Your fitness tracker records heart rate, steps, sleep patterns, GPS routes. It syncs via BLE to a smartphone app. The app connects to the internet. Art. 3(3)(d) and Art. 3(3)(e) both apply. A compliance lab quotes €9,000 per model. You have 5 models = €45,000. REDCheck: €99 per product. 5 models = €495.
€99 one-time payment · 5 PDF documents in ZIP · 30 minutes · 100% in your browser
Fitness trackers sit at the intersection of two Art. 1(2) categories: internet-connected (Art. 1(2)(a)) and wearable (Art. 1(2)(d)). Both routes lead to Art. 3(3)(e).
You enter your product specifications. REDCheck structures the cybersecurity documentation requirement by requirement, following the EN 18031 categories.
Art. 2(1)(1) defines 'radio equipment' as any product that intentionally emits or receives radio waves. A fitness tracker with BLE or WiFi is radio equipment.
Step count linked to a user account is personal data under GDPR Art. 4(1). Heart rate data is special category data under Art. 9(1). Art. 3(3)(e) applies.
The medical device exemption applies ONLY to devices regulated under Regulation (EU) 2017/745. A consumer fitness tracker without medical device classification is NOT exempt.
5 PDF documents per product model. Each cites the exact article of Directive 2014/53/EU that it covers.
Art. 1, Del. Reg. (EU) 2022/30 + Art. 3(3), Dir. 2014/53/EU.
Art. 21 + Annex V.
Arts. 3(3)(d) and (e).
Art. 18 + Annex VI.
Art. 10(9) + Annex VII.
Look before you buy — Download sample dossier (PDF, fictitious product)
Generated from your data, in your browser. No product data leaves your computer.
5 PDF documents. 30 min. €99. Art. 21 prerequisite for any conformity route.
If you fully apply EN 18031, self-declare via Module A (Annex II). If not, Art. 17(4) requires third-party involvement.
We do not sell testing. We do not sell consulting. We sell the tool that structures your cybersecurity documentation.
Wearables that process health data are under heightened scrutiny.
Arts. 40(1), 40(4) and 43.
Device-level failure can trigger GDPR enforcement. Penalties compound.
EU launch delay costs more than €99.
| Alternative | Cost | What you get |
|---|---|---|
| Compliance lab / Notified Body | €9,000–20,000/model | 3-4 months. Third-party assessment. |
| EU consultancy | €5,000–12,000/model | Custom report. Weeks. |
| Rely on medical device regulations | N/A | Only if classified under MDR 2017/745. |
| REDCheck | €99 | 5 documents, 30 min. Covers Art. 3(3)(d) + (e). |
Professional Pack: €999 for 70 generations.
Request volume pricingREDCheck generates a document structured under Art. 21 and Annex V of Directive 2014/53/EU based on the information you enter. The truthfulness, accuracy and completeness of that information is your responsibility as manufacturer of the radio equipment.
We guarantee that the document structure follows Art. 21 and Annex V of Directive 2014/53/EU and that the legal references cited are correct as of the latest verification date.
REDCheck is not legal advice. For specific situations, consult a lawyer or specialised regulatory consultancy.
Five PDF documents. Art. 21 and Annex V fully structured. Directive 2014/53/EU. Your product data never leaves your computer.