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TableofContents
INVITRODIAGNOSTICMEDICALDEVICEREGULATION(IVDR)
publishedonMay52017athttp://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN
REGULATION(EU)2017/746OFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
OfApril52017oninvitrodiagnosticmedicaldevices
andrepealingDirective98/79/EC[invitrodiagnosticdevices]and
CommissionDecision2010/227/EU[Europeandatabankformedicaldevices]
PREFACE“THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,……HAVEADOPTEDTHISREGULATION:”
176 1
CHAPTERI INTRODUCTORYPROVISIONS 187 12
SECTIONISCOPEandDEFINITIONS
187 12
Article1 Subjectmatterandcope 187 12
Article2 Definitions 188 13
SECTIONIIREGULATORYSTATUSOFPRODUCTSandCOUNSELLING
193 18
Article3 Regulatorystatusofproducts 193 18
Article4 Geneticinformation,counsellingandinformedconsent 193 18
CHAPTERII
MAKINGAVAILABLEONTHEMARKETANDPUTTINGINTOSERVICEOFDEVICES,OBLIGATIONSOFECONOMICOPERATORS,CEMARKING,FREEMOVEMENT
193 18
Article5 Placingonthemarketandputtingintoservice 193 18
Article6 Distancesales 195 20
Article7 Claims 195 20
Article8 Useofharmonisedstandards 195 20
Article9 Commonspecifications 196 21
Article10 Generalobligationsofmanufacturers 196 21
Article11 Authorisedrepresentative 198 23
Article12 Changeofauthorisedrepresentative 199 24
Article13 Generalobligationsofimporters 199 24
Article14 Generalobligationsofdistributors 200 25
Article15 Personresponsibleforregulatorycompliance 201 26
Article16 Casesinwhichobligationsofmanufacturersapplytoimporters,distributorsorotherpersons 202 27
Article17 EUdeclarationofconformity 203 28
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Article18 CEmarkingofconformity 203 28
Article19 Devicesforspecialpurposes 204 29
Article20 Partsandcomponents 204 29
Article21 Freemovement 204 29
CHAPTERIII
IDENTIFICATIONANDTRACEABILITYOFDEVICES,REGISTRATIONOFDEVICESANDOFECONOMICOPERATORS,SUMMARYOFSAFETYANDCLINICALPERFORMANCE,EUROPEANDATABASEONMEDICALDEVICES
204 29
Article22 Identificationwithinthesupplychain 204 29
Article23 Medicaldevicesnomenclature 205 30
Article24 UniqueDeviceIdentification[UDI]system 205 30
Article25 UDIdatabase 206 31
Article26 Registrationofdevices 207 32
Article27 Electronicsystemforregistrationofeconomicoperators 207 32
Article28 Registrationofmanufacturers,authorisedrepresentativesandimporters 207 32
Article29 Summaryofsafetyandperformance 208 33
Article30 Europeandatabaseonmedicaldevices 208 33
CHAPTERIV NOTIFIEDBODIES 209 34
Article31 Authoritiesresponsiblefornotifiedbodies 209 34
Article32 Requirementsrelatingtonotifiedbodies 209 34
Article33 Subsidiariesandsubcontracting 210 35
Article34 Applicationbyconformityassessmentbodiesfordesignation 210 35
Article35 Assessmentoftheapplication 210 35
Article36 Nominationofexpertsforjointassessmentofapplicationsfornotification 212 37
Article37 Languagerequirements 212 37
Article38 Designationandnotificationprocedure 212 37
Article39 Identificationnumberandlistofnotifiedbodies 213 38
Article40 Monitoringandre-assessmentofnotifiedbodies 214 39
Article41 Reviewofnotifiedbodyassessmentoftechnicaldocumentationandperformanceevaluationdocumentation 215 40
Article42 Changestodesignationsandnotifications 216 41
Article43 Challengetothecompetenceofnotifiedbodies 217 42
