mdr table of contents 2017-05 - lean entries · annexes table of contents 93 annex i general safety...
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TableofContents
MEDICALDEVICEREGULATION(MDR)
publishedonMay52017athttp://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN
REGULATION(EU)2017/745OFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of5April2017onmedicaldevices,
amendingDirective2001/83/EC[medicinalproducts],Regulation(EC)No178/2002[food]and
Regulation(EC)No1223/2009[cosmeticproducts]and
repealingCouncilDirectives90/385/EEC[activeimplantablemedicaldevices]and
93/42/EEC[medicaldevices]
PREFACE“THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,……HAVEADOPTEDTHISREGULATION:”
1
CHAPTERISCOPEandDEFINITIONS
13
Article1 Subjectmatterandscope 13
Article2 Definitions 15
Article3 Amendmentofcertaindefinitions 20
Article4 Regulatorystatusofproducts 20
CHAPTERII
MAKINGAVAILABLEONTHEMARKETANDPUTTINGINTOSERVICEOFDEVICES,OBLIGATIONSOFECONOMICOPERATORS,REPROCESSING,CEMARKING,FREEMOVEMENT
21
Article5 Placingonthemarketandputtingintoservice 21
Article6 Distancesales 22
Article7 Claims 22
Article8 Useofharmonisedstandards 22
Article9 Commonspecifications 23
Article10 Generalobligationsofmanufacturers 23
Article11 Authorisedrepresentative 25
Article12 Changeofauthorisedrepresentative 26
Article13 Generalobligationsofimporters 26
Article14 Generalobligationsofdistributors 27
Article15 Personresponsibleforregulatorycompliance 28
Article16 Casesinwhichobligationsofmanufacturersapplytoimporters,distributorsorotherpersons 29
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Article17 Single-usedevicesandtheirreprocessing 30
Article18 Implantcardandinformationtobesuppliedtothepatientwithanimplanteddevice 31
Article19 EUdeclarationofconformity 32
Article20 CEmarkingofconformity 32
Article21 Devicesforspecialpurposes 33
Article22 Systemsandprocedurepacks 33
Article23 Partsandcomponents 34
Article24 Freemovement 34
CHAPTERIII
IDENTIFICATIONANDTRACEABILITYOFDEVICES,REGISTRATIONOFDEVICESANDOFECONOMICOPERATORS,SUMMARYOFSAFETYANDCLINICALPERFORMANCE,EUROPEANDATABASEONMEDICALDEVICES
34
Article25 Identificationwithinthesupplychain 34
Article26 Medicaldevicesnomenclature 34
Article27 UniqueDeviceIdentification[UDI]system 35
Article28 UDIdatabase 36
Article29 Registrationofdevices 37
Article30 Electronicsystemforregistrationofeconomicoperators 37
Article31 Registrationofmanufacturers,authorisedrepresentativesandimporters 37
Article32 Summaryofsafetyandclinicalperformance 38
Article33 Europeandatabaseonmedicaldevices 38
Article34 FunctionalityofEudamed 40
CHAPTERIV NOTIFIEDBODIES 40
Article35 Authoritiesresponsiblefornotifiedbodies 40
Article36 Requirementsrelatingtonotifiedbodies 41
Article37 Subsidiariesandsubcontracting 41
Article38 Applicationbyconformityassessmentbodiesfordesignation 41
Article39 Assessmentoftheapplication 42
Article40 Nominationofexpertsforjointassessmentofapplicationsfornotification 43
Article41 Languagerequirements 43
Article42 Designationandnotificationprocedure 43
Article43 Identificationnumberandlistofnotifiedbodies 44
Article44 Monitoringandre-assessmentofnotifiedbodies 45
Article45 Reviewofnotifiedbodyassessmentoftechnicaldocumentationandclinicalevaluationdocumentation
46
Article46 Changestodesignationsandnotifications 46
Article47 Challengetothecompetenceofnotifiedbodies 48
