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New version applies from 11/03/2023.
18 provisions change.
Later versions: 20/03/2023, 09/07/2024, 10/01/2025, 01/01/2026, 19/07/2026.
Medical Device Regulation (MDR)
25/05/2017 → 24/04/2020: 0 inserted · 1 removed · 124 amended · 0 moved · 17 renamed · 118 unchanged
Position-only shifts inside the same heading are not changes. Amended = the printed text changed.
Preamble
Preamble · 1 unchanged
Recitals
Recitals · 101 unchanged
Recital 1 · Recital 2 · Recital 3 · Recital 4 · Recital 5 · Recital 6 · Recital 7 · Recital 8 · Recital 9 · Recital 10 · Recital 11 · Recital 12 · Recital 13 · Recital 14 · Recital 15 · Recital 16 · Recital 17 · Recital 18 · Recital 19 · Recital 20 · Recital 21 · Recital 22 · Recital 23 · Recital 24 · Recital 25 · Recital 26 · Recital 27 · Recital 28 · Recital 29 · Recital 30 · Recital 31 · Recital 32 · Recital 33 · Recital 34 · Recital 35 · Recital 36 · Recital 37 · Recital 38 · Recital 39 · Recital 40 · Recital 41 · Recital 42 · Recital 43 · Recital 44 · Recital 45 · Recital 46 · Recital 47 · Recital 48 · Recital 49 · Recital 50 · Recital 51 · Recital 52 · Recital 53 · Recital 54 · Recital 55 · Recital 56 · Recital 57 · Recital 58 · Recital 59 · Recital 60 · Recital 61 · Recital 62 · Recital 63 · Recital 64 · Recital 65 · Recital 66 · Recital 67 · Recital 68 · Recital 69 · Recital 70 · Recital 71 · Recital 72 · Recital 73 · Recital 74 · Recital 75 · Recital 76 · Recital 77 · Recital 78 · Recital 79 · Recital 80 · Recital 81 · Recital 82 · Recital 83 · Recital 84 · Recital 85 · Recital 86 · Recital 87 · Recital 88 · Recital 89 · Recital 90 · Recital 91 · Recital 92 · Recital 93 · Recital 94 · Recital 95 · Recital 96 · Recital 97 · Recital 98 · Recital 99 · Recital 100 · Recital 101
Chapter I - SCOPE AND DEFINITIONS
- amended Article 1 - Subject matter and scope Chapter I
- amended Article 2 - Definitions Chapter I
- amended Article 4 - Regulatory status of products Chapter I
Chapter I · 1 unchanged
Chapter II - MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT
- amended Article 5 - Placing on the market and putting into service Chapter II
- amended Article 6 - Distance sales Chapter II
- amended Article 7 - Claims Chapter II
- amended Article 8 - Use of harmonised standards Chapter II
- amended Article 9 - Common specifications Chapter II
- amended Article 10 - General obligations of manufacturers Chapter II
- amended Article 11 - Authorised representative Chapter II
- amended Article 12 - Change of authorised representative Chapter II
- amended Article 13 - General obligations of importers Chapter II
- amended Article 14 - General obligations of distributors Chapter II
- amended Article 15 - Person responsible for regulatory compliance Chapter II
- amended Article 16 - Cases in which obligations of manufacturers apply to importers, distributors or other persons Chapter II
- amended Article 17 - Single-use devices and their reprocessing Chapter II
- amended Article 18 - Implant card and information to be supplied to the patient with an implanted device Chapter II
- amended Article 19 - EU declaration of conformity Chapter II
- amended Article 20 - CE marking of conformity Chapter II
- amended Article 21 - Devices for special purposes Chapter II
- amended Article 22 - Systems and procedure packs Chapter II
- amended Article 23 - Parts and components Chapter II
Chapter II · 1 unchanged
Chapter III - IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
- amended Article 25 - Identification within the supply chain Chapter III
- amended Article 27 - Unique Device Identification system Chapter III
- amended Article 28 - UDI database Chapter III
- amended Article 29 - Registration of devices Chapter III
- amended Article 30 - Electronic system for registration of economic operators Chapter III
- amended Article 31 - Registration of manufacturers, authorised representatives and importers Chapter III
- amended Article 32 - Summary of safety and clinical performance Chapter III
- amended Article 33 - European database on medical devices Chapter III
- amended Article 34 - Functionality of Eudamed Chapter III
