Public consultation on Medical devices in plastic or silicone
3 December 2025 - 6 February 2026
During the consultation period, Nordic Ecolabelling gives you the opportunity to comment on our proposal for new criteria for Nordic Swan Ecolabelled Medical devices in plastic or silicone (previous named Disposable bags, tubes and accessories for health care).
Nordic Ecolabelling are revising the requirements for Medical devices in plastic or silicone (previous named: Disposable bags, tubes and accessories for health care).
The proposed criteria for Medical devices in plastic or silicone include several new product types.
Medical devices in plastic or silicone are made of plastic or silicone and are for storage, transfer or transport of fluid, gas or medicine; or for preventing leakage of fluids from the body. The products must be included under Regulation (EU) 2017/745 on medical devices and can either be single-use or reusable.
You are welcome to respond to the proposal no later than 6 February 2026.
Consultation documents
How can response be sent in?
We look forward to receiving your response via this form: RESPONSE FORM. You can give your response in English or your Nordic language.
A compilation of the consultation responses, with answers from Nordic Ecolabelling and the names of the responding organisations, will be published on the Nordic Swan Ecolabel web page.
Most important issues
- Requirement O5 Silicone: Max. 100 ppm for impurities of D4, D5 and D6, must be tested.
- Requirement O6-O8 Silicone production: Only for products made of min. 80 wt% silicone.
- Requirement O9-O14 Chemicals in polymer materials, adhesives and surface treatments: Added classifications and substances. Requirements for surface treatments are new.
- Requirement O15-O16 Packaging
For more information about the consultation process in general, read here.
If you have any questions regarding the consultation, you may contact the product manager Lena Stenseng, lst@ecolabel.dk or one of the national product specialists:
Denmark: Lone Wiberg Kruse, lwk@ecolabel.dk
Finland: Karin Bergbom, karin.bergbom@ecolabel.fi
Norway: Tove Bræin, tb@svanemerket.no
Sweden: Ulf Eriksson, ulf.eriksson@svanen.se
Please note that consultation responses should preferably be submitted through Forms. If you are unable to do so, you may submit your response by email to consultation@nordicecolabel.org.