Article44 Peerreviewandexchangeofexperiencebetweenauthoritiesresponsiblefornotifiedbodies 218 43
Article45 Coordinationofnotifiedbodies 218 43
Article46 Listofstandardfees 219 44
CHAPTERVCLASSIFICATIONandCONFORMITYASSESSMENT
219 44
Section1 CLASSIFICATION 219 44
Article47 Classificationofdevices 219 44
Section2 CONFORMITYASSESSMENT 219 44
Article48 Conformityassessmentprocedures 219 44
Article49 Involvementofnotifiedbodiesinconformityassessmentprocedures 221 46
Article50 MechanismforscrutinyofconformityassessmentsofclassDdevices 222 47
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Article51 Certificatesofconformity 222 47
Article52 Electronicsystemonnotifiedbodiesandoncertificatesofconformity 223 48
Article53 Voluntarychangeofnotifiedbody 223 48
Article54 Derogationfromtheconformityassessmentprocedures 223 48
Article55 Certificateoffreesale 224 49
CHAPTERVICLINICALEVIDENCE,PERFORMANCEEVALUATIONandPERFORMANCESTUDIES
224 49
Article56 Performanceevaluationandclinicalevidence 224 49
Article57 Generalrequirementsregardingperformancestudies 225 50
Article58 Additionalrequirementsforcertainperformancestudies 225 50
Article59 Informedconsent 227 52
Article60 Performancestudiesonincapacitatedsubjects 228 53
Article61 Performancestudiesonminors 229 54
Article62 Performancestudiesonpregnantorbreastfeedingwomen 230 55
Article63 Additionalnationalmeasures 230 55
Article64 Performancestudiesinemergencysituations 230 55
Article65 Damagecompensation 231 56
Article66 Applicationforperformancestudies 231 56
Article67 AssessmentbyMemberStates 232 57
Article68 Conductofaperformancestudy 233 58
Article69 Electronicsystemonperformancestudies 234 59
Article70 PerformancestudiesregardingdevicesbearingtheCEmarking 234 59
Article71 Substantialmodificationstoperformancestudies 235 60
Article72 CorrectivemeasurestobetakenbyMemberStatesandinformationexchangebetweenMemberStatesonperformancestudies 235 60
Article73 Informationfromthesponsorattheendofaperformancestudyorintheeventofatemporaryhaltorearlytermination 235 60
Article74 Coordinatedassessmentprocedureforperformancestudies 236 61
Article75 Reviewofthecoordinatedassessmentprocedure 238 63
Article76 Recordingandreportingofadverseeventsthatoccurduringperformancestudies 238 63
Article77 Implementingacts 239 64
CHAPTERVIIPOST-MARKETSURVEILLANCE,VIGILANCEandMARKETSURVEILLANCE
240 65
Section1 POST-MARKETSURVEILLANCE 240 65
Article78 Post-marketsurveillancesystemofthemanufacturer 240 65
Article79 Post-marketsurveillanceplan 240 65
Article80 Post-marketsurveillancereport 240 65
Article81 Periodicsafetyupdatereport[PSUR] 241 66
Section2 VIGILANCE 241 66
Article82 Reportingofseriousincidentsandfieldsafetycorrectiveactions 241 66
Article83 Trendreporting 242 67
Article84 Analysisofseriousincidentsandfieldsafetycorrectiveactions 243 68
Article85 Analysisofvigilancedata 244 69
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Article86 Implementingacts 245 70
Article87 Electronicsystemonvigilanceandpost-marketsurveillance 245 70
Section3 MARKETSURVEILLANCE 246 71
Article88 Marketsurveillanceactivities 246 71
Article89Evaluationofdevicessuspectedofpresentinganunacceptableriskorothernon-compliance
247 72
Article90 Procedurefordealingwithdevicespresentinganunacceptablerisktohealthandsafety 247 72
Article91 ProcedureforevaluatingnationalmeasuresatUnionlevel 248 73
