In December 2019, the 3rd revision of the ISO 14971 standard was released. We reported already on the main changes.

This third version has been adopted as a consensus standard in the US, while the EN ISO 14971:2012 is still the harmonized version in Europe.

How to deal with these two versions in parallel?

Know which one is applicable

We take the example of US and EU, but different regions, might have different requirements. It makes sense to first identify which are your target regions and what are the requirements in terms of standards.

Know the differences

It's probably a truism to say, but before you can move forward, you should know what you're dealing with. Are the two versions completely different or quite similar?

Make a comparison between the two. For the risk management standards' different versions, EN ISO 14971:2012 and ISO 14971:2019, we made the comparison and the differences are not huge.

Important to note is that when a standard is being harmonized in Europe (EN prefix), there can be some specific requirements described in the Annexes, which therefore need to be investigated thoroughly.

However, how does knowing the differences help in choosing the right one?

First of all, go back to the first point. If you only have one region to consider, the issue is solved. :-) Apply the version that is applicable to that specific region.

Secondly, make an evaluation of how big the impact of the differences is. If you stick to the more strict requirement it's unlikely that you'll get remarks.

In case differences are indeed big and you would need to comply to both versions, you'll have to generate two sets of documentation in parallel.

If you would like to know more how to deal with that in MatrixReq don't hesitate to contact us!