INHALT

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
(Text with EEA relevance)
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 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
ANNEXES
ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER I
GENERAL REQUIREMENTS
CHAPTER II
REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
10. Chemical, physical and biological properties
10.4. Substances
10.4.1. Design and manufacture of devices
10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances
10.4.3. Guidelines on phthalates
10.4.4. Guidelines on other CMR and endocrine-disrupting substances
10.4.5. Labelling
11. Infection and microbial contamination
13. Devices incorporating materials of biological origin
14. Construction of devices and interaction with their environment
15. Devices with a diagnostic or measuring function
16. Protection against radiation
16.1. General
16.2. Intended radiation
16.4. Ionising radiation
17. Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
18. Active devices and devices connected to them
19. Particular requirements for active implantable devices
20. Protection against mechanical and thermal risks
21. Protection against the risks posed to the patient or user by devices supplying energy or substances
22. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
CHAPTER III
REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
23. Label and instructions for use
23.1. General requirements regarding the information supplied by the manufacturer
23.2. Information on the label
23.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)
23.4. 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
4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
5. BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
6. PRODUCT VERIFICATION AND VALIDATION
6.1. Pre-clinical and clinical data
6.2. Additional information required in specific cases
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
PART A
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31
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 28 AND 29
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
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
6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses
6.3. Systems and procedure packs as referred to in Article 22
6.4. Configurable devices:
6.5. Device Software
6.5.1. UDI assignment Criteria
6.5.4. 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
4.5.4. Pre-clinical evaluation assessment
4.5.5. Clinical evaluation assessment
4.5.6. 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
CHAPTER I
DEFINITIONS SPECIFIC TO CLASSIFICATION RULES
1. DURATION OF USE
2. INVASIVE AND ACTIVE DEVICES
CHAPTER II
IMPLEMENTING RULES
CHAPTER III
CLASSIFICATION RULES
4. NON-INVASIVE DEVICES
4.1. Rule 1
4.2. Rule 2
4.3. Rule 3
4.4. Rule 4
5. INVASIVE DEVICES
5.1. Rule 5
5.2. Rule 6
5.3. Rule 7
5.4. Rule 8
6. ACTIVE DEVICES
6.1. Rule 9
6.2. Rule 10
6.3. Rule 11
6.4. Rule 12
6.5. Rule 13
7. SPECIAL RULES
7.1. Rule 14
7.2. Rule 15
7.3. Rule 16
7.4. Rule 17
7.5. Rule 18
7.6. Rule 19
7.7. Rule 20
7.8. Rule 21
7.9. Rule 22
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 IIa, class IIb and class III devices
CHAPTER II
ASSESSMENT OF THE TECHNICAL DOCUMENTATION
4. Assessment of the technical documentation applicable to class III devices and to the class IIb devices referred to in the second subparagraph of Article 52(4)
5. Specific additional procedures
5.1. Assessment procedure for certain class III and class IIb devices
5.2. Procedure in the case of devices incorporating a medicinal substance
5.3. Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable
5.3.1. Tissues or cells of human origin or their derivatives
5.3.2. Tissues or cells of animal origin or their derivatives
5.4. Procedure in the case of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body
6. Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma as referred to in Article 1(8)
CHAPTER III
ADMINISTRATIVE PROVISIONS
ANNEX X
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
2. Application
3. Assessment
4. Certificate
5. Changes to the type
6. Specific additional procedures
7. Administrative provisions
ANNEX XI
CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION
PART A
PRODUCTION QUALITY ASSURANCE
6. Quality management system
7. Surveillance
9. Administrative provisions
10. Application to class IIa devices
PART B
PRODUCT VERIFICATION
15. Verification by examination and testing of every product
17. Administrative provisions
18. Application to class IIa devices
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
1. Ethical principles
2. Methods
CHAPTER II
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
1. Application form
2. Investigator's Brochure
3. Clinical Investigation Plan
3.1. General
4. Other information
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