Article92 Othernon-compliance 249 74
Article93 Preventivehealthprotectionmeasures 249 74
Article94 Goodadministrativepractice 249 74
Article95 Electronicsystemonmarketsurveillance 250 75
CHAPTERVIII
COOPERATIONBETWEENMEMBERSTATES,MEDICALDEVICECOORDINATIONGROUP,EUREFERENCELABORATORIESandDEVICEREGISTERS
250 75
Article96 Competentauthorities 250 75
Article97 Cooperation 250 75
Article98 MedicalDeviceCoordinationGroup[MDCG] 251 76
Article99 TasksoftheMDCG 251 76
Article100 TheEuropeanUnionreferencelaboratories 251 76
Article101 Deviceregistersanddatabanks 253 78
CHAPTERIX
CONFIDENTIALITY,DATAPROTECTION,FUNDINGandPENALTIES
253 78
Article102 Confidentiality 253 78
Article103 Dataprotection 254 79
Article104 Levyingoffees 254 79
Article105 Fundingofactivitiesrelatedtodesignationandmonitoringofnotifiedbodies 254 79
Article106 Penalties 254 79
CHAPTERX FINALPROVISIONS 254 79
Article107 Committeeprocedure 254 79
Article108 Exerciseofthedelegation 255 80
Article109 Separatedelegatedactsfordifferentdelegatedpowers 255 80
Article110 Transitionalprovisions 255 80
Article111 Evaluation 256 81
Article112 Repeal 256 81
Article113 Entryintoforceanddateofapplication 257 82
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ANNEXES Tableofcontents 259 84
ANNEXI GENERALSAFETYANDPERFORMANCEREQUIREMENTS 260 85ChapterI GENERALREQUIREMENTS(from1.to8.) 260 85
ChapterII REQUIREMENTSREGARDINGPERFORMANCE,DESIGNANDMANUFACTURE 261 86
9. Performancecharacteristics 261 86
10. Chemical,physicalandbiologicalproperties 261 86
11. Infectionandmicrobialcontamination 262 87
12. Devicesincorporatingmaterialsofbiologicalorigin 262 87
13. Constructionofdevicesandinteractionwiththeirenvironment 263 88
14. Deviceswithameasuringfunction 263 88
15. Protectionagainstradiation 264 89
16. Electronicprogrammablesystems–devicesthatincorporateelectronicprogrammablesystemsandsoftwarethataredevicesinthemselves 264 89
17. Devicesconnectedtoorequippedwithanenergysource 264 89
18. Protectionagainstmechanicalandthermalrisks 265 90
19. Protectionagainsttherisksposedbydevicesintendedforself-testingornear-patienttesting 265 90
ChapterIII REQUIREMENTSREGARDINGINFORMATIONSUPPLIEDWITHTHEDEVICE 266 91
20. Labelandinstructionsforuse 266 91
20.1. Generalrequirementsregardingtheinformationsuppliedbythemanufacturer 266 91
20.2. Informationonthelabel 267 92
20.3.Informationonthepackagingwhichmaintainsthesterileconditionofadevice(‘sterilepackaging’)
268 93
20.4. Informationintheinstructionsforuse 268 93
ANNEXII TECHNICALDOCUMENTATION 272 97
1. Devicedescriptionandspecification,includingvariantsandaccessories 272 97
1.1. Devicedescriptionandspecification 272 97
1.2. Referencetopreviousandsimilargenerationsofthedevice 273 98
2. Informationtobesuppliedbythemanufacturer 273 98
3. Designandmanufacturinginformation 273 98
3.1. Designinformation 273 98
3.2. Manufacturinginformation 273 98
4. Generalsafetyandperformancerequirements 273 98
5. Benefit-riskanalysisandriskmanagement 274 99
6. Productverificationandvalidation 274 99
6.1. Informationonanalyticalperformanceofthedevice 274 99
6.1.1. Specimentype 274 99
6.1.2. Analyticalperformancecharacteristics 274 99
6.1.2.1. Accuracyofmeasurement 274 99
6.1.2.2. Analyticalsensitivity 274 99
6.1.2.3. Analyticalspecificity 274 99
