I'm trying to determine what level of traceability will be required for electronic components that form part of a Class 2 (in the US) medical device. The question is whether batch-level traceability, or manufactured-date traceability is sufficient without maintaining records to relate component reels or IC batch codes to final product.

I realize it's probably a matter of risk vs. economics, where if a lower level of tracebility is adopted, there's a risk of having to recall the entire production if something is wrong. But I'd be interested to hear your opinion, or that of your auditor or regulatory body.

I'm trying to determine what level of traceability will be required for electronic components that form part of a Class 2 (in the US) medical device. The question is whether batch-level traceability, or manufactured-date traceability is sufficient without maintaining records to relate component reels or IC batch codes to final product.

I realize it's probably a matter of risk vs. economics, where if a lower level of traceability is adopted, there's a risk of having to recall the entire production if something is wrong. But I'd be interested to hear your opinion, or that of your auditor or regulatory body.In my opinion you are right on the mark. Traceability is primarily for a "what if" scenario - usually the worst case scenario. This traceability of the components can be coupled with "traceability of the recipients" to further narrow recall/replacement costs to ameliorate time lag in getting notice to affected parties once a product becomes "suspect" and thus ameliorate potential for further damage or injury.


Secondarily, traceability can be part of an evaluation process, especially when identical components are made by multiple suppliers or even multiple machines at the same supplier.

Methods of traceability are beyond the scope of your original question, but suffice to say marking techniques can allow for individual serialization of each product and the serial number can be tied to the records of anything and everything deemed pertinent to traceability.