Need some brainstorming on the Classification of a Medical Device

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drrekha

A hub (which communicates to the Blood Pressure Monitor or glucose monitor etc ) is at present a Class II (acc to submission with FDA) and would fall into class I based on the MDDS rule. Now if this hub is to be shipped in Europe then what classification does it fall into? Based on the determination criteria as per EU directives, I feel it is Class 1 non measuring and which also means that a self declaration with no involvement of notified body will suffice.
 

Ajit Basrur

Leader
Admin
A hub (which communicates to the Blood Pressure Monitor or glucose monitor etc ) is at present a Class II (acc to submission with FDA) and would fall into class I based on the MDDS rule. Now if this hub is to be shipped in Europe then what classification does it fall into? Based on the determination criteria as per EU directives, I feel it is Class 1 non measuring and which also means that a self declaration with no involvement of notified body will suffice.

Welcome drrekha :bigwave:

You can refer to the document for device classification in Europe HERE

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D

drrekha

Thanks Ajit for your reply! I am new in the field. I already looked at the guidance document for classification rules in Europe. To be specific, I am stuck at Rule 10 b/c hub does not directly measure any blood pressure readings but it definitely talks to the digital BP (Acknowledges the reading, stores and transfers the data to the web server where clinician can see). So does that mean it also falls under active device definition and based on Rule 10 can be a class IIa/IIb? Any advice will be appreciated.
 

somashekar

Leader
Admin
Thanks Ajit for your reply! I am new in the field. I already looked at the guidance document for classification rules in Europe. To be specific, I am stuck at Rule 10 b/c hub does not directly measure any blood pressure readings but it definitely talks to the digital BP (Acknowledges the reading, stores and transfers the data to the web server where clinician can see). So does that mean it also falls under active device definition and based on Rule 10 can be a class IIa/IIb? Any advice will be appreciated.
How about class IIb per rule 9, ... All active devices intended to control or monitor the performance of active therapeutic devices in class IIb, or intended directly to influence the performance of such devices are in class IIb.
Blood Pressure Monitor or glucose monitor etc ... are class IIb
Is this making some meaning drRekha ?
 
D

drrekha

Yes it can be Class IIb as per Rule 9 if it was intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care.

But in this case the BP to which this hub is attached obtain readings of vital physiological signals in routine check ups and in self-monitoring and thus BP in this case is Class IIa. So I understand as the system (hub and BP) the classiffication would be Class IIa but for the hub alone what classficatuion makes sense. The intended use of the hub being acknowledging, storing and tranfering the readings from BP moniotr to the web server where a clinician can read. The hub does not alter any data as such.
 

somashekar

Leader
Admin
Yes it can be Class IIb as per Rule 9 if it was intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care.

But in this case the BP to which this hub is attached obtain readings of vital physiological signals in routine check ups and in self-monitoring and thus BP in this case is Class IIa. So I understand as the system (hub and BP) the classiffication would be Class IIa but for the hub alone what classficatuion makes sense. The intended use of the hub being acknowledging, storing and tranfering the readings from BP moniotr to the web server where a clinician can read. The hub does not alter any data as such.
Going by your explanation, it does not fit into active medical device ? Can we agree on this ?
If this is the case then the rules open are 1,2,3,4.
Then by rule 1 it must fall into class I.
Remember this :
- Accessories are classified in their own right separately from the device with which they are used
- If a given device can be classified according to several rules, then the highest possible class applies.
How are your competators on this classification ?
Since we are brainstorming ... Have you first decided if the product concerned is a medical device as defined in Directive 93/42/EEC or an accessory to such a medical device, if it is not excluded from the scope of this Directive and if it therefore comes within the scope of this Directive.
 
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drrekha

Yes, I think that it does not fall in the active device and also that it has no measuring function by itself. So it is Class I non measuring. The only confusion I have is that it is responsible for the transmission of the data so does it make it an active device? It seems no but just wanted an expert opinion on that. Thank you very much for help and guidance.
 

somashekar

Leader
Admin
Yes, I think that it does not fall in the active device and also that it has no measuring function by itself. So it is Class I non measuring. The only confusion I have is that it is responsible for the transmission of the data so does it make it an active device? It seems no but just wanted an expert opinion on that. Thank you very much for help and guidance.
We have not had the real MDD experts coming in on this thread, so its worth waiting. Meanwhile it will do good if you can define the Hub and how its intended use makes it a medical device. What are its inputs and outputs...
 
D

drrekha

This hub receives measurements from user devices (BP monitors) via serial port, connection and stores and forwards the measurements to the web portal via cellular telephone network. It does not come in touch with the body. It does not alter the data in anyways and does not affect the performance of the user device.
 
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