Where can I buy EN ISO 14971:2009 (Medical Device Risk Management)?

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Cathie

Starting to get Involved
#6
Re: Where can I buy the standard EN ISO 14971:2009?

It could be that you can't find it because it doesn't exist. :D According to the ISO site, 2007 is the current version.

ETA: I spoke too soon, apparently. The 2009 version is available from BSI.


:confused:if the standard is not available from ISO then is it really the current official version or is 2007? As I understand, Annexes were added and nothing else was changed. Shouldn't 2009 be on the ISO site as the official doc now?
 
M

MIREGMGR

#7
Re: Where can I buy the standard EN ISO 14971:2009?

:confused:if the standard is not available from ISO then is it really the current official version or is 2007? As I understand, Annexes were added and nothing else was changed. Shouldn't 2009 be on the ISO site as the official doc now?
As we know, under EC medical device regulations, satisfaction of a Requirement can be shown in three ways: by conformance to a harmonized standard, by conformance to a non-harmonized standard plus provision of evidence to support that conformance, and by provision of other evidence to show that the Requirement is satisfied. Your NB should automatically accept the first, will readily accept the second but with review, and probably will conduct an in-depth review of the third.

If your approach is to declare conformance to the harmonized version, then EN ISO 14971:2009 is relevant.

If instead for some reason you chose to declare conformance to the underlying standard itself, with the addition obligation to show evidence of your conformance, then ISO 14971:2007 (corrected version) would be relevant.

The two versions of the standard are different documents, with different legal roles.
 

Cathie

Starting to get Involved
#8
Re: Where can I buy the standard EN ISO 14971:2009?

Thank you MIREGMGR.

The forward of 14971:2009 states "Endorsement notice: The text of ISO 14971:2007, Corrected version 2007-10-01 has been approved by CEN as an EN ISO 14971:2009 without any modification.

Health Canada and the FDA recognize ISO 14971:2007 as their Recognized Standard.

Having a 13485 system or conforming to 21 CFR 820 you would typically refer to ISO 14971 for your risk assessments but each manufacuturer would need to detail their own risks for their own processes.

Is the 2009 version more relevant to those who want to be "certified" to ISO 14791?

The registrars we have dealt with in the past year or so all have differing opinions. Agreed, they "should automatically accept the first, will readily accept the second but with review" but we have seen non conformances issued if your external documents do not include ISO 14971:2009 even with a very detailled Risk Management Program.
 
M

MIREGMGR

#9
Re: Where can I buy the standard EN ISO 14971:2009?

The registrars we have dealt with in the past year or so all have differing opinions. Agreed, they "should automatically accept the first, will readily accept the second but with review" but we have seen non conformances issued if your external documents do not include ISO 14971:2009 even with a very detailled Risk Management Program.
I'm under the impression that if you're following the second conformance path, either ISO 14971:2007 corrected version or ISO 14971:2009 can be the basis. However, this isn't the only instance where inconsistency can exist between NBs. If you're concerned and want to avoid friction, you might want to add that item to your ongoing dialogue with your NB, and make sure in advance that the way you handle it is acceptable to them.

Of course, this begs the question: regarding risk management, why use the second conformance path? Why not just add the harmonized standard to your external documents set, and declare conformance to that version?
 
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