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


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.


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


DON’T FORGET TO FOLLOW THIS BLOG PAGE


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Friday, December 31, 2021

EU MDR Economic Operators

 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 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 requirements for Economic Operators.


Let’s discuss in detail about the requirements of Economic Operators.


ECONOMIC OPERATORS

In EU MDR 2017/745, a Manufacturer, authorized representative, importer, distributor and persons referred in article 22(1) & 22(3) are considered as Economic Operators.

 

Let’s discuss in detail about each of the Economic Operators.

 


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MANUFACTURER

The Manufacturer is a natural or legal person or an entity who manufacturers or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets the device under its name or trademark.

 

Article 10 – General Obligations of Manufacturers, states the requirements for Manufacturer.

 

Here are few of the basic responsibilities of Manufacturer’s:


1.     Responsible for Clinical Evaluation and Post Market Surveillance system.

2.  Responsible for establishing & maintaining the Technical Documentation for each product/product family.

3.     Responsible for establishing agreements & communication channels with other Economic operators.

4.     Pre-market classification & registration of the device manufactured.

5.     Responsible for satisfying the UDI System requirements as per EU MDR 2017/745.

6.     Responsible for Post Market Clinical Follow up.

 

AUTHORIZED REPRESENTATIVE

The Authorized Representative is a natural or legal person or an entity established within the European Union who has received and accepted a written mandate to act on behalf of the foreign manufacturer who is located outside the European Union, with respect to the Manufacturer’s legal obligations under this regulation.

 

Article 11 – Authorized Representative, states the requirements for Authorized Representatives.

 

Here are few of the responsibilities of Authorized Representative:


1.  The Authorized Representative is jointly responsible for Defective Medical Device Placed in the European Union Market.

2.     To fulfill the requirements & obligations as per its agreements with Manufacturer.

3.  To make sure the availability of Product Technical Documentation, registration details and other certificates in its registered location or whenever asked by the relevant regulatory authorities.

4.     Responsible for communication with Competent Authorities & other relevant regulatory authorities.

5.  Provide immediate and timely update to the manufacturer regarding the complaints and reports of incidents with respect to the device placed in European Market.

 

IMPORTER

The Importer is a natural or legal person or an entity established within the union who places a device from a third country on the Union Market.


Article 13 – General Obligations for Importers, states the requirements for Importer.

 

Here are few of the responsibilities of Importers:


1.    Responsible for UDI requirements of the device, need to ensure whether the manufacturer has satisfied all the requirements of UDI as per EU MDR 2017/745.

2.    To verify whether the device is properly labelled and provided with all the supporting documents like Instructions for use, user manuals etc.

3.     Establish and maintain communication channels with the manufacturer.

4.     To maintain a register for product complaints and other non-conformities.

 

DISTRIBUTOR

The Distributor is a natural or legal person or an entity in the supply chain, other than the manufacturer or the importer, who makes the device available on the market, up until the point of putting into service.

 

Article 14 – General Obligations for Distributor, states the requirements for Distributor.

 

Here are few of the responsibilities of Distributors:


1.     To ensure safe storage and transportation of Medical Device.

2.  To establish and maintain communication channels with manufacturer, authorized representative, importer to inform about complaints, feedback from clinicians and other non-conformities.

3.     Responsible for traceability of the product.

4.     Responsible for Product recalls & advisory notices.

 

Apart from above mentioned Economic Operators, persons referred in Article 22(1) & Article 22(3) will also be considered as an Economic Operator.

 

ARTICLE 22(1)

Natural or legal persons who combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:

(a) other devices bearing the CE marking;

(b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;

(c) other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.

 

ARTICLE 22(3)

Any natural or legal person who sterilises systems or procedure packs referred to in paragraph 1 for the purpose of placing them on the market.


Now I hope you have acquired some knowledge about EU MDR 2017/745 Economic Operators. 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


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend! 


Tuesday, December 14, 2021

EU MDR EUDAMED

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 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 requirements for EUDAMED European Database on Medical Devices.


Let’s discuss in detail about the requirements of EUDAMED European Database on Medical Devices.

 

EUDAMED is a European Database on Medical

Devices


EUDAMED is a public database that provides health and safety information for medical devices. EUDAMED stores and provides access to specific data including medical device identification, adverse events and certification information.


In EU MDR 2017/745 Article 33 provides requirements for EUDAMED.



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ARTICLE 33 EUROPEAN DATABASE ON

MEDICAL DEVICES

 

1. The European database on medical devices EUDAMED was setup for the following purposes:


To enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators.

To enable unique identification of devices within the internal market and to facilitate their traceability.

To enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant to Article 81;

To enable manufacturers to comply with the information obligations laid down in Articles 87 to 90 or in any acts adopted pursuant to Article 91;

To enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them.

 

2. EUDAMED shall include the following electronic systems:


- The electronic system for registration of devices referred to in Article 29(4).