Article48 Peerreviewandexchangeofexperiencebetweenauthoritiesresponsiblefornotifiedbodies 48
Article49 Coordinationofnotifiedbodies 49
Article50 Listofstandardfees 49
CHAPTERVCLASSIFICATIONandCONFORMITYASSESSMENT
49
Section1 CLASSIFICATION 49
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Article51 Classificationofdevices 49
Section2 CONFORMITYASSESSMENT 50
Article52 Conformityassessmentprocedures 50
Article53 Involvementofnotifiedbodiesinconformityassessmentprocedures 52
Article54 ClinicalevaluationconsultationprocedureforcertainclassIIIandclassIIbdevices 52
Article55 MechanismforscrutinyofconformityassessmentsofcertainclassIIIandclassIIbdevices 53
Article56 Certificatesofconformity 53
Article57 Electronicsystemonnotifiedbodiesandoncertificatesofconformity 54
Article58 Voluntarychangeofnotifiedbody 54
Article59 Derogationfromtheconformityassessmentprocedures 55
Article60 Certificateoffreesale 55
CHAPTERVICLINICALEVALUATIONandCLINICALINVESTIGATIONS
55
Article61 Clinicalevaluation 55
Article62 Generalrequirementsregardingclinicalinvestigationsconductedtodemonstrateconformityofdevices 57
Article63 Informedconsent 59
Article64 Clinicalinvestigationsonincapacitatedsubjects 60
Article65 Clinicalinvestigationsonminors 60
Article66 Clinicalinvestigationsonpregnantorbreastfeedingwomen 61
Article67 Additionalnationalmeasures 61
Article68 Clinicalinvestigationsinemergencysituations 61
Article69 Damagecompensation 62
Article70 Applicationforclinicalinvestigations 62
Article71 AssessmentbyMemberStates 63
Article72 Conductofaclinicalinvestigation 64
Article73 Electronicsystemonclinicalinvestigations 65
Article74 ClinicalinvestigationsregardingdevicesbearingtheCEmarking 66
Article75 Substantialmodificationstoclinicalinvestigations 66
Article76 CorrectivemeasurestobetakenbyMemberStatesandinformationexchangebetweenMemberStates 66
Article77 Informationfromthesponsorattheendofaclinicalinvestigationorintheeventofatemporaryhaltorearlytermination 67
Article78 Coordinatedassessmentprocedureforclinicalinvestigations 68
Article79 Reviewofcoordinatedassessmentprocedure 69
Article80 Recordingandreportingofadverseeventsthatoccurduringclinicalinvestigations 69
Article81 Implementingacts 70
Article82 Requirementsregardingotherclinicalinvestigations 71
CHAPTERVIIPOST-MARKETSURVEILLANCE,VIGILANCEandMARKETSURVEILLANCE
71
Section1 POST-MARKETSURVEILLANCE 71
Article83 Post-marketsurveillancesystemofthemanufacturer 71
Article84 Post-marketsurveillanceplan 72
Article85 Post-marketsurveillancereport 72
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Article86 Periodicsafetyupdatereport[PSUR] 72
Section2 VIGILANCE 73
Article87 Reportingofseriousincidentsandfieldsafetycorrectiveactions 73
Article88 Trendreporting 74
Article89 Analysisofseriousincidentsandfieldsafetycorrectiveactions 74
Article90 Analysisofvigilancedata 76
Article91 Implementingacts 76
Article92 Electronicsystemonvigilanceandonpost-marketsurveillance 77
Section3 MARKETSURVEILLANCE 78
Article93 Marketsurveillanceactivities 78
Article94 Evaluationofdevicessuspectedofpresentinganunacceptableriskorothernon-compliance 79
Article95 Procedurefordealingwithdevicespresentinganunacceptablerisktohealthandsafety 79
Article96 ProcedureforevaluatingnationalmeasuresatUnionlevel 80
Article97 Othernon-compliance 80
