Full text of EU MDR (Medical Device Regulation)

Chapter 1  –  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 2  –  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 3  –  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 4  –  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 6  –  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 8  –  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 9  –  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 10  –  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 1– General safety and performance requirements

Annex 2– Technical documentation

Annex 3– Technical documentation on post-market surveillance

Annex 4– EU declaration of conformity

Annex 5– CE marking of conformity

Annex 6– 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

Annex 7– Requirements to be met by notified bodies

Annex 8– Classification rules

Annex 9– Conformity assessment based on a quality management system and assessment of the technical documentation

Annex 10– Conformity assessment based on type examination

Annex 11– Conformity assessment based on product conformity verification

Annex 12– Certificates issued by a notified body

Annex 13– Procedure for custom-made devices

Annex 14– Clinical evaluation and post-market clinical follow-up

Annex 15– Clinical investigations

Annex 16– List of groups of products without an intended medical purpose referred to in Article 1(2)

Annex 17– Correlation table