ISO 13485 current Version: 2021

ISO 13485 Current Version of the international edition still is the ISO 13485:2016. This is the third edition of the international standard.

ISO 13485 – Current Version and European Additions

There are European additions to ISO 13485:2016 that explain its correlation to European regulations. This process is known as harmonization.You can find more information about harmonization in [this blog post].

The international edition itself always remains unchanged.

Amendment SN EN ISO 13485 A11:2021

The European Union published EN ISO 13485/A11:2021 in 2021.This amendment harmonizes ISO 13485:2016 with the MDR and IVDR.

The A11 amendment is only available as a national standard.In Switzerland, for example, it is published as SN EN ISO 13485/A11:2021.

All CENELEC member countries are required to publish the amendment without modifications, which means that all national publications—such as DIN in Germany—contain the same content.

What is SN EN ISO 13485/AC:2020?

If your products are still certified under MDD and IVDD, this part still applies.It is an amendment to the previous and now withdrawn European part SN EN ISO 13485/EN AC:2012.The changes refer exclusively to the former directives MDD and IVDD.

FDA Recognition Status

The FDA still does not recognize ISO 13485:2016 as a consensus standard.

ColabON’s Gap Analysis for ISO 13485:2016

Do you want to link the current version of ISO 13485 directly to your quality system?

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