MDR und IVDR mit Lesezeichen
Geschrieben Sven Schaumann

Medical Device Regulation (MDR und IVDR) in englischer Sprache – Inhaltsverzeichnis und einzelne pdf mit Lesezeichen

Hier Finden Sie die englische MDR und IVDR mit Lesezeichen und Kennzeichnungen aller Kapitel im pdf. Außerdem die Inhaltsverzeichnisse der MDR und IVDR in einer Übersicht sowie als einfache .txt Datei für anderweitige Verwendung, zum Beispiel zum kopieren in eine Gap-Analyse.

Erweitern Sie ihr Expertenwissen.

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Aktuelle Informationen zu relevanten Normen und FDA Guidances.
Sofortige Informationen bei neuen Fachbeiträgen.
Exklusive Anleitungen und Vorlagen:

Update 13.09.2018:
Wir haben für Sie die MDR und IVDR in zwei Dateien getrennt, damit Sie die für Sie relevante Datei einfacher durchsuchen können. Hier stehen beide Normen für Sie zur Verfügung. Für Beratung und Fragen stehen wir Ihnen gerne zur Verfügung.

Hinweis: Es ist sehr zu empfehlen diese englische Version der MDR zu verwenden. Die ins deutsche übersetzte Version der MDR enthält vielfach inhaltliche Fehler. Unter diesem Link finden Sie dennoch die von uns mit Lesezeichen ergänzte deutsche Version der MDR.


Kurzlinks:

MDR – englisch – pdf mit Lesezeichen

IVDR – englisch – pdf mit Lesezeichen

MDR und IVDR – englisch – pdf als originale Version
MDR und IVDR – englisch – als HTML Version
Link zur mehrsprachigen Website mit allen MDR Varianten

 


Medical Device Regulation (MDR) als pdf, mit Lesezeichen

Um das Lesen und Durchblättern der Medizinprodukteverordnung etwas einfacher zu gestalten haben wir deshalb die originale englische pdf-Datei der MDR etwas überarbeitet und alle Links und Kapitel in der Datei markiert. Für jedes der Kapitel finden Sie in dieser pdf Datei ein digitales Lesezeichen, damit Sie sich schneller durch die MDR klicken können.

Dadurch kann man sich zum einen einen schnelleren Überblick über alle Inhalte verschaffen, aber auch schnell zu einem Thema springen und sich dort einlesen, ohne lange suchen zu müssen.
Insbesondere bei solchen Richtlinien wie der Medical Device Regulation muss man beim Lesen mehrmals hin- und herblättern und die Lesezeichen vereinfachen das einlesen enorm.

 

MDR und IVDR als pdf mit markierten Kapiteln (Lesezeichen)

MDR und IVDR als pdf Datei mit markierten Kapiteln (Lesezeichen, Beispiel aus deutscher Version)

MDR und IVDR - Zugriff auf Lesezeichen im Browser

MDR und IVDR – Zugriff auf die pdf-Lesezeichen im Browser (Beispiel aus deutscher Version)

Inhaltsverzeichnis der Medizinprodukteverordnung (MDR), englisch

Hier eine Auflistung aller Abschnitte der englischen MDR und IVDR:

MDR Inhaltsverzeichnis als .txt Datei (englisch)
IVDR Inhaltsverzeichnis als .txt Datei (englisch)

Inhalt der MDR –  Regulation (EU) 2017/745 (englisch)


REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical
devices, amending Directive 2

CHAPTER I –
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 II –
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 III –
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 syste
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 IV –
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 V
CLASSIFICATION AND CONFORMITY ASSESSMENT

SECTION 1
Classification

Article 51 Classification of devices

SECTION 2
Conformity assessment

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

CHAPTER VI
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 VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

SECTION 1
Post-market surveillance

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

SECTION 2
Vigilance

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

SECTION 3
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

CHAPTER VIII
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 IX
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 X
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 I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

