ISO TS 24971 Updates and formal objection of the European Commission to ISO 14971

M

MIREGMGR

#21
Re: Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14

If your NB won't be practical about the user being a willing and able participant in use-risk management, you could discuss with the NB the possibility that you would cease declaration of conformance to 14971, and instead conform to the Essential Requirements via your own risk procedure that is similar to 14971 except in the areas of present conflict, where your procedure would be based on common real world practice.
 
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Salisburysteve

Starting to get Involved
#22
Re: Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14

Hi,

Our NB are making a major NC out of not reviewing 14971 compliance with the BS EN 2009/2012 update. Their case is not that we haven't reduced/assessed/managed risk appropriately but that we cannot meet ER requirement to reference 'state of the art'.. Since BS EN ISO 14971:2012 is the most recent risk standard it must be state of the art..

Glad to hear someone has ditched 14971 and gone straight to ER justification.. Tempting...

Regards,

Steve
 

Peter Selvey

Staff member
Super Moderator
#23
Re: Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14

I think in practice manufacturers have excessively relied on warnings in the instructions for use as a get out of jail free card in risk management. A lot of standards seem to encourage this as well.

It seems as if Deviation 7 is a knee jerk reaction to the other extreme by prohibiting the use of any information as a risk control. This is likely to be modified in the future back to something reasonable. There are simply too many cases where information to the user does form a valid risk control, with contraindications being a good example.

The real problem is a failure to properly verify the effectiveness of a risk control. Most warnings really don't reduce the risk, and therefore they should not be listed as a risk control. Risk management tables often show a risk as being significant prior to the warning, and then magically reduced once the warning is in place.

I find that a lot of warnings and cautions are a bit of a smokescreen, and if you look into the subject carefully, the you find there was no real risk in the first place, or the true risk control was somewhere else.

So while Deviation 7 is clearly wrong, it puts a spotlight on a serious issue.

For those with the stomach that would like to challenge Deviation 7, note that Europe has an effective constitution in the form of a treaty (OJ 2010/C 83/01). Article 4.4 states:

Under the principle of proportionality, the content and form of Union action shall not exceed what is necessary to achieve the objectives of the Treaties
Deviation 7, and in particular statement 7c is obviously one which could be challenged legally under the principle of proportionality. Disallowing all information to the user as a risk control obviously makes no sense.
 

Marcelo

Inactive Registered Visitor
#24
Re: Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14

Also, if you use information for safety as a risk control measure by ISO 14971, you need to route them to the usability engineering process aa part of the way to verify it?s implementation and effectiveness. Only putting the info in youor risk management file is not enough, but that?s what people usually do.
 
G

GPjeri

#25
Re: ISO 24971 July 2013 doc

Has anyone purchased this and would you recommend getting it; did you find it helpful?


Thanks in advance...:)
 
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