6.1.2.4. Metrologicaltraceabilityofcalibratorandcontrolmaterialvalues 275 100
6.1.2.5. Measuringrangeoftheassay 275 100
6.1.2.6. Definitionofassaycut-off 275 100
6.1.3. TheanalyticalperformancereportreferredtoinAnnexXIII 275 100
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6.2. Informationonclinicalperformanceandclinicalevidence.PerformanceEvaluationReport 275 100
6.3. Stability(excludingspecimenstability) 275 100
6.3.1. Claimedshelf-life 275 100
6.3.2. In-usestability 275 100
6.3.3. Shippingstability 276 101
6.4. Softwareverificationandvalidation 276 101
6.5 Additionalinformationrequiredinspecificcases 276 101
ANNEXIII TECHNICALDOCUMENTATIONONPOST-MARKETSURVEILLANCE 277 102
1. Thepost-marketsurveillanceplandrawnupinaccordancewithArticle79 277 102
2. ThePSUR[periodicsafetyupdatereport]referredtoinArticle81andthepost-marketsurveillancereportreferredtoinArticle80 277 102
ANNEXIV EUDECLARATIONOFCONFORMITY 278 103
ANNEXV CEMARKINGOFCONFORMITY 279 104
ANNEXVI
INFORMATIONTOBESUBMITTEDUPONTHEREGISTRATIONOFDEVICESANDECONOMICOPERATORSINACCORDANCEWITHARTICLES26(3)AND28,COREDATAELEMENTSTOBEPROVIDEDTOTHEUDIDATABASETOGETHERWITHTHEUDI-DI[UDIdeviceidentifier]INACCORDANCEWITHARTICLES25AND26andTHEUDISYSTEM
280 105
PARTA INFORMATIONTOBESUBMITTEDUPONTHEREGISTRATIONOFDEVICESANDECONOMICOPERATORSINACCORDANCEWITHARTICLES26(3)AND28
280 105
1. Informationrelatingtotheeconomicoperator 280 105
2. Informationrelatingtothedevice 280 105
PARTB COREDATAELEMENTSTOBEPROVIDEDTOTHEUDIDATABASETOGETHERWITHTHEUDI-DIINACCORDANCEWITHARTICLES25AND26 281 106
PARTC THEUDISYSTEM 282 107
1. Definitions 282 107
2. Generalrequirements 283 108
3. TheUDI 283 108
4. UDIcarrier 284 109
5. GeneralprinciplesoftheUDIdatabase 284 109
6. Rulesforspecificdevicetypes 285 110
6.1. Reusabledevicesthatarepartofkitsandthatrequirecleaning,disinfection,sterilisationorrefurbishingbetweenuses 285 110
6.2. Devicesoftware 285 110
ANNEXVII REQUIREMENTSTOBEMETBYNOTIFIEDBODIES 287 112
1. ORGANISATIONALANDGENERALREQUIREMENTS 287 112
1.1. Legalstatusandorganisationalstructure 287 112
1.2. Independenceandimpartiality 287 112
1.3. Confidentiality 289 114
1.4. Liability 289 114
1.5. Financialrequirements 289 114
1.6. Participationincoordinationactivities 289 114
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2. QUALITYMANAGEMENTREQUIREMENTS 289 114
3. RESOURCEREQUIREMENTS 290 115
3.1. General 290 115
3.2. Qualificationcriteriainrelationtopersonnel 291 116
3.3. Documentationofqualification,trainingandauthorisationofpersonnel 293 118
3.4. Subcontractorsandexternalexperts 293 118
3.5. Monitoringofcompetences,trainingandexchangeofexperience 294 119
4. PROCESSREQUIREMENTS 294 119
4.1. General 294 119
4.2. Notifiedbodyquotationsandpre-applicationactivities 294 119
4.3. Applicationreviewandcontract 295 120
4.4. Allocationofresources 295 120
4.5. Conformityassessmentactivities 295 120
4.5.1. General 295 120
4.5.2. Qualitymanagementsystemauditing 296 121
4.5.3. Productverification 297 122
4.5.4. Performanceevaluationassessment 298 123
4.5.5. Specificprocedures 299 124
4.6. Reporting 300 125
4.7. Finalreview 300 125
4.8. Decisionsandcertifications 300 125
4.9. Changesandmodifications 301 126
4.10. Surveillanceactivitiesandpost-certificationmonitoring 301 126
4.11. Re-certification 302 127
ANNEXVIII CLASSIFICATIONRULES 304 129
