Need for CE Mark - Clarification please

[Crusader]

I am just learning about CE. Have seen it everywhere all my life but now I am asked to check into getting our product certified...based on a customer request for our CE certificate. We don't have one.

Scenario:
we sell products, all over the world, that contain electrical components to roll up or down our product. The electrical components are CE / UL certified. We buy those electrical components - we don't make those electrical things. We simply assemble them into our product.

Question:
Do we need a CE certificate?

TIA!

 

[Rickser]

I can't answer whether you need it or not. In our experience, our customer required a CE certificate for a product. In was a long drawn out process. Send me a private message and I will give you our POC info. She is the expert on this stuff.

 

[CharlieUK]

It doesn't matter what components you build your system out of, what matters is what you build.

If your product is covered by one or more CE marking directives then you have to assemble a Technical File, perform necessary assessment, raise a DoC and fix the CE mark. If what you build isn't covered, you don't.
If you've got some electronics and/or mains power then chances are you need to CE mark your product and you can't just do CE+CE=CE.
Also, CE marking is not "customer decided" - it doesn't matter what they want, CE marking if EU/national legislation imposed on manufacturers.

If you provide some more information on your product, or point us at a similar product, I'm sure you'd get some more information.

 

[Crusader]

It doesn't matter what components you build your system out of, what matters is what you build.

If you provide some more information on your product, or point us at a similar product, I'm sure you'd get some more information.

Here we go:
we make projection screens with housings to hold the electronics to roll the screens down/up. All electrical components are purchased/outsourced and have the CE mark on them. Our end product does not have the CE mark.

A customer is asking for our ISO certificate and the CE mark approval certificate for our products.

Hope this sheds some light. Anyone care to jump in and provide their experience?

 

[CharlieUK]

These screens roll up and down via a motor which is controlled externally?

something like http://www.noboeurope.com/nobo/en/gb/v/1858/275/electric-wall-projection-screens.aspx ?

 

[Crusader]

These screens roll up and down via a motor which is controlled externally?

something like http://www.noboeurope.com/nobo/en/gb/v/1858/275/electric-wall-projection-screens.aspx ?

precisely.

 

[CharlieUK]

That will need CE marking

Put Electric Wall Projection Screens declaration of conformity into Google and see what other companies are doing.
(OK they're probably all doing something different), but

Low Voltage Directive applies to ...any equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, other than the equipment and
phenomena listed in Annex II.

EMC Directive applies to ...any finished appliance or combination

thereof made commercially available as a single functional unit, intended for the end user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance;

http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/ is a good starting point​

 

[Ronen E]

Charlie has pretty much passed the heaving lines applause and now it's time to tie the boat.

As far as CE marking is concerned, the above is a good starting point. However, please note: As a (legal) manufacturer placing your products on the EC market, you bear an obligation to comply with all EC legislation that applies to it - Directives, Regulations, Decisions and all the other wonderful instruments... No one will hand you out a list or stop you at the border to verify that you comply. if you comply with none, you will quickly get into trouble. If you comply with some (especially the main ones), this may take a while. If you comply with the most, you'll probably be fine, unless something bad happens... How important being in 100% compliance is to you depends on your company's (and individuals') ethics.

How do you identify "all applicable legislation"?... Hmmm, that's a tricky one. Basically, get ready to spend lots of time in front of the Europa website. Or get an expert on the subject matter. Or check what your competitors are doing. Or else... And any combination... Anyway, some of the instruments (namely, Directives) lead to CE marking, but some don't. That doesn't necessarily mean you don't need to comply with the latter, if they apply to your product. The onus to be in compliance is yours, any and either way.

Best of luck,
Ronen.

 

[regqual]

Re: Need for CE Mark - Clarification please - FDA

Hello all,

Clarification here too please...

Our product - to be released soon in USA only - was recently tested by a lab for electrical, safety, other items. The lab tested to FCC, UL and ISO standards and gave a CE marking cert, and states we must now include the CE marking on our labels. We are not prepared for the EU as yet. We are an MDDS, Class I device.
1) Can we put CE marking on our labels if we are not going to EU today (we don't have a Tech File prepared.)
2) Do we need to have a Tech File for an MDDS or just an AR sufficient?

Thank you for your guidance!

 

[Ronen E]

Re: Need for CE Mark - Clarification please - FDA

Hello all,

Clarification here too please...

Our product - to be released soon in USA only - was recently tested by a lab for electrical, safety, other items. The lab tested to FCC, UL and ISO standards and gave a CE marking cert, and states we must now include the CE marking on our labels. We are not prepared for the EU as yet. We are an MDDS, Class I device.
1) Can we put CE marking on our labels if we are not going to EU today (we don't have a Tech File prepared.)
2) Do we need to have a Tech File for an MDDS or just an AR sufficient?

Thank you for your guidance!

1) You are not allowed to affix the CE mark unless you comply with ALL applicable requirements.

2) A Technical File is a MDD requirement for all medical devices (look at annex VII).

Please note: Unduly affixing the CE mark is an offence when introducing a medical device in the EC. It is not necessarily so when introducing elsewhere. Check applicable regulations in the relevant domains (e.g. the USA).

Cheers,
Ronen.