Certifying a Bluetooth LE wearable: RED, FCC, SAR, CRA

Hugues Orgitelloupdated 7 Oct 202617 min read

A band, a watch or a ring that speaks Bluetooth Low Energy is one of the few products the EU texts name explicitly. Delegated Regulation (EU) 2022/30 defines "wearable radio equipment" (wrist watch, ring, wristband, headset, earphone, glasses) and applies the RED privacy requirement to it even when it has no internet connection; the Cyber Resilience Act lists health-monitoring wearables among its important products. Add the radio rules of each market, an RF exposure assessment at a few millimetres from the skin, the lithium cell and the Bluetooth SIG licence, and a small product collects more regimes than many larger ones. This page reads each strand from the texts as of 7 October 2026, gives the US and Canadian SAR exemption thresholds for 2.4 GHz side by side, dates every obligation, and lists the readings the texts contradict.

Overview: the strands and their texts

None of these strands replaces another, and a pre-certified radio module only covers part of the first one.

Strand	EU	United States	Canada	Detailed guide
Spectrum	RED Art. 3(2), EN 300 328 V2.2.2	FCC Part 15.247	RSS-247 issue 4	fcc-id-grantee-tcb-equipment-authorization
EMC	RED Art. 3(1)(b), EN 301 489-17 V3.3.1	Part 15 subpart B for the digital device	ICES-003	red-checklist
RF exposure	RED Art. 3(1)(a), EN 50566	47 CFR 1.1307(b), 1.1310, 2.1093	RSS-102 Issue 6	sar-procedures-iec-62209-en-50360
Electrical safety	RED Art. 3(1)(a), LVD objectives with no voltage limit	(no federal radio rule)	(no RSS)	iec-62368-1-safety-engineering
Battery	Regulation (EU) 2023/1542, UN 38.3 for transport	UN 38.3 for transport	UN 38.3 for transport	iec-62133-un-38-3-battery-safety-transport
Cybersecurity	RED Art. 3(3)(d)(e) with EN 18031, then the CRA	(voluntary Cyber Trust Mark)	(none for this product)	cyber-resilience-act-cra
Bluetooth licence	Bluetooth SIG qualification, worldwide			bluetooth-sig-qualification
Environment	RoHS, REACH, WEEE	California Proposition 65		rohs-restriction-hazardous-substances

To plan the sequence, start from certification-getting-started and certification-timeline.

Dated obligations for a wearable, 2025 to 2028

Date	What applies	Text
1 August 2025	RED Article 3(3)(d), (e), (f) for the categories in Delegated Regulation 2022/30, wearables included	Delegated Regulation (EU) 2023/2444
1 August 2025	EN 18031-1, -2, -3:2024 cited, with restrictions	Implementing Decision (EU) 2025/138
18 August 2025	Separate collection symbol on every battery	Regulation (EU) 2023/1542, Article 13(4)
18 August 2026, or 18 months after the implementing act if later	General information label and capacity label on rechargeable portable batteries	Regulation (EU) 2023/1542, Article 13(1) and (2)
7 September 2026	EN 50566:2017 with A1:2023 and A2:2025 cited	Implementing Decision (EU) 2026/2003
11 September 2026	CRA reporting of actively exploited vulnerabilities and severe incidents, also for products already on the market	Regulation (EU) 2024/2847, Articles 14, 69(3) and 71
18 February 2027	Portable batteries readily removable and replaceable by the end user	Regulation (EU) 2023/1542, Articles 11 and 96
11 December 2027	CRA applies in full; Delegated Regulation 2022/30 repealed	Regulation (EU) 2024/2847, Article 71; Delegated Regulation (EU) 2026/339
7 March 2028	EN 50566 citation with A1:2023 only is deleted	Implementing Decision (EU) 2026/2003

The radio strand: RED, FCC, ISED

Bluetooth LE operates in the 2400 to 2483.5 MHz band. The Bluetooth SIG states that Bluetooth technology supports transmit powers from -20 dBm (0.01 mW) to +20 dBm (100 mW), so "low power" is a design choice, not a property of the protocol.

