You build fitness trackers, smartwatches or health monitors with BLE and WiFi. Your EU launch is planned for Q3 2025. Art. 1(2)(d) of Delegated Regulation (EU) 2022/30: wearable radio equipment that processes personal data must comply with Art. 3(3)(e) REGARDLESS of whether it has an internet connection. And if your wearable connects to the internet via a smartphone app, Art. 3(3)(d) also applies. A consultancy quotes $18,000 per model. REDCheck generates the 5 PDF documents. 30 minutes. €99 per product.
€99 one-time payment · 5 PDF documents in ZIP · 30 minutes · 100% in your browser
Wearables are a special category under Delegated Regulation (EU) 2022/30. Art. 1(2)(d) applies Art. 3(3)(e) even without internet connection. Unique among product categories.
You enter your product specifications. REDCheck structures the cybersecurity documentation requirement by requirement, following the EN 18031 categories.
WRONG for wearables. Art. 1(2)(d) applies Art. 3(3)(e) to radio equipment designed to be worn on the body — IF it processes personal data. No internet connection required. Heart rate, step count, sleep data, GPS location — all personal data under GDPR Art. 4(1).
HIPAA is US legislation. It has no legal force in the EU. Art. 3(3)(e) requires the wearable device itself to incorporate safeguards for personal data. EN 18031-2 is the relevant European standard.
Art. 3(3)(e) applies to the RADIO EQUIPMENT — the physical wearable. Recital 8: 'all aspects and parts of the equipment should comply.' If the wearable collects or transmits personal data via BLE or WiFi, it must incorporate safeguards.
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 from EU data protection and market surveillance authorities.
Arts. 40(1), 40(4) and 43 of Directive 2014/53/EU.
A failure at the device level can also trigger GDPR enforcement. The penalties compound.
A compliance delay that pushes your EU launch from Q3 to Q4 costs more than €99.
| Alternative | Cost | What you get |
|---|---|---|
| EU consultancy | $15,000–20,000/model | 4-5 months. Delays launch. |
| Hire EU regulatory specialist | $100,000+/year | If you can afford it at Series A. |
| Rely on HIPAA compliance | $0 | HIPAA has no legal force in the EU. Zero coverage. |
| 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.