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Types of Retrospective RWD for MDR Compliance | Makrocare

As EU MDR has already entered into force and will be applicable in May 2020, the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to clinical evidence and post marketing obligations on device companies in proportion with risk class and the type of device.

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Types of Retrospective RWD for MDR Compliance | Makrocare

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  1. TYPES OF RETROSPECTIVE RWD FOR MDR COMPLIANCE www.makrocare.com

  2. 1 RETROSPECTIVE - REACTIVEDATA As a part of quality management system, the device companiesroutinelycollect,maintainthisdatasuchas complaints, feedback, vigilance dataetc. This dataincludes: Information including feedback and complaints provided byusers Information about seriousincidents Records referring to non-serious incidents and data on undesirable sidee¬ffects Information and actions from trendreporting WWW.MAKROCARE.COM

  3. EMR & ChartReview: 2 RETROSPECTIVE- EMR, CHART REVIEW AND REGISTRIESDATA Thedevicecompaniescanobtainthisretrospectivedata from some of the physicians/ hospitals, based on the knowledgeoftheirdevicebeingused.Thisincludesdata already reported in EMR, hospital files and charts related to device safety, performance and effectiveness etc. This data includes clinical case records in the outpatient or inpatient service, registration entries, adverse event monitoring systems, investigation report filing systems and so on. It is not necessary that the device companies would need all the data reported in EMR or hospital files or charts, however, depending on the clinical evaluation need and gaps they need to address in providing clinical evidence for safety and performance,theycancollecttherelevantdatapoints. WWW.MAKROCARE.COM

  4. EMR & CHART REVIEW The only thing they need to pay attention to statistical significanceintermsofthenumberofpatients’datato havemeaningfulandconclusiveanalysis/resultsofthis data.Sometimesevenaggregatedatacanbehelpfulto fulfillthegapsrelatedtoclinicalevidence. Thefollowingdatapointswouldbeadequateto derive meaningful clinical evidence suchas: • Patient keydemographics, • Critical safety data points -AEs/ Seriousincidences • Device performance/eff¬ectiveness data points • Duration of followup/use • Any specific feedbacketc. WWW.MAKROCARE.COM

  5. DEVICE REGISTRIES DATA Device registries allow assessment of medical device performanceinareal-worldsetting.Registriescontain data on large numbers of patients receiving care in diverse clinical settings and capturing the clinical outcome over an extensive period. The registries data is also great sources of retrospective data; however, sometimes challenge could be identification of my deviceinthedata.However,ifitispossibletoidentify my device or predicate device, the data can be used e¬ffectively for clinical evidence. With the implementationofUDIsystem,deviceregistrieswould be great a source of retrospective data to assess long termoutcomes. WWW.MAKROCARE.COM

  6. DEVICE REGISTRIES DATA The following aspects of this retrospective patient data if addressed properly, the data can be used e¬ffectivelyingeneratingclinicalevidenceasperEU- MDR requirements, instead of planning any costly prospective clinicalstudy. • Identification device from EMR, insuranceclaims and registriesdata • Patient number – statistical significance • Needofmoregranularandproceduraldata • Adequate duration offollow up • Appropriateuseofdataintextformatsuchas surgicalnotes WWW.MAKROCARE.COM

  7. THANK YOU Read fullArticle www.makrocare.com WWW.MAKROCARE.COM

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