Recital 79 Presumption of conformity based on harmonised standards

In order to facilitate assessment of conformity with the requirements laid down in this Regulation, there should be a presumption of conformity 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; which are in conformity with harmonised standards means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012;, which translate the essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements set out in this Regulation into detailed technical specifications means a technical specification as defined in Article 2, point (4), of Regulation (EU) No 1025/2012;, and which are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council(²⁸)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).. That Regulation provides for a procedure for objections to harmonised standards means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012; where those standards means a standard as defined in Article 2, point (1), of Regulation (EU) No 1025/2012 of the European Parliament and of the Council (^29^); Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). do not entirely satisfy the requirements set out in this Regulation. The standardisation process should ensure a balanced representation of interests and effective participation of civil society stakeholders, including consumer means a natural person who acts for purposes which are outside that person’s trade, business, craft or profession; organisations. International standards means an international standard as defined in Article 2, point (1)(a), of Regulation (EU) No 1025/2012; that are in line with the level of cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; protection aimed for by the essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements set out in this Regulation should also be taken into account, in order to facilitate the development of harmonised standards means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012; and the implementation of this Regulation, as well as to facilitate compliance for companies, in particular 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; and those operating globally.