BS EN ISO 14971:2019+A11:2021 released

Y

yodon

Leader
Super Moderator
Just saw that this new amendment to 14971:2019 was released. Has anyone picked it up? Are we back to the :2012 content deviations? Is this likely to be harmonized under the MDR?
 
M

monoj mon

Trusted Information Resource
I don't have the complete amendment yet, but I have got the preview document from here and the table content there says that it only has added Annex ZA and Annex ZB in the amendment.

Annex ZA(informative): Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered.
Annex ZB(informative): Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered.

You can buy a cheaper version of the amendment from here! A single user license is about 7-8 Euro.
 
C

cool1984

Involved In Discussions
I found Annex ZA&ZB published in Pireview at NEK EN ISO 14971:2019/A11:2021.
(I just registered recently, so I can't seem to get the URL address yet. Sorry)

Could you please tell me if the annex ZA&ZB in this preview is all the information? Does annex ZA still have a table?
 
J

Jean_B

Trusted Information Resource
Without getting compromisingly specific: there are tables in there.

They are one-way: what of MDR and IVDR is (partly) covered by 14971:2019. You must still check GSPR versus these for complete coverage to have clear demonstration of risk mgt compliance.
The part things specifically excludes device-specific aspects and usability (62366-*).
Unmentioned as not covered by presumption of compliance seem to be 1 (acceptable risk as weighed etc), 2 (not stated as needing to inform risk acceptability policy of the standard, which is odd vs how it was done for the 2012 one), 6 (normal use effect over lifetime of device) and 7 (transport and storage).
Nothing of annex 1 chapter ii, thus also missing biological evaluation aspects, sterility, etc. (Annex 1 chapter 1 doesn't call out to chapter 2, so it isn't covered by calling it in from something in the table).

Furthermore it makes the same deadly assumption of being able to 1:1copy-overwrite the definitions for terms of the standard with the definitions from the regulation as the previous one, except for the now whopping 7 reduction policies which are barely meaningfully distinguishable, yet that need to be implemented as if they were.
There's also a note (which cannot contain requirements) requiring things no other part of the main body makes requirements on (which at least tries to reach chapter 2).

I know/presume this cannot be easy work to get right and get consensus on, but its current shape is a formality and not a help/boon to anybody, whether manufacturer, patient, user or inspecting body. It doesn't add anything over 14971, nor technically ensure all appropriate risk mgt is declared.

Note: no rights can be derived from my above statement for technical file review commentary or audits (obviously).

Edit: god one can make many typos when typing on mobile. Fixed most (probably)
 
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