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

Article 5

Placing on the market and putting into service

Article 6

Distance sales

Article 7

Claims

Article 8

Use of harmonized 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 (PRRC)

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

Article 25

Identification within the supply chain

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 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

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 60

Certificate of free sale

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 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 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 (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

Article 101

Competent authorities

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 110

Data protection

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 118

Amendment to Regulation EC 178/2002 (food)

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

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

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

Annex

EU declaration of conformity

Annex

CE marking of conformity

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

1.3.

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 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

1.

Duration of use

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

1.

Quality management system

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

1.

Conformity assessment based on tpe examination

2.

Application

3.

Assessment

4.

Certificate

5.

Changes to the type

6.

Specific additional procedures

7.

Administrative provisions

1. - 3.

Conformity assessment based on product conformity verification

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

Annex

Certificates issed by a notified body

Annex

Procedure for custom-made devices

Annex

Clinical evaluation and Post-market clinical follow-up

Chapter I
1.

Ethical principles

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)

Annex

Correlation table