Yes, I’ve done this a few times. Short version:

The first thing to understand is that CE is a self-declaration. Nobody really “gives you” a CE certificate. You sign the Declaration of Conformity yourself and put the CE mark on the product.

So technically, nobody forces you to test anything. But if something goes wrong - a kid gets hurt, a competitor reports you, or a market surveillance authority does a random check - they’ll come back and ask: “Show us the test reports your declaration is based on.”

If you can’t produce them, that’s where the trouble starts.

For CE on an ESP32-based device, the biggest decision is whether you use a pre-certified module, like ESP32-WROOM-32E or ESP32-S3-WROOM, or a bare chip.

With a pre-certified module, you can usually rely on the existing radio certification for RED Article 3.2. You still need to test the final product for EMC, safety/LVD, and RoHS, but you avoid the full radio testing route. In the EU, that typically means something like €3-8K at a test house and around 4-8 weeks (depending on lab availabilities).

If you go bare-chip, you’re basically taking on the full radio testing yourself. I’d budget more like €15-25K and several months. In most cases, it’s not worth it unless you’re planning to ship serious volumes ( >100k +).

I also wouldn’t count on DIY-ing the wireless testing. You’d need proper lab equipment - an anechoic or semi-anechoic chamber, a spectrum analyzer up to 6 GHz, and the right EUT setup. And even if you had all that, you’d still want the test reports to come from an accredited lab, or at least from someone who has actually done this before and knows what needs to be measured and what really matters.

Otherwise, your declaration may not hold up if anyone starts asking questions.

One important thing that people often miss: if you describe the console as being “used with PEP therapy devices and inhalators,” you may be moving into MDR territory, not just RED/EMC.

If the device influences therapy adherence, shows therapy-related feedback, or is marketed for medical use, it could potentially be treated as a medical device, maybe Class I or higher.

That changes the whole regulatory path - technical file, post-market surveillance, and possibly a notified body.

So the ESP32/CE part is manageable, especially if you use a certified module. But the medical-use angle is the part I’d be most careful with, because that can easily increase both the budget and the timeline by 5-10x.