Recital 4 Harmonisation of legal patchwork

While existing Union law applies to certain products with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;, there is no horizontal Union regulatory framework establishing comprehensive cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements for all products with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;. The various acts and initiatives taken thus far at Union and national levels only partially address the identified cybersecurity-related problems and risks means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident;, creating a legislative patchwork within the internal market, increasing legal uncertainty for both manufacturers means a natural or legal person who develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under its name or trademark, whether for payment, monetisation or free of charge; 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 means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; of those products has a particularly strong cross-border dimension, as products with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; manufactured in one Member State or third country are often used by organisations and consumers means a natural person who acts for purposes which are outside that person’s trade, business, craft or profession; 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, ‘small enterprises’ and ‘medium-sized enterprises’ mean, respectively, microenterprises, small enterprises and medium-sized enterprises as defined in the Annex to Recommendation 2003/361/EC; and small and medium-sized enterprises means a financial entity that is not a small enterprise and employs fewer than 250 persons and has an annual turnover that does not exceed EUR 50 million and/or an annual balance sheet that does not exceed EUR 43 million; as defined in the Annex to Commission Recommendation 2003/361/EC(⁵)Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).. The Union regulatory landscape should be harmonised by introducing horizontal cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements for products with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;. In addition, legal certainty for economic operators means the manufacturer, the authorised representative, the importer, the distributor, or other natural or legal person who is subject to obligations in relation to the manufacture of products with digital elements or to the making available of products with digital elements on the market in accordance with this Regulation; and users, as well as a better harmonisation of the internal market and proportionality for microenterprises, ‘small enterprises’ and ‘medium-sized enterprises’ mean, respectively, microenterprises, small enterprises and medium-sized enterprises as defined in the Annex to Recommendation 2003/361/EC; and small and medium-sized enterprises means a financial entity that is not a small enterprise and employs fewer than 250 persons and has an annual turnover that does not exceed EUR 50 million and/or an annual balance sheet that does not exceed EUR 43 million;, creating more viable conditions for economic operators means the manufacturer, the authorised representative, the importer, the distributor, or other natural or legal person who is subject to obligations in relation to the manufacture of products with digital elements or to the making available of products with digital elements on the market in accordance with this Regulation; aiming to enter that market, should be ensured across the Union.