Inhalt der MDR – Regulation (EU) 2017/745 (englisch)
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical
devices, amending Directive 2
CHAPTER I –
SCOPE AND DEFINITIONS
Article 1 Subject matter and scope
Article 2 Definitions
Article 3 Amendment of certain definitions
Article 4 Regulatory status of products
CHAPTER II –
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT
Article 5 Placing on the market and putting into service
Article 6 Distance sales
Article 7 Claims
Article 8 Use of harmonised standards
Article 9 Common specifications
Article 10 General obligations of manufacturers
Article 11 Authorised representative
Article 12 Change of authorised representative
Article 13 General obligations of importers
Article 14 General obligations of distributors
Article 15 Person responsible for regulatory compliance
Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons
Article 17 Single-use devices and their reprocessing
Article 18 Implant card and information to be supplied to the patient with an implanted device
Article 19 EU declaration of conformity
Article 20 CE marking of conformity
Article 21 Devices for special purposes
Article 22 Systems and procedure packs
Article 23 Parts and components
Article 24 Free movement
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
Article 25 Identification within the supply chain
Article 26 Medical devices nomenclature
Article 27 Unique Device Identification syste
Article 28 UDI database
Article 29 Registration of devices
Article 30 Electronic system for registration of economic operators
Article 31 Registration of manufacturers, authorised representatives and importers
Article 32 Summary of safety and clinical performance
Article 33 European database on medical devices
Article 34 Functionality of Eudamed
CHAPTER IV –
NOTIFIED BODIES
Article 35 Authorities responsible for notified bodies
Article 36 Requirements relating to notified bodies
Article 37 Subsidiaries and subcontracting
Article 38 Application by conformity assessment bodies for designation
Article 39 Assessment of the application
Article 40 Nomination of experts for joint assessment of applications for notification
Article 41 Language requirements
Article 42 Designation and notification procedure
Article 43 Identification number and list of notified bodies
Article 44 Monitoring and re-assessment of notified bodies
Article 45 Review of notified body assessment of technical documentation and clinical evaluation documentation
Article 46 Changes to designations and notifications
Article 47 Challenge to the competence of notified bodies
Article 48 Peer review and exchange of experience between authorities responsible for notified bodies
Article 49 Coordination of notified bodies
Article 50 List of standard fees
CHAPTER V
CLASSIFICATION AND CONFORMITY ASSESSMENT
SECTION 1
Classification
Article 51 Classification of devices
SECTION 2
Conformity assessment
Article 52 Conformity assessment procedures
Article 53 Involvement of notified bodies in conformity assessment procedures
Article 54 Clinical evaluation consultation procedure for certain class III and class IIb devices
Article 55 Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
Article 56 Certificates of conformity
Article 57 Electronic system on notified bodies and on certificates of conformity
Article 58 Voluntary change of notified body
Article 59 Derogation from the conformity assessment procedures
Article 60 Certificate of free sale
CHAPTER VI
CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
Article 61 Clinical evaluation
Article 62 General requirements regarding clinical investigations conducted to demonstrate conformity of devices
Article 63 Informed consent
Article 64 Clinical investigations on incapacitated subjects
Article 65 Clinical investigations on minors
Article 66 Clinical investigations on pregnant or breastfeeding women
Article 67 Additional national measures
Article 68 Clinical investigations in emergency situations
Article 69 Damage compensation
Article 70 Application for clinical investigations
Article 71 Assessment by Member States
Article 72 Conduct of a clinical investigation
Article 73 Electronic system on clinical investigations
Article 74 Clinical investigations regarding devices bearing the CE marking
Article 75 Substantial modifications to clinical investigations
Article 76 Corrective measures to be taken by Member States and information exchange between Member States