Article98 Preventivehealthprotectionmeasures 80
Article99 Goodadministrativepractice 81
Article100 Electronicsystemonmarketsurveillance 81
CHAPTERVIII
COOPERATIONBETWEENMEMBERSTATES,MEDICALDEVICECOORDINATIONGROUP,EXPERTLABORATORIES,EXPERTPANELSandDEVICEREGISTERS
82
Article101 Competentauthorities 82
Article102 Cooperation 82
Article103 MedicalDeviceCoordinationGroup[MDCG] 82
Article104 SupportbytheCommission 83
Article105 TasksoftheMDCG 83
Article106 Provisionofscientific,technicalandclinicalopinionsandadvice 84
Article107 Conflictofinterests 86
Article108 Deviceregistersanddatabanks 86
CHAPTERIX
CONFIDENTIALITY,DATAPROTECTION,FUNDINGandPENALTIES
86
Article109 Confidentiality 86
Article110 Dataprotection 87
Article111 Levyingoffees 87
Article112 Fundingofactivitiesrelatedtodesignationandmonitoringofnotifiedbodies 87
Article113 Penalties 87
CHAPTERX FINALPROVISIONS 87
Article114 Committeeprocedure 87
Article115 Exerciseofthedelegation 88
Article116 Separatedelegatedactsfordifferentdelegatedpowers 88
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Article117 AmendmenttoDirective2001/83/EC[medicinalproducts] 88
Article118 AmendmentstoRegulation(EC)No178/2002[food] 89
Article119 AmendmentstoRegulation(EC)No1223/2009[cosmeticproducts] 89
Article120 Transitionalprovisions 89
Article121 Evaluation 90
Article122 Repeal 90
Article123 Entryintoforceanddateofapplication 91
ANNEXES Tableofcontents 93
ANNEXI GENERALSAFETYANDPERFORMANCEREQUIREMENTS 94
ChapterI GENERALREQUIREMENTS(from1.to9.) 94
ChapterII REQUIREMENTSREGARDINGDESIGNANDMANUFACTURE 95
10. Chemical,physicalandbiologicalproperties 95
11. Infectionandmicrobialcontamination 97
12.Devicesincorporatingasubstanceconsideredtobeamedicinalproductanddevicesthatarecomposedofsubstancesorofcombinationofsubstancesthatareabsorbedbyorlocallydispersedinthehumanbody
98
13. Devicesincorporatingmaterialsofbiologicalorigin 98
14. Constructionofdevicesandinteractionwiththeirenvironment 99
15. Deviceswithadiagnosticormeasuringfunction 99
16. Protectionagainstradiation 100
17. Electronicprogrammablesystems–Devicesthatincorporateelectronicprogrammablesystemsandsoftwarethataredevicesinthemselves 100
18. Activedevicesanddevicesconnectedtothem 101
19. Particularrequirementsforactiveimplantabledevices 101
20. Protectionagainstmechanicalandthermalrisks 102
21. Protectionagainsttherisksposedtothepatientoruserbydevicessupplyingenergyorsubstances 102
22. Protectionagainsttherisksposedbymedicaldevicesintendedbythemanufacturerforusebylaypersons
102
ChapterIII REQUIREMENTSREGARDINGTHEINFORMATIONSUPPLIEDWITHTHEDEVICE 103
23. Labelandinstructionsforuse 103
23.1. Generalrequirementsregardingtheinformationsuppliedbythemanufacturer 103
23.2. Informationonthelabel 104
23.3.Informationonthepackagingwhichmaintainsthesterileconditionofadevice('sterilepackaging')
104
23.4. Informationintheinstructionsforuse 105
ANNEXII TECHNICALDOCUMENTATION 108
1. Devicedescriptionandspecification,includingvariantsandaccessories 108
1.1. Devicedescriptionandspecification 108
1.2. Referencetopreviousandsimilargenerationsofthedevice 108
2. Informationtobesuppliedbythemanufacturer 108
3. Designandmanufacturinginformation 109
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4. Generalsafetyandperformancerequirements 109
5. Benefit-riskanalysisandriskmanagement 109
6. Productverificationandvalidation 109