Chapter III · 1 unchanged
Chapter IV - NOTIFIED BODIES
- amended Article 35 - Authorities responsible for notified bodies Chapter IV
- amended Article 36 - Requirements relating to notified bodies Chapter IV
- amended Article 37 - Subsidiaries and subcontracting Chapter IV
- amended Article 38 - Application by conformity assessment bodies for designation Chapter IV
- amended Article 39 - Assessment of the application Chapter IV
- amended Article 40 - Nomination of experts for joint assessment of applications for notification Chapter IV
- amended Article 42 - Designation and notification procedure Chapter IV
- amended Article 43 - Identification number and list of notified bodies Chapter IV
- amended Article 44 - Monitoring and re-assessment of notified bodies Chapter IV
- amended Article 45 - Review of notified body assessment of technical documentation and clinical evaluation documentation Chapter IV
- amended Article 46 - Changes to designations and notifications Chapter IV
- amended Article 47 - Challenge to the competence of notified bodies Chapter IV
- amended Article 48 - Peer review and exchange of experience between authorities responsible for notified bodies Chapter IV
Chapter IV · 3 unchanged
Chapter V - CLASSIFICATION AND CONFORMITY ASSESSMENT
- amended Article 51 - Classification of devices Chapter V › Section 1
- amended Article 52 - Conformity assessment procedures Chapter V › Section 2
- amended Article 53 - Involvement of notified bodies in conformity assessment procedures Chapter V › Section 2
- amended Article 54 - Clinical evaluation consultation procedure for certain class III and class IIb devices Chapter V › Section 2
- amended Article 55 - Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices Chapter V › Section 2
- amended Article 56 - Certificates of conformity Chapter V › Section 2
- amended Article 57 - Electronic system on notified bodies and on certificates of conformity Chapter V › Section 2
- amended Article 58 - Voluntary change of notified body Chapter V › Section 2
- amended Article 59 - Derogation from the conformity assessment procedures Chapter V › Section 2
- amended Article 60 - Certificate of free sale Chapter V › Section 2
Chapter VI - CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
- amended Article 61 - Clinical evaluation Chapter VI
- amended Article 62 - General requirements regarding clinical investigations conducted to demonstrate conformity of devices Chapter VI
- amended Article 63 - Informed consent Chapter VI
- amended Article 64 - Clinical investigations on incapacitated subjects Chapter VI
- amended Article 65 - Clinical investigations on minors Chapter VI
- amended Article 66 - Clinical investigations on pregnant or breastfeeding women Chapter VI
- amended Article 68 - Clinical investigations in emergency situations Chapter VI
- amended Article 69 - Damage compensation Chapter VI
- amended Article 70 - Application for clinical investigations Chapter VI
- amended Article 71 - Assessment by Member States Chapter VI
- amended Article 72 - Conduct of a clinical investigation Chapter VI
- amended Article 73 - Electronic system on clinical investigations Chapter VI
- amended Article 74 - Clinical investigations regarding devices bearing the CE marking Chapter VI
- amended Article 75 - Substantial modifications to clinical investigations Chapter VI
- amended Article 76 - Corrective measures to be taken by Member States and information exchange between Member States Chapter VI
- 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 Chapter VI
- amended Article 78 - Coordinated assessment procedure for clinical investigations Chapter VI
- amended Article 80 - Recording and reporting of adverse events that occur during clinical investigations Chapter VI
- amended Article 81 - Implementing acts Chapter VI
- amended Article 82 - Requirements regarding other clinical investigations Chapter VI
Chapter VI · 2 unchanged
Chapter VII - POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
- amended Article 83 - Post-market surveillance system of the manufacturer Chapter VII › Section 1