Article 77 Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
Article 78 Coordinated assessment procedure for clinical investigations
Article 79 Review of coordinated assessment procedure
Article 80 Recording and reporting of adverse events that occur during clinical investigations
Article 81 Implementing acts
Article 82 Requirements regarding other clinical investigations
CHAPTER VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
SECTION 1
Post-market surveillance
Article 83 Post-market surveillance system of the manufacturer
Article 84 Post-market surveillance plan
Article 85 Post-market surveillance report
Article 86 Periodic safety update report
SECTION 2
Vigilance
Article 87 Reporting of serious incidents and field safety corrective actions
Article 88 Trend reporting
Article 89 Analysis of serious incidents and field safety corrective actions
Article 90 Analysis of vigilance data
Article 91 Implementing acts
Article 92 Electronic system on vigilance and on post-market surveillance
SECTION 3
Market surveillance
Article 93 Market surveillance activities
Article 94 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
Article 95 Procedure for dealing with devices presenting an unacceptable risk to health and safety
Article 96 Procedure for evaluating national measures at Union level
Article 97 Other non-compliance
Article 98 Preventive health protection measures
Article 99 Good administrative practice
Article 100 Electronic system on market surveillance
CHAPTER VIII
COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS
Article 101 Competent authorities
Article 102 Cooperation
Article 103 Medical Device Coordination Group
Article 104 Support by the Commission
Article 105 Tasks of the MDCG
Article 106 Provision of scientific, technical and clinical opinions and advice
Article 107 Conflict of interests
Article 108 Device registers and databanks
CHAPTER IX
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
Article 109 Confidentiality
Article 110 Data protection
Article 111 Levying of fees
Article 112 Funding of activities related to designation and monitoring of notified bodies
Article 113 Penalties
CHAPTER X
FINAL PROVISIONS
Article 114 Committee procedure
Article 115 Exercise of the delegation
Article 116 Separate delegated acts for different delegated powers
Article 117 Amendment to Directive 2001/83/EC
Article 118 Amendment to Regulation (EC) No 178/2002
Article 119 Amendment to Regulation (EC) No 1223/2009
Article 120 Transitional provisions
Article 121 Evaluation
Article 122 Repeal
Article 123 Entry into force and date of application
ANNEXES
ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER I
GENERAL REQUIREMENTS
CHAPTER II
REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
CHAPTER III
REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
ANNEX II
TECHNICAL DOCUMENTATION
ANNEX III
TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
ANNEX IV
EU DECLARATION OF CONFORMITY
ANNEX V
CE MARKING OF CONFORMITY
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
PART A
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31
PART B
CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29
PART C
THE UDI SYSTEM
ANNEX VII
REQUIREMENTS TO BE MET BY NOTIFIED BODIES
ANNEX VIII
CLASSIFICATION RULES
CHAPTER I
DEFINITIONS SPECIFIC TO CLASSIFICATION RULES
CHAPTER II
IMPLEMENTING RULES
CHAPTER III
CLASSIFICATION RULES
ANNEX IX
CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
CHAPTER I
QUALITY MANAGEMENT SYSTEM
CHAPTER II
ASSESSMENT OF THE TECHNICAL DOCUMENTATION
CHAPTER III
ADMINISTRATIVE PROVISIONS
ANNEX X
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
ANNEX XI
CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION
PART A
PRODUCTION QUALITY ASSURANCE
PART B
PRODUCT VERIFICATION
ANNEX XII
CERTIFICATES ISSUED BY A NOTIFIED BODY
CHAPTER I
GENERAL REQUIREMENTS
CHAPTER II
MINIMUM CONTENT OF THE CERTIFICATES
ANNEX XIII
PROCEDURE FOR CUSTOM-MADE DEVICES
ANNEX XIV
CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
PART A
CLINICAL EVALUATION
PART B
POST-MARKET CLINICAL FOLLOW-UP
ANNEX XV
CLINICAL INVESTIGATIONS
CHAPTER I
GENERAL REQUIREMENTS
CHAPTER II
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
CHAPTER III
OTHER OBLIGATIONS OF THE SPONSOR
ANNEX XVI
LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
ANNEX XVII
CORRELATION TABLE
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