1. IMPLEMENTINGRULES(from1.1to1.10.) 304 129
2. CLASSIFICATIONRULES 304 129
2.1. Rule1 304 129
2.2 Rule2 304 129
2.3. Rule3 305 130
2.4. Rule4 305 130
2.5. Rule5 305 130
2.6. Rule6 305 130
2.7. Rule7 305 130
ANNEXIXCONFORMITYASSESSMENTBASEDONAQUALITYMANAGEMENTSYSTEMANDONASSESSMENTOFTECHNICALDOCUMENTATION
306 131
ChapterI QUALITYMANAGEMENTSYSTEM 306 131
1. (notitle) 306 131
2. Qualitymanagementsystemassessment 306 131
3. SurveillanceassessmentapplicabletoclassCandclassDdevices 308 133
ChapterII ASSESSMENTOFTHETECHNICALDOCUMENTATION 309 134
4. AssessmentofthetechnicaldocumentationofclassB,CandDdevicesandbatchverificationapplicabletoclassDdevices
309 134
5. Assessmentofthetechnicaldocumentationofspecifictypesofdevices 311 136
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5.1. AssessmentofthetechnicaldocumentationofclassB,CorDdevicesforself-testingandnear-patienttesting 311 136
5.2. Assessmentofthetechnicaldocumentationofcompaniondiagnostics 312 137
ChapterIII ADMINISTRATIVEPROVISIONS 313 138
ANNEXX CONFORMITYASSESSMENTBASEDONTYPEEXAMINATION 314 139
1. (notitle) 314 139
2. Application 314 139
3. Assessment 314 139
4. Certificate 316 141
5. Changestothetype 316 141
6. Administrativeprovisions 316 141
ANNEXXI CONFORMITYASSESSMENTBASEDONPRODUCTIONQUALITYASSURANCE 317 142
1. (notitle) 317 142
2. (notitle) 317 142
3. Qualitymanagementsystem 317 142
4. Surveillance 317 142
5. VerificationofmanufacturedclassDdevices 317 142
6. Administrativeprovisions 318 143
ANNEXXII CERTIFICATESISSUEDBYANOTIFIEDBODY 319 144
ChapterI GENERALREQUIREMENTS 319 144
ChapterII MINIMUMCONTENTOFTHECERTIFICATES 319 144
ANNEXXIIIPERFORMANCEEVALUATION,PERFORMANCESTUDIESandPOST-MARKETPERFORMANCEFOLLOW-UP
321 146
PARTAPERFORMANCEEVALUATIONandPERFORMANCESTUDIES
321 146
1. Performanceevaluation 321 146
1.1. Performanceevaluationplan 321 146
1.2. Demonstrationofthescientificvalidityandtheanalyticalandclinicalperformance 322 147
1.2.1. Demonstrationofthescientificvalidity 322 147
1.2.2. Demonstrationoftheanalyticalperformance 322 147
1.2.3. Demonstrationoftheclinicalperformance 322 147
1.3. Clinicalevidenceandperformanceevaluationreport 323 148
1.3.1 (notitle) 323 148
1.3.2. Performanceevaluationreport 323 148
1.3.3. (notitle) 323 148
2. Clinicalperformancestudies 323 148
2.1. Purposeofclinicalperformancestudies 323 148
2.2. Ethicalconsiderationsforclinicalperformancestudies 324 149
2.3. Methodsforclinicalperformancestudies 324 149
2.3.1. Clinicalperformancestudydesigntype 324 149
2.3.2. Clinicalperformancestudyplan[CPSP] 324 149
2.3.3. Clinicalperformancestudyreport 326 151
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3. Otherperformancestudies 326 151
PARTB POST-MARKETPERFORMANCEFOLLOW-UP[PMPF] 326 151
ANNEXXIV INTERVENTIONALCLINICALPERFORMANCESTUDIESANDCERTAINOTHERPERFORMANCESTUDIES 328 153
ChapterIDOCUMENTATIONREGARDINGTHEAPPLICATIONFORINTERVENTIONALCLINICALPERFORMANCESTUDIESANDOTHERPERFORMANCESTUDIESINVOLVINGRISKSFORTHESUBJECTSOFTHESTUDIES
328 153
1. Applicationform 328 153
2. Investigator’sbrochure[IB] 329 154
3. PerformancestudyplanasreferredtoinSections2and3ofAnnexXIII 329 154
4. Otherinformation 329 154
ChapterII OTHEROBLIGATIONSOFTHESPONSOR 330 155
ANNEXXV CORRELATIONTABLE[betweenCouncilDirective98/79/ECforinvitrodiagnosticmedicaldevicesandthisRegulation]
331 156