PD CEN_TR 17223-2018 Guidance on the relationship between EN ISO 134852016 (Medical devices文档格式.docx
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PD CEN_TR 17223-2018 Guidance on the relationship between EN ISO 134852016 (Medical devices文档格式.docx
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TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices.
Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.
Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.
©
TheBritishStandardsInstitution2018
PublishedbyBSIStandardsLimited2018
ISBN9780580519123
ICS03.100.70;
11.040.01
CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.
ThisPublishedDocumentwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31March2018.
Amendments/corrigendaissuedsincepublication
Date Textaffected
CEN/TR17223
March2018
Documentd'
orientationsurlarelationentre1'
ENISO
13485:
2016(Dispositifsmedicaux-Systemesde
managementdelaqualite-Exigencesadesfins
reglementaires)etleReglementeuropeenrelatifaux
dispositifsmedicauxainsiqueleReglementrelatifaux
dispositifsmedicauxdediagnosticinvitro
LeitfadenzumZusammenhangzwischenENISO
2016(Medizinprodukte-
Qualitatsmanagementsysteme-Anforderungenfur
regulatorischeZwecke)unddeneuropaischen
VerordnungenuberMedizinprodukteundIn-vitro-
Diagnostika
TECHNICALREPORT
RAPPORTTECHNIQUE
TECHNISCHERBERICHT
Englishversion
GuidanceontherelationshipbetweenENISO13485:
2016
(Medicaldevices-Qualitymanagementsystems-
Requirementsforregulatorypurposes]andEuropean
MedicalDevicesRegulationandInVitroDiagnostic
MedicalDevicesRegulation
ThisTechnicalReportwasapprovedbyCENon12February2018.IthasbeendrawnupbytheTechnicalCommitteeCEN/CLC/JTC3.
CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommitteesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,FormerYugoslavRepublicofMacedonia,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandUnitedKingdom.
CEN-CENELECManagementCentre:
RuedelaScience23,B-1040Brussels
Ref.No.CEN/TR17223:
2018E
2018CEN/CENELECAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembersandforCENELECMembers.
2018(E)
Contents Page
EuropeanForeword 3
Introduction 4
1 Scope 7
2 Normativereferences 7
3 Termsanddefinitions 7
4 RelationshipbetweentheEuropeanRegulationsforMedicalDevicesandinvitroDiagnostic
MedicalDevicesandtheclausesofENISO13485 7
7
EuropeanForeword
Thisdocument(CEN/TR17223:
2018)hasbeenpreparedbyTechnicalCommitteeCEN/CLC/JTC3,"
Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices”,thesecretariatofwhichisheldbyNEN.
Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.
Introduction
ThisTechnicalReporthasbeenpreparedtoprovideguidanceontherelationshipbetweenENISO13485:
2016[Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes)andtherequirementsintheEuropeanRegulationsonMedicalDevices(MDR)-Regulation(EU)2017/745-andinvitroDiagnosticMedicalDevices(IVDR)-Regulation(EU)2017/746.
ENISO13485describesaqualitymanagementsystemthatisapplicabletomedicaldevicesandisintendedforregulatorypurposes.TheEuropeanRegulationsformedicaldevicesandENISO13485presentholisticrequirementsforsystematicapplicationofaprocessapproachtoqualitymanagementintowhichanorganizationcanincorporateregulatoryrequirementsthatareapplicabletoitsactivities.Astherequirementsareintegratedandbuildoneachother,alltherequirementsapplicabletotheorganizations’activitiesandtheapplicableregulatoryrequirementsneedtobeapplied.Itisnotintendedthatrequirementsareimplementedinisolationfromthecompletesystem.WhilethisTechnicalReportdescribestheinterrelationshipofindividualparagraphs,orpartsofaparagraph,oftheRegulationswithparticularsubclausesofENISO13485,thisisnotintendedtoimplythatthesesubclausescanbeimplementedintheabsenceoftheentirequalitymanagementsystemdescribedinthestandard.
ThisTechnicalReportfocusesonthegeneralobligationsofthemanufacturer(Article10)andtheconformityassessmentrequirements(AnnexesIXandXI)oftheEuropeanRegulationsforMedicalDevicesandinvitroDiagnosticMedicalDevices.CompliancewithallthenormativeclausesinENISO13485willensurethataprocessisinplacetoaddressqualitymanagementsystemaspectsrelatedtomedicaldevices,whichareincludedinArticle10andAnnexesIXandXIoftheRegulations.
