What changes on 24/04/2020
The text in force from 25/05/2017 compared with the text from 24/04/2020.
0 inserted
124 amended
1 deleted
0 moved
Read the act as of 24/04/2020 · other versions: 25/05/2017 · 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
- amended Article 113 - Penalties
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
- amended Annex I - GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
- amended Annex II - TECHNICAL DOCUMENTATION
- amended Annex III - TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
- amended Annex IV - EU DECLARATION OF CONFORMITY
- amended Annex IX - CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
- amended Annex V - CE MARKING OF CONFORMITY
- amended 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
- amended Annex VII - REQUIREMENTS TO BE MET BY NOTIFIED BODIES
- amended Annex VIII - CLASSIFICATION RULES
- amended Annex X - CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
- amended Annex XI - CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION
- amended Annex XII - CERTIFICATES ISSUED BY A NOTIFIED BODY
- amended Annex XIII - PROCEDURE FOR CUSTOM-MADE DEVICES
- amended Annex XIV - CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
- amended Annex XV - CLINICAL INVESTIGATIONS
- amended Annex XVI - LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
- amended Annex XVII - CORRELATION TABLE
- deleted Annex ES last in force on the version of 25/05/2017