Does the CRA apply to wearables?
Likely yes
Likely yes. A wearable is connected hardware with embedded software, sold commercially in the EU: a product with digital elements [[F-005]] [[F-007]]. The exception is a wearable that is a medical device, which is excluded [[F-010]].
The deciding factors
| Factor | If true | If false | Source |
|---|---|---|---|
| Made available on the EU market | Scope questions continue | Likely out of scope | F-101 |
| Supplied in the course of a commercial activity | Scope questions continue | Likely out of scope (or the open-source light regime) | F-007 |
| Has a direct or indirect connection to a device or network | It is a product with digital elements | Likely out of scope | F-005 |
| Covered by a listed sectoral exclusion | Likely out of scope | Scope questions continue | F-010 |
Check your own product
Start the short scope check with the product type pre-selected. Every legally material fact — EU availability, commercial activity, exclusions, your role — is asked, never assumed.
Example scenarios
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Fitness tracker with wellness features, sold in the EU
Likely in scope · role: _
Connected hardware sold commercially: a product with digital elements in scope.
Deciding fact: Art. 3(1), Art. 2(1)
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ECG wearable certified under the medical devices regulation
Likely out of scope · role: _
Medical devices are excluded from this Regulation and regulated under Regulation (EU) 2017/745 instead.
Deciding fact: Art. 2(2)–(4), (6)–(7)
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Wearable whose data sync and features run on your cloud
Likely in scope · role: _
In scope; where the device cannot perform a function without your own backend, that remote processing is part of the product.
Deciding fact: Art. 3(1), Art. 2(1)
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Not sure whether the pairing to a phone counts as a connection
It depends on one fact · role: _
Connection is the deciding fact. Bluetooth pairing to a phone is a direct connection to a device; answer yes and the wearable is likely in scope.
Deciding facts: Art. 3(1), Art. 2(1); Art. 3(1), Art. 2(1)
Each scenario is a fixture: the shared CEMarque rules engine evaluates its inputs at build time and the page cannot be served if the outcome shown here differs from the engine's.
Edge cases
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Why
Wearables are connected hardware
A product with digital elements is a software or hardware product with a direct or indirect connection to a device or network [1]. A wearable pairs with a phone, syncs to a cloud or connects to Wi-Fi; that is a direct or indirect connection. Sold to consumers, it is made available in the course of a commercial activity [2].
The medical device line
Products covered by the medical devices regulation and the in vitro diagnostics regulation are excluded from this Regulation [3]. A wearable with a certified medical function follows that regime; a wearable that only makes wellness claims does not, and stays in scope here [3]. Which side a product sits on is a regulatory-classification question decided under the medical devices rules, not under this Regulation.
The phone app and the cloud
Where the wearable is designed to rely on your own remote data processing and cannot perform a function without it, that remote processing is part of the product with digital elements [4] [5]. The companion app is itself software supplied commercially and is a product with digital elements in its own right [1].
Availability
Made available on the market means supply for distribution or use on the EU market in the course of a commercial activity [6]. Sales through EU retailers or EU-facing web stores meet it.
Timing
Article 14 reporting applies from 2026-09-11; full requirements and CE marking apply from 2027-12-11. Dates come from the Facts Table entries cited below, evaluated for the first example; run the check for your own product's dates.
What to do next
CRARequired only answers applicability. CEMarque carries your answers forward and adds your role, class, conformity route, dates, obligations, and a permanent cited verdict.
Check my product Run the full cited determination on CEMarque
Related applicability questions
Sources
- F-005 A product with digital elements is a software or hardware product and its remote data processing solutions, including components placed on the market separately, whose intended purpose or reasonably foreseeable use includes a direct or indirect logical or physical data connection to a device or network. Art. 3(1), Art. 2(1) EUR-Lex ↩
- F-007 The Regulation applies to products made available on the market in the course of a commercial activity; charging a price, charging for support, monetising via advertising or data, or otherwise intending to monetise are commercial activity. Art. 2(1), Art. 3(22), Recitals EUR-Lex ↩
- F-010 Excluded: medical devices (Regulation (EU) 2017/745) and in vitro diagnostics (2017/746) and motor-vehicle type-approved products (2019/2144) (Art. 2(2)); civil aviation products certified under Regulation (EU) 2018/1139 (Art. 2(3)); marine equipment under Directive 2014/90/EU (Art. 2(4)); spare parts made to identical specifications (Art. 2(6)); products developed or modified exclusively for national security or defence, or designed exclusively to process classified information (Art. 2(7)). Art. 2(2)–(4), (6)–(7) EUR-Lex ↩
- F-006 Remote data processing means data processing at a distance for which the software is designed and developed by the manufacturer, or under the responsibility of the manufacturer, and the absence of which would prevent the product from performing one of its functions. Art. 3(2) EUR-Lex ↩
- F-107 Where a product depends on your own remote data processing (a backend or API without which it cannot perform one of its functions), that remote processing is part of the product: it is covered by the essential requirements, the technical documentation and market surveillance alongside the client software or device. Art. 3(1)–(2), Annex I, Annex VII EUR-Lex ↩
- F-101 Made available on the market means supply for distribution or use on the EU market in the course of a commercial activity. Art. 3(22) EUR-Lex ↩
CRARequired answers applicability only, using scope logic and cited regulatory facts maintained by CEMarque, which encodes Regulation (EU) 2024/2847 and published guidance as of Facts v2026.09.4 (10 September 2026). Results are "likely" or "conditional" readings of your answers, not a legal opinion and not a conformity assessment. Run the full cited determination on CEMarque before you act. Methodology.