European Union (RED)

Under Directive 2014/53/EU, three essential requirements always apply, and a fourth applies to wearables:

• Article 3(1)(a): health and safety, including the safety objectives of the Low Voltage Directive with no voltage limit applying. A 3.7 V wearable is therefore not outside electrical safety because it is below LVD voltages. RF exposure sits here too.
• Article 3(1)(b): electromagnetic compatibility. The cited standard is EN 301 489-17 V3.3.1 (Decision (EU) 2025/893), which calls up the common part EN 301 489-1; EN 301 489-1 is not cited on its own.
• Article 3(2): efficient use of spectrum, with EN 300 328 V2.2.2 for 2.4 GHz wideband transmission.
• Article 3(3)(e): protection of personal data and privacy. See the cybersecurity section below for why a wearable is caught even without internet.

Under Article 17, internal production control (Annex II) is available for Article 3(2) and 3(3) only when the cited harmonised standards are applied in full; otherwise a notified body is involved. Everything ends in an EU declaration of conformity and the CE marking. Prepare the plan with red-checklist and cert-test-plan-template.

United States (FCC) and Canada (ISED)

In the US a Bluetooth LE transmitter is authorised under FCC Part 15.247 and receives an FCC ID through certification. The digital modulation limits in the eCFR text:

Parameter in 47 CFR 15.247	Limit
Minimum 6 dB bandwidth, digital modulation (paragraph (a)(2))	500 kHz
Maximum conducted output power, digital modulation (paragraph (b)(3))	1 W, with directional antenna gain of 6 dBi or less (paragraph (b)(4))
Power spectral density (paragraph (e))	8 dBm in any 3 kHz band
Emissions outside the band (paragraph (d))	At least 20 dB below the highest in-band 100 kHz level
RF exposure (paragraph (i))	The application for a portable device must contain a statement of compliance with 1.1307(b), 1.1310, 2.1091 and 2.1093, with the technical basis

In Canada the equivalent is RSS-247 issue 4 for the radio, RSS-102 Issue 6 for RF exposure, and an ISED certification number issued by ISED or a recognised certification body. See ised-canada-radio-certification.

Item	EU (RED)	US (FCC)	Canada (ISED)
Spectrum text	EN 300 328 V2.2.2	47 CFR 15.247	RSS-247
RF exposure text	EN 50566 (cited), Recommendation 1999/519/EC limits	47 CFR 1.1307(b), 1.1310, 2.1093	RSS-102 Issue 6
Outcome	EU declaration of conformity, CE marking	FCC ID	ISED certification number
Third party	Notified body only when cited standards are not applied in full	Telecommunication Certification Body	ISED or recognised certification body
Module reuse	No modular grant; module reports are evidence	Modular grant within its conditions, "Contains FCC ID" label (15.212)	Module certification within its conditions, see the ISED guide

Most wearables integrate a pre-certified BLE module. Under the FCC rules its modular grant can be reused only within its grant conditions, and the host carries a label such as "Contains FCC ID" when the module ID is not visible (47 CFR 15.212). The RED has no modular grant: the wearable maker declares conformity of the finished product. In both cases the module was not assessed strapped to a wrist, so RF exposure has to be addressed for the wearable itself. Compare approaches in ce-vs-fcc-emc and eu-us-dual-certification.

Bluetooth SIG qualification

Bluetooth SIG qualification is a contractual programme tied to the SIG patent/copyright and trademark licences, not a radio approval. The process changed on 1 July 2024 and the current rules are in QPRD v5 (21 April 2026):

Former term	Current term	For a wearable built on a module
QDID	Design Number (DN); QDID remains a legacy reference	Ask the module supplier for the DN or QDID
End Product Listing (EPL)	Option 1, single existing Design, unmodified	No ICS change, no test plan
Full qualification	Option 2a (combine existing Designs) or 2b (new or modified Design)	Applies if you change the ICS Form or the stack
Listing or declaration fee	Product Qualification Fee	Charged for the first product that includes a given Design

The submission is made under the account of the member that markets the product. Fees, membership levels and the Core 6.x versions are in bluetooth-sig-qualification.

