Hi,

Is there any sort of list covering which Harmonized Standards might be used to show compliance to a specific Essential Requirement (MDD)?
Or is all this up to the manufacturer to decide?

best regards
t.

Yes I believe they are shown on the Europa web site.

The Europa website list all the harmonized standards. For MDD see:

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

The last page of each standard should have a table showing which sections of the Essential Requirement the standard meets.

Almost each harmonized standard has an Annex ZA, which contains a reference matrix between the clauses of the standard and the related essential requirements from Annex 1 MDD.

So the path is the following:

Goto the New Approach Website (http://www.newapproach.org/Directives/DirectiveList.asp), follow the link to the list of the harmonized standards. Search the harmonized standards for your product, get the standard an look for the Annex ZA, where you find the essential requirements for your product addressed in the standard.