![]() Under the EU MDR, risk is defined in Article 2 as The detailed requirements of which are listed in the new Annex I Chapter I (3). With the notified bodies expecting that manufacturers have a risk management system which conforms to EN ISO 14971, the new EU MDR contains an explicit obligation in the new Article 10 (2), that manufacturers establish, document, implement and maintain a system for risk management. Moreover, apart from software devices, there is no article in the MDD that requires manufacturers to have a risk management system. ![]() There is no explicit requirement in the MDD that manufacturers should eliminate or reduce the risks associated with an individual device, that adequate protection measures are taken in relation to risks that cannot be eliminated, and that users are informed about any residual risks.
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