Difference between CE declaration and EU Conformity

Hi,

Not sure this is right question to ask here.

Hope someone can explain the difference between CE declaration and EU conformity

My guess is that CE declaration is statement saying our product meets EU conformity.

Or is it EU sits above CE, i.e. if we meet CE then we can self declare for EU.

Please advise

MK

 

Not my strongest area but let me give it a go since you haven't gotten a response yet. I mainly work on medical devices so my response may be tilted in that direction.

To legally market medical devices in the EU, they must be CE marked. Low risk devices are allowed to be "self declared" (or self certified) rather than having a notified body do a conformity assessment to enable CE marking. To qualify for CE marking, you have to demonstrate conformity to the applicable regulations; i.e., for devices, the Medical Device Regulation (MDR). For devices, the MDR fans out from the requirements to all the relevant standards (e.g., ISO 13485, ISO 14971, ea al.) and guidance docs (e.g., the MEDDEVs) (and while compliance to those are voluntary, it's the best path forward for CE marking).

I would expect that your reference to "EU conformity" would be to any applicable regulations / directives the product might fall under.

I know there are similar requirements for (non medical device) "machines" (i.e., the Machine Directive) but I don't know the ins and outs of getting CE marked for those.

You might want to reach out to a Notified Body (e.g., BSI, TUV) for a better response for your case in particular.