Are there products with digital elements covered by other Union legislation that are exempted from the CRA?

The CRA does not apply to products with digital elements:

to which Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices apply;
to which Regulation (EU) 2019/2144 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users applies;
certified in accordance with Regulation (EU) 2018/1139 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency; see also section 2.1 Regulation (EU) 2018/1139 on common rules in the field of civil aviation.

The CRA also does not apply to equipment that falls within the scope of Directive 2014/90/EU on marine equipment; see also section 2.2 Directive (EU) 2014/90 on marine equipment.

Delegated Regulation (EU) 2025/1535 also excludes from the application of the CRA products with digital elements that fall within the scope of Regulation (EU) No 168/2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles, with the exception of L1e category vehicles designed to pedal.

Disclaimer

Disclaimer: This document is prepared by the Commission services and should not be considered as representative of the European Commission’s official position. The replies to the FAQs do not extend in any way the rights and obligations deriving from applicable legislation nor introduce any additional requirement. The expressed views are not authoritative and cannot prejudge any future actions the European Commission may take, including potential positions before the Court of Justice of the European Union, which is competent to authoritatively interpret Union law.