Friday, June 11, 2021

EU MDR Timeline, Chapter and Annex

 

Hi friends!!!

 

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.

 

Let’s get into the topic.

 

WHY EU MDR 2017/745?

 

The incidents like PIP Breast implant scandal forced medical device regulators to think about revising the medical device directive. It resulted in the European Union Medical Device Regulation EU MDR 2017/745. 

The European Union adopted the new Medical Device Regulation called EU MDR 2017/745, replacing the two existing directives, the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC. The evolution of technology in the field of healthcare has forced the formation of new medical device regulation. It is also aimed to overcome certain shortcomings in earlier directives.



Image courtesy: Wikipedia
Licensed under: CC Share Alike

 

WHAT IS EU MDR 2017/745 TIMELINE?

 

EU MDR 2017/745 entered into force on 26 May, 2017.


Beginning date of application for EU MDR 2017/745 is on 26 May, 2021. From this date, new devices entering into the market have to be certified under EU MDR 2017/745. Certificates of devices which are already issued under MDD before this date may remain valid for additional 3 years till May 26, 2024.


From 26 May, 2024 – 25 May, 2025 the MDD Devices which are already placed on the market before may continue to be made available.


Last date for putting devices into market according to MDR is on 26 May, 2025. After this date, all devices placed on the market must be in conformity with the EU MDR 2017/745. The devices certified under the EU MDD can no longer be sold or distributed.

 

WHAT ARE THE CHAPTERS IN EU MDR

2017/745?

 

The following are the chapters in EU MDR 2017/745.

 

Chapter I: Scope and Definitions.

Chapter II: Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, 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.

Chapter IV: Notified bodies.

Chapter V: Classification and conformity assessment.

Chapter VI: Clinical evaluation and clinical investigations.

Chapter VII: Post-market surveillance, vigilance and market surveillance.

Chapter VIII: Cooperation between Member States, Medical Device Coordination Group, expert laboratories, expert panels and device registrars.

Chapter IX: Confidentiality, data protection, funding and penalties.

Chapter X: Final provisions.

 

WHAT ARE THE ANNEXES OF EU MDR

2017/745?

 

The following are the Annexures of EU MDR 2017/745.

 

ANNEX 1: General safety and performance requirements.

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 supplied with the registration of devices and economic operators in accordance with article 23 and data elements of UDI in accordance with article 22.

ANNEX VII: Minimum requirements to be met by notified body.

ANNEX VIII: Classification criteria.

ANNEX IX: Conformity assessment based on full quality assurance and design examination.

ANNEX X: Conformity assessment based on type examination.

ANNEX XI: Conformity assessment based on production quality assessment.

ANNEX XII: Custom made devices.

ANNEX XIII: Minimum content of certificates issued by a notified body.

ANNEX XIV: Clinical evidence and post market follow up.

ANNEX XV: Clinical Investigations.

ANNEX XVI: Products without intended medical purpose.

ANNEX XVII: Correlation table.


Now I hope you have acquired some knowledge about EU MDR 2017/745 Timeline, Chapter and Annex. 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! 


Friday, May 28, 2021

Spirometer

 Hi friends!!!


In our previous blogs we have discussed about Oxygen Concentrator, Medical Device Product Life Cycle, Telemedicine, Infant Incubator. Please check out for the link below.


Oxygen Concentrator


Medical Device Product Life Cycle


Telemedicine


Infant Incubator


Today we are going to discuss about Spirometer.


The Spirometer is a important medical device used to diagnose the lung condition. Being a healthcare professional, its important to know in detail about Spirometer 


Let's get into the topic. 


WHAT IS SPIROMETER?


The spirometer is a medical device used to gain understanding about how well the lung functions. The spirometer measures the amount air inhaled and exhaled by the lungs and the speed at which the air is inhaled and exhaled into the lungs. Spirometer is also called as respirometer. The spirometer is used to understand conditions like asthma and also to understand the recovery of lungs after a chronic lung disease. The study done using spirometer is called spirometry. The spirometry is a type of pulmonary function test. The spirometry is used to determine whether the lung conditions is obstructive (exhalation is impaired) or restrictive (inhalation is impaired).



Image courtesy: Wikimedia commons
Licensed under: CC Share Alike

 

OBSTRUCTIVE LUNG DISEASE


In obstructive lung disease there is a difficulty in exhaling and emptying the air in the lungs completely due to damage of the lungs and narrowing of airways.

 

RESTRICTIVE LUNG DISEASE


The restrictive lung disease is a condition in which there is a little air in the lungs and it does a poor job in transferring oxygen into the blood.

