Essential Requirements Checklist - (MDD 93/42 / EEC)

[Gilberto Machado Soares]

Hello,

I have a question about the Essential Requirements Checklist (MDD 93/42 / EEC). For each standard updated in its EN ISO version, should I update the Essential Requirements Checklist ?, I have this question because this checklist is NB approved, so with each revision, I would have to submit them for approval or should I update them and wait for the next periodic audit of the CE marking (MDD) for NB approval of the checklist?[/quote]

 

[Marc]

This is causing confusion. This belongs in a forum post, not as a forum resource. I have attached it below.

 

[Ronen E]

For each standard updated in its EN ISO version, should I update the Essential Requirements Checklist ?

No.

What really matters in this context is the addition of a new version to the harmonized standards list published in the Official Journal (OJEU). The publication of an EN standard doesn't automatically add it to the list, though it's a predictor that it's likely to be added at some point in the foreseeable future. Please note that the list for the MDD hasn't been updated in almost 2 years and it most likely won't be updated ever again.

Even when a new version is added, it usually doesn't mean that the old version is immediately de-harmonized. There's usually a substantial transition period. And last, even when a standard or a version is removed (typically superseded) you can still refer to it in your ER checklist; only in a different manner - not as providing "automatic" presumption of conformity, or indicating compliance with the State of the Art (latest version), but "just" as a means of showing some level of compliance - sometimes deemed sufficient.

this checklist is NB approved, so with each revision, I would have to submit them for approval

Normally you wouldn't, unless the change represents something really major. In most cases you can simply revise the ER checklist (which is, by the way, not a mandatory requirement in itself - just a convenience), and the NB will (may) review on their next audit.