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

[Ellpee]

Yes, but the Essential Requirements are notoriously vague, which is why I thought that the "proper" way to fulfill the Essential Requirements was to use a harmonised standard. But do you mean that there are harmonised standards that have requirements that are not really needed to be compliant with the Essential Requirements of the directive which the standard is harmonised toward?

Looking at the EMC directive, the Essential Requirements are only two:

Equipment shall be so designed and manufactured, having regard to the state of the art, as to ensure that:
(a) the electromagnetic disturbance generated does not exceed the level above which radio and telecommunications
equipment or other equipment cannot operate as intended;
(b) it has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to
operate without unacceptable degradation of its intended use.

I would say that for at least the EMC standards I've read & worked with, all requirements can be interpreted to be required to be fulfilled for the product to fulfill those two Essential Requirements, but maybe there's some finer detail here I'm overlooking or to which I'm not aware.

Also, I'm not trying to be obtuse or anything, I'm just a bit confused in general and trying to understand in what scenarios a product might not comply with all requirements in the harmonised standard of a directive, but still be compliant with the directive.

Also, to answer your second question, "Are you confident that the product is compliant with the machinery directive and is safe to use?".

No, but I don't have any "hard evidence" that the product isn't compliant with the MD. For the EMCD I can point towards the test report that the external design partner has made and say "they have used a generic EMC standard when there's a suitable product specific standard available, which is not OK". But for the MD I'm extremely suspicious towards the test report they have for MD compliance, but the test report has been made according to a harmonised standard to which I'm not familiar and that I don't have access to, so I can't read the standard and verify that the external design partner has made a good job. I'm forced to trust them when they say "trust us, the product is compliant", which is somewhat of an issue in of itself, but as often people don't always want to be made aware of that quality issues exists as long as the money keeps coming in....

Also realized I forgot to answer your question on what country we are located in, it's Sweden.

 

[CharlieUK]

The test levels and limits in generic standards are generally very similar to those in product specific standards - the difference is in the detail as to how the equipment should be configured, monitored and what the acceptable performance criteria are, which are better in the product standards, but not always perfect.

Providing that you have some emissions test report that shows the product passes the required class A or class B limit whilst it is operating, I'm not sure that you have much cause for concern that would require a product recall.

I'm more concerned by your comments relating to Machinery Directive
- Just because a Machinery report references a Harmonised Standard, doesn't mean that it is the correct one nor that it has been applied correctly.
- You don't have any hard evidence that it doesn't comply, but you say that you don't trust what they have done, but aren't able to review that work yourself - I strongly recommend that you hire an external competent 3rd party to review it for you.
- You may not have the standard, but you can read them (in English) for a couple of Euro at Search - EVS standard evs.ee | en and in my view you shouldn't be signing a DoC for a product without being confident that it is compliant.

 

[Jen Kirley]

- 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.

I wonder if I correctly understand that a revision to product design as well as documentation may be needed. Once you determine that, if a design revision and updated V&V is needed then I would understand it to require a recall and replacement with the revised product plus its documentation. This important question should be given over to your legal team, as notifications to regulator may also be required and this becomes about much more than a question about certification.

 

[Ellpee]

The test levels and limits in generic standards are generally very similar to those in product specific standards - the difference is in the detail as to how the equipment should be configured, monitored and what the acceptable performance criteria are, which are better in the product standards, but not always perfect.

Providing that you have some emissions test report that shows the product passes the required class A or class B limit whilst it is operating, I'm not sure that you have much cause for concern that would require a product recall.

I'm more concerned by your comments relating to Machinery Directive
- Just because a Machinery report references a Harmonised Standard, doesn't mean that it is the correct one nor that it has been applied correctly.
- You don't have any hard evidence that it doesn't comply, but you say that you don't trust what they have done, but aren't able to review that work yourself - I strongly recommend that you hire an external competent 3rd party to review it for you.
- You may not have the standard, but you can read them (in English) for a couple of Euro at Search - EVS standard evs.ee | en and in my view you shouldn't be signing a DoC for a product without being confident that it is compliant.

Yes, my hope is that the product will pass the testing towards a product-specific standard, at which point we might just have to re-issue a new DoC (given of course the very large assumption that the product is also compliant towards MD/LVD)


- Just because a Machinery report references a Harmonised Standard, doesn't mean that it is the correct one nor that it has been applied correctly.
No, and we are now starting to involve an external company to review the products compliance towards the Machinery Directive, thankfully.

And also thankfully, I'm not the person who has signed the DoC, or will sign a potential new DoC.

But my original question still remains: If we would need to change what standards we have listed on a DoC, and this change should apply to products in the field, I assume that is something that CAN be done, and if so it should be communicated to customers somehow? Is there any guidance from the EC on this process?

 

[Ellpee]

I wonder if I correctly understand that a revision to product design as well as documentation may be needed. Once you determine that, if a design revision and updated V&V is needed then I would understand it to require a recall and replacement with the revised product plus its documentation. This important question should be given over to your legal team, as notifications to regulator may also be required and this becomes about much more than a question about certification.

Yes, a recall might be required, but it would most likely be a product correction on-site, given the size of the products. But the only documentation we are required to provide to customers are the DoC and the Instructions for Use, if I'm not mistaken. Our product does not require the use of Notified Bodies, so then I don't think we would need to inform any regulators about a product recall right?

 

[CharlieUK]

There's no provision in the Directives for issuing a new DoC because you issued the wrong one in the past.
What you did was issue a DoC based on the documented assessment that you had at the time the DoC was signed.

What there is provision for, is issuing a new DoC when there is a "substantial modification" to a product. For example, this would occur if an in-life software update allowed a radio product to operate in an additional band or at a higher power. In the event that this was done, a new DoC would be issued.

Please don't confuse shipping a product with an insufficient DoC and shipping one that presents a risk. The MD doesn't cover this very well, but all NLF aligned Directive published since 2010, including EMC, include the following requirement from Decision 768/2008:

8. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the
applicable Community harmonisation legislation shall immediately take the necessary corrective measures to bring that product into conformity,
to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, manufacturers shall immediately inform the competent
national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the noncompliance
and of any corrective measures taken.

Note - the risk is that it doesn't comply with Directive, not that it doesn't comply with a standard - there is an important difference.