CE marking

Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are marketed in the EU.

CE marking is only obligatory for the following product groups (not for the raw materials used for making them):

  • Active implantable medical devices
  • Appliances burning gaseous fuels
  • Cableway installations designed to carry persons
  • Construction products
  • Ecodesign of energy related products
  • Electromagnetic compatability
  • Equipment and protective systems intended for use potentially explosive atmospheres
  • Explosives for civil uses
  • Hot water boilers
  • In vitro diagnostic medical devices
  • Lifts
  • Low voltage
  • Machinery
  • Measuring instruments
  • Medical devices
  • Noise emission in the environment
  • Non-automatic weighing instruments
  • Personal protective equipment
  • Pressure equipment
  • Pyrotechnics
  • Radio equipment
  • Recreational craft
  • Restriction of Hazardous Substances in Electrical and Electronic Equipment
  • Safety of toys
  • Simple pressure vessels
  • EU fertilising products

EU legislation

It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking, as clearly highlighted in the relevant EU regulation on product requirements and market surveillance which clearly declares:

  • "(33) Points of entry at the external borders are well placed to detect unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner even before they are placed on the market."

  • "Article 27 Controls of products entering the Community market:

(c) the CE marking has been affixed to the product in a false or misleading manner."

  • "Article 30 General principles of the CE marking:

2. The CE marking as presented in Annex II shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product."

Conclusions

Affixing CE marking to non conforming products, such as the raw materials or ingredients, such as 3D resins used for making medical devices is considered as "placing on the market unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner."

3D resins as supplied are not medical devices, but unsafe photoreactive liquids, which react undergoing a photochemical synthetic reaction in the printers, which perfrom as photochemical reactors, which selectively "cure" the resins in certain zones, layer by layer or continuously, to shape "solid" 3D prints, which after postcuring and postprocessing, are placed on the market as medical devices. The safety of a medical device is responsibility of the medical device manufacturer. False and misleading CE marking of 3D resins, pretending to consider them medical devices is not legal and it does not fulfil the minimum requirements for providing any level of health and safety protection in general, health and safety at the workplace, protection of consumers, protection of the environment and security.

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