Regulatory Open Forum

Hello RAPS Team, 

Is below time correct to report Serious Incident Customer Complaint?
This is timeline, we have in our Customer Complaint form.

Thanks

Anon,

If you are addressing EU MDR (which should be at this time since needed to update since May 2021) the "Other" is 15 days not 30 days.  It used to be 30 days, though under the new regulation this was changed.  The rest is correct.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Presuming you are speaking of the medical device sector, there are a number of revisions that are needed in your information in order to avoid a written citation against you from these agencies, and in order to avoid under-reporting or over-reporting or late reporting.  I explain further below.

First, remember that "Serious Incident" is a reportability term that only applies under Europe's device Regulations. That term isn't recognized in the U.S., jurisdiction, nor in Canada, where each of those agencies instead require use of their own terminology (U.S. = "reportable event", "MDR-reportable event", or "reportable adverse event"; Canada = "reportable incident").  This is important because, for example, the U.S. FDA is supremely demanding about using its specific vocabulary and has issued Warning Letters and 483 Observations against systems that fail to use FDA's terms.

Next, these requirements are statutory/regulatory/legislative requirements, not "guidelines".  You may again be reasonably subject to written citations from these agencies if they find that your procedure calls these mandates "guidelines". And using the "guidelines" terminology leaves open the possibility of under-reporting.

Another correction needed in your matrix is that the U.S. FDA's 5-day reporting threshold is not "potential risk to public health".  Such a criterion would lead to over-reporting thereby sending a false signal to the FDA.  Instead, the FDA's 5-day reporting threshold is that an MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health or FDA has made a written request for the submission of a 5-day report.

Another correction is that the FDA has other MDR-reporting triggers (which happen to be the most common in my experience) that are missing from your matrix; specifically, those involving certain malfunctions even when such malfunction did not lead to death or serious injury. 

I also see other deficiencies in your matrix as well.  You may want to consider getting some expert assistance to be sure your procedures are fulling aligned with the applicable regulatory requirements. Feel free to reach out for further assistance if you feel you could use an extra set of expert eyes and hands.

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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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