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We are ISO 13485:2016 should we be audited to ISO 14971


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You are correct. It is not required. However, it is expected that a medical device manufacturer will follow this standard for risk management. There is no need to have a certification to this standard. However, when your company is performing internal audits, it is a good idea to include a ISO 14971 audit.

Ronen E

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By whom? And, if it is not required, why would they expect it?
1. NBs - Other than being harmonized (the preferred path) under the MDD, it's considered state of the art.
2. IEC 60601 (where it applies) directly relies on it.

Theoretically, medical devices risk management can be done "free style" (not to ISO 14971), but in most practical senses it will be much more difficult/complicated. Why? Because. Don't get me started.
By whom? And, if it is not required, why would they expect it?
Auditors/ NBs. They will look for compliance to any standard that is applicable. MDR and ISO 13485 call out the importance of risk management, and a recognized standard exists for MD risk management. (It's a great standard BTW, very helpful). We are audited against ISO 11607 and ISO 11137 because we have gamma sterilized products.


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If you have not claimed compliance to ISO 14971, then you do not have to comply.
As above, there will be expectations by external agencies that you will have complied with 14971, but if you can demonstrate that you have complied with the regulation of the markets you are accessing (rather than any recognised/harmonised standard) then that will trump anything else.
You are required to comply with the regulations not international standards.
Though there will be some here who may point to subtleties around 13485/Canada/MDSAP.
We are ISO 13485:2016 should we be audited to ISO14971
Within ISO 13485:2016 there are several references to ISO 14971.

It´s important to understand whether you are a medical device manufacturer or not. (Also suppliers and others can have ISO 13485).
If you manufacture medical devices in Europe, you´ll hardly be able to register them without ISO 14971.
But you do not get a certificate for ISO 14971 like you get one for ISO 13485.
For example, in case you comply to any other standard, you also do not get a certificate for each of them.
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