Harmonized List - MDD 93/42/EEC

#1
I work in class IIa product regulatory area and in December we will have a CE marking audit (MDD 93/42 / EEC), we have the Essential Requirements Checklist, in which there are all internal documents and standards applicable to each ER item. We also have a list of all standards applicable to our product, my question is: do we have standards with a revision more current than the harmonized list, so do I update these lists with current versions? or leave the version present on the harmonized list?
 
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#2
Gilberto,

the process of harmonisation has come to a standstill with the last update in 2017. Meanwhile, a number of standards has been updated with a revision more current. Some notified bodies refer to current standard revisions by arguing that only these reflect the "state of the art". So it would be prudent to update your ER checklist to the most up-to-date standard revisions, provided your gap analysis readily allows to do so.

HTH,
 
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