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Medical Device Regulation (MDR)
In Vitro Diagnostic Medical Devices Regulation (IVDR)
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In-vitro-Diagnostika Seminare
Deutsche Version
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Medical Device Regulation (MDR)
Recitals
Recitals 1 - 10
Recitals 11 - 20
Recitals 21 - 30
Recitals 31 - 40
Recitals 41 - 50
Recitals 51 - 60
Recitals 61 - 70
Recitals 71 - 80
Recitals 81 - 90
Recitals 91 - 101
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 compliancen
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 system
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
Notes
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
Notes Annex I
Annex II: Technical documentation
Notes Annex II
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
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
In Vitro Diagnostic Medical Devices Regulation (IVDR)
Recitals
Recitals 1 - 10 (IVDR)
Recitals 11 - 20 (IVDR)
Recitals 21 - 30 (IVDR)
Recitals 31 - 40 (IVDR)
Recitals 41 - 50 (IVDR)
Recitals 51 - 60 (IVDR)
Recitals 61 - 70 (IVDR)
Recitals 71 - 80 (IVDR)
Recitals 81 - 90 (IVDR)
Recitals 91 - 101 (IVDR)
Chapter I: Introductory provisions
Section 1: Scope and definitions
Article 1: Subject matter and scope
Article 2: Definitions
Section 2: Regulatory status of products and counselling
Article 3: Regulatory status of products
Article 4: Genetic information, counselling and informed consent
Chapter II: Making available on the market and putting into service of devices, obligations of economic operators, 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: EU declaration of conformity
Article 18: CE marking of conformity
Article 19: Devices for special purposes
Article 20: Parts and components
Article 21: 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 22: Identification within the supply chain
Article 23: Medical devices nomenclature
Article 24: Unique Device Identification system
Article 25: UDI database
Article 26: Registration of devices
Article 27: Electronic system for registration of economic operators
Article 28: Registration of manufacturers, authorised representatives and importers
Article 29: Summary of safety and performance
Article 30: European database on medical devices
Chapter IV: Notified bodies
Article 31: Authorities responsible for notified bodies
Article 32: Requirements relating to notified bodies
Article 33: Subsidiaries and subcontracting
Article 34: Application by conformity assessment bodies for designation
Article 35: Assessment of the application
Article 36: Nomination of experts for joint assessment of applications for notification
Article 37: Language requirements
Article 38: Designation and notification procedure
Article 39: Identification number and list of notified bodies
Article 40: Monitoring and re-assessment of notified bodies
Article 41: Review of notified body assessment of technical documentation and performance evaluation documentation
Article 42: Changes to designations and notifications
Article 43: Challenge to the competence of notified bodies
Article 44: Peer review and exchange of experience between authorities responsible for notified bodies
Article 45: Coordination of notified bodies
Article 46: List of standard fees
Chapter V: Classification and conformity assessment
Section 1: Classification
Article 47: Classification of devices
Section 2: Conformity assessment
Article 48: Conformity assessment procedures
Article 49: Involvement of notified bodies in conformity assessment procedures
Article 50: Mechanism for scrutiny of conformity assessments of class D devices
Article 51: Certificates of conformity
Article 52: Electronic system on notified bodies and on certificates of conformity
Article 53: Voluntary change of notified body
Article 54: Derogation from the conformity assessment procedures
Article 55: Certificate of free sale
Chapter VI: Clinical evidence, performance evaluation and performance studies
Article 56: Performance evaluation and clinical evidence
Article 57: General requirements regarding performance studies
Article 58: Additional requirements for certain performance studies
Article 59: Informed consent
Article 60: Performance studies on incapacitated subjects
Article 61: Performance studies on minors
Article 62: Performance studies on pregnant or breastfeeding women
Article 63: Additional national measures
Article 64: Performance studies in emergency situations
Article 65: Damage compensation
Article 66: Application for performance studies
Article 67: Assessment by Member States
Article 68: Conduct of a performance study
Article 69: Electronic system on performance studies
Article 70: Performance studies regarding devices bearing the CE marking
Article 71: Substantial modifications to performance studies
Article 72: Corrective measures to be taken by Member States and information exchange between Member States on performance studies
Article 73: Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
Article 74: Coordinated assessment procedure for performance studies
Article 75: Review of the coordinated assessment procedure
Article 76: Recording and reporting of adverse events that occur during performance studies
Article 77: Implementing acts
Chapter VII: Post-market surveillance, vigilance and market surveillance
Section 1: Post-market surveillance
Article 78: Post-market surveillance system of the manufacturer
Article 79: Post-market surveillance plan
Article 80: Post-market surveillance report
Article 81: Periodic safety update report
Section 2: Vigilance
Article 82: Reporting of serious incidents and field safety corrective actions
Article 83: Trend reporting
Article 84: Analysis of serious incidents and field safety corrective actions
Article 85: Analysis of vigilance data
Article 86: Implementing acts
Article 87: Electronic system on vigilance and post-market surveillance
Section 3: Market surveillance
Article 88: Market surveillance activities
Article 89: Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
Article 90: Procedure for dealing with devices presenting an unacceptable risk to health and safety
Article 91: Procedure for evaluating national measures at Union level
Article 92: Other non-compliance
Article 93: Preventive health protection measures
Article 94: Good administrative practice
Article 95: Electronic system on market surveillance
Chapter VIII: Cooperation between member states, medical device coordination group, eu reference laboratories and device registers
Article 96: Competent authorities
Article 97: Cooperation
Article 98: Medical Device Coordination Group
Article 99: Tasks of the MDCG
Article 100: The European Union reference laboratories
Article 101: Device registers and databanks
Chapter IX: Confidentiality, data protection, funding and penalties
Article 102: Confidentiality
Article 103: Data protection
Article 104: Levying of fees
Article 105: Funding of activities related to designation and monitoring of notified bodies
Article 106: Penalties
Chapter X: Final provisions
Article 107: Committee procedure
Article 108: Exercise of the delegation
Article 109: Separate delegated acts for different delegated powers
Article 110: Transitional provisions
Article 111: Evaluation
Article 112: Repeal
Article 113: Entry into force and date of application
Notes
Annexes
Annex I: General safety and performance requirements
Chapter I: General requirements
Chapter II: Requirements regarding performance, design and manufacture
Chapter III: Requirements regarding 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
Part A: Information to be submitted upon the registration of devices and economic operators in accordance with articles 26(3) and 28
Part B: Core data elements to be provided to the udi database together with the udi-di in accordance with articles 25 and 26
Part C: The UDI System
Annex VII: Requirements to be met by notified bodies
Annex VIII: 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 production quality assurance
Annex XII: Certificates issued by a notified body
Chapter I: General requirements
Chapter II: Minimum content of the certificates
Annex XIII: Performance evaluation, performance studies and post-market performance follow-up
Part A: Performance evaluation and performance studies
Part B: Post-market performance follow-up
Annex XIV: Interventional clinical performance studies and certain other performance studies
Chapter I: Documentation regarding the application for interventional clinical performance studies and other performance studies involving risks for the subjects of the studies
Chapter II: Other obligations of the sponsor
Annex XV: Correlation table
Medical Device Seminars
In-vitro-Diagnostika Seminare
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IN VITRO DIAGNOSTIC MEDICAL DEVICES
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