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Risk Benefit Analysis - ISO 14971:2012 Requirements
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Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
Risk Benefit Analysis - ISO 14971:2012 Requirements
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Risk Benefit Analysis - ISO 14971:2012 Requirements - Page 4

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  Post Number #25  
Old 7th February 2018, 09:21 PM
Peter Selvey

Total Posts: 872
Re: Risk Benefit Analysis - ISO 14971:2012 Requirements

Yes, apologies - the original thread is more about the Annex Z wording than the broader context of risk / benefit.

In my opinion the whole model of acceptable risk (i.e. measure the risk, compare against limit, if below do nothing, if above take action or use risk/benefit) is flawed, so we are kind of floundering around trying to patch up issues around the edges when what is really needed is a new core.

But to defend Annex Z a little:
In the other thread I mentioned 3 types of "information for safety": obvious, lazy, and genuine. There is a 4th - irresponsible - where the risk is significant and but nothing is done except a warning, when there were other options on the table. That happens more often than you think, and seems to be the obvious trigger for Annex Z.

For example: digital thermometers take around 10 minutes to stabilise. We don't want to wait 10 minutes, so manufacturers use a predictive method: good devices watch for 30-60s and then use a software algorithm to estimate the final temperature. Then some manufacturers realised if they put "measures in just 10s" on the box, then they can sell more.

Problem is ... 10s only works under highly controlled conditions, which are rarely found out in the real world. High errors occur in practice which then influence clinical decisions. For example if your kid's real temp is 41.2C you should go to the emergency dept., but if the 10s thermometer reads 39.7C you might sweat it out at home. The kid dies at 3am. Because of a 10s thermometer. And you can buy these from your local pharmacy. A regulated medical device.

The manufacturers of the 10s products probably know that there are high errors in practice, but hide behind a warning which is documented as being acceptable risk.

Frustrated with situations like this, Europe pumped out Annex Z. The gist of Annex Z is to say: we don't care what you wrote in the risk management file, a 10s thermometer does not meet the requirements of the directive, get it off the market.

I agree that the wording in Annex Z seems to have overstepped the mark, especially the logic to say that risk/benefit is always required for individual risks. But again, a couple of key points:

First, it's an informative annex. Informative annexes are not mandatory or enforceable, the are not part legal framework which gives a presumption of conformity (harmonised standards)

Second: it does not indicate what records are required, which is the core point of this thread. ISO 14971 has several requirements where no records are required, and that's an important distinction. One example already mentioned is the trigger for using Clause 6.5, when solutions were "not practicable" - no records are required with respect to what solutions were considered and rejected or why. Annex Z is pointing out that you always need to keep the risk/benefit profile in mind, but there is no requirement to keep any records.

So, Annex Z does not change what you document in the risk management file. It's really a legal point that had to be made - without Annex Z, Europe appeared to be legally bound to accept the decisions in the manufacturer's risk management file, under Article 5, Section 1 of the MDD (presumption of conformity). Annex Z clarifies that EN ISO 14971 is only a partial standard, and compliance with EN ISO 14971 does not infer a legal presumption of conformity where Annex I refers to risk.
Thank You to Peter Selvey for your informative Post and/or Attachment!

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