Re-releasing new Declaration of Conformity with new harmonised standards for products in the field

[Ellpee]

Hi!

We have an issue at my company where we have discovered that one of our products in the field is not CE-compliant due to it not being compliant with all the technical requirements in one of the harmonised standards we have written on the DoC. The harmonised standard in question is also a generic product standard, while all of our other products follow a product-specific standard.

Can we just re-test the product towards the product-specific standard and if it passes all the requirements of that standard, release a new DoC for the product with the new product-specific harmonised standard listed instead of the old generic harmonised standard? We have a number of products in the field that were then sent with a DoC which claims compliance towards a standard that we are not compliant with. Would we need to send the new DoC with the new harmonised standard specifically to each customer that has one of these products, and tell them the previous DoC is now not valid anymore?

 

[ChrisM]

When you say "due to it not being compliant with all the technical requirements in one of the harmonised standards we have written on the DoC", do you mean that you simply did not test to all the requirements (so you do not know if it is fully compliant) or you tested it but it failed?
If the former, the you'd better have the testing carried out ASAP and keep your fingers crossed; if the latter then you may need to seek immediate legal advice concerning possible recall. If the former.... well you may also need to seek legal advice in the interim whilst you await the results of testing as from what you have said above, technically you have made a Declaration that you cannot prove is true.

 

[CharlieUK]

what Directives are applicable to the product?
It sounds like you're referring to the EMC Directive with generic and product standard but what other Directives are applicable?

 

[Ed Panek]

The cleanest, least auditor-pulling method I would use is to replace the unit free of charge. What you are describing sounds full of pitfalls and explaining it to a regulatory authority is a place I wouldn't want to be. An in-warranty exchange is simpler and demonstrates more control. Otherwise, you are relying on the untrained user to ensure the right documents are in the right place.

We shipped a product without proper documentation. We reviewed records and this is the only one like this. Our containment was to return this unit and inspect it, then push it through the production testing again and determine its fitness as we would a new unit. That story has few strings to pull.

 

[Ellpee]

When you say "due to it not being compliant with all the technical requirements in one of the harmonised standards we have written on the DoC", do you mean that you simply did not test to all the requirements (so you do not know if it is fully compliant) or you tested it but it failed?

- The product was designed by a design company for us, and they were responsible for delivering a design that was CE compliant. We have now found out however that the work they did had several flaws in it, and we have very strong suspicions that the product is in fact not compliant with the CE directive. They delivered a test report which claimed all tests passed, but we have now discovered a few requirements in the standard that were simply ignored, which together with some other facts have caused us to doubt the entire test report.

If the former, the you'd better have the testing carried out ASAP and keep your fingers crossed; if the latter then you may need to seek immediate legal advice concerning possible recall. If the former.... well you may also need to seek legal advice in the interim whilst you await the results of testing as from what you have said above, technically you have made a Declaration that you cannot prove is true.

We are definitely aware that a product recall might be required, but we are now in the process of investigating our possible options, but we will most likely have to contact expert help to sort out the situation. But I'm also asking due to interest, if we have previously issued a DoC that was not correct, could we issue a new DoC which lists other harmonised standards for compliance (of course given that the product would fulfill these new standards), and claim that the new DoC "overrules" the old DoC, and the product is now compliant since we have issued a new, correct DoC? Or what is the legal process for correcting an incorrect DoC that has been shipped with products into the field?

 

[Ellpee]

As to Charlie's questions:
what Directives are applicable to the product?
It sounds like you're referring to the EMC Directive with generic and product standard but what other Directives are applicable?
The product falls under the Machinery Directive, LVD, EMCD, and RoHS according to our analysis. Our DoC lists compliance with the MD, EMCD, and RoHS. We have harmonised standards for the MD & LVD listed under MD (to show LVD compliance according to Annex 1, §1.5.1), and other harmonised standards listed under EMCD & RoHS respectively.

