Declaration of conformity Vs Declaration of incoporation 2

[BexBex1000]

We currently produce a range of peristaltic and centrifugal pumps. We therefore produce a TCF file and do the relevant testing to comply to the complete units (pumps, motors, gearboxes, etc) we sell. One question we have though is when we sell a pump without a motor and gearbox as we do outside of the European union do we have to certify these pumps with a declaration of incorporation instead? Reading through the machinery directive and then looking at all the varied approaches by other similar companies in the same field seems to indicate different takes on the same subject. If anyone has any experience to share on this matter it would be much appreciated as we gather as much evidence from as many different sources as possible, thank you in advance. Apologies if posted in the wrong area.

 

[3DDave]

Not an expert - but this appears to be written by them:

https://www.hseni.gov.uk/articles/declaration-incorporation

As far as I can tell, the main thing is that machine builders are not to abuse the Declaration of Incorporation by leaving guards and other required features off of otherwise fully functional equipment in order to claim they are incomplete devices. If one can use the machine by ordinary installation (bolting it to the floor or plugging it into an electrical outlet) then it requires a Certificate of Conformance.

It seems like a pump that has no drive system cannot be taken as fully functional and will therefore qualify for Declaration of Incorporation.

This does seem to be more appropriate a question for a lawyer in the field of machinery contracts.

The tricky part is the "instructions for incorporation." Those are probably available from competitors, but it's another area for a lawyer with experience to be involved. For which I am sorry - best of luck.

 

[Rputvin]

The company I work for produces pump stations, mostly for the US market. We just built one for EU and went the Incorporation route and passed the certification on to the equipment supplier that our pump station serves (as agreed upon by both parties). The wording of the Declaration of Incorporation, and the several examples I used for reference, is such that the final assembly would need to be certified inclusive of our equipment, and our equipment is of no use except as an included accessory in that specific machine as it's a custom design.

If you're selling the wet end off a pump "into the market" I believe you'd still need a Declaration of Conformity unless the end user that mates it to a motor is then certifying the completed pump or otherwise including the pump into a broader certification/conformity assessment.

Edit: that is to say - if your customer is OEM machine builders in Europe that will be incorporating your product into a certified machine you have one answer, if you're selling to retail shelves/distributor/etc for any person to buy and use it how they see fit you have another answer.

 

[Hoxton123]

The important phrase is 'Placing on the Market'.

The entity who ‘places’ the final product ‘on the market’ has the responsibility to meeting the Regulation or Member State’s law if it is a Directive.

(A Regulation applies equally to all Member States at the same time.
A Directive requires each Member State to transpose this into their domestic law by a certain date. The MS has to meet the minimum requirement of the Directive, but could make them more severe)

Prior to that, transactions between manufacturers and suppliers to not have to meet the end requirements.

The Machinery Safety Directive will be superseded by the Machinery Safety Regulation, this will formally permit ‘Partly Completed Machinery’ to be sold without meeting the full requirements of the Regulation.