Article 1

Subject matter and scope


Section 1
Scope and Definitions
Article 2
Definitions


Chapter I: Introductory provisions Article 3

Regulatory status of products

(Articles 1-4) Section 2
Regulatory Status of products and
Counselling Article 4
Genetic information, counselling and 
informed consent

Article 5
Placing on the market and putting into service


ANNEXES  Article 6

Distance sales

Article 7
Article 107 Committee procedure  Claims


Article 108 Exercise of the delegation  Article 8

Use of harmonised standards

Article 109 Separate delegated acts for
different delegated powers

Article 9
Common specifications

Article 110 Transitional provisions  Chapter X: Final provisions
Article 10
(Articles 107-113) General obligations of manufacturers

Article 111 Evaluation 

Article 112 Repeal  Article 11

Authorised representative

Article 113 Entry into force and date of
application
 Article 12
Change of authorised representative


Chapter II: Making available on the Article 13

Article 102 Confidentiality market and putting into service of General obligations of importers


UnterpArticle 103 Data protection unkt 2 

devices,
Article 14
obligations of economic operators, 
General obligations of distributors
Article 104 Levying of fees  CE marking, free movement
Chapter IX: Confidentiality, data
(Articles 5-21) Article 15
Article 105 Funding of activities related to protection, funding and penalties Person responsible for regulatory compliance

designation and monitoring of notified  (Articles 102-106)
bodies Article 16
Cases in which obligations of manufacturers
Article 106 Penalties Article 106 Penalties  apply to importers, distributors or other

persons

Article 96 Competent authorities  Article 17

EU declaration of conformity


Article 97 Cooperation 
Article 98 Medical Device Coordination Group 
Article 99 Tasks of the MDCG 
Article 18
CE marking of conformity

Chapter: VIII Cooperation between
Member States, Medical Device Article 19

Coordination Group, EU reference Devices for special purposes

Article 100 The European Union reference

laboratories and device registers
 Article 20
laboratories (Articles 96-101) 
Parts and components

Article 101 Device registers and data banks 

Article 21
Free movement


Article 78 Post-market surveillance system of

the manufacturer

Article 22
Identification within the supply chain

Article 79 Post-market surveillance plan 
Section 1 Post-Market Surveillance Article 23
Medical devices nomenclature

Article 80 Post-market surveillance report 

Article 81 Periodic safety update report  Article 25

UDI database


Article 82 Reporting of serious incidents and Chapter III: Identification and

 Article 27
field safety corrective actions traceability of devices, registration
Electronic system for registration of 
of devices and of economic economic operators
Article 83 Trend reporting 
In-vitro diagnostic operators, summary of safety and
clinical performance, European Article 28
Article 84 Analysis of serious incidents and
field safety corrective actions
 regulation (IVDR) - database on medical devices
Registration of manufacturers, authorised 
representatives and importers

Article 85 Analysis of vigilance data 

Section 2 Vigilance
Consolidated (Articles 22-30)
Article 29


Article 86 Implementing acts 

Chapter VII: Post-market version 01.03.2020 Summary of safety and performance

surveillance, vigilance and market Article 30

surveillance European database on medical devices

Article 87 Electronic system on vigilance and
post-market surveillance
 (Articles 78-95)

Article 88 Market surveillance activities  Article 31

Authorities responsible for notified bodies

Article 89 Evaluation of devices suspected of
presenting an unacceptable risk or other non-  Article 32
Requirements relating to notified bodies

compliance

Article 33
Article 90 Procedure for dealing with devices 
Subsidiaries and subcontracting
presenting an unacceptable risk to health 
and safety
Article 34
Application by conformity assessment bodies 
Article 91 Procedure for evaluating national for designation
measures at Union level
 Section 3 Market Surveillannce

Article 35
Article 92 Other non-compliance  Assessment of the application


Article 93 Preventive health protection Article 36

measures
 Nomination of experts for joint assessment 
of applications for notification
Article 94 Good administrative practice 
Article 37
Language requirements

Article 95 Electronic system on market
surveillance

Article 38
Designation and notification procedure


Article 56 Performance evaluation and Article 39

clinical evidence
 Identification number and list of notified 
Chapter IV: Notified Bodies bodies
Article 57 General requirements regarding (Articles 31-46)
performance studies
 Article 40
Monitoring and re-assessment of notified 
Article 59 Informed consent  bodies

Article 60 Performance studies on Article 41

incapacitated subjects
 Review of notified body assessment of
technical documentation


Article 61 Performance studies on minors  and performance evaluation documentation

Article 62 Performance studies on pregnant Article 42

 Changes to designations and notifications

or breastfeeding women

Article 63 Additional national measures  Article 43

Challenge to the competence of notified 
bodies
Article 64 Performance studies in emergency
situations

Article 44
Peer review and exchange of experience
Article 65 Damage compensation  
between authorities responsible for notified
bodies
Article 66 Application for performance
studies

Article 45
Coordination of notified bodies

Article 67 Assessment by Member States 
Article 46
Article 68 Conduct of a performance study  
List of standard fees
Chapter VI: Clinical evidence,
Article 69 Electronic system on performance performance evaluation
studies

and performance studies
Section 1 Article 47
Article 70 Performance studies regarding
(Articles 56-77) Classification Classification of devices

devices bearing the CE marking

Article 48
Conformity assessment procedures

Article 71 Substantial modifications to
performance studies

Article 49
Article 72 Corrective measures to be taken by Involvement of notified bodies in conformity 
Member States and information exchange assessment procedures
between Member States on performance
 Chapter V: Classification and
studies conformity assessment Article 50
(Articles 47-55) Mechanism for scrutiny of conformity 
Article 73 Information from the sponsor at assessments of class D devices
the end of a performance study or in the
event of a temporary halt or early

termination Article 51
Certificates of conformity

Section 2
Article 74 Coordinated assessment Conformity Assessment
procedure for performance studies
 Article 52
Electronic system on notified bodies and on 
Article 75 Review of the coordinated certificates of conformity
assessment procedure

Article 53
Article 76 Recording and reporting of adverse Voluntary change of notified body

events that occur during performance 
studies Article 54
Derogation from the conformity assessment 
Article 77 Implementing acts  procedures

Article 55
Certificate of free sale
