Hi friends!!!

In our previous blog, we have discussed about the following topics.

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.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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