Starting September 7, 2020 FDA's Medical Device Reports, MDR, will harmonize with the IMDRF code sets. This change will affect eMDR and eSubmitter. FDA recommends that reporters prepare to use the harmonized codes in MDRs, starting on September 7, 2020. https://www.fda.gov/medical-devices/mdr-adverse-event-codes/coding-resources
The EU has already the IMDRF codes in the Manufacturer's Incident Report, MIR, which applies to the three directives and the two regulations.
Does anybody know of other regulatory regions that have or planned to adopt the IMDRF codes?
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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