93/42/EEC Declaration of Conformity and Harmonized Standards

Ronen E

Problem Solver
Staff member
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#11
Personally (without having any awareness of the business priorities) I would conduct the gap analysis to demonstrate compliance with ERs, reference the new standard on the DoC (because I don't fully agree with referencing a different standard from the one in the report) and tell the auditor to learn the rules, with a request for review of the NC to the NB.
Ditto!
 
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apuigvert

Involved In Discussions
#12
This is not generally an acceptable argument. Testing to the newer standard may suffice for satisfying the ER, but "presuming compliance" has a very specific meaning in the MDD context, and that is reserved only to harmonized standards. With a harmonized standard, compliance with the ER is considered automatic (no NB discretion); with any other standard (even a newer version of a harmonized one), the NB will weigh the evidence and decide whether the ER have been in fact satisfied.



The gap analysis is only an aid in justifying that the ER have been met. It doesn't entitle you to claim compliance with a standard that wasn't verified against, even if its requirements are a subset of the ones in the standard that was verified. You should only declare compliance with the standard(s) specified on the test reports.

Cheers,
Ronen.
ok! that is good to know. Thank you!
 

apuigvert

Involved In Discussions
#13
Because it's just not cricket?...It could be done but OP needs to consider what they want to achieve and in what timescales

1. do they want the NC to "go away"?
Either do what the auditor wants (quicker, may lead to problems down the road)
Complain to the NB (slightly longer)

2. do they want to state compliance with the harmonised standard or the newer standard on DoC
if newer standard...just state it and complain to NB in option 1
if the harmonised standard (I do not know the standard so excuse my comment if wrong), it is preferable that the report references it, but with the gap analysis, if it demonstrates that the new standard is tighter and the product is still compliant with the harmonised standard, then I don't know of any reason why you can't claim compliance with the harmonised standard.

e.g. (horendously simplified)
new standard requires result = 5+/-0.1units
harmonised standard requires result = 5 +/-1unit
compliance with new standard automatically infers compliance with harmonised standard


One thing that they MUST do, is demonstrate compliance with the ER's, this would be achieved by conducting a gap analysis between new version and the harmonised standard and justifying how the differences still comply/do not impact compliance with the ERs



Personally (without having any awareness of the business priorities) I would conduct the gap analysis to demonstrate compliance with ERs, reference the new standard on the DoC (because I don't fully agree with referencing a different standard from the one in the report) and tell the auditor to learn the rules, with a request for review of the NC to the NB.
Yes, that is exactly what we were planning.

GAP analysis to demonstrate conformity with ERs and state on the DoC the Standards declared on the lab report.

Thanks for your opinions!
 
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