GUDID web application online. The latterenables the submission of DI records in bulk as XML files thatare compliant with Health Level 7 (HL7) Structured ProductLabeling (SPL).The GUDID does not include the PI but rather the DI as the keyto obtaining device information from the database, togetherwith a standard set of basic identifying attributes for eachdevice with a UDI.Fig. 4 UDI Labeling (Adapted from GS1)14Static:Device identifier (DI) Dynamic:Production Identifier (PI) UDIMachine readableHuman 51(21)1234GTINManufact.DateExpirationDateLot. NoSerial No Capgemini 201913European Commission f (29/05/2019): Eudamed Data Exchange Guidelines. ss on 10.07.2019)GS1 b: Unique Device Identification (UDI). cess on 10.07.2019)1412

4.0 Capgemini’s ApproachCapgemini helps companies to adhere to the stringent regulations of the European Union and the FDA, to staycompetitive and relevant in the market. Capgemini’s MDR and UDI structured approach encompasses a strategy for endto-end MDR & UDI compliance and predefined roadmap execution.1312

4.1 Service PortfolioCapgemini offers a unique and diversified service portfolioconsisting of the following (see Fig. 5):Our approach delivers profound sector expertise combiningdepth of knowledge and comprehension of the areas affected byMDR to provide customers with extensive benefits.With the support of more than 200 regulatory submissionsand after having aided more than 30 product categories intheir development, Capgemini has been gaining experiencewith medical devices and in health care for more than 17 years.Hence, Capgemini is accurate in identifying the changes of deviceclassifications, can enable product compliance and certificationby partner ecosystems and is able to reduce time consumptionby achieving compliance with templates for MDR impactassessment and process maps.Capgemini also offers business accelerators like the “AcceleratedSolution Environment” (ASE) or the global platform “AppliedInnovation Exchange” (AIE) for exchange, networking andexecution. Their major advantage is to facilitate the quickdevelopment of business solutions and the alignment ofstakeholders to solve even complex business problems. Methodslike rapid ideation, design thinking and hackathons support thesolution-finding process and generation of results. In general, theworking culture and particularly the working methods betweendifferent functional areas are improved.As a part of Capgemini, idean – our global strategic design arm –best embodies Design Thinking capabilities to rapidly innovate ina customer-centric way. They are able to create high-value digitalproducts and services to unlock customer value and marketopportunity for medical device and healthcare companies.Capgemini brings together deep domain and technologyexpertise for the digital as well as the physical world of productsand is ready to support the medical device industry in achievingcompliance effectively and efficiently. Capgemini ensures thatmedical device companies launch their products in accordancewith the new guidelines of the European Union.Fig. 5 Capgemini’s Service PortfolioLabeling and UniqueDevice Identification (UDI)New Requirement: Product Labeling& Content ManagementPost Market Surveillance (PMS)More stringent requirements forPMS activitiesDevice Re-classification‘Essential Requirements’ replacedby ‘General Safety & PerformanceRequirements (GSPR)’ ProductCompliance & RemediationCapgemini’sServicePortfolioClinical EvaluationTechnical DocumentationNew Requirement: DHF Creation& RemediationMore stringent requirements forclinical data: Clinical EvaluationReporting (CER) Capgemini 201914

4.2 Case Studies UDI4.3. 1st Case Study MDRThe following outlines challenges facing the customer andCapgemini’s solution approach as well as issues already tackledand benefits. Capgemini supports the reinforcement ofprocedures regarding UDI management for internal collaboratorsand external partners.Capgemini developed a roadmap for the implementation of MDRat a medical device company in Europe.4.2.1 Brief Description of the ProjectIn this project, Capgemini ensured that regulatory relevant dataprinted on product labels was also included in the customer’sproduct master data and transferred to governmentaldatabases.The cross-functional data gathering affected variousdepartments and processes. Workflow management softwarewith BPM functionality to prepare, document and facilitate thepublication of medical device data was used to create the UniqueDevice ID Management for the customer. To ensure complianceand transparency, the customer reinforced its proceduresregarding UDI management for internal collaborators andexternal partners.4.2.2 Issues Faced during the ProjectIn 2020, the customer needs to transmit the basic UDI-DI andrelated product data to regulatory agencies. But knowledgewithin the company about required information for submissionwas scarce and no electronic process for capturing UDI relatedinformation was established. In addition, the infrastructure tosave the relevant information was not available.4.3.1 Brief Description of the ProjectFor this project, Capgemini facilitated the communicationbetween the different workstreams at the customer’s site andthe MDR program manager. Capgemini provided guidance on theproject plan and ensured that the workstreams were activatedand engaged. Work stream integration and coordination ensuredmeeting the deadlines and achieving the milestones. Theworkstreams involved included: Within the scope of project monitoring, reporting and control,Capgemini: 4.2.3 Solution ProvidedCapgemini introduced a browser-based solution integrated intothe customer’s material master creation process. A three-stepapproach for UDI record creation was provided:1.2.3.initiation of the creation of a legislation-based UDI manually,process triggered or automaticallydata capture by different data ownersrecord approval incl. digital signatureThe UDI record was automatically saved in SAP MDG and theUDI was embedded into the product re-launch process withbulk creation.4.2.4 BenefitsThe solution increased the process efficiency and productivityof the customer’s company. It also improved the controlover process executions, response time and process delivery.Furthermore, the process visibility was enhanced, and humaneffort reduced, resulting in time and cost savings. The result wasa more scalable, flexible, consistent and reliable UDI creationsystem.15the clinical & post market clinical follow-upvigilance & Post Market Surveillance (PMS)labelingintroduction for use of hazardous substancesUDI and EUDAMEDportfolio and technical documentationorganizationcommunicationchange management conducted a comprehensive gap assessment of the currentprocess and technical documentation affected by the newMDR requirementsformed an understanding of the business impact includingproject execution, remediation, and potential organizationaland operating model changesdeveloped a pragmatic 3-year roadmap to enable thecustomer to achieve and maintain long-term regulatorycompliance with the MDR.4.3.2 Issues Faced during the ProjectSince different business units were responsible for differentparts of the workflows, the exchange of information washindered. Further issues were the prioritization of tasks andmilestones which led to deadlines not being met. The customeralso struggled with a lack of robust Standard OperatingProcedures (SOPs).

4.3.3 Solution ProvidedCapgemini identified a point of contact for all businessunits involved to facilitate communication and exchange ofinformation between different workstreams. Regular weeklyfollow-ups and touchpoint meetings were introduced to reviewopen tasks and deliverables. The meetings were preparedby workstream owners ensuring project deliverables werecompleted and on time.The repository for MDR project documents was updatedregularly with meeting minutes, MDR guidance and projectrelated documents. Various project management trackingand estimation tools specific to different work streams weredeveloped, including the following:1.2.Tracking tools: for gap assessments on labels and Instructions for Use(IFUs) to track the coverage of various items indicatedas per the new MDR from a process perspective for MDR product classifications to track the progress ofproduct classification changes as per MDR for technical file documentations to track product wisetechnical file sections tracked against their existingformat (electronical/physical)Resource estimation tools: for clinical affairs to estimate resources based onpriority of CER completion, kick-off meeting, literaturesearch/review, compilation of source data activities for PMS to estimate resources based on planning andreporting hours of a PMS, PSUR and PMCF report for workstream roadmaps to track the milestone

the new regulations will officially be applied (see Fig. 1). Given their broadened scope and increased complexity, the new MDR regulations pose a significant compliance challenge to medical device companies. Among the most complex are: focus on life cycle management more extensive requirements for