MedTech Regulatory Insights August 2025

MedTechRegulatoryInsightsAugust2025

REGULATORY RADAR

Team-NBClariesSoftwareQualicationunderIVDR

Team-NBreleasedanupdatedpositionpaperclarifyingwhensoftwarequalifiesasanIVDunderRegulation(EU)2017/746 Theguidance highlightsstandalonesoftware,intendedpurpose,anddiagnosticfunctionalityaskeycriteria ItaimstoharmonizeNotifiedBodies interpretationsandsupportconsistentconformityassessmentdecisions,particularlyforborderlinecases ReadthePostionPaper(PDF)

OrphanIVDDevicesGetNBAttention

Team-NBhaspublisheditsfirstpositionpaperfocusedonorphanIVDs emphasizingregulatoryflexibilityfordiagnosticstargetingrarediseases Itacknowledgestheuniquemarket,economic,andclinicalconstraintsfacedbymanufacturersandcallsforproportionateapproachesduring conformityassessment ThisdocumentencouragesdialogueonbalancingaccessandregulatorycomplianceundertheIVDR ReadthePostionPaper(PDF)

EUAddsNewExpertPanel&ClariesAdminRules

TheEuropeanCommissionadoptedImplementingDecision 2025/1324toupdateadministrativeelementstiedtoexpert panelsundertheMDRandIVDR Thedecisionimproves clarityarounddocumentationhandling responsetimelines andconsultationprocesses Italsoformalizesthecreationof anadditionalexpertpanelinthemedicaldevicesectorto supportefficientevaluations

ReadtheOcia Decison(PDF)

SingaporeHSARevisesChangeNoticationGuidance(GN-21,Rev.6)

HSAreleasedRevision6ofGN-21 updatingitsguidanceonchangenotificationforregisteredmedicaldevices Itincludesclearerdefinitionsof majorandminorchanges,illustrativeexamples,andnewdecision-makingflowcharts Therevisionhelpsregistrantsassesswhetherachange requiresnotification,enhancingregulatorypredictabilityandcomplianceforSingapore’sdevicemarket ViewtheGuidance(PDF)

India’sCDSCOPublishesSubjectExpertCommittee(SEC)Guidance India’sCDSCOpublishedguidancedescribingtheoperationsofSubjectExpert Committees(SECs) whichreviewhigh-riskandinnovativemedicaldevices

ThedocumentoutlinesSECcomposition submissionexpectations timelines andevaluationprinciples ThismovebringsgreatertransparencytoIndias regulatoryprocessandhelpsmanufacturersunderstandSECinvolvementin pre-submissionandreviewstages AccesstheGuidance(CDSCOsite)

FDALaunchesRegulatoryAcceleratorforDigital HealthInnovators

TheFDAintroducedtheRegulatoryAccelerator aninitiative tosupportdigitalhealthdevelopersnavigatingUS regulatorypathways ItcompilescuratedFDAresources tailoredtosoftware-baseddevices coveringsubmission prep qualityexpectations andreviewprocesses Thetoolis especiallyusefulforstartupsseekingfastermarketentry withcompliant,high-qualitysubmissions ExploreRegulatoryAccelerator

BostonScienticLaunchesAVVIGOGuidanceSystem

BostonScientifichasintroducedtheAVVIGO+Multi-ModalGuidanceSystem,designedtooptimizepercutaneouscoronaryintervention(PCI) The systemintegratesIVUS FFR andco-registrationcapabilitiestoprovidehigh-resolution real-timeimagingandphysiologicaldata enablingmore precisediagnosisandtreatmentofcoronaryarterydisease TheintuitiveinterfaceimprovesworkflowefficiencyduringPCIprocedures ExploreAVVIGO+

MedLumicsHitsMilestonewithAblaViewPFASystem

MedLumicsannouncedthat10patientshavebeentreatedinitsFirst-in-ManclinicaltrialfortheAblaViewPulsedFieldAblation(PFA)System The systemfeaturesreal-timevisualguidance,enhancingprecisionincardiacablationforatrialfibrillation Theannouncementfollowsleadership changes withanewCEOandBoardMembersteeringinnovation

Readthefulrelease

AITechforBreastCancerRiskGetsFDABreakthroughStatus

WashingtonUniversityresearchershavereceivedFDABreakthroughDeviceDesignationforanAI-basedbreastcancerriskpredictiontool The modelanalyzesmammogramdataandpatientrecordstopredictcancerlikelihoodwithgreateraccuracy particularlyforunderservedpopulations

