Which products are excluded from the CRA?
Likely no
Likely no for excluded products. Medical devices and in vitro diagnostics, type-approved motor-vehicle products, and certain aviation, marine, defence, national-security and spare-part cases are excluded from the Regulation [[F-010]].
The deciding factors
| Factor | If true | If false | Source |
|---|---|---|---|
| Covered by a listed sectoral exclusion | Likely out of scope | Scope questions continue | F-010 |
| The exclusion follows the product's own regulatory home | Excluded only when that regime actually covers it | In scope | F-010 |
| Has a direct or indirect connection to a device or network | It is a product with digital elements | Likely out of scope | F-005 |
| Supplied in the course of a commercial activity | Scope questions continue | Likely out of scope (or the open-source light regime) | F-007 |
Check your own product
Start the short scope check. Every legally material fact — EU availability, commercial activity, exclusions, your role — is asked, never assumed.
Example scenarios
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Software certified as a medical device
Likely out of scope · role: _
Medical devices are excluded from this Regulation and follow Regulation (EU) 2017/745.
Deciding fact: Art. 2(2)–(4), (6)–(7)
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Telematics unit type-approved as part of a vehicle
Likely out of scope · role: _
Type-approved motor-vehicle products are excluded.
Deciding fact: Art. 2(2)–(4), (6)–(7)
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Aftermarket dashcam, not type-approved
Likely in scope · role: _
Not covered by the vehicle exclusion, so an ordinary connected hardware product in scope.
Deciding fact: Art. 3(1), Art. 2(1)
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Spare part supplied only to replace an identical component
Likely out of scope · role: _
Spare parts made available to replace identical components are excluded.
Deciding fact: Art. 2(2)–(4), (6)–(7)
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
The list
Excluded from the Regulation are medical devices and in vitro diagnostic devices under their own regulations, motor-vehicle products type-approved under Regulation (EU) 2019/2144, civil aviation products certified under Regulation (EU) 2018/1139, marine equipment under Directive 2014/90/EU, spare parts made to identical specifications, and products developed or modified exclusively for national security or defence or designed exclusively to process classified information [1].
Exclusions follow the regulatory home
Each exclusion turns on whether the named regime actually covers the product, or, for defence and national security, whether the product is made exclusively for that purpose [1]. A certified medical device is excluded; a sensor module sold for building automation is a product with digital elements in scope [1] [2]. Dual-use products sold to civil customers too are not made exclusively for defence [1]. An aftermarket vehicle accessory that is not type-approved is not covered by the vehicle exclusion.
What exclusions do not do
They do not remove products by technology or by customer type. A connected product supplied commercially in the EU is in scope unless a listed exclusion applies to it [2] [3] [1]. The scope check asks the exclusion question once, with the list, and applies nothing by inference.
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-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-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 ↩
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.