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Vigilance
Reporting – Medical Devices
Field Safety Notice (FSN) Reporting
Field Safety Notice (FSN) Reporting
FSNs related to devices placed on the Czech market and reported to SÚKL are published
here
Serious adverse incident reporting (MDR/IVDR) by the manufacturer (MIR)
Field Safety Corrective Action (FSCA) Reporting by the manufacturer
Reporting of Interruption or Discontinuation of Supply of certain medical devices by the Manufacturer (In accordance with art. 10 a)
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