Overlap between Assembly of Machinery in Machine Directive and Fixed Installation in EMC Directive?

[Ellpee]

Hi! I'm working with the compliance of a company assembling lines of analysis instrumentation for biological analysis. The company doesn't design any of the instruments themselves, they purchase finished, CE compliant instruments & machines and assemble them into larger workflows based on each customers requirements. They also write software to talk to all instruments and facilitate/coordinate the operation of each instrument in the assembly.

As I've understood it, an installation like this can fall into two definitions:

1) Assembly of Machinery in the Machine Directive (definition taken from §38 of Guide to the Application of the Machinery Directive)
For a group of units of machinery or partly completed machinery to be considered as an assembly of machinery, all of these criteria must be fulfilled:
− the constituent units are assembled together in order to carry out a common function, for example, the production of a given product;
− the constituent units are functionally linked in such a way that the operation of each unit directly affects the operation of other units or of the assembly as a
whole, so that a risk assessment is necessary for the whole assembly;
− the constituent units have a common control system – see §184: comments on section 1.2.1, and §203: comments on section 1.2.4.4 of Annex I.

2) Fixed Installation in the EMC Directive (definition taken from EMC Directive, Article 3 (3))
‘fixed installation’ means a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location;

I believe in this instance it should be considered an Assembly of Machinery since all instruments in the line are assembled together to carry out a common function (analysis of biological samples), they are linked in a way that the operation of each unit directly affects other units in the line, and they have a common control system in that they are operated by the software suite developed by the company I'm working with. If I'm correct in this interpretation of the MD, then a full conformity assessment should be carried out.

Where I'm hesistant is if this would also be classified as a Fixed Installation according to the EMCD? If that is the case, then how should I interpret the following clause from the EMCD (§36):
Due to their specific characteristics, fixed installations need not be subject to the affixing of the CE marking or to the EU declaration of conformity.

I doubt that this clause would allow the company to ignore the MD (and any potential LVD requirements as well)?

 

[ChrisM]

Where I'm hesistant is if this would also be classified as a Fixed Installation according to the EMCD? If that is the case, then how should I interpret the following clause from the EMCD (§36):
Due to their specific characteristics, fixed installations need not be subject to the affixing of the CE marking or to the EU declaration of conformity.

You only have to CE-Mark against one directive. If you have good reasons and evidence to believe that the Machinery Directive is the applicable one (and from what you have written, this does appear to be the case), you only need to have the product marked against this one. Of course it still has to meet any other applicable requirements.

 

[Ellpee]

What do you mean with the "You only have to CE-mark against one directive"? A single product can fall under the scope of several directives, and the fact that our electrical product falls under the Machinery Directive doesn't mean we can ignore the EMC aspects of the product? At least that is how interpret section 2.7 of the Blue Guide?

The way I've been taught how to do CE is that you apply all applicable directives (in our case that would be the Machinery Directive (including the essential requirements of the Low Voltage Directive, according to §63 of the "Guide to application of the Machinery Directive 2006/42/EC")), and then select suitable harmonised standards to fulfill the Essential Requirements of each directive?

 

[ChrisM]

Perhaps I have not written that as well as I could have? I believe that you are correct in what you say, but I think that the Declaration of Conformity will only reference one Directive

 

[Ellpee]

No, the DoC should list all applicable directives. I can't post links here, but almost all example DoCs I've seen online have had multiple directives listed on them.

 

[emceng]

I'm not familiar with the MD, but I think you're overcomplicating this a bit. If the company is purchasing CE marked equipment and putting it together into an assembly line the EMCD doesn't apply to the assembly line - each piece is CE marked, and it wouldn't need to be assessed as a fixed installation. Fixed installations are intended for huge equipment that is fixed in place, like power plants or HVAC systems. Industrial equipment, even if bolted to the floor, would fall under normal CE mark procedures not fixed installation requirements.

 

[Ellpee]

Ok, but then the company is still assembling different CE marked products into a new product (since they are selling the entire assembly/analysis line as a single product), and CE + CE =! CE should apply?

 

[CharlieUK]

You need to review scope and exemptions for each Directive and Regulation in turn:

- From what you say, the Machinery Directive applies.

- The EMC Directive applies to the manufacturer of each individual instrument when it is placed on the market by the original manufacturer. If you were the end user combining the items, you would be out of scope of any further responsibility under the EMC Directive as you're the end user. You are not the end user, so you do have a responsibility under the EMC Directive, but if each combination of machines is a custom configuration for an end installation, you can follow the "Fixed Installation" route under the EMC Directive, installing the equipment using "good engineering practice", which would include following original manufacturer installation instructions.

- RoHS applies to each individual instrument when it was placed on the market by the original manufacturer. Providing you are not acting as an "importer" I would say you have no further responsibility under RoHS.

From what you have described, I would say that the end assembly line should be CE marked for the Machinery Directive only.

 

[emceng]

Well said Charlie. Under the EMC Directive, there is no need to CE mark the final assembly line. CE + CE =! CE, but if it isn't required on the assembly line it doesn't matter.

 

[Ellpee]

Thanks for the very detailed reply!

I assume that fulfilling the essential requirements of the Low Voltage Directive is still applicable though, since these are electrical instruments being assembled into a new configuration?