Generally,itisnotmeaningfultolinkindividualclausesofENISO13485tospecificgeneralsafetyandperformancerequirements(AnnexI).TheGeneralRequirementsinChapter1ofAnnex1,however,relatetotheapplicationofriskandtherequirementsforthemanufacturertoimplementariskmanagementsystem.AsthegeneralobligationofthemanufacturerinArticle10requirestheimplementationofariskmanagementsystemandENISO13485requiresprocessesforriskmanagementinproductrealization,therelationshipsbetweenChapter1inthegeneralsafetyandperformancerequirementsandthecorrespondingsubclausesofENISO13485:
2016areincludedinthisTechnicalReport.SpecificdetailsofariskmanagementsystemformedicaldevicesareprovidedinENISO14971.
ThescopeofENISO13485indicatesthatthestandardcanbeappliedby:
— organizationsinvolvedinoneormorestagesofthelife-cycle,includingdesignanddevelopment,production,storageanddistribution,installation,orservicingofamedicaldeviceanddesignanddevelopmentorprovisionofassociatedactivities(e.g.technicalsupport),and
— suppliersorexternalpartiesthatprovideproduct,includingqualitymanagementsystem-relatedservices,tosuchorganizations.
Assuch,ENISO13485maybeappliedbyothereconomicoperatorsinthesupplychainsuchasauthorizedrepresentatives,importers,distributorsorassemblersofsystemsorprocedurepacks.Consequently,ENISO13485canalsosupportmeetingtheregulatoryobligationsforauthorizedrepresentatives(Article11),Importers(Article13),Distributors(Article14)orassemblersofsystemsorprocedurepacks(MDRArticle22).
However,becausethisisanadoptionofaninternationalstandard,intendedtobeapplicableinjurisdictionsallovertheworld,itisnottheprimarygoalofthestandardtocoverexactlytheEuropeanqualitymanagementsystemrequirements.Therefore,forallofthequalitymanagementsystemrequirements,conformityisnotentirelyachievedbycomplyingonlywiththerequirementsspecifiedinENISO13485.ManufacturersandconformityassessmentbodieswillneedtofeedthequalitymanagementsystemrequirementsintheapplicableEuropeanRegulationintotheprocessesprovidedbyENISO13485.
Forexample,Article15oftheEuropeanRegulationsdefinespecificrequirementsforapositionof'
personresponsibleforregulatorycompliance’.WhilethispositionisnotexplicitlymentionedinENISO13485,itconstitutesaregulatoryrequirementthatwouldneedtobeincorporatedintothequalitymanagementsystemofanorganizationseekingtocomplywiththeRegulations.Onceincorporatedintothequalitymanagementsystem,relatedrequirements,forexampleforcompetence,definitionofresponsibilitiesandinterrelationships,wouldapplytothisposition.
Inaddition,theEuropeanRegulationsrequiretheincorporationofcertainprocessesinthequalitymanagementsystem,suchasclinicalevaluation,riskmanagement,post-marketsurveillance,andassignmentofuniquedeviceidentification.ENISO13485requirestheintegrationoftheseprocessesintothequalitymanagementsysteminaccordancewithregulatoryrequirementsbutdoesnotexplicitlyincludethedetailsoftheparticularEuropeanUnionregulatoryrequirementswithinthestandard.
ExplanationontherelationshipbetweentherequirementsofENISO13485and:
— EuropeanRegulationsonMedicalDevices(Regulation(EU)2017/745)isprovidedinthisTechnicalReportinTable1;
and,
— EuropeanRegulationsoninvitroDiagnosticMedicalDevices(Regulation(EU)2017/746)isprovidedinthisTechnicalReportinTable2.
NOTE1WhenarequirementdoesnotappearinTable1orTable2,itmeansthatitisnotaddressedbyENISO13485:
2016.
Inadditiontorequirementsonthemanufacturer’squalitymanagementsystem,Article10andAnnexesIXandXIoftheEuropeanRegulationsincludeadescriptionoftheregulatoryprocessesandactivitiesundertakenbythenotifiedbody,competentauthorityandEuropeanCommission,whichareoutsideofthescopeofENISO13485andthereforenotcoveredbythestandard.
NOTE2Inmanyplaces,AnnexXIoftheEuropeanregulationsrefersbacktoparagraphsinAnnexIX.InTables1and2,theapplicabletextfromAnnexIXisincorporatedunderthereferenceforAnnexXI.
Article8oftheEurope
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