What changes on 25/05/2017
The text in force from 05/05/2017 compared with the text from 25/05/2017.
1 inserted
123 amended
0 deleted
0 moved
Read the act as of 25/05/2017 · other versions: 24/04/2020 · 11/03/2023 · 20/03/2023 · 09/07/2024 · 10/01/2025 · 01/01/2026 · 19/07/2026
Chapter I
- amended Article 1 - Subject matter and scope
- amended Article 2 - Definitions
- amended Article 4 - Regulatory status of products
Chapter II
- amended Article 5 - Placing on the market and putting into service
- amended Article 6 - Distance sales
- amended Article 7 - Claims
- amended Article 8 - Use of harmonised standards
- amended Article 9 - Common specifications
- amended Article 10 - General obligations of manufacturers
- amended Article 11 - Authorised representative
- amended Article 12 - Change of authorised representative
- amended Article 13 - General obligations of importers
- amended Article 14 - General obligations of distributors
- amended Article 15 - Person responsible for regulatory compliance
- amended Article 16 - Cases in which obligations of manufacturers apply to importers, distributors or other persons
- amended Article 17 - Single-use devices and their reprocessing
- amended Article 18 - Implant card and information to be supplied to the patient with an implanted device
- amended Article 19 - EU declaration of conformity
- amended Article 20 - CE marking of conformity
- amended Article 21 - Devices for special purposes
- amended Article 22 - Systems and procedure packs
- amended Article 23 - Parts and components
Chapter III
- amended Article 25 - Identification within the supply chain
- amended Article 27 - Unique Device Identification system
- amended Article 28 - UDI database
- amended Article 29 - Registration of devices
- amended Article 30 - Electronic system for registration of economic operators
- amended Article 31 - Registration of manufacturers, authorised representatives and importers
- amended Article 32 - Summary of safety and clinical performance
- amended Article 33 - European database on medical devices
- amended Article 34 - Functionality of Eudamed
Chapter IV
- amended Article 35 - Authorities responsible for notified bodies
- amended Article 36 - Requirements relating to notified bodies
- amended Article 37 - Subsidiaries and subcontracting
- amended Article 38 - Application by conformity assessment bodies for designation
- amended Article 39 - Assessment of the application
- amended Article 40 - Nomination of experts for joint assessment of applications for notification
- amended Article 42 - Designation and notification procedure
- amended Article 43 - Identification number and list of notified bodies
- amended Article 44 - Monitoring and re-assessment of notified bodies
- amended Article 45 - Review of notified body assessment of technical documentation and clinical evaluation documentation
- amended Article 46 - Changes to designations and notifications
- amended Article 47 - Challenge to the competence of notified bodies
- amended Article 48 - Peer review and exchange of experience between authorities responsible for notified bodies
Chapter V › Section 1
Chapter V › Section 2
- amended Article 52 - Conformity assessment procedures
- amended Article 53 - Involvement of notified bodies in conformity assessment procedures
- amended Article 54 - Clinical evaluation consultation procedure for certain class III and class IIb devices
- amended Article 55 - Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
- amended Article 56 - Certificates of conformity
- amended Article 57 - Electronic system on notified bodies and on certificates of conformity
- amended Article 58 - Voluntary change of notified body
- amended Article 59 - Derogation from the conformity assessment procedures
- amended Article 60 - Certificate of free sale
Chapter VI
- amended Article 61 - Clinical evaluation
- amended Article 62 - General requirements regarding clinical investigations conducted to demonstrate conformity of devices
- amended Article 63 - Informed consent
- amended Article 64 - Clinical investigations on incapacitated subjects
- amended Article 65 - Clinical investigations on minors
- amended Article 66 - Clinical investigations on pregnant or breastfeeding women
- amended Article 68 - Clinical investigations in emergency situations
- amended Article 69 - Damage compensation
- amended Article 70 - Application for clinical investigations
- amended Article 71 - Assessment by Member States
- amended Article 72 - Conduct of a clinical investigation
- amended Article 73 - Electronic system on clinical investigations
- amended Article 74 - Clinical investigations regarding devices bearing the CE marking
- amended Article 75 - Substantial modifications to clinical investigations
- amended Article 76 - Corrective measures to be taken by Member States and information exchange between Member States
- amended Article 77 - Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
- amended Article 78 - Coordinated assessment procedure for clinical investigations
- amended Article 80 - Recording and reporting of adverse events that occur during clinical investigations
- amended Article 81 - Implementing acts
- amended Article 82 - Requirements regarding other clinical investigations
Chapter VII › Section 1
- amended Article 83 - Post-market surveillance system of the manufacturer
- amended Article 84 - Post-market surveillance plan
- amended Article 86 - Periodic safety update report
Chapter VII › Section 2
- amended Article 87 - Reporting of serious incidents and field safety corrective actions
- amended Article 88 - Trend reporting
- amended Article 89 - Analysis of serious incidents and field safety corrective actions
- amended Article 91 - Implementing acts
- amended Article 92 - Electronic system on vigilance and on post-market surveillance
Chapter VII › Section 3
- amended Article 93 - Market surveillance activities
- amended Article 94 - Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
- amended Article 95 - Procedure for dealing with devices presenting an unacceptable risk to health and safety
- amended Article 96 - Procedure for evaluating national measures at Union level
- amended Article 97 - Other non-compliance
- amended Article 98 - Preventive health protection measures
- amended Article 99 - Good administrative practice
- amended Article 100 - Electronic system on market surveillance
Chapter VIII
- amended Article 102 - Cooperation
- amended Article 103 - Medical Device Coordination Group
- amended Article 105 - Tasks of the MDCG
- amended Article 106 - Provision of scientific, technical and clinical opinions and advice
- amended Article 107 - Conflict of interests
Chapter IX
- amended Article 109 - Confidentiality
- amended Article 110 - Data protection
- amended Article 111 - Levying of fees
Chapter X
- amended Article 114 - Committee procedure
- amended Article 115 - Exercise of the delegation
- amended Article 117 - Amendment to Directive 2001/83/EC
- amended Article 118 - Amendment to Regulation (EC) No 178/2002
- amended Article 119 - Amendment to Regulation (EC) No 1223/2009
- amended Article 120 - Transitional provisions
- amended Article 122 - Repeal
- amended Article 123 - Entry into force and date of application
Outside any heading
- inserted Annex ES
- amended Annex I
- amended Annex II
- amended Annex III
- amended Annex IV
- amended Annex IX
- amended Annex V
- amended Annex VI
- amended Annex VII
- amended Annex VIII
- amended Annex X
- amended Annex XI
- amended Annex XII
- amended Annex XIII
- amended Annex XIV
- amended Annex XV
- amended Annex XVI
- amended Annex XVII