Technical Documentation Review: Responding to a Nonconformity

Ronen E

Problem Solver
Staff member
Moderator
#11
I do agree, however, the requirement is not that manufacturers only show compliance with essential requirements, as, related to the standards, there's this requirement:



It only requires a description, not a justification, so it's still not a requirement as I mentioned anyway.
Marcelo,

Your quote from the MDD (reproduced below) is from Annex II, so it only applies in those cases where the manufacturer chooses the Annex II route. Besides, it only requires listing the standards that will be applied. In my understanding, if the manufacturer chooses NOT to apply some standards, or even just doesn't apply some standards without a clear decision/consideration, this clause doesn't require doing anything about it.

3.2. Application of the quality system must ensure that the products conform to the provisions of this Directive which apply to them at every stage, from design to final inspection. All the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly manner in the form of written policies and procedures such as quality programmes, quality plans, quality manuals and quality records.

It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).

It shall include in particular an adequate description of:

(...)

(c) the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:

(...)

— the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,

(...)
 
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Marcelo

Inactive Registered Visitor
#12
Your quote from the MDD (reproduced below) is from Annex II, so it only applies in those cases where the manufacturer chooses the Annex II route
In fact, the same text with a slight variation is present in Annexes II, III, VII and VII, which means in practice it is required in for all routes.

Besides, it only requires listing the standards that will be applied. In my understanding, if the manufacturer chooses NOT to apply some standards, or even just doesn't apply some standards without a clear decision/consideration, this clause doesn't require doing anything about it.
In the case of not using harmonized standards, it requires a description of the solution, not a list of standards. The list of standards is in the first part of the text.

But again, it does not require that you compare your "alternative" solutions if not using harmonized standard, it only requires that you describe then. The NB would need to verify the alternate solutions, but as you mentioned, they usually do not have enough expertise.
 

Ronen E

Problem Solver
Staff member
Moderator
#13
But again, it does not require that you compare your "alternative" solutions if not using harmonized standard, it only requires that you describe then. The NB would need to verify the alternate solutions, but as you mentioned, they usually do not have enough expertise.
I'm glad that we agree on the essence.

Coming back to the original question, there is no requirement in the MDD to list or justify standards that are not applied.
 

Mark Meer

Trusted Information Resource
#14
I agree with Ronen.
Mark, my statement that "Compliance with the MDD equals compliance with all the relevant harmonized standards to your organization" is not incorrect.
It's NB gospel truth :)
Coming back to the original question, there is no requirement in the MDD to list or justify standards that are not applied.
I think we're all in agreement here that:

1. In principle, and strictly by regulations, standards are voluntary, and you don't have to justify not using them as long as ER compliance can be demonstrated.

2. Many NBs are increasingly choosing to treat standards as defacto mandatory (due, in part, to lack of expertise to adequately evaluate alternate compliance evidence).

..and I'd go so far as to add:

3. This places increasing burden on Manufaturers, as they don't know what to expect when interacting with NBs. The "safe" route (explicit compliance to all applicable harmonized standards) often involves greater resources (with little or no value-added - except for NB appeasement), whereas using your own solutions is a gamble, depending on the NB.

Overall, a bad state of affairs for the industry, IMO.
:(

It is unfortunate that dealings with NBs are becoming increasingly more and more bureaucratic in nature. That is my opinion.
Agreed.
 

sriramsl

Involved In Discussions
#15
Thanks a lot all of you for your insights on this thread. Very useful information and answers for a very important and relevant question.
Thanks again
Sriram
 
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