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Hi,
I have a few questions on the SAE reporting under MDR:
1. Do all the SAEs and Device Deficiencies that might have led to SAE have to be reported under MDR (as currently under MDD) or only device/procedure related events and Device Deficiencies that might have led to SAE (where the relationship is reasonably possible)?
2. IMDRF coding - will the coding be mandatory for the SAE reporting?
3. If yes, what systems can accommodate IMDRF coding?
4. Will there be any common specification developed for the SAE reporting under MDR (similar to MEDDEV 2.7/3 under MDD)? If yes, when?
Thank you in advance for clarifying some of the open questions.