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  4. Medical devices and medicinal products in plastic and silicone 098

Medical devices and medicinal products in plastic and silicone 098

Products such as oxygen masks, urine catheters, gastric tubes, dialysis treatment bags, prolapse rings and syringes are included. Nordic Swan Ecolabel medical devices and medicinal products in plastic and silicone meet strict requirements for chemicals in materials, adhesives and surface treatments, are free from halogenated rubbers and plastics, such as PVC and meet requirements to packaging to promote recycling.

The requirements include:

  • Prohibition of halogenated plastics and rubbers.
  • Environmental and health properties of chemicals used in materials, adhesives and surface treatments. Among others, PFAS and endocrine disruptors are prohibited.
  • Materials and design of packaging to promote recycling.
  • For products mainly made of silicone: At manufacturing of silicone raw material, emissions of dust and chlorides into air and copper and zinc into wastewater are limited. Also, data for energy consumption must be reported.

The product group includes products mainly made of plastic or silicone that 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 or the EU Medicinal Products Directive (2001/83/EC).

There are 99 Ecolabelled products from 5 companies within productgroup.

  • Welcome to apply for a Nordic Swan Ecolabel licence!

    This is how you do:

    1. Read the application guide.
    2. Log in to the Nordic Ecolabelling Portal.
    3. Start your application.

     

    If this is the first time you are applying, the authorized signatory must fill in your company information and approve the application conditions. In this way, you get login to the portal and the right to assign access to other colleagues.

     

    Request login

    To the Nordic Ecolabelling Portal

    Some special cases can not be done in the Nordic Ecolabelling Portal. Contact your advisor for such cases. More information can be found on "Application step by step".

  • Valid from 1/1 2026

    Amount excluding VAT

    Application fees

    		  
    Application for a new licence 3 401 EUR
    Application for renewal 1 699 EUR

    Annual licence fee

    The licence fee for the Nordic Swan Ecolabelled products is based on their turnover in the Nordic region.

    Up to 31.394 million EUR. 0,3% of the products' turnover
    More than 31.394 million EUR. 0,05% of the products' turnover
    Minimum fee in the Nordic region 2 267 EUR per year.
    Fixed fee applicable to turnover outside the Nordic region 2 267 EUR per year for turnover exceeding 300 000 EUR.

    Fee for extension / change of licence

    Fixed fee that is charged depending on how long the work takes.

    Up to 4 hours 424 EUR
    4-8 hours 849 EUR
    8 or more hours 1 699 EUR

    Fee for on-site inspections

    One on-site visit within the Nordic region is included in the application for a new or renewed licence.

    Additional on-site inspection within the Nordic region 565 EUR per visit
    On-site inspection outside the Nordic region, but within Europe 1 699 EUR per visit
    On-site inspection outside Europe 2 834 EUR per visit
    Additional fee for on-site inspections lasting longer than one day 1 132 EUR per day

     

     

    About the fees

    For clarification of fees, click here.

    Ecolabelling Sweden AB has no financial profit purpose and is financed through the fees above along with an annual government grant. The company is however liable for VAT according to article 56 of the European Council Directive 2006/112/EC.

    Invoicing is made in SEK with the exchange rate from the first banking day of the year.

    When both the applicant and the manufacturer are micro-enterprises, the application fee is reduced by 50%. A micro-enterprise is in this context defined as an enterprise with less than 10 employees and an annual turnover (of both ecolabelled and not ecolabelled products) below 2 million EUR.

     

    Fee regulations PDF
    General info about fees

    Valid from 1/1 2025

    Amount excluding VAT

    Application fees

    		  
    Application for a new licence 3 348 EUR
    Application for renewal 1 673 EUR

    Annual licence fee

    The licence fee for the Nordic Swan Ecolabelled products is based on their turnover in the Nordic region.

    Up to 30.9 million EUR. 0,3% of the products' turnover
    More than 30.9 million EUR. 0,05% of the products' turnover
    Minimum fee in the Nordic region 2 232 EUR per year.
    Fixed fee applicable to turnover outside the Nordic region 2 232 EUR per year for turnover exceeding 300 000 EUR.

    Fee for extension / change of licence

    Fixed fee that is charged depending on how long the work takes.

