Is a manufacturer allowed to integrate components that are important or critical products with digital elements that do not follow harmonised standards?
Yes, manufacturers are free to integrate components that are important or critical products that have not been designed in accordance with harmonised standards – regardless of whether such harmonised standards are available or not.
The application of harmonised standards is a means to demonstrate compliance, but is not the only means to do so.
Furthermore, as discussed in entries 4.4.1 What does the CRA prescribe when integrating components? and 4.4.3 In order to exercise due diligence, should a manufacturer only integrate components that bear the CE marking?, the manufacturer is not required to integrate only components that bear the CE marking.
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.