Rule 11 Question - CE approvals for software as well as the medical device

[Ed Panek]

Our NB approved our device as Class IIa under MDD. The device is a blue tooth biometric sensor that communicates with a smart device application. We are being questioned why we didnt have two CE approvals for software as well as the device. Neither can work without the other which the FDA accepted. Comments?

 

[Marcelo]

Hi, as your comment is about medical devices, I suggest you use the EU Medical Device Regulations. I'll move your question there.

 

[JoshuaFroud]

I'm interested as to who is questioning you?

I currently have a single CE application and technical file covering a physical device and its supporting PC based software. These are also both covered by the same 510(k).

We also have a a seperate stand alone piece of software that has its own CE Technical file. That while predominatly used in conjunction with our device it does not have to be. Which is why it has its on CE file.

Is the smart device application available without the device in any way?

 

[Ed Panek]

The app can be downloaded freely via Google Play or the Apple app store but the app is useless without the bluetooth patch. There is no method to input data to the application other than our BT patch.

Its not a NB or regulatory body questioning us but a potential partner who wants to use our device in support of their drug development

 

[Watchcat]

If the software was included in the information the NB reviewed to support certification (pet peeve here, NBs don't approve anything), then the answer is that the software was included in the one certification. If the software was not included, then I would look at it as a separate device and consult the MDD to see if it is a medical device that falls within its scope.

 

[Ronen E]

One would be a medical device and the other an accessory to it. Since they are both useless without each other, and it's impossible to say which is what, it's almost an inevitable conclusion that they're both parts of one medical device and a single certification should cover both.

 

[Watchcat]

If pharma companies are your target market, it occurs to me that you might want to look at your DoC and certificate as potential marketing materials. Pharma companies typically know little to nothing about device regulation, but they usually do know that software is a hot regulatory topic. From that perspective, their question isn't unreasonable, and this company might not be the last one to ask.

Different companies format their DoCs differently and different NBs do the same with their certificates, I think. Ideally, you would want your DoC to state exactly what it is that you are declaring conforms (i.e., "blue tooth biometric sensor and smart device app.") If you can get your NB to do the same on your certificate, even better.

Of course, given the state of things in the EU right now, it might not be easy (to put it mildly) to engage with your NB on this...

 

[Parul Chansoria]

The smartphone here shall be classified as a component/accessory rather than a seperate device, as both the application and the sensor is not intended to work independently.

As per Annex IX Chapter II ‘Implementing rule’ states “ Application of the classification rules shall be governed by the intended purpose of the devices and Software, which drives a device or influences the use of a device, falls automatically in the same class”, hence, a separate CE mark shall not be applicable since the intended purpose is to use the device in conjunction with the app which is a part of the device.

Also, as per the FDA guidance “Policy for Device Software Functions and Mobile Medical Applications” Software functions that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or analyzing medical device data are considered as accessories to the connected device. The FDA considers such software functions as an extension of the intended use and functionality of the connected medical device. Hence, the device software function would be required to comply with the regulations applicable to the connected medical device in order to address any associated risks and but a separate submission shall not be applicable.

Further, if the app is available to be freely downloaded from Google Play/Apple app store, it should be clearly mentioned that the app would only work if the Bluetooth patch in order to avoid false assumptions.