First, I'm surprised that you are moving forward with the MDD, given the pending issues with the MDR. I infer your strategy with your NB is to get the certificate under the MDD and then move to the MDR Article 120 transition.
Given your description of the device, I'm not convinced it meets the definition of machinery in the Machinery Directive Article 2(a). Assume it does.
The MDD says that if your device is covered by the machinery directive, then you must also meet Annex I of the machinery directive, MD. However, when the MDD is more explicit than the MD, the MDD governs.
This means you must go through the MD Annex I, determine which requirements apply and which ones do not. If a requirement applies, then you must determine if there is a more specific requirement in the MDD. The best method is an MD Annex I checklist in which you determine the applicable requirements. If a requirement is applicable, but less specific than the MDD, then cite the MDD Annex I requirement by number.
You will have to follow MD Article 12 to assess conformity and also prepare a Declaration of Conformity.
When you get to the MDR, you will have a similar situation with the MD, Article 1(12). I recommend you do the MDR analysis at same time, since you will be thinking about the issues. Under the MDR, you will not write separate Declarations of Conformity. Instead you will prepare one consolidated DoC.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 03-Sep-2019 04:38
From: Anonymous Member
Subject: When to write a Machinery directive EHSR checklist?
This message was posted by a user wishing to remain anonymous
We are in the final stages of completing our MDD documentation and the applicability of the machinery directive has been raised. The device has small moving parts which would be user-accessible upon opening a cover (finger trapping hazard); multiple cut-out switches on opening the cover have been implemented to mitigate this risk.
After reading some of the previous posts on this forum and MDD Article 3 (below), I think the machinery directive is applicable.
"Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery ( 24 ) shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive.
Therefore, we need to address the applicable machinery EHSR's* with a checklist in a similar way to the Essential Requirements checklists used for MDD. However, I don't think any of the machinery EHSR's that are more specific would apply to our device.
In writing this I am talking myself into it, but do I need to create an EHSR checklist for the applicable EHSR's* and detail out individually why we don't need to address any of them?
*I have come across a joint industry recommendation doc from COCIR that provides a rationale for which EHSR's are applicable/not covered by MDD.