Hi friends!!!
In our previous blog, we have discussed about the following topics.
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation – Part 1
EU MDR Technical Documentation – Part 2
EU MDR General Safety and Performance Requirement
EU MDR Information on the Label
EU MDR Post Market Clinical Follow Up
EU MDR Unique Device Identification – Part 1
EU MDR Unique Device Identification – Part 2
EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.
Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 Chapters & Articles.
Let’s discuss in detail about Chapters & Articles.
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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 harmonized standards
ARTICLE 9:
Common specifications
ARTICLE 10:
General obligations of manufacturers
ARTICLE 11:
Authorized representative
ARTICLE 12:
Change of authorized 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 purpose
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 Device 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, authorized
representative 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 of devices
ARTICLE 51: Classification
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: Electronic system on notified bodies and on
certificates of conformity
ARTICLE 60: Certificate of free sale
Now I hope you have acquired some knowledge about EU MDR 2017/745 Chapters & Articles. We will discuss about remaining chapters & articles in next blog.
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