- amended Article 84 - Post-market surveillance plan Chapter VII › Section 1
- amended Article 86 - Periodic safety update report Chapter VII › Section 1
- amended Article 87 - Reporting of serious incidents and field safety corrective actions Chapter VII › Section 2
- amended Article 88 - Trend reporting Chapter VII › Section 2
- amended Article 89 - Analysis of serious incidents and field safety corrective actions Chapter VII › Section 2
- amended Article 91 - Implementing acts Chapter VII › Section 2
- amended Article 92 - Electronic system on vigilance and on post-market surveillance Chapter VII › Section 2
- amended Article 93 - Market surveillance activities Chapter VII › Section 3
- amended Article 94 - Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance Chapter VII › Section 3
- amended Article 95 - Procedure for dealing with devices presenting an unacceptable risk to health and safety Chapter VII › Section 3
- amended Article 96 - Procedure for evaluating national measures at Union level Chapter VII › Section 3
- amended Article 97 - Other non-compliance Chapter VII › Section 3
- amended Article 98 - Preventive health protection measures Chapter VII › Section 3
- amended Article 99 - Good administrative practice Chapter VII › Section 3
- amended Article 100 - Electronic system on market surveillance Chapter VII › Section 3
Chapter VII · 2 unchanged
Chapter VIII - COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS
- amended Article 102 - Cooperation Chapter VIII
- amended Article 103 - Medical Device Coordination Group Chapter VIII
- amended Article 105 - Tasks of the MDCG Chapter VIII
- amended Article 106 - Provision of scientific, technical and clinical opinions and advice Chapter VIII
- amended Article 107 - Conflict of interests Chapter VIII
Chapter VIII · 3 unchanged
Chapter IX - CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
- amended Article 109 - Confidentiality Chapter IX
- amended Article 110 - Data protection Chapter IX
- amended Article 111 - Levying of fees Chapter IX
- amended Article 113 - Penalties Chapter IX
Chapter IX · 1 unchanged
Chapter X - FINAL PROVISIONS
- amended Article 114 - Committee procedure Chapter X
- amended Article 115 - Exercise of the delegation Chapter X
- amended Article 117 - Amendment to Directive 2001/83/EC Chapter X
- amended Article 118 - Amendment to Regulation (EC) No 178/2002 Chapter X
- amended Article 119 - Amendment to Regulation (EC) No 1223/2009 Chapter X
- amended Article 120 - Transitional provisions Chapter X
- amended Article 122 - Repeal Chapter X
- amended Article 123 - Entry into force and date of application Chapter X
Chapter X · 2 unchanged
Annexes
- removed Annex ES
- amendedrenamed Annex I - GENERAL SAFETY AND PERFORMANCE REQUIREMENTS was “Annex I”
- amendedrenamed Annex II - TECHNICAL DOCUMENTATION was “Annex II”
- amendedrenamed Annex III - TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE was “Annex III”
- amendedrenamed Annex IV - EU DECLARATION OF CONFORMITY was “Annex IV”
- amendedrenamed Annex V - CE MARKING OF CONFORMITY was “Annex V”
- amendedrenamed 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 was “Annex VI”
- amendedrenamed Annex VII - REQUIREMENTS TO BE MET BY NOTIFIED BODIES was “Annex VII”
- amendedrenamed Annex VIII - CLASSIFICATION RULES was “Annex VIII”
- amendedrenamed Annex IX - CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION was “Annex IX”
- amendedrenamed Annex X - CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION was “Annex X”
- amendedrenamed Annex XI - CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION was “Annex XI”
- amendedrenamed Annex XII - CERTIFICATES ISSUED BY A NOTIFIED BODY was “Annex XII”
- amendedrenamed Annex XIII - PROCEDURE FOR CUSTOM-MADE DEVICES was “Annex XIII”
- amendedrenamed Annex XIV - CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP was “Annex XIV”
- amendedrenamed Annex XV - CLINICAL INVESTIGATIONS was “Annex XV”
- amendedrenamed Annex XVI - LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) was “Annex XVI”
- amendedrenamed Annex XVII - CORRELATION TABLE was “Annex XVII”