Affixing a CE Mark
Many products require CE marking before they can be sold in the EU. The CE Marking process involves compliance with certain directives or regulations, and after obtaining approval, you then need to affix the CE mark correctly.
A CE mark is a clear indication that the product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. This requirement applies to all manufacturers around the world who want to place their product on the EU Market.
Essential requirements while fixing the CE Mark –
The CE mark should be
- Visible
- Legible
- Indelible
While affixing the CE Mark, both the initials “CE” should have the same vertical dimension and minimum of 5mm (unless specified differently).
If you are reducing or enlarging the CE mark on your product, it is essential for you to respect the proportions of the two letters. The CE marking can take different forms regarding colour, solid or hollow. It is essential for the initials to remain visible.
Your product might have a different size or be of a different nature. In the case where it is not feasible to affix the marking on the product itself, you can:
- Affix the mark to the packaging (if there is any), or
- To any accompanying documents
If your product is subject to several EU directives/regulations which require a CE marking to be affixed, the accompanying documents must indicate that your product conforms to all applicable EU directives/regulations.
Our Experts at Med-Di-Dia will assist you with the complete process and can provide many other complimentary services. Feel Free to contact us to discuss your Medical Device requirements.
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