Thisinnovationmayenableearlierdetectionandmorepersonalizedscreeningstrategies

Learnmore

ArterialCannulaRecall:EdwardsLifesciencesActsonWireExposureRisk

EdwardsLifesciencesrecalledspecificarterialcannulasduetoadefectthatmayexposeinternalwires,riskingvesselinjury TheFDAclassified thisasaClassIrecallduetothepotentialforseriousharmduringcardiacprocedures

FDArecallnotce

EarlyAlert:BaxterFlagsInfusionPumpMalfunction

Baxterissuedanearlywarningaboutinfusionpumpissuesthatcouldcauseinaccuratedosing Thepotentialmalfunctionmayresultinover-or under-infusion Usersareurgedtomonitordevicescarefullyandfollowinterimsafetyinstructions

FDAalert

CranialDrillRecall:RiskofDeviceDisassembly

IntegraLifeSciencesrecalledCodmanDisposablePerforatorsduetoriskofdisassemblyduringcranialprocedures ThisClassIrecalladdresses potentialpatientharmorsurgicaldisruptioncausedbythedrillheaddetachingfromtheshaft

FDArecalldetails

StaplerCartridgeCorrection:LockoutIssuePromptingFieldFix

EthiconEndo-SurgeryissuedacorrectionforEndopathEchelonstaplercartridgesduetounintentionallockoutsmid-surgery Thoughnotaformal recall,affectedlotsmustbereviewed,andnewhandlingguidancefollowed Noinjuriesreported

FDAcorrectionnotice

ASKTHEEXPERT

WhilepreparingClinicalEvaluationReport(CER)fortheCEmarkingofabloodglucosemonitoringsystem(ClassIIadevice)thatusesaglucose, howdoyoudeterminethecorrectclinicalevaluationroute?

Considerations for route of evaluation:

1 ClinicalEvaluationBasedonExistingData(Article61(10)ofMDR)

Ifthedevicetechnologyisalreadyclinicallyvalidatedinsimilardevices,existingclinicaldata(eg,publishedstudies)canbeusedtodemonstrate safetyandperformance

2 ClinicalEvaluationBasedonNewClinicalInvestigations(Article61(1)ofMDR)

Ifthedeviceintroducesnewfeatures clinicalinvestigationsmustbeconductedtogatherfreshsafetyandperformancedata ForallclassIII devicesandfortheclassIIbdevicesitismandatory

Forabloodglucosemonitor chooseOption1ifthesensoriswell-established Option2ifthesoftwareisinnovative

TRIVIA

PHAvs.FMEAinMedicalDeviceRiskManagement

Didyouknow?PreliminaryHazardAnalysis(PHA)andFailureModesandEffectsAnalysis(FMEA)arebothusedinmedicaldeviceriskmanagement butatdifferentstagesandfordifferentpurposes PHAistypicallyappliedearlytoidentifybroadsystem-levelhazards,whileFMEAdigsinto specificfailuremodesduringdesignandproduction

Areyouabletodifferentiatebetweenthetwo?

Letsdecodethisfurtherinourlatestpost

VisittheTriviaPostonLinkedIn

GujaratMedicalExpowillconvenetop-tiermedicalprofessionals innovators andindustryplayerstospotlightadvancementsindiagnostics medicaldevices,andhealthcareinfrastructure TheeventpromotescollaborationandgrowthwithinIndiasMedTechlandscape 13–15September2025| VigyanBhavan Ahmedabad India Registerhere

9thAnnualMedicalDeviceRegulatoryandQualitySummit2025

Thissummitwillgatherregulatoryexperts,qualityleaders,andMedTechprofessionalstodiscussIndiasevolvingregulatoryframework,global harmonization,clinicalevaluations,andpost-marketobligations Amust-attendforRA/QAprofessionals 21–22August2025|PridePlazaHotel Aerocity NewDelhiAirport

Eventdetals

Conclusion:

Thecorrectclinicalevaluationroutedependsonthedevicesriskclass novelty legacystatusandclinicalevidenceavailability guidingthe approvalprocessinalignmentwithMDRArticles61andMDCGrecommendations

Read further:

https://wwwlinkedincom/posts/neujin

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