Audio and wearables
EU Declaration of Conformity for Smartwatches and Fitness Trackers: requirements and checklist
By Ing. Jaroslav Křepelka, Owner, DoC solutions s.r.o. · Updated 22 September 2026
A smartwatch is radio equipment worn on the body that almost always processes personal data: heart rate, location, contacts. That combination makes the RED data-protection requirement mandatory since 1 August 2025, on top of the usual radio, EMC and safety requirements, and a body-worn SAR assessment.
This page covers smartwatches and fitness trackers for general consumer use, including models with GPS or LTE. Devices with a medical purpose are a different regime, explained below.
Checklist: what your smartwatch / fitness tracker declaration must contain
- Model exactly as on the case back or packaging, with each size, band and connectivity variant (Bluetooth-only, LTE)
- Name and postal address of the manufacturer (and of the authorised representative, if appointed)
- The statement that the declaration is issued under the sole responsibility of the manufacturer
- Radio Equipment Directive 2014/53/EU, including Delegated Regulation (EU) 2022/30
- RoHS Directive 2011/65/EU
- The harmonised standards for radio, EMC, safety, SAR and cybersecurity, with versions
- Place and date of issue, name and function of the signatory, and the signature
Which EU legislation applies
| Legislation | Applies? | In the DoC? | Notes |
|---|---|---|---|
| Radio Equipment Directive2014/53/EU | Applies | In the DoC: Yes | Safety, EMC and radio. Smartwatches are not among the product categories covered by the USB-C common charger rules. |
| Data protection and cybersecurity delegated actDelegated Regulation (EU) 2022/30 | Applies | In the DoC: Yes | Applicable since 1 August 2025. The data-protection requirement applies to wearable radio equipment that can process personal data, even without internet access; network protection applies to models that communicate over the internet, and the fraud-protection requirement to models that enable payments. |
| RoHS Directive2011/65/EU | Applies | In the DoC: Yes | Restriction of hazardous substances in electrical and electronic equipment. |
| Medical Device Regulation(EU) 2017/745 | Depends on model | In the DoC: Yes | Only if the watch is placed on the market with a medical purpose, such as detecting atrial fibrillation. It then needs MDR conformity assessment, and Delegated Regulation 2022/30 no longer applies to it. |
| Batteries Regulation(EU) 2023/1542 | Applies | In the DoC: No | Obligations for the built-in battery, including end-user removability from 18 February 2027 (Article 11) unless an exception applies. |
| WEEE Directive2012/19/EU | Applies | In the DoC: No | Producer registration in every EU country where you sell and the crossed-out wheeled bin symbol. |
Typical harmonised standards
A harmonised standard gives presumption of conformity only in the version cited in the Official Journal of the EU. Always check the current list for each directive before you issue or update a declaration (European Commission: harmonised standards); the versions below are the ones commonly used at the time of writing, and the right selection depends on your product.
Radio and EMC
Versions shown are cited under RED in Implementing Decision (EU) 2022/2191 as amended; for EN 301 489-1 and the LTE common part EN 301 908-1 use the version listed in the Official Journal.
- ETSI EN 300 328 V2.2.2Bluetooth and 2.4 GHz Wi-Fi
- ETSI EN 303 413 V1.2.1GNSS receivers (GPS, Galileo) — for models with satellite positioning
- ETSI EN 301 908-1 and EN 301 908-13 V13.3.1LTE user equipment — for cellular models
- ETSI EN 301 489-1 with EN 301 489-17 V3.3.1 and EN 301 489-52EMC for radio equipment (-52 for cellular user equipment)
Safety and SAR
- EN 62368-1ICT equipment safety (LVD list: 2014 edition; current edition EN IEC 62368-1:2024 + A11:2024)
- EN 50566:2017 + A1:2023Specific absorption rate (SAR) of wireless devices used on the body, including limb-worn devices
Data protection and cybersecurity
- EN 18031-2:2024Radio equipment processing personal data (cited with restrictions)
- EN 18031-1:2024Internet-connected radio equipment (cited with restrictions)
- EN 18031-3:2024Radio equipment processing virtual money or monetary value, for watches with payment functions (cited with restrictions)
Hazardous substances (RoHS)
- EN IEC 63000:2018Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
Already have a declaration for your smartwatch / fitness tracker?
A certification expert checks it against everything on this page and tells you exactly what to fix. Written report in 48 hours, €99 per product (excl. VAT).
Common mistakes in smartwatch / fitness tracker declarations
The data-protection requirement is not addressed
Since 1 August 2025 wearables that can process personal data must meet RED Article 3(3)(e). A declaration that does not mention Delegated Regulation 2022/30, and a technical file without a security assessment, will not survive a review.
Health claims without medical-device compliance
Marketing a watch as detecting or monitoring a disease turns it into a medical device. Stick to wellness claims or go through the MDR.
SAR not assessed
A watch transmits close to the body; body-worn SAR under EN 50566 (or a justified low-power exclusion) belongs in the technical file, especially for LTE models.
LTE and non-LTE versions share one declaration without distinction
Cellular variants need their own radio standards and SAR evidence. The declaration should identify which model numbers include which radios.
Charging cradle and adapter overlooked
If a mains adapter is supplied, it needs its own conformity (LVD, EMC, ecodesign for external power supplies).
What you need besides the declaration
- Technical documentation
- Radio, EMC, safety and SAR reports, a data-protection and security risk assessment with evidence for EN 18031, battery data and RoHS documentation. Keep it for 10 years.
- Privacy information
- The GDPR applies to the service behind the watch; product documentation should describe what data the device processes and how users can delete it.
- Marking and instructions
- CE marking, crossed-out wheeled bin, model and manufacturer details, and user and safety information in the local language, including frequency bands and maximum transmit power.
- Economic operator in the EU
- An importer, authorised representative or responsible person established in the EU (Article 4 of Regulation (EU) 2019/1020).
No EU presence yet? We can act as your EU authorised representative or responsible person.
Frequently asked questions
Does a smartwatch have to meet the RED cybersecurity rules?
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Yes. As wearable radio equipment that processes personal data, it must meet the data-protection requirement of Delegated Regulation (EU) 2022/30 since 1 August 2025, and the network-protection requirement if it can communicate over the internet.
Does a smartwatch need USB-C?
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No. Smartwatches are not among the categories listed in Annex Ia of the Radio Equipment Directive.
When is a smartwatch a medical device?
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When it is placed on the market with a medical purpose, such as diagnosing or monitoring a disease. General fitness and wellness features do not make it a medical device.
What does MyCECheck check on a smartwatch declaration?
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RED and the delegated act, the radio, SAR and cybersecurity standards for each connectivity variant, the claims boundary to medical devices, and the battery and economic-operator obligations. Written report within 48 hours.
Already have a declaration for your smartwatch / fitness tracker?
A certification expert checks it against everything on this page and tells you exactly what to fix. Written report in 48 hours, €99 per product (excl. VAT).