1 / 13

Medical Device Regulation: Implications for Medical Device Manufacturers.

Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.<br>Learn More: https://www.pepgra.com/device-manufacturers/<br>

pepgra
Download Presentation

Medical Device Regulation: Implications for Medical Device Manufacturers.

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. NEWMEDICALDEVICE REGULATION: ImplicationsforMedical DeviceManufacturers TAGS:  Pepgra | MedicalDeviceReporting | MedicalDevice  Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  2. BACKGROUND TheimplementationofthenewMedicalDeviceRegulations (MDR) on25thMay, 2017 haspresentedmedicaldevicemanufacturerswithseveraldrasticchangesinthe decadesoldregulatoryframeworkoftheEuropean Union (EU). ThenewMDRhaseffectivelyreplacedthepreviousmedicaldevicedirective (93/42/EEC) oftheEUandalsothedirectivesrelatingtoactiveimplantablemedicaldevices (90/385/EEC). ThenewMDRofferedmedicaldevicemanufacturerswithalreadyapproveddevicesin themarketwithacompliancetimeofthreeyearstill26thMay, 2020. Forcertainmedicaldevicemanufacturers, thenewMDRofferedextratimefollowing thedateofapplicationwhichenablesthemtoprovidenewproductstothemedical devicemarketforamaximumextendedtimeoffouryears. However, inthiscase, extra requirementswouldbeapplicableforthisadditionalperiodoftransition. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  3. ObjectiveoftheNewMDR ThekeyobjectivesofnewMDRtomakeatwodimensionalimpactinenhancingthe safetyofmedicaldevices (LaegeMiddleStyrelsen, 2019) are: Reinforcingtherulesassociatedwithplacingnewmedicaldeviceswithinthemarket. Increasingsurveillancepostthedevice’savailabilityinthemarket. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  4. ImplicationsoftheNewMDRfor MedicalDeviceManufacturers The new MDR warrants the need for conclusive and hard evidence that is based on data for existing as well as new medical devices (Lehmann, 2019). Implications are: Setup systems for managing quality and risk. Consistently gather clinical evidence for their devices following its market release, to validate the effectiveness as well as safety of the device. Provide data reports on a new Centralized Electronic System which will be easily available to the public. Be responsible for determining devices that requires reclassification and those that require additional review by a notified body. Setup systems that encompass their financial obligations in the event of unwarranted harm that arises from a defective device. With the new MDR in force, the objective is to reinforce the rules associated with clinical investigation of medical devices, with a view to improve the availability of valid clinical information. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  5. ChallengesforMedicalDevice Manufacturers Medicaldevicemanufacturersareexpectedtoaffectsubstantialalterationsinterms ofquality assurance, productdevelopmentanddatareporting. EnforcementofthenewMDRwouldmeanhighercostimplicationsandextended timerequiredfornewproductdevelopment. Theprocessofclinicalmonitoringandgatheringevidenceforrecertificationof existingproductscouldalsoprovetobeanexpensiveproposition. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  6. FOURKEYCHALLENGES POSSEDBYNEWMDR POSESFORMEDICAL DEVICEMANUFACTURERS Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  7. Majormodificationswillbeeffectedtotheclassificationof medicaldevices. Inthiscase, requirementswouldbelargelyevaluatedbased onriskitpresentstopatients. Forinstance, specificdevicesthatwillbeusedonspinalcord willmoveuptheorderfromclassIItoclassIII. RECLASSIFICATION  Asaprocess, reclassificationofdeviceswillhavetoundergo expensiveprocessofcertificationfornewproductsandalso recertifyingproductsthatarealreadyinthemarket. ThefocusofthenewMDRwouldshiftfromapprovalof producttoitswholelifecycle, warrantinghigherclinical assessmentpriortoapproval. Thiswouldnodoubtsubstantiallyslowdowntheproduction ofmedicaldevices. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  8. HighClinicalTestingNeeds Anotherkeychallengethatmanufacturersareconfrontedwithpertainstotheincreaseinrequirementsfor clinicaltesting. Owingtoreclassification, manufacturersinthepastwhowerenotrequiredtoexecuteclinicaltesting, now needtobeabletodoso. Newregulationsalsonecessitateareevaluationofclinicaldatapertainingtodevicesthatalreadyexistinthe market. Intheeventthatthedatadoesnotmatchthenewrequirements, medicaldevicesneedtobeputthrough additionaltestingforrecertification. Thisfurtheraugmentsthecostofsustaining legacy devices. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  9. HighDemandforNotified Bodies Notifiedbodies (NBs) actedasconsultantsinfacilitatingmedicaldevicemanufacturerstoadheretothe requirementsforCEmarkings. WiththeenactmentofthenewMDR, NBswillassumetheroleofenforcerswhowillassessallmedicaldevices (otherthanIVDs), thosethatfallaboveclassI. TheshortageofNBstoevaluatedevices, specificallyindevicesclassesthatareofhigherrisk, willleadtoadelay inapprovalforproductsandslowtheentryofadeviceintothemarket. TimelinesareboundtobeincreasedconsideringthatNBshaveahugevolumeofdatatoreview. Thisinturn, wouldtendtoincreasecostsonthewhole. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  10. SignificanceonPost-Market Surveillance UnderthenewMDR, muchstressisbeinglaiduponpost-market surveillance. Thiswouldcompriseofpreemptivemonitoringoftheperformanceof medicaldevicesforyearlysafetyupdatesfordevicesfallinginthehighrisk class, recertificationandpromptreportingofincidentsconcerningdevice safety. Thiskindofintensemonitoringandreportingforsafetyrequiresadditional resourceswhichwouldprovetobeastrainformedicaldevicemanufacturers. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  11. Compliance ThenewMDRpresentssomedisruptivechangesthathavefarreachingimplicationsformedicaldevicemanufacturers. Withthetransitionperiodalmostatend, thereareseveralmodificationsthatdevicemanufacturersneedtoenforceto ensuresuccessofexistingandnewdevices. TheextentandintricacyofthechallengepresentedbythenewMDRwouldrequiredevicemanufacturerstobringabout substantialchangesindomainsasvastas; datareporting, productdevelopment, manufacturingproceduresandquality assurance. TocomplywiththenewMDR, devicemanufacturerscanstrategizeandconductagapanalysistoidentifywhethertheir existingdevicescomplywiththenewMDR. ExcellentleadershipisvitaltofacilitatethesmoothtransitiontothenewMDRwhiledevelopingastrategyforexecution thatcomprisesofpresettimelinesandtechniquestomonitorprogresswithregardstocompliance. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  12. Medicaldevicemanufacturerscouldsetupacoreleadershipteamthatwouldincludeexpertsfromqualityassurance,Medicaldevicemanufacturerscouldsetupacoreleadershipteamthatwouldincludeexpertsfromqualityassurance, clinicalormedicalaffairs, R & D, regulatoryaffairs, manufacturing, labeling, biocompatibility, sterilizationand marketing. MembersoftheteamneedtoestablishanactivecommunicationwithNBswhilesettingprojectharmonization betweenproductportfoliosandbusinessunits (PremierResearch, 2019). Ontheotherhand, medicaldevicemanufacturersareapproachingexternalentities (ContractResearchOrganizations) toacquiresupportandguidancetoensurecompliance (Lehmann, 2019). Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

  13. GETINTOUCH WITHUS ContactUs Freelancer Consultant EMAIL ADDRESS sales@pepgra.com Guest Blog Editor PHONE NUMBER EMAIL ADDRESS +919884350006 +44- 7424810299 hr@workfoster.com Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

More Related