NIS2 applies to public and private entities in one of 18 sectors listed in Annex I or Annex II of the Directive, provided the entity meets the medium enterprise size threshold: at least 50 employees or €10 million annual turnover. Certain categories fall within scope regardless of size. Where the organisation operates across multiple EU Member States, scope must be assessed against each country's national transposition legislation separately, as Member States have implemented the Directive in different ways.
The sector and size criteria are a starting point. National competent authorities retain the power to designate additional entities beyond the standard thresholds. If your organisation operates in energy, transport, banking, financial infrastructure, healthcare, water, digital infrastructure, or a number of other sectors, a scope analysis is the right first step.