REGULATION (EU) 2017/745

CHAPTER I: SCOPE AND DEFINITIONS

Article 1: Subject matter and scope
Article 2: Definitions
EU Q&A
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 10a: Obligations in case of interruption or discontinuation of supply of certain devices
EU GL
EU Q&A
Article 11: Authorised representative
Article 12: Change of authorised representative
Article 13: General obligations of importers
EU Q&A
Article 14: General obligations of distributors
EU Q&A
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 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 I: Classification

Article 51: Classification of devices

SECTION II: 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 I: 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 II: 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 91: Implementing acts
Article 92: Electronic system on vigilance and on post-market surveillance

SECTION III: 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
EU GL
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
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 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 assessment of the technical documentation
ANNEX X: Conformity assessment based on type examination
ANNEX XI: Conformity assessment based on product conformity verification
ANNEX XII: Certificates issued by a notified body
ANNEX XIII: Procedure for custom-made devices
ANNEX XV: Clinical investigations
ANNEX XVI: List of groups of products without an intended medical purpose referred to in Article 1(2)
ANNEX XVII: Correlation table