RF exposure: SAR at the wrist

A wearable is used against the body, so the exposure assessment is made at the distance it is actually worn. The limits depend on where it is worn:

Body location	EU (Recommendation 1999/519/EC)	US (47 CFR 1.1310)
Wrist, hand, ankle, foot (watch, band, ring)	4 W/kg over 10 g (limbs)	4 W/kg over 10 g (extremities: hands, wrists, feet, ankles, pinnae)
Chest strap, pendant, clip on the trunk	2 W/kg over 10 g	1.6 W/kg over 1 g
Earphone, glasses (head)	2 W/kg over 10 g	1.6 W/kg over 1 g, 4 W/kg over 10 g for the pinna

Exemption thresholds at 2.4 GHz, US and Canada

The US and Canadian texts set numerical exemptions; the RED does not. Values below are computed or read from the texts; "power" is the output power the text names.

Separation distance	FCC 1.1307(b)(3)(i)(B), Pth at 2.48 GHz	ISED RSS-102 Table 11 at 2450 MHz	ISED, limb-worn (× 2.5)
5 mm or less	2.72 mW at 5 mm (no formula below 5 mm)	3 mW	7.5 mW
10 mm	10.2 mW	7 mW	17.5 mW
15 mm	22.0 mW	16 mW	40 mW
20 mm	38.1 mW	32 mW	80 mW
25 mm	58.3 mW	56 mW	140 mW
Any distance	1 mW blanket exemption, 1.1307(b)(3)(i)(A)	1 mW only for implanted medical devices

How to read it:

• FCC. A single source is exempt at 1 mW or less of available maximum time-averaged power, at any distance. Otherwise the greater of time-averaged power and ERP must not exceed P_th = ERP_{20 cm} × (d/20 cm)^x, with ERP_{20 cm} = 3060 mW between 1.5 and 6 GHz and x = -log₁₀(60 / (ERP_{20 cm} × √f)). The rule allows this formula only from 0.5 cm to 40 cm; check KDB 447498 for distances under 0.5 cm. The text defines source-based time averaging from the duty cycle inherent to the device, which matters for an LE radio that transmits briefly.
• ISED. The limits are output power adjusted for tune-up tolerance, for separation distances up to 20 cm. For limb-worn devices, where 10 g averaging applies, the table values are multiplied by 2.5. Interpolation between frequencies is required, between distances it is allowed.
• EU. EN 50566 (hand-held and body-mounted devices, 30 MHz to 6 GHz) is the cited standard; since 7 September 2026 it is cited with A2:2025. EN 62479, the low-power assessment standard, is not cited under the RED: a manufacturer may use it as another technical specification, justified in the technical documentation file, without presumption of conformity.

Arithmetic for orientation: 0 dBm is 1 mW and +4 dBm is about 2.5 mW. A watch radio set at +4 dBm conducted, with its antenna 5 mm from the skin, is close to the FCC and ISED thresholds before antenna gain and time averaging are considered. Measurement methods (IEC/IEEE 62209-1528) and limits are detailed in sar-procedures-iec-62209-en-50360.

Electrical safety and battery

Product safety

Article 3(1)(a) of the RED applies the Low Voltage Directive safety objectives with no voltage limit. IEC 62368-1 is the usual standard for audio, video and ICT equipment and replaced IEC 60950-1 and IEC 60065, which the IEC withdrew on 29 March 2024. It is not cited under the RED; under the LVD the cited edition is EN 62368-1:2014 + AC:2015. Used for a wearable, it is listed in the technical file as another technical specification. See iec-62368-1-safety-engineering.

