Saturday, January 29, 2022

EU MDR Chapter & Articles - Part 2

Hi friends!!!

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

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

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 Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

EU MDR Chapter & Articles - Part 1

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.

In our previous blog we discussed our Chapter I - Chapter V and its articles. Let’s discuss in detail about remaining Chapters & Articles.

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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 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

Now I hope you have acquired some knowledge about EU MDR 2017/745 Chapters & Articles. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

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

Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

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Wednesday, January 12, 2022

EU MDR Chapter & Articles - Part 1

Hi friends!!!

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

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

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 Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

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.