EU MDR 2017/745
Sectors
Articles (123)
Article 1 — Subject matter and scopeArticle 2 — DefinitionsArticle 3 — Amendment of certain definitionsArticle 4 — Regulatory status of productsArticle 5 — Placing on the market and putting into serviceArticle 6 — Distance salesArticle 7 — ClaimsArticle 8 — Use of harmonised standardsArticle 9 — Common specificationsArticle 10 — General obligations of manufacturersArticle 11 — Authorised representativeArticle 12 — Change of authorised representativeArticle 13 — General obligations of importersArticle 14 — General obligations of distributorsArticle 15 — Person responsible for regulatory complianceArticle 16 — Cases in which obligations of manufacturers apply to importers, distributors or other personsArticle 17 — Single-use devices and their reprocessingArticle 18 — Implant card and information to be supplied to the patient with an implanted deviceArticle 19 — EU declaration of conformityArticle 20 — CE marking of conformityArticle 21 — Devices for special purposesArticle 22 — Systems and procedure packsArticle 23 — Parts and componentsArticle 24 — Free movementArticle 25 — Identification within the supply chainArticle 26 — Medical devices nomenclatureArticle 27 — Unique Device Identification systemArticle 28 — UDI databaseArticle 29 — Registration of devicesArticle 30 — Electronic system for registration of economic operatorsArticle 31 — Registration of manufacturers, authorised representatives and importersArticle 32 — Summary of safety and clinical performanceArticle 33 — European database on medical devicesArticle 34 — Functionality of EudamedArticle 35 — Authorities responsible for notified bodiesArticle 36 — Requirements relating to notified bodiesArticle 37 — Subsidiaries and subcontractingArticle 38 — Application by conformity assessment bodies for designationArticle 39 — Assessment of the applicationArticle 40 — Nomination of experts for joint assessment of applications for notificationArticle 41 — Language requirementsArticle 42 — Designation and notification procedureArticle 43 — Identification number and list of notified bodiesArticle 44 — Monitoring and re-assessment of notified bodiesArticle 45 — Review of notified body assessment of technical documentation and clinical evaluation documentationArticle 46 — Changes to designations and notificationsArticle 47 — Challenge to the competence of notified bodiesArticle 48 — Peer review and exchange of experience between authorities responsible for notified bodiesArticle 49 — Coordination of notified bodiesArticle 50 — List of standard feesArticle 51 — Classification of devicesArticle 52 — Conformity assessment proceduresArticle 53 — Involvement of notified bodies in conformity assessment proceduresArticle 54 — Clinical evaluation consultation procedure for certain class III and class IIb devicesArticle 55 — Mechanism for scrutiny of conformity assessments of certain class III and class IIb devicesArticle 56 — Certificates of conformityArticle 57 — Electronic system on notified bodies and on certificates of conformityArticle 58 — Voluntary change of notified bodyArticle 59 — Derogation from the conformity assessment proceduresArticle 60 — Certificate of free saleArticle 61 — Clinical evaluationArticle 62 — General requirements regarding clinical investigations conducted to demonstrate conformity of devicesArticle 63 — Informed consentArticle 64 — Clinical investigations on incapacitated subjectsArticle 65 — Clinical investigations on minorsArticle 66 — Clinical investigations on pregnant or breastfeeding womenArticle 67 — Additional national measuresArticle 68 — Clinical investigations in emergency situationsArticle 69 — Damage compensationArticle 70 — Application for clinical investigationsArticle 71 — Assessment by Member StatesArticle 72 — Conduct of a clinical investigationArticle 73 — Electronic system on clinical investigationsArticle 74 — Clinical investigations regarding devices bearing the CE markingArticle 75 — Substantial modifications to clinical investigationsArticle 76 — Corrective measures to be taken by Member States and information exchange between Member StatesArticle 77 — Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early terminationArticle 78 — Coordinated assessment procedure for clinical investigationsArticle 79 — Review of coordinated assessment procedureArticle 80 — Recording and reporting of adverse events that occur during clinical investigationsArticle 81 — Implementing actsArticle 82 — Requirements regarding other clinical investigationsArticle 83 — Post-market surveillance system of the manufacturerArticle 84 — Post-market surveillance planArticle 85 — Post-market surveillance reportArticle 86 — Periodic safety update reportArticle 87 — Reporting of serious incidents and field safety corrective actionsArticle 88 — Trend reportingArticle 89 — Analysis of serious incidents and field safety corrective actionsArticle 90 — Analysis of vigilance dataArticle 91 — Implementing actsArticle 92 — Electronic system on vigilance and on post-market surveillanceArticle 93 — Market surveillance activitiesArticle 94 — Evaluation of devices suspected of presenting an unacceptable risk or other non-complianceArticle 95 — Procedure for dealing with devices presenting an unacceptable risk to health and safetyArticle 96 — Procedure for evaluating national measures at Union levelArticle 97 — Other non-complianceArticle 98 — Preventive health protection measuresArticle 99 — Good administrative practiceArticle 100 — Electronic system on market surveillanceArticle 101 — Competent authoritiesArticle 102 — CooperationArticle 103 — Medical Device Coordination GroupArticle 104 — Support by the CommissionArticle 105 — Tasks of the MDCGArticle 106 — Provision of scientific, technical and clinical opinions and adviceArticle 107 — Conflict of interestsArticle 108 — Device registers and databanksArticle 109 — ConfidentialityArticle 110 — Data protectionArticle 111 — Levying of feesArticle 112 — Funding of activities related to designation and monitoring of notified bodiesArticle 113 — PenaltiesArticle 114 — Committee procedureArticle 115 — Exercise of the delegationArticle 116 — Separate delegated acts for different delegated powersArticle 117 — Amendment to Directive 2001/83/ECArticle 118 — Amendment to Regulation (EC) No 178/2002Article 119 — Amendment to Regulation (EC) No 1223/2009Article 120 — Transitional provisionsArticle 121 — EvaluationArticle 122 — RepealArticle 123 — Entry into force and date of application