CHAPTER I
GENERAL REQUIREMENTS

CHAPTER II
REQUIREMENTS REGARDING DESIGN AND MANUFACTURE

CHAPTER III
REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE

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

PART A
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31

PART B
CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29

PART C
THE UDI SYSTEM

ANNEX VII
REQUIREMENTS TO BE MET BY NOTIFIED BODIES

ANNEX VIII
CLASSIFICATION RULES

CHAPTER I
DEFINITIONS SPECIFIC TO CLASSIFICATION RULES

CHAPTER II
IMPLEMENTING RULES

CHAPTER III
CLASSIFICATION RULES

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

CHAPTER I
QUALITY MANAGEMENT SYSTEM

CHAPTER II
ASSESSMENT OF THE TECHNICAL DOCUMENTATION

CHAPTER III
ADMINISTRATIVE PROVISIONS

ANNEX X
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION

ANNEX XI
CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION

PART A
PRODUCTION QUALITY ASSURANCE

PART B
PRODUCT VERIFICATION

ANNEX XII
CERTIFICATES ISSUED BY A NOTIFIED BODY

CHAPTER I
GENERAL REQUIREMENTS

CHAPTER II
MINIMUM CONTENT OF THE CERTIFICATES

ANNEX XIII
PROCEDURE FOR CUSTOM-MADE DEVICES

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

PART A
CLINICAL EVALUATION

PART B
POST-MARKET CLINICAL FOLLOW-UP

ANNEX XV
CLINICAL INVESTIGATIONS

CHAPTER I
GENERAL REQUIREMENTS

CHAPTER II
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION

CHAPTER III
OTHER OBLIGATIONS OF THE SPONSOR

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

ANNEX XVII
CORRELATION TABLE


Inhalt der IVDR – Regulation (EU) 2017/746 (englisch)


REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA
relevance)

CHAPTER I
INTRODUCTORY PROVISIONS

Section 1
Scope and definitions

Article 1 Subject matter and scope
Article 2 Definitions

Section 2
Regulatory status of products and counselling

Article 3 Regulatory status of products
Article 4 Genetic information, counselling and informed consent

CHAPTER II
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, 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 EU declaration of conformity
Article 18 CE marking of conformity
Article 19 Devices for special purposes
Article 20 Parts and components
Article 21 Free movement

CHAPTER III
IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES

Article 22 Identification within the supply chain
Article 23 Medical devices nomenclature
Article 24 Unique Device Identification system
Article 25 UDI database
Article 26 Registration of devices
Article 27 Electronic system for registration of economic operators
Article 28 Registration of manufacturers, authorised representatives and importers
Article 29 Summary of safety and performance
Article 30 European database on medical devices

CHAPTER IV
NOTIFIED BODIES

Article 31 Authorities responsible for notified bodies
Article 32 Requirements relating to notified bodies
Article 33 Subsidiaries and subcontracting
Article 34 Application by conformity assessment bodies for designation
Article 35 Assessment of the application
Article 36 Nomination of experts for joint assessment of applications for notification
Article 37 Language requirements
Article 38 Designation and notification procedure
Article 39 Identification number and list of notified bodies
Article 40 Monitoring and re-assessment of notified bodies
Article 41 Review of notified body assessment of technical documentation and performance evaluation documentation
Article 42 Changes to designations and notifications
Article 43 Challenge to the competence of notified bodies
Article 44 Peer review and exchange of experience between authorities responsible for notified bodies
Article 45 Coordination of notified bodies
Article 46 List of standard fees

CHAPTER V
CLASSIFICATION AND CONFORMITY ASSESSMENT

Section 1
Classification

Article 47 Classification of devices

Section 2
Conformity assessment

Article 48 Conformity assessment procedures
Article 49 Involvement of notified bodies in conformity assessment procedures
Article 50 Mechanism for scrutiny of conformity assessments of class D devices
Article 51 Certificates of conformity
Article 52 Electronic system on notified bodies and on certificates of conformity
Article 53 Voluntary change of notified body
Article 54 Derogation from the conformity assessment procedures
Article 55 Certificate of free sale