Lithium cell: transport and safety

• UN 38.3 applies to the cell and battery type before transport, by air, sea, road or rail. In practice the wearable maker obtains the test summary from the cell supplier and only tests when it assembles its own pack. The 2026 IATA guidance exempts button cells installed in equipment from the duty to make the summary available. For shipping, see hazmat-imdg-iata-lithium-shipping.
• IEC 62133-2 covers secondary lithium cells and batteries. A primary lithium coin cell falls under IEC 60086-4 instead.

Regulation (EU) 2023/1542, article by article

A wearable cell is a "portable battery": sealed, 5 kg or less, not designed for industrial use.

Article	Obligation	Applies to a wearable cell?
13(4)	Separate collection symbol; if it would be smaller than 0.47 × 0.47 cm on the battery, a 1 × 1 cm symbol on the packaging instead	Yes, since 18 August 2025
13(1), 13(2)	General information label; capacity label for rechargeable portable batteries	Yes, from 18 August 2026 or 18 months after the implementing act, whichever is later
11(1)	Battery readily removable and replaceable by the end user with commercially available tools	Yes, from 18 February 2027
11(2)(a)	Removal by independent professionals allowed for appliances used in an environment regularly subject to splashing water, water streams or immersion, intended to be washable or rinseable, where required for safety	Only if the wearable fits these words
11(3)	No removability duty where continuity of power and a permanent connection are needed for safety, or for data integrity in products that collect and supply data as their main function	Needs a documented reason that fits the text
9	Performance and durability values	No: portable batteries of general use only, button cells excluded
77	Battery passport	No: LMT, industrial above 2 kWh and electric vehicle batteries only

Details in eu-battery-regulation and iec-62133-un-38-3-battery-safety-transport.

Cybersecurity: RED Article 3(3), then the CRA

RED: wearables are named

Article 1(2)(d) of Delegated Regulation (EU) 2022/30 applies Article 3(3)(e) to radio equipment "designed or intended, whether exclusively or not exclusively, to be worn on, strapped to, or hung from" any part of the human body or clothing, if it can process personal data, traffic data or location data. Recital 12 explains why: wearables pose risks "even in the absence of an internet connection". Article 3(3)(d) applies in addition if the wearable can communicate over the internet "whether it communicates directly or via any other equipment" (Article 1(1)), which covers a band that syncs through a phone. Article 3(3)(f) only concerns internet-connected equipment that lets the user transfer money or monetary value.

The cited standards are EN 18031-1 (point d) and EN 18031-2 (point e), CEN-CENELEC standards cited with restrictions by Decision (EU) 2025/138. One restriction concerns products that let the user not set or use any password (clauses 6.2.5.1 and 6.2.5.2); another concerns access control for toys and childcare equipment. If a restriction applies, Article 17 requires a notified body. Medical devices under Regulation (EU) 2017/745 are excluded by Article 2(1). Delegated Regulation 2022/30 is repealed from 11 December 2027 by Delegated Regulation (EU) 2026/339, when the CRA takes over.

Cyber Resilience Act

The CRA (Regulation (EU) 2024/2847) applies to products with digital elements with a data connection to a device or network, so to a BLE wearable, but not to products covered by the MDR or IVDR (Article 2(2)).

CRA provision	Content for a wearable
Annex III, class I, point 19	"Personal wearable products to be worn or placed on a human body that have a health monitoring (such as tracking) purpose" outside the MDR and IVDR, or wearables "intended for the use by and for children"
Article 32(2)	For class I: module A only if harmonised standards, common specifications or a certification scheme at level "substantial" are applied in full; otherwise module B + C or module H
Article 14	Notification of actively exploited vulnerabilities and severe incidents, with an early warning within 24 hours; applies from 11 September 2026
Article 69(3)	Article 14 also applies to products placed on the market before 11 December 2027
Article 71	Chapter IV (notified bodies) from 11 June 2026; everything else from 11 December 2027

Point 19 says "health monitoring (such as tracking)", so an activity tracker should be checked against that wording before it is placed in the default category. EN 303 645, the ETSI consumer IoT baseline (V3.1.3), is useful design input but is not a cited standard under the RED. See en-303-645-iot-cybersecurity, cyber-resilience-act-cra and product-cybersecurity-explained.

