CE marking
CE marking is the EU conformity marking used for specific product categories covered by EU harmonisation legislation. By affixing the CE marking, the manufacturer indicates that the product complies with the applicable EU requirements for safety, health and environmental protection, and can be placed on the EU/EEA market.
- Official overview: CE marking (Your Europe – European Union)
- European Commission portal: CE marking (European Commission)
When is CE marking required?
CE marking is required only for products that fall under specific EU harmonisation legislation. Typical product groups include (non-exhaustive list):
- Active implantable medical devices
- In vitro diagnostic medical devices
- Medical devices
- Machinery
- Radio equipment
- Low voltage equipment
- Electromagnetic compatibility (EMC)
- Personal protective equipment (PPE)
- Construction products
- Measuring instruments
- Pressure equipment
- Other product categories covered by EU harmonisation legislation
CE marking applies to finished products, not to raw materials
Photopolymer 3D resins are supplied as raw materials used to manufacture parts. In general, raw materials and ingredients do not require CE marking, because CE marking applies to the finished product placed on the market within the scope of EU harmonisation legislation.
This is particularly important for photopolymer additive manufacturing: the liquid resin undergoes a physical (liquid to solid) and chemical transformation during printing and post-processing. Therefore, the safety and performance of a printed part depend on the complete validated workflow (printer + parameters + cleaning + post-curing + post-processing + quality controls), not on the liquid resin alone.
Affixing CE marking where it does not apply is not allowed
EU law establishes that the CE marking may only be affixed where EU harmonisation legislation provides for it. For example, Regulation (EC) No 765/2008 states:
"The CE marking ... shall be affixed only to products to which its affixing is provided for ... and shall not be affixed to any other product."
For this reason, presenting a liquid resin as if it were a CE-marked medical device (or any CE-marked finished product) can be misleading. CE marking is relevant to the finished device/product and its conformity assessment pathway.
Medical devices: CE marking under EU MDR
Medical devices placed on the EU market must comply with the applicable EU medical device framework, including conformity assessment, technical documentation and manufacturer responsibilities. For medical devices, CE marking is defined and used within the EU Medical Device Regulation (MDR):
Practical takeaway: CE marking is obtained for finished medical devices manufactured under a controlled and validated system by the responsible manufacturer. It is not a label that can be “transferred” from a raw photoreactive liquid to the finished device without device-level validation.
Related 3Dresyns guidance
- Biocompatible 3D resins for medical devices
- About certification of biomedical devices and food/pharma packaging
Need support?
If you need help defining a controlled workflow (printing parameters, cleaning, post-curing and repeatability logic) for safety-critical or regulated applications, contact us by email: info@3dresyns.com.
Disclaimer
This page is provided for general informational purposes and does not constitute legal or regulatory advice. Manufacturers remain responsible for determining the applicable regulatory pathway and ensuring compliance for their specific products, intended use and validated manufacturing processes.