Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April... (32017R0746)
INHALT
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )
- REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- of 5 April 2017
- on
- in vitro
- diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
- (Text with EEA relevance)
- 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
- ANNEXES
- ANNEX I
- GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
- CHAPTER I
- GENERAL REQUIREMENTS
- CHAPTER II
- REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE
- 9. Performance characteristics
- 10. Chemical, physical and biological properties
- 11. Infection and microbial contamination
- 12. Devices incorporating materials of biological origin
- 13. Construction of devices and interaction with their environment
- 14. Devices with a measuring function
- 15. Protection against radiation
- 16. Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
- 17. Devices connected to or equipped with an energy source
- 18. Protection against mechanical and thermal risks
- 19. Protection against the risks posed by devices intended for self-testing or near-patient testing
- CHAPTER III
- REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE
- 20. Label and instructions for use
- 20.1. General requirements regarding the information supplied by the manufacturer
- 20.2. Information on the label
- 20.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’):
- 20.4. Information in the instructions for use
- ANNEX II
- TECHNICAL DOCUMENTATION
- 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
- 1.1. Device description and specification
- 1.2. Reference to previous and similar generations of the device
- 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
- 3. DESIGN AND MANUFACTURING INFORMATION
- 3.1. Design information
- 3.2. Manufacturing information
- 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
- 5. BENFIT-RISK ANALYSIS AND RISK MANAGEMENT
- 6. PRODUCT VERIFICATION AND VALIDATION
- 6.1. Information on analytical performance of the device
- 6.1.1. Specimen type
- 6.1.2. Analytical performance characteristics
- 6.1.2.1. Accuracy of measurement
- 6.1.2.2. Analytical sensitivity
- 6.1.2.3. Analytical specificity
- 6.1.2.4. Metrological traceability of calibrator and control material values
- 6.1.2.5. Measuring range of the assay
- 6.1.2.6. Definition of assay cut-off
- 6.1.3. The analytical performance report referred to in Annex XIII.
- 6.2. Information on clinical performance and clinical evidence. Performance Evaluation Report
- 6.3. Stability (excluding specimen stability)
- 6.3.1. Claimed shelf-life
- 6.3.2. In-use stability
- 6.3.3. Shipping stability
- 6.4. Software verification and validation
- 6.5. Additional information required in specific cases
- ANNEX III
- TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
- 1. The post-market surveillance plan drawn up in accordance with Article 79.
- 2. The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.
- 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 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM
- PART A
- INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28
- 1. Information relating to the economic operator
- 2. Information relating to the device
- 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
- 1. Definitions
- Automatic identification and data capture (‘AIDC’)
- Basic UDI-DI
- Unit of Use DI
- Configurable device
- Configuration
- UDI-DI
- Human Readable Interpretation (HRI)
- Packaging levels
- Production Identifier (UDI-PI)
- Radio Frequency Identification (‘RFID’)
- Shipping containers
- Unique Device Identifier (‘UDI’)
- UDI carrier
- 2. General requirements
- 3. The UDI
- 4. UDI carrier
- 5. General principles of the UDI database
- 6. Rules for specific device types
- 6.1. Reusable devices that are part of kits and that require cleaning, disinfection, sterilisation or refurbishing between uses
- 6.2. Device software
- 6.2.1. UDI assignment Criteria
- 6.2.4. UDI placement criteria for software
- ANNEX VII
- REQUIREMENTS TO BE MET BY NOTIFIED BODIES
- 1. ORGANISATIONAL AND GENERAL REQUIREMENTS
- 1.1. Legal status and organisational structure
- 1.2. Independence and impartiality
- 1.3. Confidentiality
- 1.4. Liability
- 1.5. Financial requirements
- 1.6. Participation in coordination activities
- 2. QUALITY MANAGEMENT REQUIREMENTS
- 3. RESOURCE REQUIREMENTS
- 3.1. General
- 3.2. Qualification criteria in relation to personnel
- 3.3. Documentation of qualification, training and authorisation of personnel
- 3.4. Subcontractors and external experts
- 3.5. Monitoring of competences, training and exchange of experience
- 4. PROCESS REQUIREMENTS
- 4.1. General
- 4.2. Notified body quotations and pre-application activities
- 4.3. Application review and contract
- 4.4. Allocation of resources
- 4.5. Conformity assessment activities
- 4.5.1. General
- 4.5.2. Quality management system auditing
- 4.5.3. Product verification
- Assessment of the technical documentation
- Type-examinations
- Verification by examination and testing of every product batch
- 4.5.4. Performance evaluation assessment
- 4.5.5. Specific Procedures
- 4.6. Reporting
- 4.7. Final review
- 4.8. Decisions and certifications
- 4.9. Changes and modifications
- 4.10. Surveillance activities and post-certification monitoring
- 4.11. Re-certification
- ANNEX VIII
- CLASSIFICATION RULES
- 1. IMPLEMENTING RULES
- 2. CLASSIFICATION RULES
- 2.1. Rule 1
- 2.2. Rule 2
- 2.3. Rule 3
- 2.4. Rule 4
- 2.5. Rule 5
- 2.6. Rule 6
- 2.7. Rule 7
- ANNEX IX
- CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
- CHAPTER I
- QUALITY MANAGEMENT SYSTEM
- 2. Quality management system assessment
- 2.3. Audit
- 3. Surveillance assessment applicable to class C and class D devices
- CHAPTER II
- ASSESSMENT OF THE TECHNICAL DOCUMENTATION
- 4. Assessment of the technical documentation of class B, C and D devices and batch verification applicable to class D devices
- 5. Assessment of the technical documentation of specific types of devices
- 5.1. Assessment of the technical documentation of class B, C and D devices for self-testing and near-patient testing
- 5.2. Assessment of the technical documentation of companion diagnostics
- CHAPTER III
- ADMINISTRATIVE PROVISIONS
- ANNEX X
- CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
- 2. Application
- 3. Assessment
- 4. Certificate
- 5. Changes to the type
- 6. Administrative provisions
- ANNEX XI
- CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE
- 3. Quality management system
- 4. Surveillance
- 5. Verification of manufactured class D devices
- 6. Administrative provisions
- 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
- 1. PERFORMANCE EVALUATION
- 1.1. Performance evaluation plan
- 1.2. Demonstration of the scientific validity and the analytical and clinical performance:
- 1.2.1. Demonstration of the scientific validity
- 1.2.2. Demonstration of the analytical performance
- 1.2.3. Demonstration of the clinical performance
- 1.3. Clinical evidence and performance evaluation report
- 1.3.2. Performance evaluation report
- 2. CLINICAL PERFORMANCE STUDIES
- 2.1. Purpose of clinical performance studies
- 2.2. Ethical considerations for clinical performance studies
- 2.3. Methods for clinical performance studies
- 2.3.1. Clinical performance study design type
- 2.3.2. Clinical performance study plan
- 2.3.3. Clinical performance study report
- 3. OTHER 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
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