You are a UK wearable company — fitness trackers, smartwatches, health bands, earbuds, smart rings. You have UKCA marking for the UK. For the EU, you need CE marking. From 1 August 2025, Delegated Regulation (EU) 2022/30 activates Art. 3(3)(e) for wearable radio equipment under Art. 1(2)(d) — any device worn on the body (wrist, head, neck, trunk, feet) that processes personal data. Heart rate, step count, sleep patterns, GPS location, voice recordings — all personal data under Art. 4(1) of the GDPR. The UK has no equivalent requirement. A European consultancy quotes £8,000–15,000 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
Wearable radio equipment has the broadest scope under Delegated Regulation (EU) 2022/30. Art. 1(2)(d) applies Art. 3(3)(e) to wearables that process personal data — regardless of whether they connect to the internet. If they DO connect to the internet, Art. 3(3)(d) applies too.
You enter your product specifications. REDCheck structures the cybersecurity documentation requirement by requirement, following the EN 18031 categories.
Art. 1(2)(d) of Delegated Regulation (EU) 2022/30 applies Art. 3(3)(e) to wearable radio equipment that processes personal data — REGARDLESS of internet connectivity. A fitness tracker worn on the wrist that records heart rate, step count or sleep patterns processes personal data under Art. 4(1) GDPR. Internet is irrelevant. Art. 3(3)(e) applies to your BLE-only tracker.
Since Brexit, UKCA is valid only in Great Britain. The UK has NOT adopted Delegated Regulation (EU) 2022/30. There is no UKCA equivalent of Art. 3(3)(e) for wearables. For the EU market, CE marking under Directive 2014/53/EU with cybersecurity documentation is a separate, mandatory requirement.
The UK Product Security and Telecommunications Infrastructure Act 2022 focuses on passwords, vulnerability reporting and update periods for consumer connectable products. It does NOT require cybersecurity technical documentation under EN 18031 mapped to Annex V. It is a different regime with different requirements. Compliance with PSTI does not satisfy Directive 2014/53/EU.
5 PDF documents generated from your wearable data. 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. Requirement-by-requirement documentation.
Arts. 3(3)(d) and (e). Structured risk table.
Art. 18 + Annex VI.
Art. 10(9) + Annex VII.
Look before you buy — Download sample dossier (PDF, fictitious product) — Real structure, real articles, real format. Fictitious data.
Generated from your data, in your browser. No product data leaves your computer.
5 PDF documents. 30 min. €99 per product. The documentation that Art. 21 requires BEFORE your product can bear CE marking.
If you fully apply EN 18031, you can self-declare via Module A (Annex II) without a Notified Body. If you partially apply or don't apply the harmonised standards, Art. 17(4) requires third-party involvement. REDCheck does not replace a Notified Body — it generates the documentation that is a prerequisite for any conformity route.
We do not sell testing. We do not sell consulting. We sell the tool that structures your cybersecurity documentation under Art. 21 and Annex V.
Art. 46 of Directive 2014/53/EU requires Member States to establish penalties that are effective, proportionate and dissuasive.
Art. 40 of Directive 2014/53/EU. Market surveillance authorities can require withdrawal across all 27 Member States.
Amazon EU marketplaces require CE conformity documentation. UKCA is not accepted. Wearable listings without cybersecurity documentation may be suspended without notice.
A wearable that processes personal data without adequate cybersecurity safeguards may also trigger GDPR enforcement. Art. 3(3)(e) and GDPR protect the same data — a failure in one regime signals a risk in the other.
| Alternative | Cost | What you get |
|---|---|---|
| EU cybersecurity consultancy | £8,000–15,000 | Per model. Weeks of wait. |
| UK-based regulatory advisor | £5,000–10,000 | May not know EN 18031 structure. |
| Assemble documentation yourself | £0 (your time) | EN 18031 has 600+ pages. No template. |
| REDCheck | €99 | 5 documents, 30 min, per model |
If you document 10 or more product models, write to us for the Professional Pack: €999 for 70 generations with a single license key. One generation per product model.
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. We do not guarantee that a specific document will be accepted by a market surveillance authority in a specific case, nor by a commercial buyer in a procurement process.
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. The ZIP you download is yours permanently.