Directive 2014/53/EU · Del. Reg. 2022/30Generate my documentation — €99
ACTIVE — Enforcement tracker · Deadline dashboard · Transposition status — Updated weekly from EUR-Lex, Safety Gate, OEIL & 12 official sourcesView regulatory intelligence →

You manufacture TWS earbuds in the US. Under Art. 1(2)(d), they are wearable radio equipment — and Art. 3(3)(e) applies even if they don’t connect to the internet. If they do connect, Art. 3(3)(d) applies too.

Your TWS earbuds are worn on the head. Art. 1(2)(d)(i) defines wearable radio equipment as equipment 'designed or intended to be worn on, strapped to, or hung from any part of the human body, including the head.' Art. 3(3)(e) applies if it processes personal data — regardless of internet connectivity. This is different from most other products. If your earbuds also connect to the internet via a phone app, Art. 3(3)(d) also applies. DOUBLE requirement. REDCheck generates the 5 PDF documents. 30 minutes. €99.

Generate my RED documentation — €99Free: do my TWS earbuds need RED cybersecurity documentation?

€99 one-time payment · 5 PDF documents in ZIP · 30 minutes · 100% in your browser

Directive 2014/53/EU · Art. 3(3)(d)(e)(f) · Art. 21 + Annex V · Art. 18 + Annex VI · Art. 10(9) + Annex VII · Delegated Reg. (EU) 2022/30 · EN 18031-1, -2, -3

Cybersecurity documentation for TWS earbuds: the numbers

TWS earbuds occupy a special regulatory category. As wearable radio equipment, they are subject to Art. 3(3)(e) without needing to be internet-connected. This is unique.

Art. 1(2)(d)
Wearable radio equipment — TWS earbuds worn on the head. Art. 3(3)(e) applies if personal data is processed — NO internet connection required.
Art. 1(1)
Internet-connected radio equipment — if your earbuds connect to the internet via phone app, Art. 3(3)(d) ALSO applies.
€99 (~$108)
Per product model. REDCheck. Covers both Art. 3(3)(d) and (e) where applicable.

What REDCheck does with your earbuds data

You enter your product specifications. REDCheck determines the applicable requirements based on your product’s wearable classification and internet connectivity.

1
Company details
Legal name, role under Directive 2014/53/EU (manufacturer, Art. 10), country, EU contact.
2
Product classification
TWS earbuds worn on head → wearable under Art. 1(2)(d)(i). If they process personal data (voice data, biometric data, usage data, location) → Art. 3(3)(e) applies regardless of internet. If they also connect to the internet via app → Art. 3(3)(d) applies under Art. 1(1).
3
Cybersecurity assessment
EN 18031-2 (personal data) and, if applicable, EN 18031-1 (network): access control, authentication, secure communications, updates, vulnerability management.
4
Risk assessment
Implementation status for each applicable requirement. Structured risk table.
5
EU Declaration of Conformity
Art. 18 + Annex VI. Must list BOTH Art. 3(3)(d) and (e) where applicable.
6
Download ZIP
5 PDFs. Add to technical file. Retain 10 years (Art. 10(4)).

Three mistakes TWS earbuds manufacturers make about EU cybersecurity

❌
COMMON MISTAKE

"Our earbuds only use BLE — no internet, no cybersecurity"

For WEARABLE radio equipment, Art. 3(3)(e) applies even WITHOUT internet connectivity. Art. 1(2)(d) specifically targets equipment worn on the body — including the head. If your BLE earbuds process personal data (voice recordings, biometric data, usage patterns), Art. 3(3)(e) applies regardless of internet access.

❌
COMMON MISTAKE

"Earbuds are just audio devices — they don’t process personal data"

If your earbuds have a microphone (all TWS earbuds do), they are capable of processing voice data. Voice data from an identifiable person is personal data under GDPR Art. 4(1). If your app logs listening habits or pairs with a named account, Art. 3(3)(e) applies.

❌
COMMON MISTAKE

"We have CE marking for EMC and safety — we’re done"

CE marking for EMC and safety does not cover the cybersecurity requirements of Art. 3(3)(d) and (e). These are SEPARATE obligations activated from 1 August 2025.

What's in the ZIP

5 PDF documents per product model. Each cites the exact article of Directive 2014/53/EU that it covers.

1

Product Classification

Art. 1, Del. Reg. (EU) 2022/30 + Art. 3(3), Dir. 2014/53/EU.

2

Cybersecurity Technical Documentation

Art. 21 + Annex V.

3

Risk Assessment

Arts. 3(3)(d) and (e).

4

EU Declaration of Conformity

Art. 18 + Annex VI.

5

Simplified Declaration + Label

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.

What you pay

🧾 EUROPEAN LAB / CONSULTANCY
$5,500–$11,000
Per model. 3–6 months. TWS earbuds with dual requirement may cost more. 5 models = $27,500–$55,000.
✓ REDCHECK
€99 (~$108)
5 documents. 30 min per model. 5 models = €495 (~$540).

