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classification of heart lung machine
Although you need to be a bit more specific on which heart lung machine you are referring to. But still I will try to give an answer based on AI response. From the list of notified devices, we have the following similar device: Device Name: Cardiopulmonary bypass heart-lung machine console. IntendedRead more
Although you need to be a bit more specific on which heart lung machine you are referring to. But still I will try to give an answer based on AI response.
From the list of notified devices, we have the following similar device:
Device Name: Cardiopulmonary bypass heart-lung machine console.
Intended Use: A cardiopulmonary bypass heart- lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.
Notification details: dated 3 Sept, 2020 with File. No.29/Misc/03/2020-DC (200)
Device class: B
Comparing the intended use of the heart-lung machine with the notified device, we can see that they are very similar. The heart-lung machine is also a device that is used to interface with the basic units of a gas exchange system, including pumps, oxygenator, and heat exchanger, just like the notified device.
As per the Medical Device Rules 2017, the classification principles are based on the level of risk the device poses to the patient. Class B devices are those with low to moderate risk.
Given that the heart-lung machine is a critical life-supporting device used in major surgeries, it can be considered to have a moderate level of risk. It is not as high-risk as an implantable device, but higher than a simple bandage or thermometer.
Therefore, based on the similarity to the notified device and the risk assessment as per the MDR 2017 rules, the most likely class for the heart-lung machine is Class B.
Kindly let me know if that solved your query 🙂
See lessCustomized medical device packaging matenals. falls under which classification
Customized medical device packaging materials Based on the information provided: - This is a packaging material for medical devices. - It is customized, which means it is designed specifically for a particular medical device. Referring to the Medical Device Rules, 2017 (MDR 2017) for classification:Read more
Customized medical device packaging materials
Based on the information provided:
– This is a packaging material for medical devices.
– It is customized, which means it is designed specifically for a particular medical device.
Referring to the Medical Device Rules, 2017 (MDR 2017) for classification:
As per the Basic Principles and parameters for classification of medical devices in MDR 2017:
1. The intended use/purpose of the device: The intended use of this customized packaging material is to protect and contain the medical device, ensuring its sterility and integrity until use.
2. The level of invasiveness and the duration of use: This is a non-invasive device that comes in contact with the medical device, but not directly with the patient.
3. The risks the device may pose to the patient: The risks associated with this packaging material are relatively low, as it is not directly in contact with the patient. However, improper packaging can potentially impact the sterility and safety of the contained medical device.
Comparing this with the notified devices in the reference list, I could not find a similar device.
Based on the above analysis, the most likely class for this customized medical device packaging material is Class B.
The reasoning is that the packaging material, while not directly in contact with the patient, plays a critical role in maintaining the sterility and safety of the medical device. Therefore, it is classified as a medium-risk device under Class B as per the MDR 2017 guidelines.
See lessWhat is loan license?
Loan license: if someone already have manufacturing license for some product but due to some reason he could not continue to manufacture Then another person manufacture the same product on his license it is called loan license
Loan license: if someone already have manufacturing license for some product but due to some reason he could not continue to manufacture
Then another person manufacture the same product on his license it is called loan license
See lessIf my base licence is gone through the retention, should I take renewed FSC for export of our medical devices ?
Yes you are required with new application for FSC.
Yes you are required with new application for FSC.
See lessHow to include change in model name of device in existing import license?
You need t apply for endorsement in the existing licence.
You need t apply for endorsement in the existing licence.
See lessIs shelf life applicable to stainless steel and titanium medical device?
No it's not applicable to non sterile stainless & titanium devices
No it’s not applicable to non sterile stainless & titanium devices
See lessFor loan license device master file would be Submitted by actual manufacturers or by the person who is taking loan license?
devices master file are submitted by Who taking loan license
devices master file are submitted by Who taking loan license
See less