 

HOW SPIROMETRY TEST IS PERFORMED?


1. Patient’s nostrils will be closed by placing a clip onto the patient’s nose.


2. A hose attached with mouth piece at one end is given to the patients. Then the patients are asked to seal the mouth piece with their lips.


3. Patient’s have to take deep breathe in and breathe out into the tube. This step is repeated atleast three times to verify the consistency in patient’s breathing. The highest reading out of three is taken as a final result.


4. There should not be any air leaks between patient’s mouth and the mouth piece of the spirometer.

 

WHAT ARE THE COMPONENTS OF SPIROMETER?


The components of spirometer include mouthpiece, hose and an electronic setup to measure air flow. The patient breaths using the mouth piece, which generates air flow into the tube. This air is then converted into an electrical signal using a sensor.

 

WORKING PRINCIPLE OF SPIROMETER


A jar is kept inverted in a chamber of water. The height of jar in the water chamber is proportionate to the amount of air inside the jar. One end of the jar is attached to the mouth piece through which the patient breaths. The other end of the jar is connected to the weight via pulleys. When the patient exhales via mouth piece, the pressure inside the jar increases greater than atmospheric pressure which makes the height of the jar increase above the water. When the patient inhales via mouth piece, the pressure inside the jar decreases than the atmospheric pressure which makes the height of the jar decrease in the water. When the jar moves inside the water chamber due to the exhalation and inhalation of the patient, the weight attached to the jar also moves accordingly. The movement of the jar is then converted into electrical signal and displayed in the form of a graph called spirogram.



Image courtesy: Wikimedia commons
Licensed under: CC Share Alike

 

WHAT IS SPIROGRAM?


When spirometry test is performed, the result is shown in a graph called spirogram. The volume of air inhaled and exhaled is shown along X axis in litres and flow rate is shown along Y axis in litres per second. The inspiration results are plotted below the X axis and the expiration results are plotted above the X axis. Based on the shape and magnitude of the graph, many airway obstruction diseases are diagnosed.

 

IMPORTANT PARAMETERS OF SPIROMETRY TEST

 

FORCED VITAL CAPACITY


The largest amount of air that can be forcefully exhaled after breathing in as much as you can. The value which is lower than normal forced vital capacity indicates a restricted breathing.

 
FORCED EXPIRATORY VOLUME


The amount of air that can be exhaled from lungs in one second. The value lower than normal forced expiratory volume indicates significant obstruction.


Now I hope you have acquired some knowledge about Spirometer. 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! 


Saturday, May 8, 2021

Oxygen Concentrator

 

Hi friends!!!


In our previous blogs we have discussed about Medical Device Product Life Cycle, Telemedicine, Infant Incubator. Please check out for the link below.


Medical Device Product Life Cycle


Telemedicine


Infant Incubator


Today we are going to discuss about Oxygen Concentrator.


In current situation of COVID, Oxygen Concentrator is a important life saving device. Being a healthcare professional, its important to know in detail about Oxygen Concentrator. 


Let's get into the topic. 


WHAT IS OXYGEN CONCENTRATOR?


The Oxygen Concentrator is a medical device used to deliver oxygen to patients suffering from breathing related problems. The Oxygen Concentrator is used when oxygen level in patients’ blood stream is lower than the normal level.


The oxygen level is usually measured using SpO2. The normal level of oxygen in body ranges from 95%-100%. The oxygen level of 94% or below can be considered as lower oxygen saturation level.


The Oxygen Concentrator has housing which consists of compressor, filters, tubing, nasal cannula and face mask. The portable Oxygen Concentrator has a battery attached.


Image courtesy: Wikimedia commons
Licensed under: CC Share Alike


HOW DOES OXYGEN CONCENTRATOR

WORKS?


The Oxygen Concentrator gathers the surrounding atmospheric air and passes it onto the series of filters to remove dust particles and other contaminants. The Oxygen Concentrator then compresses it to the required density and delivers atmospheric oxygen as purified medical grade oxygen into a delivery system. From delivery system, oxygen is passed to the patients via special mask or nasal cannula attached to patients face. The delivery system can be pulsed delivery system or continuous delivery system.


The air we breathe contains 79% of nitrogen and 21% of oxygen. The Oxygen Concentrator has two cylinders which has an inbuilt sieve beds. One of these cylinders is used to remove nitrogen gas from atmospheric air and deliver purified medical grade oxygen. The other cylinder is used to expel the absorbed nitrogen into the atmosphere. The Oxygen Concentrator has a user interface where users can adjust the level of oxygen concentration and delivery settings.


WHAT ARE THE TYPES OF OXYGEN CONCENTRATOR?


