Standalone Medical Device Software Qualification

[NarK1]

Dear All!

Could you please help me to define the qualification of our standalone software.
The intended use of the software is the following:
This is a remote monitoring software solution intended to collect and store data from physiological measurement to use at home. It also allows for the automated transmission of the data to a remote secure server and the storage in a database. Then the data will be available for consultation in the web by the user and clinicians for analysis and intervention. The device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucose meter, weight scale, pulse oximeter, blood pressure monitor and thermometer. All these sensors already have CE marking according with 93/42/EEC and 98/79/EEC directives. One solution of the software provides real-time monitoring and another with emergency monitoring emitting alerts.

1. We have two kinds of solutions. One with storing functions and another with storing and alert functions. Are they both medical devices?
By using figure 1 in MEDDEV 2.1/6 - Qualification and Classification of standalone software, storing is not covered by MDD and storing+alerts is covered by MDD. But in the recommendation NB-Med/2.2/Rec4 ? Software and medical devices, 3.1.1, iii), example 6, the two solutions can be medical devices.
And if I use figure 2 in MEDDEV 2.1/6, storing+alerts is a IVD device ? because of the glucose meter sensor. Which one is right in your opinion?

Kind regards

 

[bio_subbu]

Dear All!

Could you please help me to define the qualification of our standalone software.
The intended use of the software is the following:
This is a remote monitoring software solution intended to collect and store data from physiological measurement to use at home. It also allows for the automated transmission of the data to a remote secure server and the storage in a database. Then the data will be available for consultation in the web by the user and clinicians for analysis and intervention. The device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucose meter, weight scale, pulse oximeter, blood pressure monitor and thermometer. All these sensors already have CE marking according with 93/42/EEC and 98/79/EEC directives. One solution of the software provides real-time monitoring and another with emergency monitoring emitting alerts.

1. We have two kinds of solutions. One with storing functions and another with storing and alert functions. Are they both medical devices?
By using figure 1 in MEDDEV 2.1/6 - Qualification and Classification of standalone software, storing is not covered by MDD and storing+alerts is covered by MDD. But in the recommendation NB-Med/2.2/Rec4 – Software and medical devices, 3.1.1, iii), example 6, the two solutions can be medical devices.
And if I use figure 2 in MEDDEV 2.1/6, storing+alerts is a IVD device – because of the glucose meter sensor. Which one is right in your opinion?

Kind regards

Hi

It Seems like "Aging in Place" product. Aging in Place is a system for home care monitoring (for care recipients(aged people at home)) uses through Information technology (IT) and mobile telecommunication to monitor the patient’s health remotely. Can you please confirm or provide some additional information?.

 

[NarK1]

Hello,

First of all, thank you for your reply. You are correct, the remote monitoring software is used for all people that need to control their blood pressure, heart rate, temperature, glucose and weight. This software will be implemented in a tablet or pc and connect to this are the respective sensors. This data will then be available for consultation in the web by the user or clinicians. This software has two different solutions, one only stores, represent and transmit the data and the other can to the same plus signal an alert if the physiological values are in critical values. My question is if the two solutions are covered under medical devices directives. If you need more information please just ask.

Kind regards,

 

[Marcelo]

If any of the monitoring (storage or not) intends to alert for a clinical situation based on the sensors, and then someone has to act upon the monitoring, then it?s a medical device.

The risk class will be based on the risk classes of the monitored parameters (the most strict).

Note that even your mention of "represent" may make it a medical device because your representation, for example, can include some calculation on the data to fit the presentation format.

 

[NarK1]

Obrigado Marcelo. I have a question, when you wrote "The risk class will be based on the risk classes of the monitored parameters (the most strict)" but by the MEDDEV 2.4/1 Rev.9, page 43, Note 1, "Vital physiological processes and parameters include, for example respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological processes in anesthesia, intensive care or emergency care are in Class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals in routine check ups and in self-monitoring are in Class IIa.". So the classification is by the most strict monitored parameter or by the intended use of the device? By the way do you think is class IIa or IIb? By the above note I think is IIa but I'm not sure, if you have another type of guidelines that you can recommend it will be very helpful.

Kind regards,

 

[Marcelo]

It would be by the intended use of the device that gets the parameters. One way to think about this is that your device is an "extension" of the other device, so if the other device is intended to be used in anesthesia, and due to this it is a class IIb (that comment is just generic anyway, you know), the your device would be a class IIb.

 

[isoalchemist]

Although you are talking MEDDEV, take a look at the FDA Medical Device Data System classification. If I understand correctly you are collecting data from "approved" medical devices and allowing that information to be communicated.

That is different than if you are developing or controlling the collection device and software. You are in a very interesting area that walks the line between unregulated, to Class I to Class II depending on the features in the US. The same appears true in the MEDDEV so it is important to really define what your system does and how it does it to make your determinations.