UKCA marking
The UKCA mark (UK Conformity Assessed) is the UK product marking used for certain regulated product categories placed on the market in Great Britain (England, Scotland and Wales). It indicates that a product meets applicable UK requirements for safety, health and environmental protection within the scope of the relevant regulation.
Official guidance
Do 3D printing resins require UKCA marking?
In general, 3Dresyns® photopolymer resins are raw materials used to manufacture parts. UKCA marking and MHRA medical device registration apply to the finished medical device placed on the market (and the manufacturer responsible for it), not to the liquid resin as supplied.
Put simply: a resin is not a medical device. A printed medical device is the finished product manufactured under a controlled workflow (printer + parameters + cleaning + post-curing + post-processing + quality controls) and released by the device manufacturer.
For medical device manufacturers in Great Britain
Medical devices are regulated under UK MDR 2002
Medical devices in Great Britain are regulated under the Medical Devices Regulations 2002 (UK MDR 2002) (as amended). This framework governs requirements such as conformity routes, documentation, and market access obligations for devices.
MHRA registration applies to device manufacturers and device suppliers
Under UK MDR 2002, the MHRA must be informed/registration may be required for companies that place medical devices on the GB market (e.g., manufacturers, relabellers, refurbishers, system/procedure packs, and certain IVD activities). This does not apply to raw materials (such as photopolymer resins) supplied as ingredients for manufacturing.
Borderline products
If you are unsure whether your finished product is a medical device or a borderline product, consult:
Custom-made devices
Custom-made devices in Great Britain follow specific rules under UK MDR 2002. If you manufacture custom-made devices, use the official guidance to confirm your obligations (including statements and documentation requirements):
CE marking and UKCA: practical note for GB market access
For many product areas in Great Britain, the UK has introduced longer-term flexibility allowing businesses to use either UKCA or CE marking (within the scope of the applicable regulations). Medical devices follow a dedicated regulatory framework and transition timelines, which should be checked using MHRA publications.
- Continued recognition of EU requirements, including CE marking (GB market) (GOV.UK)
- Implementation of the future regulation of medical devices (MHRA roadmap) (GOV.UK)
Common misconception: “UKCA-marked resin” does not make a medical device compliant
UKCA marking (or any “certification-like” claim) applied to a liquid resin does not transfer regulatory responsibility away from the medical device manufacturer and does not validate the safety of a finished device. Safety and conformity must be demonstrated for the finished part produced under a validated manufacturing workflow.
Related 3Dresyns guidance
- Biocompatible 3D resins for medical devices
- About certification of biomedical devices and food/pharma packaging
Disclaimer
This page is provided for general informational purposes and does not constitute legal or regulatory advice. Device manufacturers remain responsible for determining the applicable regulatory pathway and ensuring compliance for their specific products, intended use and validated manufacturing processes.