- The UDI-database referred to in Article 28.

- The electronic system on registration of economic operators referred to in Article 30

- The electronic system on notified bodies and on certificates referred to in Article 57.

- The electronic system on clinical investigations referred to in Article 73.

- The electronic system on vigilance and post-market surveillance referred to in Article 92.

- The electronic system on market surveillance referred to in Article 100.

 

3. The data shall be entered into Eudamed by the Member States, notified bodies, economic operators and sponsors as specified in the provisions on the electronic systems referred to in paragraph 2. The Commission shall provide for technical and administrative support to users of Eudamed.


4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2.


5. Eudamed shall contain personal data only insofar as necessary for the electronic systems referred to in paragraph 2 of this Article to collate and process information in accordance with this Regulation. Personal data shall be kept in a form which permits identification of data subjects for periods no longer than those referred to in Article 10(8).


6. The Commission and the Member States shall ensure that data subjects may effectively exercise their rights to information, of access, to rectification and to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall also ensure that data subjects may effectively exercise the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data are deleted, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, but no later than 60 days after a request is made by a data subject.


Now I hope you have acquired some knowledge about EU MDR 2017/745 EUDAMED. 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


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend! 

Tuesday, November 30, 2021

EU MDR Classification Rules

 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 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 requirements for Medical Device Classification.


Let’s discuss in detail about the Classification Rules as per EU MDR 2017/745.


EU MDR MEDICAL DEVICE

CLASSIFICATION


In EU MDR 2017/745, Annex VIII Classification Rules talks about Medical Device Classification. Annex VIII has following chapters.

Chapter 1: Definitions specific to classification rules

Chapter 2: Implementing rules

Chapter 3: Classification rules

 

In EU MDR Medical Device is Classified as following

Class I

Class Is – Products which are delivered Sterile

Class Im – Products which has Measuring Function.

Class Ir – Surgical Instruments which are Reusable

Class IIa

Class IIb

Class III

 

The above-mentioned classification is Based on the Risk of the Device and Classification Rules mentioned in Chapter III of Annex VIII.

 

RISK CLASSIFICATION


For example: If the Risk of the Device is Low, Device will be classified as Class I in consideration with the Classification rules. If the Risk of the Device is High, Device is classified as Class III in consideration with Classification rules. (Risk increases, medical device class also increases & vice versa).

Level of Risk possessed by Medical Device is based on following criteria.

1.    Intended Use.

2.    Duration of Use.

Transient Use: Normally intended for continuous use of less than 60 minutes.

Short Term Use: Normally intended for continuous use of 60 minutes – 30 days.

Long Term Use: Normally intended for continuous use of more than 30 days.

3.    Patient Exposure.

4.    Type of Device.

5.    Invasiveness. 

6.    Based on the Severity of harm.

 


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CLASSIFICATION RULES


The Classification Rules are grouped into four.

1. Non-Invasive Devices.

    Non-Invasive device covers Rule 1 – Rule 4.

2. Invasive Devices.

    Invasive Device covers Rule 5 – Rule 8.

3. Active Devices.

    Active Devices covers Rule 9 – Rule 13.

4. Special Rules

    Special Rules covers Rule 14 – Rule 22.

 

The actual rules are as follows:

Rule 1– Non-invasive devices.

Rule 2 – Non-invasive devices intended for channeling or storing (including cells).

Rule 3 – Non-invasive devices that modify biological or chemical composition of blood, body liquids, other liquids and cells.

Rule 4 – Non-invasive devices in contact with injured skin or mucous membrane.

Rule 5 – Devices invasive in body orifices.

Rule 6 – Surgically invasive devices for transient/impermanent use.

Rule 7 – Surgically invasive devices for short term use.

Rule 8 – Surgically invasive devices for long term use and implantable (including any device administering medicinal products, surgical mesh or spinal disc).

Rule 9 – Active therapeutic devices intended to exchange or administer energy.

Rule 10 – Active devices for diagnosis and monitoring that emit ionizing radiation.

Rule 11 – Software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes (from class I to class III).

Rule 12 – Active devices intended to administer and/or remove medicinal products, body liquids or other substances.

Rule 13 – All other active devices.

Rule 14 – Devices incorporating a medicinal substance including human blood or plasma

Rule 15 – Contraception or prevention of the transmission of sexually transmitted diseases

Rule 16 – Specific disinfecting, cleaning, and rinsing devices

Rule 17 – Devices specifically intended for recording of diagnostic images generated by X-ray radiation

Rule 18 – Devices utilising non-viable tissues or cells of human origin or tissues of animal or derivatives

Rule 19 – Devices incorporating or consisting of nanomaterial

Rule 20 – Invasive devices with respect to body orifices to administer medicinal products by inhalation

Rule 21 – Substances or combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed

Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management


Now I hope you have acquired some knowledge about EU MDR 2017/745 Classification Rules. 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


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend!