Why does Official Journal list superseded standards?

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Pads38

Trusted Information Resource
#2
The answer is shown in the top left corner of the OJ - the date. It was last revised in November 2017 so is, basically, out of date.

I understand that there is lots of work going on to create the first OJ for use with the new MDR (rather than MDD).
 

SKM.Sunil

Involved In Discussions
#4
Quick question ........ why does Official Journal still list superseded standards? For example, it shows EN 62366:2008 instead of EN 62366-1:2015.

Maybe I'm looking at the wrong list --> when I google "OJEU harmonized standards" I end up at the following link: Medical devices - Internal Market, Industry, Entrepreneurship and SMEs - European Commission.

Thanks

As Ronen E said........you may have reports according to old standard, and you decided to perform only a gap analysis.
These are called outdated instead obsolete.

obsolete standards are those, whose existence completely erased or taken over by another new named standard.
 

DamienL

Starting to get Involved
#5
Thanks both for your responses:
These are called outdated instead obsolete.

obsolete standards are those, whose existence completely erased or taken over by another new named standard.
For the example I took from the OJ, the status of EN62366:2008 is "Superseded, Withdrawn", replaced By: EN 62366-1:2015 and PD IEC/TR 62366-2:2016. Surely that's 'obsolete', not just outdated?



To clarify - it's certainly outdated but it's still officially in effect (relevant to devices that will continue beyond May under the MDD)
So my understanding is that for CE Mark we would need to comply with the superseded version, not the current one?
 

Ronen E

Problem Solver
Staff member
Moderator
#6
So my understanding is that for CE Mark we would need to comply with the superseded version, not the current one?
These are harmonized standards - you don't need to comply with any of them, current, outdated, obsolete, whatever.
You may comply with those that are legally in effect as such - for MDD compliance those would be the ones listed in the last OJ-published list (there won't be another) - and benefit the presumption of conformity.
Other than that you may comply with the state of the art standards (typically the latest revision), which will make your audit-life a tiny bit easier, or with any standard or other method you can justify sufficiently. But then you don't get the presumption of conformity and you don't collect $200 :)
 
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