What changes on 05/05/2017
The text in force from 05/06/2012 compared with the text from 05/05/2017.
242 inserted
0 amended
0 deleted
0 moved
Read the act as of 05/05/2017 · other versions: 25/05/2017 · 24/04/2020 · 11/03/2023 · 20/03/2023 · 09/07/2024 · 10/01/2025 · 01/01/2026 · 19/07/2026
Chapter I
- inserted Article 1 - Subject matter and scope
- inserted Article 2 - Definitions
- inserted Article 3 - Amendment of certain definitions
- inserted Article 4 - Regulatory status of products
Chapter II
- inserted Article 5 - Placing on the market and putting into service
- inserted Article 6 - Distance sales
- inserted Article 7 - Claims
- inserted Article 8 - Use of harmonised standards
- inserted Article 9 - Common specifications
- inserted Article 10 - General obligations of manufacturers
- inserted Article 11 - Authorised representative
- inserted Article 12 - Change of authorised representative
- inserted Article 13 - General obligations of importers
- inserted Article 14 - General obligations of distributors
- inserted Article 15 - Person responsible for regulatory compliance
- inserted Article 16 - Cases in which obligations of manufacturers apply to importers, distributors or other persons
- inserted Article 17 - Single-use devices and their reprocessing
- inserted Article 18 - Implant card and information to be supplied to the patient with an implanted device
- inserted Article 19 - EU declaration of conformity
- inserted Article 20 - CE marking of conformity
- inserted Article 21 - Devices for special purposes
- inserted Article 22 - Systems and procedure packs
- inserted Article 23 - Parts and components
- inserted Article 24 - Free movement
Chapter III
- inserted Article 25 - Identification within the supply chain
- inserted Article 26 - Medical devices nomenclature
- inserted Article 27 - Unique Device Identification system
- inserted Article 28 - UDI database
- inserted Article 29 - Registration of devices
- inserted Article 30 - Electronic system for registration of economic operators
- inserted Article 31 - Registration of manufacturers, authorised representatives and importers
- inserted Article 32 - Summary of safety and clinical performance
- inserted Article 33 - European database on medical devices
- inserted Article 34 - Functionality of Eudamed
Chapter IV
- inserted Article 35 - Authorities responsible for notified bodies
- inserted Article 36 - Requirements relating to notified bodies
- inserted Article 37 - Subsidiaries and subcontracting
- inserted Article 38 - Application by conformity assessment bodies for designation
- inserted Article 39 - Assessment of the application
- inserted Article 40 - Nomination of experts for joint assessment of applications for notification
- inserted Article 41 - Language requirements
- inserted Article 42 - Designation and notification procedure
- inserted Article 43 - Identification number and list of notified bodies
- inserted Article 44 - Monitoring and re-assessment of notified bodies
- inserted Article 45 - Review of notified body assessment of technical documentation and clinical evaluation documentation
- inserted Article 46 - Changes to designations and notifications
- inserted Article 47 - Challenge to the competence of notified bodies
- inserted Article 48 - Peer review and exchange of experience between authorities responsible for notified bodies
- inserted Article 49 - Coordination of notified bodies
- inserted Article 50 - List of standard fees
Chapter V › Section 1
Chapter V › Section 2
- inserted Article 52 - Conformity assessment procedures
- inserted Article 53 - Involvement of notified bodies in conformity assessment procedures
- inserted Article 54 - Clinical evaluation consultation procedure for certain class III and class IIb devices
- inserted Article 55 - Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
- inserted Article 56 - Certificates of conformity
- inserted Article 57 - Electronic system on notified bodies and on certificates of conformity
- inserted Article 58 - Voluntary change of notified body
- inserted Article 59 - Derogation from the conformity assessment procedures
- inserted Article 60 - Certificate of free sale
Chapter VI
- inserted Article 61 - Clinical evaluation
- inserted Article 62 - General requirements regarding clinical investigations conducted to demonstrate conformity of devices
- inserted Article 63 - Informed consent
- inserted Article 64 - Clinical investigations on incapacitated subjects
- inserted Article 65 - Clinical investigations on minors
- inserted Article 66 - Clinical investigations on pregnant or breastfeeding women
- inserted Article 67 - Additional national measures
- inserted Article 68 - Clinical investigations in emergency situations
- inserted Article 69 - Damage compensation
- inserted Article 70 - Application for clinical investigations
- inserted Article 71 - Assessment by Member States
- inserted Article 72 - Conduct of a clinical investigation
- inserted Article 73 - Electronic system on clinical investigations
- inserted Article 74 - Clinical investigations regarding devices bearing the CE marking
- inserted Article 75 - Substantial modifications to clinical investigations
- inserted Article 76 - Corrective measures to be taken by Member States and information exchange between Member States
- inserted Article 77 - Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
- inserted Article 78 - Coordinated assessment procedure for clinical investigations
- inserted Article 79 - Review of coordinated assessment procedure
- inserted Article 80 - Recording and reporting of adverse events that occur during clinical investigations
- inserted Article 81 - Implementing acts
- inserted Article 82 - Requirements regarding other clinical investigations
Chapter VII › Section 1
