Ironbarque

Medical Device Consulting Regulatory Quality Complaince

Complaint System

Do not see the CER as just another separate report that you have simply because the regulations say you have  to have it. Use it to improve your Complaint System. 

Your Design History File (incorporating your Risk Management File and Useability File) automatically creates a structure by which to assess received complaints. The input HARMS identified early in the device development phase define the severity of complaints/incidents for MDR and Vigilance Reporting.  Your Design (and process) FMECA define known failure modes to determine whether the failure mode is anticipated or a new (potentially systematic) failure that could result in a recall.

Reporting decisions should be documented in a procedure and the agony of "do we report or do we not" removed. The level of reporting required is prospectively defined.  If the device is a PMA (or even a recent 510k). or a Design Dossier AND you have submitted your Risk Management File (it is hard not to) then you have on file, AND APPROVED, the prospective basis of your complaint/MDR/Vigilance reporting decisions.

Recall decisions are simplified. In the USA, the three levels of recall defined in 21 CFR 7 based purely upon harm.  The MEDDEV guidance, although more verbose, uses a similar trigger for recall:  death or serious deterioration in health.

The more positive side of this is that, with good design documentation, you have identified prospectively a set of failure modes, graded by harm, and you have estimates of expected failure rates.  You are required to track the reported failure rates against these estimates and you do NOT report incidents that are expected and foreseeable.

You do the same amount of work in both cases - you just get better value for the dollar spent if you think of the CER in the right way.