Recital 37 Effects on health of natural persons

Relevant entities means a natural or legal person created and recognised as such under the national law of its place of establishment, which may, acting under its own name, exercise rights and be subject to obligations; should also be obliged to report incidents means an incident as defined in Article 6, point (6), of Directive (EU) 2022/2555; that have caused or are capable of causing the death of natural persons or considerable damage to natural persons’ health as such incidents means an incident as defined in Article 6, point (6), of Directive (EU) 2022/2555; are particularly serious cases of causing considerable material or non-material damage. For instance, an incident means an incident as defined in Article 6, point (6), of Directive (EU) 2022/2555; affecting a relevant entity means a natural or legal person created and recognised as such under the national law of its place of establishment, which may, acting under its own name, exercise rights and be subject to obligations; could cause unavailability of healthcare or emergency services, or the loss of confidentiality or integrity of data with an effect on the health of natural persons. For the purpose of determining whether an incident means an incident as defined in Article 6, point (6), of Directive (EU) 2022/2555; has caused or is capable of causing considerable damage to a natural person’s health, relevant entities means a natural or legal person created and recognised as such under the national law of its place of establishment, which may, acting under its own name, exercise rights and be subject to obligations; should take into account whether the incident means an incident as defined in Article 6, point (6), of Directive (EU) 2022/2555; caused or is capable of causing severe injuries and ill-health. For that purpose, the relevant entities means a natural or legal person created and recognised as such under the national law of its place of establishment, which may, acting under its own name, exercise rights and be subject to obligations; should not be required to collect additional information to which they do not have access.