With the publication of ISO 14971 in 2019 and the related Technical Report (ISO/TR 24971:2020) there have been a lot of analyses of the requirements in that revision of the standard versus the previous versions of the ISO standard (ISO 14971:2007) and the European Harmonized version (EN ISO 14971:2012).
However, I have not seen many (if any) analyses of the differences between ISO 14971:2019 and the MDR. I’ll tackle that in this blog. Then in a follow-up, since ISO 14971:2019 has now been harmonized to MDR (as of May 2022), I’ll discuss the potential implications of that on our practical risk management activities.
Major differences
Additional differences
Final points
Conclusion
As we can see from the above, there are a few important conceptual differences between the MDR requirements for risk management and those in ISO 14971:2019. However, with the harmonization of ISO 14971:2019 recently, these differences may be “smoothed out”.
The next part in this blog will look at the implications of that harmonization (as of May 11, 2022 given that this gives the standard a “presumption of conformity to the requirements of the MDR” (per Article 8 and as described in Annex Z of the harmonized version of the standard), yet there these differences – e.g.
- Do we need to disclose ALL residual risks or just the significant ones?
- Do we still need to do individual benefit-risk analyses for all residuals risks (as one of the deviations in EN ISO 14971:2012 required) or can we finally let that go and align with what EN ISO 14971:2019 says?