- inserted Article 83 - Post-market surveillance system of the manufacturer
- inserted Article 84 - Post-market surveillance plan
- inserted Article 85 - Post-market surveillance report
- inserted Article 86 - Periodic safety update report
Chapter VII › Section 2
- inserted Article 87 - Reporting of serious incidents and field safety corrective actions
- inserted Article 88 - Trend reporting
- inserted Article 89 - Analysis of serious incidents and field safety corrective actions
- inserted Article 90 - Analysis of vigilance data
- inserted Article 91 - Implementing acts
- inserted Article 92 - Electronic system on vigilance and on post-market surveillance
Chapter VII › Section 3
- inserted Article 93 - Market surveillance activities
- inserted Article 94 - Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
- inserted Article 95 - Procedure for dealing with devices presenting an unacceptable risk to health and safety
- inserted Article 96 - Procedure for evaluating national measures at Union level
- inserted Article 97 - Other non-compliance
- inserted Article 98 - Preventive health protection measures
- inserted Article 99 - Good administrative practice
- inserted Article 100 - Electronic system on market surveillance
Chapter VIII
- inserted Article 101 - Competent authorities
- inserted Article 102 - Cooperation
- inserted Article 103 - Medical Device Coordination Group
- inserted Article 104 - Support by the Commission
- inserted Article 105 - Tasks of the MDCG
- inserted Article 106 - Provision of scientific, technical and clinical opinions and advice
- inserted Article 107 - Conflict of interests
- inserted Article 108 - Device registers and databanks
Chapter IX
- inserted Article 109 - Confidentiality
- inserted Article 110 - Data protection
- inserted Article 111 - Levying of fees
- inserted Article 112 - Funding of activities related to designation and monitoring of notified bodies
- inserted Article 113 - Penalties
Chapter X
- inserted Article 114 - Committee procedure
- inserted Article 115 - Exercise of the delegation
- inserted Article 116 - Separate delegated acts for different delegated powers
- inserted Article 117 - Amendment to Directive 2001/83/EC
- inserted Article 118 - Amendment to Regulation (EC) No 178/2002
- inserted Article 119 - Amendment to Regulation (EC) No 1223/2009
- inserted Article 120 - Transitional provisions
- inserted Article 121 - Evaluation
- inserted Article 122 - Repeal
- inserted Article 123 - Entry into force and date of application
Outside any heading
- inserted Recital 1
- inserted Recital 2
- inserted Recital 3
- inserted Recital 4
- inserted Recital 5
- inserted Recital 6
- inserted Recital 7
- inserted Recital 8
- inserted Recital 9
- inserted Recital 10
- inserted Recital 11
- inserted Recital 12
- inserted Recital 13
- inserted Recital 14
- inserted Recital 15
- inserted Recital 16
- inserted Recital 17
- inserted Recital 18
- inserted Recital 19
- inserted Recital 20
- inserted Recital 21
- inserted Recital 22
- inserted Recital 23
- inserted Recital 24
- inserted Recital 25
- inserted Recital 26
- inserted Recital 27
- inserted Recital 28
- inserted Recital 29
- inserted Recital 30
- inserted Recital 31
- inserted Recital 32
- inserted Recital 33
- inserted Recital 34
- inserted Recital 35
- inserted Recital 36
- inserted Recital 37
- inserted Recital 38
- inserted Recital 39
- inserted Recital 40
- inserted Recital 41
- inserted Recital 42
- inserted Recital 43
- inserted Recital 44
- inserted Recital 45
- inserted Recital 46
- inserted Recital 47
- inserted Recital 48
- inserted Recital 49
- inserted Recital 50
- inserted Recital 51
- inserted Recital 52
- inserted Recital 53
- inserted Recital 54
- inserted Recital 55
- inserted Recital 56
- inserted Recital 57
- inserted Recital 58
- inserted Recital 59
- inserted Recital 60
- inserted Recital 61
- inserted Recital 62
- inserted Recital 63
- inserted Recital 64
- inserted Recital 65
- inserted Recital 66
- inserted Recital 67
- inserted Recital 68
- inserted Recital 69
- inserted Recital 70
- inserted Recital 71
- inserted Recital 72
- inserted Recital 73
- inserted Recital 74
- inserted Recital 75
- inserted Recital 76
- inserted Recital 77
- inserted Recital 78
- inserted Recital 79
- inserted Recital 80
- inserted Recital 81
- inserted Recital 82
- inserted Recital 83
- inserted Recital 84
- inserted Recital 85
- inserted Recital 86
- inserted Recital 87
- inserted Recital 88
- inserted Recital 89
- inserted Recital 90
- inserted Recital 91
- inserted Recital 92
- inserted Recital 93
- inserted Recital 94
- inserted Recital 95
- inserted Recital 96
- inserted Recital 97
- inserted Recital 98
- inserted Recital 99
- inserted Recital 100
- inserted Recital 101
- inserted Preamble
- inserted Annex I - GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
- inserted Annex II - TECHNICAL DOCUMENTATION
- inserted Annex III - TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
- inserted Annex IV - EU DECLARATION OF CONFORMITY
- inserted Annex IX - CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
- inserted Annex V - CE MARKING OF CONFORMITY
- inserted Annex VI - INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM
- inserted Annex VII - REQUIREMENTS TO BE MET BY NOTIFIED BODIES
- inserted Annex VIII - CLASSIFICATION RULES
- inserted Annex X - CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
- inserted Annex XI - CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION
- inserted Annex XII - CERTIFICATES ISSUED BY A NOTIFIED BODY
- inserted Annex XIII - PROCEDURE FOR CUSTOM-MADE DEVICES
- inserted Annex XIV - CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
- inserted Annex XV - CLINICAL INVESTIGATIONS
- inserted Annex XVI - LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
- inserted Annex XVII - CORRELATION TABLE