Environment: RoHS, REACH, WEEE

Framework	Object	Deliverable	Guide
RoHS	Restricted substances in EEE	Technical documentation (EN IEC 63000), mention in the EU declaration	rohs-restriction-hazardous-substances
REACH Article 33	Candidate List substances above 0.1 % w/w in an article	Information to recipients	reach-chemical-substances-svhc
Waste Framework Directive, Article 9(1)(i)	Same substances	SCIP notification to ECHA	reach-chemical-substances-svhc
WEEE	Waste electrical equipment	Crossed-out wheeled bin, producer registration	weee-electronics-waste-eu
Batteries 2023/1542	The cell	See the battery table above	eu-battery-regulation

For California, California Proposition 65 may require a warning: see california-prop-65-warnings.

Wellness or medical device

The line is drawn by the manufacturer's intended purpose under Article 2(1) of Regulation 2017/745: "diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease", among other purposes. The hardware can be identical on both sides.

Product claim	Regime	What changes
Step count, calories, sleep for lifestyle	Consumer product	RED (with 3(3)(e)); CRA default category unless the "health monitoring (such as tracking)" wording of Annex III point 19 catches it
Heart rate presented as a health monitoring function	Consumer product if no medical purpose is claimed	CRA class I (Annex III, point 19)
Detection of arrhythmia, SpO2 for diagnosis, monitoring of a disease	Medical device	MDR; class from Annex VIII, Rule 10 (active diagnostic and monitoring devices) or Rule 11 (software): class IIa, IIb when variations of vital parameters could result in immediate danger, class III for software whose decisions may cause death or irreversible deterioration
Any MDR device	Medical device	RED Article 3(3) delegated act and CRA do not apply (Regulation 2022/30 Article 2(1), CRA Article 2(2))

The MDR route (classification, quality system, clinical evaluation, notified body for class IIa and above) is in mdr-medical-device-regulation, the medical safety standard in iec-60601-1-medical-electrical-safety, and the whole case in certification-medical-wearable. For the US medical route, see FDA 510(k), De Novo and PMA.

Claims the texts contradict

Common claim (some made by earlier versions of this page)	What the texts say
"RED Article 3(3) only applies to internet-connected equipment."	Article 1(2)(d) of Delegated Regulation 2022/30 applies 3(3)(e) to wearable radio equipment that can process personal data, with or without internet.
"A BLE wearable transmits under 10 mW, so SAR is exempt."	Bluetooth supports up to +20 dBm (100 mW). The FCC exemption at 0.5 cm and 2.48 GHz is about 2.7 mW, ISED gives 3 mW at 5 mm or less (7.5 mW limb-worn); the RED has no threshold.
"EMC is assessed with EN 301 489-1 and EN 301 489-17."	EN 301 489-17 V3.3.1 is cited (Decision 2025/893); EN 301 489-1 is not cited on its own.
"The module carries a QDID; EPL gives a reduced-fee Declaration ID."	Design Numbers replaced the QDID on 1 July 2024; reuse is QPRD option 1 and one Product Qualification Fee is charged for the first product with a given Design.
"Without SIG qualification a product cannot join Find My, Fast Pair or Matter."	The SIG texts govern the Bluetooth licences and listing; ecosystem programmes have their own rules, which these sources do not set.
"UN 38.3 is needed before air or sea shipment."	UN 38.3 applies to transport by any mode, and it tests the cell and battery type, not the wearable.
"The Battery Regulation adds durability duties and, in time, a battery passport."	Durability values (Article 9) cover portable batteries of general use, button cells excluded; the passport (Article 77) covers LMT, industrial above 2 kWh and EV batteries.
"CRA essential requirements apply at the end of 2027, nothing before."	Article 14 reporting has applied since 11 September 2026, also to products already on the market (Article 69(3)).
"EN 18031 is aligned with, but stricter than, EN 303 645."	Neither Decision 2025/138 nor Regulation 2022/30 makes that comparison; EN 18031 is the cited standard, EN 303 645 is not.
"AFib detection is likely class IIa."	Rules 10 and 11 give class IIa as the starting point and IIb or III depending on the risk of the decisions or variations; the answer depends on the intended purpose.
"A medical wearable must also meet EN 18031 and the CRA."	Both the RED delegated act (Article 2(1)) and the CRA (Article 2(2)) exclude devices covered by the MDR.

