While existing Union law applies to certain products with digital elements, there is no horizontal Union regulatory framework establishing comprehensive cybersecurity requirements for all products with digital elements. The various acts and initiatives taken thus far at Union and national levels only partially address the identified cybersecurity-related problems and risks, creating a legislative patchwork within the internal market, increasing legal uncertainty for both manufacturers and users of those products and adding an unnecessary burden on businesses and organisations to comply with a number of requirements and obligations for similar types of products. The cybersecurity of those products has a particularly strong cross-border dimension, as products with digital elements manufactured in one Member State or third country are often used by organisations and consumers across the entire internal market. This makes it necessary to regulate the field at Union level to ensure a harmonised regulatory framework and legal certainty for users, organisations and businesses, including microenterprises and small and medium-sized enterprises as defined in the Annex to Commission Recommendation 2003/361/EC (5) . The Union regulatory landscape should be harmonised by introducing horizontal cybersecurity requirements for products with digital elements. In addition, legal certainty for economic operators and users, as well as a better harmonisation of the internal market and proportionality for microenterprises and small and medium-sized enterprises, creating more viable conditions for economic operators aiming to enter that market, should be ensured across the Union.