Medical Device Regulation (MDR) 2017/745
The Medical Device Regulation (MDR) 2017/745 is the applicable European law for all economic partners involved in medical devices. The MDR consists of 10 Chapters and 17 Annexes. Find here the overview of the text and Expert explanations and opinions.
Chapters
Article 1
Subject matter and scope
Article 2
Definitions
Article 3
Amendment of certain definitions
Article 4
Regulatory status of products
Reprocessing, CE marking, Free movement
Article 5
Placing on the market and putting into service
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 16
Cases in which opbligations 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
and clinical performance, European database on medical devices
Article 26
Medical devices nomenclature
Article 27
Unique device identification (UDI) system
Article 28
Use of harmonized standards
Article 29
Rgistration of devices
Article 30
Electornic system for registration of economic operators
Article 31
Registration of manufacturers, authorized representatives and importers
Article 32
Summary of safety and clinical performance
Article 33
European database on medical devices
Article 34
Functionality of EUDAMED
Article 35
Authorised responsible for notified bodies
Article 36
Requirements related 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 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
Article 51
Classification of devices
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 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 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 investigation
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
Implementig acts
Article 82
Requirements regarding other clinical investigations
Article 84
Post-market surveillance plan
Article 85
Post-market surveillance report
Article 86
Periodic safety update report (PSUR)
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
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
Expert panels and Device Register
Article 102
Cooperation
Article 103
Medical device coordination group (MDCG)
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 interest
Article 108
Device registers and data banks
Article 109
Confidentiality
Article 111
Levying of fees
Article 112
Funding of activities related to designation and monitoring of notified bodies
Article 113
Penalties
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 (MPD)
Article 119
Amendment to Regulation EC 1223/2009 (cosmetic products)
Article 120
Transitional provisions
Article 121
Evaluation
Article 122
Repeal
Article 123
Entry into force and date of application
Annexes
1. - 9.
General requirements
10.
Chemical, physical and biological properties
11.
Infection and microbial contamination
12.
Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances or of combination of substances that are absorbed by or locally dispersed in the human body
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
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
23.
Label and instructions for use (IFU)
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
1.
Device description and specification, including variants and accessories
1.1.
Device description and specification
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
1.1.
The post-market surveillance plan drawn up in accordance with article 84
1.2.
The PSUR referred to in article 86 and post-market surveillance report referred to in article 85
Part A
1.
Information relating to the economic operator
2.
Information relating to the device
Part B
Core data elements to be provided to teh UDI database together with the UDI-DI in accordance with articles 28 and 29
Part C
1.
Definitions
2.
General requirements
3.
The UDI
4.
UDI carrier
5.
General principles of the UDI database
6.
Rules for specific device types
6.1.
Implantable devices
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
1.
Organisational and general requirements
1.1.
Legal status and organisational structure
1.2.
Independence and impartiality
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 or 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.
Qualification criteria in relation to personnel
4.3.
Application review and contract
4.4.
Allocation of resources
4.5.
Conformity assessment activities
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
2.
Invasive and active devices
3.
Implementing 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
2.
Quality management system assessment
3.
Surveillance assessment applicable to class IIa, class IIb and class III devices
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 procedures 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 redered non-viable
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)
7. - 8.
Administrative provisions
2.
Application
3.
Assessment
4.
Certificate
5.
Changes to the type
6.
Specific additional procedures
7.
Administrative provisions
4. - 5.
Production quality assessment
6.
Quality management system
7.
Surveillance
8.
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 referred to in article 1(8)
9.
Administrative provisions
10.
Application ot class IIa devices
11. - 14.
Product verification
15.
Verification by examination and testing of every product
16.
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 referred to in article 1(8)
17.
Administrative provisions
18.
Application ot class IIa devices
2.
Methods
Chapter II
1.
Application form
2.
Investigator’s brochure (IB)
3.
Clinical investigation plan (CIP)
4.
Other information
Chapter III
Other obligations of the sponsor
Annex
List of groups of products without an intended medical purpose referred to in article 1(2)
