№ files_lp_3_process_7_073993
Structured regulatory reporting template for manufacturers within the Medical Devices Vigilance System defining administrative, device, distribution and IMDRF-coded trend data requirements for initial and follow-up submissions.
Version: 1.1
Document type: Reporting template
System: Medical Devices Vigilance System
Purpose: Initial and follow-up trend reporting
Scope: Medical devices and in vitro diagnostic devices
Applicable legislation: MDD/AIMDD; IVDD; MDR; IVDR
Geographical scope: EEA, Great Britain, Switzerland, Turkey
Reporting basis: Increase in frequency or severity of not serious incidents or expected undesirable side-effects; increase of expected erroneous results; other specified trends
Submitting entity: Manufacturer or Authorised representative
Required coding system: IMDRF medical device problem, health effect, cause investigation and component codes
Sections: Administrative information; Medical device information; Description of trend
Price: 8 / 10 USD
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