Eureka 32017R0746 Sign in

incident

as defined in Regulation (EU) 2017/746 of the European Parliament and of the Council of 5…, Article 2, point (67) (Definitions)

any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device

Open in the act with Eureka

Install the extension for EUR-Lex

Also defined in