Incident

The definition is broad on purpose. Every incident is recorded and assessed, but only serious incidents are reported individually; others feed trend reporting and post-market surveillance.

‘incident’ means 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 undesirable side-effect;

EU MDR, Article 2(64)

‘incident’ means 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;

IVDR, Article 2(67)

The MDR includes any undesirable side-effect. The IVDR replaces this with harm resulting from a medical decision, or action taken or not taken, on the basis of information or results provided by the device.