Biosensor prototype for scientific research and CE certification

Other Hardware Sensors
1

I would like to make a biosensor prototype consisting of an Arduino Nano (5Volts) connected to an EMG (electromyographic) sensor and the related sketch.

Can I use this prototype for experimental purposes on people who are well-informed in advance that it is a device for exclusively experimental use aimed at optimizing the sketch of the prototype itself and verifying the hypothesis that the use of this sensor can increase the effectiveness of a biofeedback treatment (however conducted with other professional tools)?

There is therefore no sale or profit, but only a use for experimental purposes; the device therefore, after the trial period, returns to me.

Or the prototype must have the CE certification?

2

Ask your lawyer and then ask your insurance agent.

Paul

3

Thank you for suggestion but my lawyer is not informed about this specific topic; but I will place the same question to my insurance.

In the meantime, is there anyone who has had direct or indirect experience on this specific topic? In the field of research, in Europe, can Arduino prototypes not yet CE certified be used?

Thank you.

4

My understanding is that CE applies to everything you build, there are no exceptions for 'development' purposes.

The requirment is sort of hidden, and I suspect it was deliberate, from the summary of the Radio Equipment Directive (the RED guide).

The RED guide does include an excemption to CE for products that are for personal use that are 'put on the market'.

However, when you dive into the real detail thats in the much bigger BLUE guide, whilst the personal use excemption is there for personal use items that are 'put on the market', there is an additional requirement thats not mentioned in the RED guide.

The BLUE guide contains the requirement to follow CE for items that are 'put into service' and there is no personal use excemption.

You can 'self certify' for CE, but then you need to be sure the stuff you build would be compliant if it was tested.

Thats assuming you were using RF somewhere in your sensor setup ............................

5

Thank you for the answer.

I don't want to use an RF module in my setup. I want to use the following setup:

  • Arduino controller board (CE certified)
  • EMG sensor (CE certified)
  • Vibrating motor (CE certified)

I can use them separately and simply connect them together with connectors, or I can put them all together in a box.

Have I to selfcertify this system in this case?

6

all315:
Thank you for the answer.

I don't want to use an RF module in my setup. I want to use the following setup:

  • Arduino controller board (CE certified)
  • EMG sensor (CE certified)
  • Vibrating motor (CE certified)

I can use them separately and simply connect them together with connectors, or I can put them all together in a box.

Have I to selfcertify this system in this case?

Yes, in theory at least, since its the finished article that needs to be certified, not the component parts.

7

I hope you do realise that the CE logo on a product is just that: the CE logo on a product. That doesn't mean the product is, in fact, formally certified.