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

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
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?


Involved In Discussions
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

VP QA RA Small Med Dev Company FDA and ISO13485:16
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


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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

Problem Solver
Staff member
Super Moderator
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.


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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...
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