And yes, I was referring to the EMC Directive. Currently the product has been tested according to the EN 61000 family of standards, but there is a specific EMC standard for our type of products (which is lab equipment), which is the EN IEC 61326-1 standard. In this case, since the requirements might be somewhat similar (I can't tell since I don't have access to the 61000 family of standards), if we would re-test the product to the EN IEC 61326-1 standard and it would pass the test, could we just re-issue a new DoC listing compliance towards the EMCD with the EN IEC 61326-1 standard instead of the 61000 family of standards? Or what would be the proper process to adress products in the field that have an incorrect DoC?

 

[Ellpee]

The cleanest, least auditor-pulling method I would use is to replace the unit free of charge. What you are describing sounds full of pitfalls and explaining it to a regulatory authority is a place I wouldn't want to be. An in-warranty exchange is simpler and demonstrates more control. Otherwise, you are relying on the untrained user to ensure the right documents are in the right place.

We shipped a product without proper documentation. We reviewed records and this is the only one like this. Our containment was to return this unit and inspect it, then push it through the production testing again and determine its fitness as we would a new unit. That story has few strings to pull.

Yes, I very much agree with you and it's what I'm pushing for in this case, but as always, money rules and people holding the money in the company might not agree. I also can't really tell what the legal consequences could be for something like this. I've tried researching what the legal ramifications could be for various cases of non-compliance with the CE mark for non-medical products. I've found a lot of news articles about legal consequences for medical companies that have violated the regulatory requirements, but since we don't operate in the medical space I assume the consequences wouldn't be the same.

So when my superiors ask what the legal consequences could be, I can't really answer that, because I don't know, and I haven't been able to find a clear answer in the EU documents, all I've seen is that it is up to each member country to determine suitable punitive actions for non-compliance.

 

[CharlieUK]

>The product falls under the Machinery Directive, LVD, EMCD, and RoHS according to our analysis.
Machinery Directive includes protection requirements of the LVD, so the applicable Directives are Machinery, EMC and RoHS.

There is an important difference between "non compliance with the Essential Requirements of a Directive" and "non compliance with a standard" - the 1st one is a conformity issue, the 2nd one is not - and not complying with a standard (or not testing against it) does not automatically make the product non-compliant.

Compliance with a Harmonised Standard published in the Official Journal gives a presumption of conformity, but the use of harmonised standards are not mandatory for any of those Directives (assuming the product is not in Annex IV of the Machinery Directive and you haven't used a Notified Body)

In terms of what to do:

RoHS Directive - once it is on the market, enforcement is very unlikely if at all.

EMC Directive - once it on the market, EMC enforcement is non-existent for all practical purposes unless you cause interference to licensed radio services (notable cellular networks as they pay large amount of money for their spectrum and products affecting network performance will be found). In my experience, should this be done, the best approach is to fix the problem asap (I've helped a company in the UK with this very problem and because they cooperated there was no penalty)

Machinery Directive - this is the most important one and this gives by far the biggest potential to injure someone. Speaking again about the UK - if someone is injured in the work place, HSE will investigate and they do prosecute through the courts and it could be the manufacturer, the employer or both.

The simple, and difficult, thing about EU Directives, is that the legal declaration is against the Essential Requirements of the Directive - the use of standards is merely a tool to assist you doing this - yes it's by far the most common route, but it's just a tool.

You may benefit from having your machinery directive compliance documentation reviewed by a competent 3rd party (that's not me for Machinery,I specialise in Radio and EMC) - which country are you based in?

 

[Ellpee]

Ok, this might be a major misunderstanding from me then, I was under the assumption that if we have used a harmonised standard to show compliance towards a directive, and then don't fulfill all applicable requirements of that standard, we would automatically be non-compliant with the directive. Why would that not be true?

And could you give an example of when not fulfilling a requirement in a harmonised standard wouldn't mean that you don't fulfill the Essential Requirements of a directive?

 

[CharlieUK]

It’s difficult to explain on a forum but Directives require that you comply with the Essential Requirements
That is all
The use of Harmonised Standards is recommended and test labs will always recommend that you test against them (because that’s what they do)

Ideally you would have tested against them but just because you haven’t doesn’t mean you need to recall the product

Are you confident that the product is compliant with the machinery directive and is safe to use?