6.1. Pre-clinicalandclinicaldata 109
6.2. Additionalinformationrequiredinspecificcases 110
ANNEXIII TECHNICALDOCUMENTATIONONPOST-MARKETSURVEILLANCE 112
1.1. Thepost-marketsurveillanceplandrawnupinaccordancewithArticle84 112
1.2. ThePSUR[periodicsafetyupdatereport]referredtoinArticle86andthepost-marketsurveillancereportreferredtoinArticle85
112
ANNEXIV EUDECLARATIONOFCONFORMITY 113
ANNEXV CEMARKINGOFCONFORMITY 114
ANNEXVI
INFORMATIONTOBESUBMITTEDUPONTHEREGISTRATIONOFDEVICESANDECONOMICOPERATORSINACCORDANCEWITHARTICLES29(4)AND31,COREDATAELEMENTSTOBEPROVIDEDTOTHEUDIDATABASETOGETHERWITHTHEUDI-DI[UDIdeviceidentifier]INACCORDANCEWITHARTICLES28AND29,andTHEUDISYSTEM
115
PARTA INFORMATIONTOBESUBMITTEDUPONTHEREGISTRATIONOFDEVICESANDECONOMICOPERATORSINACCORDANCEWITHARTICLES29(4)AND31 115
1. Informationrelatingtotheeconomicoperator 115
2. Informationrelatingtothedevice
PARTB COREDATAELEMENTSTOBEPROVIDEDTOTHEUDIDATABASETOGETHERWITHTHEUDI-DI[UDIdeviceidentifier]INACCORDANCEWITHARTICLES28AND29 116
PARTC THEUDISYSTEM 117
1. Definitions 117
2. Generalrequirements 118
3. TheUDI 118
4. UDIcarrier 119
5. GeneralprinciplesoftheUDIdatabase 120
6. Rulesforspecificdevicetypes 120
6.1. Implantabledevices 120
6.2. Reusabledevicesrequiringcleaning,disinfection,sterilisationorrefurbishingbetweenuses 120
6.3. SystemsandprocedurepacksasreferredtoinArticle22 121
6.4. Configurabledevices 121
6.5. Devicesoftware 121
ANNEXVII REQUIREMENTSTOBEMETBYNOTIFIEDBODIES 123
1. ORGANISATIONALANDGENERALREQUIREMENTS 123
1.1. Legalstatusandorganisationalstructure 123
1.2. Independenceandimpartiality 123
1.3. Confidentiality 124
1.4. Liability 125
1.5. Financialrequirements 125
1.6. Participationincoordinationactivities 125
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2. QUALITYMANAGEMENTREQUIREMENTS 125
3. RESOURCEREQUIREMENTS 126
3.1. General 126
3.2. Qualificationcriteriainrelationtopersonnel 126
3.3. Documentationofqualification,trainingandauthorisationofpersonnel 129
3.4. Subcontractorsandexternalexperts 129
3.5. Monitoringofcompetences,trainingandexchangeofexperience 130
4. PROCESSREQUIREMENTS 130
4.1. General 130
4.2. Notifiedbodyquotationsandpre-applicationactivities 130
4.3. Applicationreviewandcontract 130
4.4. Allocationofresources 131
4.5. Conformityassessmentactivities 131
4.5.1. General 131
4.5.2. Qualitymanagementsystemauditing 132
4.5.3. Productverification 133
4.5.4. Pre-clinicalevaluationassessment 134
4.5.5. Clinicalevaluationassessment 134
4.5.6. Specificprocedures 135
4.6. Reporting 135
4.7. Finalreview 136
4.8. Decisionsandcertifications 136
4.9. Changesandmodifications 137
4.10. Surveillanceactivitiesandpost-certificationmonitoring 137
4.11. Re-certification 138
ANNEXVIII CLASSIFICATIONRULES 140
ChapterI DEFINITIONSSPECIFICTOCLASSIFICATIONRULES 140
1. Durationofuse 140
2. Invasiveandactivedevices 140
ChapterII IMPLEMENTINGRULES(from3.1.to3.7.) 140
ChapterIII CLASSIFICATIONRULES 141
4. Non-invasivedevices 141
4.1. Rule1 141
4.2. Rule2 141
4.3. Rule3 141
4.4. Rule4 141
5. Invasivedevices 142
5.1. Rule5 142
5.2. Rule6 142
5.3. Rule7 142
5.4. Rule8 143
6. Activedevices 143
6.1. Rule9 143
6.2. Rule10 143
6.3. Rule11 144
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6.4. Rule12 144
6.5. Rule13 144
7. Specialrules 144
7.1. Rule14 144
7.2. Rule15 144
7.3. Rule16 144
7.4. Rule17 144