CHAPTER VI
CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES

Article 56 Performance evaluation and clinical evidence
Article 57 General requirements regarding performance studies
Article 58 Additional requirements for certain performance studies
Article 59 Informed consent
Article 60 Performance studies on incapacitated subjects
Article 61 Performance studies on minors
Article 62 Performance studies on pregnant or breastfeeding women
Article 63 Additional national measures
Article 64 Performance studies in emergency situations
Article 65 Damage compensation
Article 66 Application for performance studies
Article 67 Assessment by Member States
Article 68 Conduct of a performance study
Article 69 Electronic system on performance studies
Article 70 Performance studies regarding devices bearing the CE marking
Article 71 Substantial modifications to performance studies
Article 72 Corrective measures to be taken by Member States and information exchange between Member States on performance studies
Article 73 Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
Article 74 Coordinated assessment procedure for performance studies
Article 75 Review of the coordinated assessment procedure
Article 76 Recording and reporting of adverse events that occur during performance studies
Article 77 Implementing acts

CHAPTER VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

Section 1
Post-market surveillance

Article 78 Post-market surveillance system of the manufacturer
Article 79 Post-market surveillance plan
Article 80 Post-market surveillance report
Article 81 Periodic safety update report

Section 2
Vigilance

Article 82 Reporting of serious incidents and field safety corrective actions
Article 83 Trend reporting
Article 84 Analysis of serious incidents and field safety corrective actions
Article 85 Analysis of vigilance data
Article 86 Implementing acts
Article 87 Electronic system on vigilance and post-market surveillance

Section 3
Market surveillance

Article 88 Market surveillance activities
Article 89 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
Article 90 Procedure for dealing with devices presenting an unacceptable risk to health and safety
Article 91 Procedure for evaluating national measures at Union level
Article 92 Other non-compliance
Article 93 Preventive health protection measures
Article 94 Good administrative practice
Article 95 Electronic system on market surveillance

CHAPTER VIII
COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS

Article 96 Competent authorities
Article 97 Cooperation
Article 98 Medical Device Coordination Group
Article 99 Tasks of the MDCG
Article 100 The European Union reference laboratories
Article 101 Device registers and databanks

CHAPTER IX
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES

Article 102 Confidentiality
Article 103 Data protection
Article 104 Levying of fees
Article 105 Funding of activities related to designation and monitoring of notified bodies
Article 106 Penalties

CHAPTER X
FINAL PROVISIONS

Article 107 Committee procedure
Article 108 Exercise of the delegation
Article 109 Separate delegated acts for different delegated powers
Article 110 Transitional provisions
Article 111 Evaluation
Article 112 Repeal
Article 113 Entry into force and date of application

ANNEXES

ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

CHAPTER I
GENERAL REQUIREMENTS

CHAPTER II
REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE

CHAPTER III
REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE

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 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM

PART A
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC
OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28

PART B
CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN
ACCORDANCE WITH ARTICLES 25 AND 26

PART C
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

CHAPTER I
QUALITY MANAGEMENT SYSTEM

CHAPTER II
ASSESSMENT OF THE TECHNICAL DOCUMENTATION

CHAPTER III
ADMINISTRATIVE PROVISIONS

ANNEX X
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION

ANNEX XI
CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE

ANNEX XII
CERTIFICATES ISSUED BY A NOTIFIED BODY

CHAPTER I
GENERAL REQUIREMENTS

CHAPTER II
MINIMUM CONTENT OF THE CERTIFICATES

ANNEX XIII
PERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP

PART A
PERFORMANCE EVALUATION AND PERFORMANCE STUDIES

PART B
POST-MARKET PERFORMANCE FOLLOW-UP

ANNEX XIV
INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES

CHAPTER I
DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES

CHAPTER II
OTHER OBLIGATIONS OF THE SPONSOR

ANNEX XV
CORRELATION TABLE

 



Vorsicht:
Wir haben die gesamte Richtlinie sorgfältig gelesen, markiert und Lesezeichen eingefügt. Trotzdem können wir keine Gewährleistung oder Garantie auf Vollständigkeit oder Korrektheit übernehmen.
Bitte auf jeweils aktuellste und vollständige Version unter eur.lex prüfen. Die offiziellen Links sind oben zu finden.


(erste Version:21.01.2018)

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