Market-entry checklist

1. Fix the intended purpose. Wellness, health monitoring (CRA class I) or medical (MDR): it decides which cybersecurity regime applies.
2. Choose the module. Collect its FCC grant conditions, ISED certification, RED test reports and its Bluetooth DN or QDID.
3. Radio. EN 300 328 V2.2.2 and EN 301 489-17 V3.3.1 (EU), 47 CFR 15.247 (US), RSS-247 (Canada).
4. RF exposure. Compute the FCC P_th and the RSS-102 limit at the real separation distance; measure SAR if above; document the EU assessment against EN 50566.
5. Bluetooth SIG. Qualify under option 1 if the Design is unmodified, under your own membership.
6. Safety and battery. EN 62368-1 as another technical specification, UN 38.3 summary and IEC 62133-2 or IEC 60086-4 evidence from the cell maker.
7. Battery Regulation. Collection symbol now, labels from 18 August 2026 at the earliest, removability from 18 February 2027 or a documented Article 11 exception.
8. Cybersecurity. EN 18031-1 and -2 with a check of the 2025/138 restrictions; a vulnerability reporting process in place for CRA Article 14.
9. Environment. RoHS (EN IEC 63000), REACH Article 33 and SCIP, WEEE registration.
10. File and marks. Technical documentation file, EU declaration of conformity, CE marking, FCC ID or "Contains FCC ID", ISED number, WEEE and battery symbols.

For budgets, see certification-costs.

Common pitfalls

Pitfall	Consequence	Fix
Treating SIG qualification as radio approval	Product placed without RED, FCC or ISED conformity	Run the SIG file and the radio files separately
Reusing the module SAR position	Exposure not assessed where the wearable is worn	Compute thresholds at the real distance, measure if above
Assuming no internet means no RED cybersecurity	3(3)(e) missed for a wearable	Apply Article 1(2)(d) of 2022/30
Adding a health monitoring claim late	CRA class I with a stricter assessment route	Fix the claims before the cybersecurity plan
Sealing the battery without a documented exception	Non-compliance with Article 11 from 18 February 2027	Design for removability or document 11(2)(a) or 11(3)
Shipping prototype cells without UN 38.3 evidence	Shipment refused	Get the summary from the cell supplier before ordering

Further reading

• certification-getting-started: where to start a certification effort.
• bluetooth-sig-qualification: the Bluetooth SIG programme in detail.
• sar-procedures-iec-62209-en-50360: SAR assessment and exemptions.
• iec-62133-un-38-3-battery-safety-transport: battery safety and transport.
• certification-medical-wearable: the medical-purpose wearable case.
• eu-us-dual-certification: a parallel CE and FCC strategy.
• certification-lorawan-sensor: another product scenario, with a primary-cell battery.

