Revised list of harmonized standards for medical device directives in the EU

Marcelo

Inactive Registered Visitor
#1
Not sure if everyone is aware, but the lists of harmonized standards for all medical devices directives in the EU have been completely updated.

This complete overhaul seems to be, at first, because of the inclusion of a new column relating the first publication of the standard on the OJ, which is the " Date from which the use of this standard guarantees a presumption of conformity to the essential requirements it covers" (a little different for the IVDMD).

I didn´t do a full review, but it seems at first that there were no additions.

Harmonized standards - AIMDD - http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/implmedd.html#(*)

Harmonized standards - IVMDD - http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/invimedd.html#(*)

Harmonized standards - MDD - http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html#(*)
 
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