There are two types of oxygen concentrator, Portable oxygen concentrator and Stationary oxygen concentrator. The key difference between stationary and portable oxygen concentrator are oxygen output, size & weight, power source, price.


PORTABLE OXYGEN CONCENTRATOR


The portable oxygen concentrator has two types of delivery settings, pulsed and continuous flow delivery settings. The pulsed mode is used to deliver oxygen only when patients inhale. These types of pulsed mode portable oxygen concentrators are more compact in design and have more battery life. The portable oxygen concentrator can be used with multiple forms of power sources, AC and DC.


STATIONARY OXYGEN CONCENTRATOR


The stationary oxygen concentrator has continuous flow delivery system. The continuous flow mode delivers constant air flow continuously. This type of oxygen concentrator is required for patients in need of oxygen even during sleep. The stationary oxygen concentrator have higher oxygen output and lower cost.


ADVANTAGES OF OXYGEN CONCENTRATOR


The modern day Oxygen Concentrator has more advantage over traditional oxygen tanks because the traditional oxygen tanks may cause fire when there is a leak.


The traditional oxygen tanks are large in size and difficult to move. In case of modern-day Oxygen Concentrator, it is easy to move and are available in portable form to be used everywhere.


DISADVANTAGES OF OXYGEN CONCENTRATOR


The main disadvantage of oxygen concentrator is that it requires electrical power to function. However, this problem can be solved in portable oxygen concentrator as it have battery backup.


Now I hope you have acquired some knowledge about Oxygen Concentrator. 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! 



Sunday, April 25, 2021

Medical Device Product Life Cycle


Hi friends!!!


In our previous blog we have discussed about Telemedicine. Please check out for the link below.


Telemedicine


Today we are going to discuss about Medical Device Product Life Cycle


Being a healthcare professional, its important to know in detail about Medical Device Product Life Cycle. 


Let's get into the topic. 


MEDICAL DEVICE

PRODUCT LIFE

CYCLE

 

The concept of Product Life Cycle (PLC) is common for products across different industries. The Life Cycle of Medical Device is a concept derived from broader concept of PLC.

 

The Medical Devices need to be handled differently in each stage of its product life cycle. In olden stages, there were series of regulations which focused only on certain important stages of product life cycle like Design and Development. But in recent times due to the development of standards like ISO 13485:2016 and EU MDR 2017/745 the emphasis is spread equally on all the stages of Medical Device Product Life Cycle.

 

Let’s take a detailed look into each stage of Medical Device Product Life Cycle.




 

PHASES OF

MEDICAL DEVICE

LIFE CYCLE

 

The Medical Device goes through six phases in its entire life span. The following are the six phases of Medical Device Life Cycle.

 

CONCEPT

 

In the Concept phase, a medical device exists in an idea form. It is every important to evaluate the idea. The idea is evaluated by conducting feasibility study and by analyzing the potential risks. The potential markets and target customer groups are identified. The intended use of the medical device is defined.

 

PLANNING

 

In planning phase, the user requirements were captured and converted into technical specification. Later on, prototypes will be developed based on the technical specifications. Several tests will be performed on initial prototypes. The user feedback will be obtained. The project plan and timeline will be defined. The roles and responsibilities of each personnel will be defined as per the project plan.

 

DESIGN


The Design & Development stage has to be carried out with following factors in mind. Manufacturing limitations, ease of component assembly, cost efficiency of processing, intended use, serviceability etc. In this stage, the design verification and design validation will be made. The Design & Development stage shall follow a risk-based approach using tools like FMEA. In this stage, the medical device is designed, tested, review and designed again for further improvement.

 

VALIDATION

 

During Validation phase, the process validation is conducted. In process validation, machine parameters are defined by conducting operational and performance qualification. The medical device is testing in a real time clinical setup like hospitals and clinics. It is called as clinical validation.  The medical device is labelled and initiation for regulatory submissions will be made.

 

LAUNCH

 

After obtaining all the regulatory approvals and certifications, the medical device is launched into the market. The medical device is distributed to healthcare providers, hospitals and clinics. All the sales and marketing activities will be initiated. Product demo’s and clinician training will be given.

 

POST MARKET

 

The Post Market stage is gaining more importance in current regulatory setup. Once the product is launched into the market, the post market surveillance activities begin. The medical device adverse events will be recorded and necessary actions will be initiated. The adverse events will also be reported to applicable regulatory authorities. Product improvement is made based on the feedback obtained during post market phase. Clinical follow-up visits will be carried.


Now I hope you have acquired some knowledge about Medical Device Product Life Cycle. 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!