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Europäische und internationale Rechtsgrundlagen für Medizinprodukte

2017/745 (EU) – „Medizinprodukte” (Verordnung)

2017/745 (EU) – ”Medical Devices Regulation" (Englisch)

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 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

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

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

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 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 investigation

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

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

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

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

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

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

ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

ANNEX II TECHNICAL DOCUMENTATION

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

ANNEX VII REQUIREMENTS TO BE MET BY NOTIFIED BODIES

ANNEX VIII CLASSIFICATION RULES

ANNEX IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION

ANNEX X CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION

ANNEX XI CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION

ANNEX XII CERTIFICATES ISSUED BY A NOTIFIED BODY

ANNEX XIII PROCEDURE FOR CUSTOM-MADE DEVICES

ANNEX XIV CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP

ANNEX XV CLINICAL INVESTIGATIONS

ANNEX XVI LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)

ANNEX XVII CORRELATION TABLE

2017/746 (EU) − „In-vitro-Diagnostika” (Verordnung)

722/2012 (EU) – „Verwendung von Gewebe tierischen Ursprungs” (Verordnung)

2016/425/EU − „Persönliche Schutzausrüstungen” (Verordnung)

2017/2185 (EU) – „Verzeichnis der Codes und der ihnen entsprechenden Produktarten zur Bestimmung des Geltungsbereichs der Benennung einer Benannten Stelle” (Durchführungsverordnung)

2020/1207 (EU) – „Gemeinsame Spezifikationen für die Aufbereitung von Einmalprodukten” (Durchführungsverordnung)

2021/2078 (EU) − „Europäische Datenbank für Medizinprodukte (Eudamed)" (Durchführungsverordnung)

2021/2226 (EU) − „Elektronische Gebrauchsanweisungen für Medizinprodukte" (Durchführungsverordnung)

2022/2346 (EU) − „Festlegung gemeinsamer Spezifikationen für Produkte ohne medizinische Zweckbestimmung" (Durchführungsverordnung)

2022/2347 (EU) − „Neuklassifizierung von Gruppen bestimmter aktiver Produkte ohne medizinische Zweckbestimmung" (Durchführungsverordnung)

2023/1194 (EU) − „Übergangsbestimmungen für Produkte ohne medizinische Zweckbestimmung (Anhang XVI)" (Durchführungsverordnung)

2023/2197 (EU) − „Zuteilung einmaliger Produktkennungen für Kontaktlinsen” (Delegierte Verordnung)

2019/939 (EU) – „Benennung der Zuteilungsstellen, die für den Bereich eines Systems zur Zuteilung von eindeutigen Produktidentifikationen im Bereich der Medizinprodukte benannt sind” (Durchführungsbeschluss)

2019/1396 (EU) – „Benennung von Expertengremien für Medizinprodukte” (Durchführungsbeschluss)

90/385/EWG – „Aktive implantierbare medizinische Geräte” (Richtlinie)

93/42/EWG – „Medizinprodukte” (Richtlinie)

98/79/EG – „In-vitro-Diagnostika” (Richtlinie)

2006/42/EG – „Maschinen” (Richtlinie)

2010/32/EU – „Vermeidung von Verletzungen durch scharfe/spitze Instrumente im Krankenhaus- und Gesundheitssektor” (Richtlinie)

MEDDEV-Leitlinien

Harmonisierte Normen für Medizinprodukte zur Unterstützung der MDR

Deutsche Rechtsgrundlagen für Medizinprodukte

A0102 2017/745 (EU) – ”Medical Devices Regulation" (Englisch)

Regulation 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. (Veröffentlicht im Amtsblatt der Europäischen Union ABl. Nr. L 117 vom 5. Mai 2017, S. 1)

Die hier vorliegende konsolidierte Fassung enthält den Originaltext sowie alle bisherigen Berichtigungen:

- 1. Korrigendum vom 3. Mai 2019- 2. Korrigendum vom 27. Dezember 2019- Änderungsverordnung 2020/561 vom 23. April 2020- Änderungsverordnung 2023/502 vom 1. Dezember 2022- Änderungsverordnung 2023/607 vom 15. März 2023

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and

Article 168(4)(c) thereof,

Having regard to the proposal from the European Commission,

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