Hello all
ISO TC 210 / IEC TC 62A - JWG 1 - Application of risk management to medical devices - had a meeting this week in Lubeck, Germany.
The main discussion was regarding the (internal as it is still a working draft) comments to ISO TR 24971, the guidance on the application of ISO 24971.
There were a lot of discussions, changes and removals, but in the end I think we managed to get a good revised document. For example, one of my main concerns, the chapter on how to use standards together with ISO 14971, was only slightly modified to correct an error, with the rest being kept.
A committee draft will be circulated for all National Committees in the following days so more people can comment on the work already done.
Another important discussion was the formal objection of the European Commission against ISO 14971. As with EN ISO 13485:2012, the solution in the future EN ISO 14971:2012 will be in the form of revised Annexes Zs (relating the standard to essential principles).
However, in the case of EN ISO 14971, there will be some "deviations" from the standard which in fact wil create a lot of problems to device manufacturers.
For example, one of the deviations is that, even though ISO 14971 says that for low, negligible risks, the manufacturer is not require to take any measure, the official interpretation of the directive (and which will be considered a deviation of the revised EN ISO 14971) is that all risk, regardless of being negligible or not, have to be reduced as much as possible. This creates a somewhat impossible situation in which manufacturers have to go after ALL risks, even the ones in which the probability is extremaly low or the severity is negligible.
And this is only one of the 7 "weird" deviations.
I'm really not sure how things will work out after the pblication of the revised standard.
Anyway, JWG 1 did decide that there's no need to revise ISo 14971 right now due to these interpretations fo the EU, which I think is a prudent position.
ISO TC 210 / IEC TC 62A - JWG 1 - Application of risk management to medical devices - had a meeting this week in Lubeck, Germany.
The main discussion was regarding the (internal as it is still a working draft) comments to ISO TR 24971, the guidance on the application of ISO 24971.
There were a lot of discussions, changes and removals, but in the end I think we managed to get a good revised document. For example, one of my main concerns, the chapter on how to use standards together with ISO 14971, was only slightly modified to correct an error, with the rest being kept.
A committee draft will be circulated for all National Committees in the following days so more people can comment on the work already done.
Another important discussion was the formal objection of the European Commission against ISO 14971. As with EN ISO 13485:2012, the solution in the future EN ISO 14971:2012 will be in the form of revised Annexes Zs (relating the standard to essential principles).
However, in the case of EN ISO 14971, there will be some "deviations" from the standard which in fact wil create a lot of problems to device manufacturers.
For example, one of the deviations is that, even though ISO 14971 says that for low, negligible risks, the manufacturer is not require to take any measure, the official interpretation of the directive (and which will be considered a deviation of the revised EN ISO 14971) is that all risk, regardless of being negligible or not, have to be reduced as much as possible. This creates a somewhat impossible situation in which manufacturers have to go after ALL risks, even the ones in which the probability is extremaly low or the severity is negligible.
And this is only one of the 7 "weird" deviations.
I'm really not sure how things will work out after the pblication of the revised standard.
Anyway, JWG 1 did decide that there's no need to revise ISo 14971 right now due to these interpretations fo the EU, which I think is a prudent position.
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