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Sources and references

Sources & references

1. Directive 2014/53/EU (RED), radio equipment, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
2. Delegated Regulation (EU) 2022/30, Article 3(3)(d), (e) and (f) of the RED (wearable radio equipment, Article 1(2)(d)), EUR-Lex eur-lex.europa.eu/eli/reg_del/2022/30/oj
3. Delegated Regulation (EU) 2023/2444, application from 1 August 2025, EUR-Lex eur-lex.europa.eu/eli/reg_del/2023/2444/oj
4. Delegated Regulation (EU) 2026/339, repeal of 2022/30 from 11 December 2027, EUR-Lex eur-lex.europa.eu/eli/reg_del/2026/339/oj
5. Implementing Decision (EU) 2025/138, EN 18031-1, -2 and -3 cited with restrictions, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/138/oj
6. Implementing Decision (EU) 2025/893, EN 301 489 parts cited under the RED, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/893/oj
7. Implementing Decision (EU) 2026/2003, EN 50566 with A2:2025, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2026/2003/oj
8. ETSI EN 300 328 V2.2.2 (2019-07), 2.4 GHz wideband data transmission, ETSI www.etsi.org/deliver/etsi_en/300300_300399/300328/02.02.02_60/en_300328v020202p.pdf
9. 47 CFR 15.247, operation in the 2400 to 2483.5 MHz band, eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15/subpart-C/section-15.247
10. 47 CFR 1.1307, RF exposure exemption criteria (paragraph (b)(3)), eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-1/subpart-I/section-1.1307
11. 47 CFR 1.1310, radiofrequency radiation exposure limits, eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-1/subpart-I/section-1.1310
12. Council Recommendation 1999/519/EC, exposure of the general public to electromagnetic fields, EUR-Lex eur-lex.europa.eu/eli/reco/1999/519/oj
13. 47 CFR 15.212, modular transmitters, eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15/subpart-C/section-15.212
14. RSS-247, issue 4: DTS, FHS and LE-LAN devices, ISED Canada ised-isde.canada.ca/site/spectrum-management-telecommunications/en/devices-and-equipment/radio-equipment-standards/radio-standards-specifications-rss/rss-247-digital-transmission-systems-dtss-frequency-hopping-systems-fhss-and-licence-exempt-local
15. RSS-102 Issue 6 (December 15, 2023), RF exposure compliance, Table 11 SAR exemption limits, ISED Canada ised-isde.canada.ca/site/spectrum-management-telecommunications/en/devices-and-equipment/radio-equipment-standards/radio-standards-specifications-rss/rss-102-radio-frequency-rf-exposure-compliance-radiocommunication-apparatus-all-frequency-bands
16. Qualification Program Reference Document (QPRD) v5, 2026-04-21, Bluetooth SIG www.bluetooth.com/wp-content/uploads/Files/Specification/HTML/QPRD/out/en/index-en.html
17. Qualify your product, Bluetooth Qualification Process overview, Bluetooth SIG www.bluetooth.com/develop-with-bluetooth/qualify/
18. Understanding Bluetooth range (transmit power from -20 dBm to +20 dBm), Bluetooth SIG www.bluetooth.com/learn-about-bluetooth/key-attributes/range/
19. Regulation (EU) 2017/745 on medical devices (MDR), Article 2(1) and Annex VIII, EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj
20. Regulation (EU) 2024/2847 (Cyber Resilience Act), Articles 2, 14, 32, 69, 71 and Annex III, EUR-Lex eur-lex.europa.eu/eli/reg/2024/2847/oj
21. ETSI EN 303 645, cyber security for consumer Internet of Things (all versions), ETSI www.etsi.org/deliver/etsi_en/303600_303699/303645/
22. Regulation (EU) 2023/1542 concerning batteries and waste batteries, Articles 9, 11, 13, 77 and 96, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1542/oj
23. UN Manual of Tests and Criteria, Section 38.3 (lithium batteries), UNECE unece.org/transport/dangerous-goods/rev-8-amend-1-manual-tests-and-criteria-eighth-revised-edition
24. Lithium Battery Guidance Document, 2026 (based on the 67th edition of the IATA DGR), industry guidance, IATA www.iata.org/contentassets/05e6d8742b0047259bf3a700bc9d42b9/lithium-battery-guidance-document.pdf
25. Regulation (EC) No 1907/2006 (REACH), EUR-Lex eur-lex.europa.eu/eli/reg/2006/1907/oj
26. Directive 2008/98/EC Waste Framework (legal basis for SCIP), EUR-Lex eur-lex.europa.eu/eli/dir/2008/98/oj