7.5. Rule18 145
7.6. Rule19 145
7.7. Rule20 145
7.8. Rule21 145
7.9. Rule22 145
ANNEXIX CONFORMITYASSESSMENTBASEDONAQUALITYMANAGEMENTSYSTEMANDONASSESSMENTOFTECHNICALDOCUMENTATION
146
ChapterI QUALITYMANAGEMENTSYSTEM 146
1. (notitle) 146
2. Qualitymanagementsystemassessment 146
3. SurveillanceassessmentapplicabletoclassIIa,classIIbandclassIIIdevices 148
ChapterII ASSESSMENTOFTHETECHNICALDOCUMENTATION 149
4. AssessmentofthetechnicaldocumentationapplicabletoclassIIIdevicesandtotheclassIIbdevicesreferredtointhesecondsubparagraphofArticle52(4) 149
5. Specificadditionalprocedures 150
5.1 AssessmentprocedureforcertainclassIIIandclassIIbdevices 150
5.2. Procedureinthecaseofdevicesincorporatingamedicinalsubstance 151
5.3. Procedureinthecaseofdevicesmanufacturedutilising,orincorporating,tissuesorcellsofhumanoranimalorigin,ortheirderivatives,thatarenon-viableorrenderednon-viable 152
5.4. Procedureinthecaseofdevicesthatarecomposedofsubstancesorofcombinationsofsubstancesthatareabsorbedbyorlocallydispersedinthehumanbody 153
6.Batchverificationinthecaseofdevicesincorporating,asanintegralpart,amedicinalsubstancewhich,ifusedseparately,wouldbeconsideredtobeamedicinalproductderivedfromhumanbloodorhumanplasmaasreferredtoinArticle1(8)
153
ChapterIII ADMINISTRATIVEPROVISIONS(from7.to8.) 154
ANNEXX CONFORMITYASSESSMENTBASEDONTYPEEXAMINATION 1551. (notitle) 155
2. Application 155
3. Assessment 155
4. Certificate 156
5. Changestothetype 156
6. Specificadditionalprocedures 156
7. Administrativeprovisions 156
ANNEXXI CONFORMITYASSESSMENTBASEDONPRODUCTCONFORMITYVERIFICATION 157
1.to3. (notitle) 157
PARTA PRODUCTIONQUALITYASSURANCE 157
4.to5. (notitle) 157
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6. Qualitymanagementsystem 157
7. Surveillance 158
8.Batchverificationinthecaseofdevicesincorporating,asanintegralpart,amedicinalsubstancewhich,ifusedseparately,wouldbeconsideredtobeamedicinalproductderivedfromhumanbloodorhumanplasmareferredtoinArticle1(8)
158
9. Administrativeprovisions 158
10. ApplicationtoclassIIadevices 158
PARTB PRODUCTVERIFICATION 159
11.to14. (notitle) 159
15. Verificationbyexaminationandtestingofeveryproduct 159
16.Batchverificationinthecaseofdevicesincorporating,asanintegralpart,amedicinalsubstancewhich,ifusedseparately,wouldbeconsideredtobeamedicinalproductderivedfromhumanbloodorhumanplasmareferredtoinArticle1(8)
160
17. Administrativeprovisions 160
18. ApplicationtoclassIIadevices 160
ANNEXXII CERTIFICATESISSUEDBYANOTIFIEDBODY 161ChapterI GENERALREQUIREMENTS 161
ChapterII MINIMUMCONTENTOFTHECERTIFICATES 161
ANNEXXIII PROCEDUREFORCUSTOM-MADEDEVICES 163
ANNEXXIVCLINICALEVALUATIONandPOST-MARKETCLINICALFOLLOW-UP
164
PARTA CLINICALEVALUATION 164
PARTB POST-MARKETCLINICALFOLLOW-UP[PMCF] 165
ANNEXXV CLINICALINVESTIGATIONS 167
ChapterI GENERALREQUIREMENTS 167
1. Ethicalprinciples 167
2. Methods 167
ChapterII DOCUMENTATIONREGARDINGTHEAPPLICATIONFORCLINICALINVESTIGATION 167
1. Applicationform 167
2. Investigator’sBrochure[IB] 168
3. ClinicalInvestigationPlan[CIP] 169
4. Otherinformation 171
ChapterIII OTHEROBLIGATIONSOFTHESPONSOR 171
ANNEXXVI LISTOFGROUPSOFPRODUCTSWITHOUTANINTENDEDMEDICALPURPOSEREFERREDTOINARTICLE1(2)
173
ANNEXXVII CORRELATIONTABLE[betweenCouncilDirective90/385/EECforactiveimplantablemedicaldevices,CouncilDirective93/42/EECformedicaldevicesandthisRegulation] 174