Technical documentation and third-party testing: two layers

● LAYER 1

Cybersecurity technical documentation (Annex V)

5 PDF documents. 30 min. €99 per product. For wearables, this must address Art. 3(3)(e) even without internet connectivity.

∅ LAYER 2

Conformity assessment by a Notified Body

If you fully apply EN 18031-2 (and EN 18031-1 where applicable), you can self-declare via Module A (Annex II). If you partially apply, Art. 17(4) requires Notified Body involvement.

We do not sell testing. We do not sell consulting. We sell the tool that structures your cybersecurity documentation.

What happens without cybersecurity documentation

Art. 46 of Directive 2014/53/EU requires effective, proportionate and dissuasive penalties.

🇪🇺
Market withdrawal
Immediate

Arts. 40(1), 40(4) and 43.

🇩🇪
Germany — Produktsicherheitsgesetz
€3,000–€30,000

Germany is the largest EU market for consumer electronics.

🛒
Amazon and marketplace listing removal
Revenue loss

TWS earbuds are a high-volume category on Amazon EU.

🎧
Wearable-specific scrutiny
Increased inspection

Wearable radio equipment has a SEPARATE legal basis under Art. 1(2)(d). Market surveillance specifically targets this category.

Alternatives

AlternativeCostWhat you get
European Notified Body$5,500–$11,000/model3–6 months. Dual (d)+(e) may cost more.
US/EU cybersecurity consultancy$8,000–$20,000/modelCustom report. May not know wearable-specific Art. 1(2)(d).
Assemble yourself$0 (your time)EN 18031: 600+ pages. Art. 1(2)(d) wearable classification is a nuance most DIY approaches miss.
REDCheck€99 (~$108)5 documents, 30 min. Handles wearable classification + dual requirement automatically.

Manufacturing more than one earbuds model?

Professional Pack: €999 for 70 generations.

Request volume pricing
Reply within one business day.

What REDCheck guarantees and what it does not

REDCheck 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.

Frequently asked questions

My earbuds only use BLE to stream audio to the phone. No internet. Does Art. 3(3)(d) apply?
Art. 3(3)(d) applies to internet-connected radio equipment (Art. 1(1)). If your earbuds ONLY use BLE for audio streaming and the phone app does NOT transmit data to the internet, Art. 3(3)(d) may not apply. However, Art. 3(3)(e) still applies under Art. 1(2)(d) if your earbuds process personal data.
What counts as 'personal data' for TWS earbuds?
Under GDPR Art. 4(1): voice recordings via microphone, biometric data (heart rate if health-tracking), listening habits linked to a user account, location data via the phone, device identifiers linked to a person.
We are a US startup with Series A. Our board expects EU launch in Q3. Can we meet the deadline?
REDCheck generates documentation in 30 minutes per model. If you have 5 models, you can complete all documentation in a single day. Module A (self-declaration) is immediate if you fully apply EN 18031.
Will the Cyber Resilience Act change the wearable classification?
The CRA does not use the same wearable classification. It categorizes products by risk class. REDCheck covers the RED window from 1 August 2025 to 11 December 2027. For CRA documentation, SolidwareTools offers CRACheck.
Is it a subscription?
No. One-time payment. Each license includes a 30-day editing window and up to 10 regenerations. The 5 PDF documents you download are yours permanently.
Can I request a refund?
Under Art. 16(m) of Directive (EU) 2011/83 on consumer rights, by activating the license you give express consent to the immediate generation of the digital content, waiving the 14-day right of withdrawal. Refunds are accepted only for reproducible technical failures reported to hello@solidwaretools.com within 14 days of purchase.
What if the regulation changes?
If Directive 2014/53/EU, Delegated Regulation (EU) 2022/30 or the EN 18031 standards change during your license validity period, you can regenerate the documents with the updated version of the generator at no additional cost.

Official legal sources

⚠️ Important notice: REDCheck is a documentary self-assessment tool, not legal advice or a third-party audit. The document is generated from the data you enter. The accuracy of the data is your responsibility under Art. 10(1) of Directive 2014/53/EU. REDCheck does not replace a conformity assessment by a Notified Body where required under Art. 17(4) of the Directive.

Your TWS earbuds are wearable radio equipment. Art. 3(3)(e) applies — even without internet. Generate the documentation in 30 minutes.

Five PDF documents. Art. 21 and Annex V fully structured. Directive 2014/53/EU. Your product data never leaves your computer.

€99 per product (~$108)
One-time payment · No subscription · 30 minutes · 10 regenerations · 30-day editing window · Professional Pack: €999
Generate my RED documentation — €99

Related landings

🐾 GPS trackers

GPS pet tracker manufacturer US: EU cybersecurity Art. 3(3)(d)

🇺🇸 US guide

Do I need RED cybersecurity documentation to sell in Europe?

💰 Cost

How much does RED cybersecurity documentation cost?

✓ Last regulatory check: 6 May 2026 · No substantive changes detected · View history