Reporting by Manufacturers for Serious Adverse Events or Field Safety Corrective Actions.In accordance with Article 87 of the MDR, the reporting by manufacturers of any serious adverse event or field safety corrective action involving devices placed on the Union market, except for “expected side effects” clearly documented in the product information, quantified in the technical documentation, and subject to trend reporting under Article 88.
Reporting of Serious Adverse Events and Field Safety Corrective Actionsadmin2024-12-04T02:03:06+03:00