1. When placing a product with digital elements on the market, manufacturers shall ensure that it has been designed, developed and produced in accordance with the essential cybersecurity requirements set out in Part I of Annex I.

2. For the purpose of complying with paragraph 1, manufacturers shall undertake an assessment of the cybersecurity risks associated with aproduct with digital elements and take the outcome of that assessment into account during the planning, design, development, production, delivery and maintenance phases of the product with digital elements with a view to minimisingcybersecurity risks, preventing incidents and minimising their impact, including in relation to the health and safety of users.