ISO 14971:2019 amendment A11:2021 questions

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bolesen

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We purchased the ISO 14971 standard from ISO when it was released in late 2020.
I noticed EN ISO 14971 amended to show the relationship with European Regulations for medical devices A European amendment to EN ISO 14971 - Medical devices - Application of risk management to medical devices was published in December 2021.
The amendment is designated EN ISO 14971:2019+A11:2021. The amendment replaces the European Foreword and adds two new Annex Zs - designated ZA and ZB

Couple questions:
1. Can I download the latest amended EN ISO 14971:2019+A11:2021 or do I need to purchase the amendments?
2. Are the amendments required/needed to implement 14971:2019 into my QMS and Risk Management Documentation?
 
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mihzago

mihzago

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This particular amendment includes informational annexes that describe gaps with the EU MDR. The normative part of the standard, which describes all risk management process requirements is unchanged compared to the non EN version, and so you can use the non EN version to implement into your QMS.

All base versions and amendments have to be purchased, and most shops will try to rip you off, but there's one place that still offers standards are reasonable prices:
EVS-EN ISO 14971:2019/A11:2021
 
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bolesen

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mihzago said:
This particular amendment includes informational annexes that describe gaps with the EU MDR. The normative part of the standard, which describes all risk management process requirements is unchanged compared to the non EN version, and so you can use the non EN version to implement into your QMS.

All base versions and amendments have to be purchased, and most shops will try to rip you off, but there's one place that still offers standards are reasonable prices:
EVS-EN ISO 14971:2019/A11:2021
Click to expand...

Thanks for your response and link, I was hoping the EN amendments could be purchased separately.
 
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indubioush

Ah ha!
bolesen said:
Thanks for your response and link, I was hoping the EN amendments could be purchased separately.
Click to expand...
Sometimes you can find a pdf preview that includes the annex you need. Looks like BSI no longer does this unfortunately. If you have a CE mark product, it is best to get only the EU versions with included annexes rather than buying both the ISO original and EU version. Of course the timing on compliance will come in to play...
 
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ca_moni

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