    Up to 4 hours 418 EUR
    4-8 hours 836 EUR
    8 or more hours 1 673 EUR

    Fee for on-site inspections

    One on-site visit within the Nordic region is included in the application for a new or renewed licence.

    Additional on-site inspection within the Nordic region 557 EUR per visit
    On-site inspection outside the Nordic region, but within Europe 1 673 EUR per visit
    On-site inspection outside Europe 2 790 EUR per visit
    Additional fee for on-site inspections lasting longer than one day 1 115 EUR per day

     

     

    About the fees

    For clarification of fees, click here.

    Ecolabelling Sweden AB has no financial profit purpose and is financed through the fees above along with an annual government grant. The company is however liable for VAT according to article 56 of the European Council Directive 2006/112/EC.

    Invoicing is made in SEK with the exchange rate from the first banking day of the year.

    When both the applicant and the manufacturer are micro-enterprises, the application fee is reduced by 50%. A micro-enterprise is in this context defined as an enterprise with less than 10 employees and an annual turnover (of both ecolabelled and not ecolabelled products) below 2 million EUR.

     

  • Information on the latest version of the criteria for medical devices and medicinal products in plastic and silicon

    3.0: New criteria generation

    Nordic Ecolabelling adopted version 3.0 of the criteria for Nordic Swan Ecolabel Medical devices and medicinal products in plastic and silicone on 1 June 2026. The criteria are valid until 31 August 2031.

    2.10 ⇛ 2.11: Adjustment of criteria

    Nordic Ecolabelling decided on 21 April 2026 to adjust requirement O5 and O6 regarding exemption for H360 for UV-cured acrylates-based adhesives. The new version is called 2.11.

    2.9 ⇛ 2.10: Prolongation of criteria

    Nordic Ecolabelling decided on 10 March 2026 to prolong the validity of the criteria to the 31 August 2028. The new version is called 2.10.

    2.8 ⇛ 2.9: Prolongation of criteria

    Nordic Ecolabelling decided on 14 October 2025 to prolong the criteria until 31 August 2027. The new version is called 2.9.

    2.7 ⇛ 2.8: Adjustment of criteria

    Nordic Ecolabelling decided on 1 April 2025 to adjust requirement O5 regarding an exemption for titanium dioxide (CAS No. 13463-67-7) classified as H351.

    2.6 ⇛ 2.7: Adjustment of criteria

    Nordic Ecolabelling decided on 15 October 2024 to adjust requirement O5 regarding an exemption for antioxidants classified as toxic to reproduction cat 2 (H361) in polyisoprene parts on the conditions described in the requirement.

    2.5 ⇛ 2.6: Adjustment of criteria

    Nordic Ecolabelling decided on 16 April, 2024 to adjust requirement O6 regarding an exemption for antioxidants classified as toxic to reproduction cat 2 (H361) in polyisoprene parts on the conditions described in the requirement.

    2.4 ⇛ 2.5: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged with 24 months. The new version is called 2.5 and is valid until 31 Decenmber 2026.

    2.3 ⇛ 2.4: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged with 12 months. The new version, 2.4, is valid until 31 Decenmber 2024.

    2.2 ⇛ 2.3: Adjustment of criteria

    Requirement O5 and O6 have been adjusted. The new version, 2.3, is valid until 31 December 2023.

    2.1 ⇛ 2.2: Adjustment of criteria

    Requirement O5 has been adjusted. The new version, 2.2, is valid until 31 December 2023.

    2.0 ⇛ 2.1: Adjustment of criteria

    The criteria have been adjusted for exceptions for dyes classified as H317. The new version, 2.1, is valid until 31 December 2023.

    1.8 ⇛ 2.0: New criteria generation

    The criteria for disposable bags, tubes and accessories for health care have been revised. The new version, 2.0 is valid until 31 Decenmber 2023.

    1.7 ⇛ 1.8: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged with 6 months. The new version, 1.8, is valid until 31 Decenmber 2020.

    1.6 ⇛ 1.7: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged. At the same time, requirement R6 Recycling system, was removed. The new version, 1.7, is valid until June 30, 2020.

    1.5 ⇛ 1.6: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged. At the same time, requirement R7 Marketing, was removed. The new version, 1.6, is valid until March 31, 2019.

    1.4 ⇛ 1.5: Prolongation of the validity of the criteria

    The validity of Nordic Ecolabel's criteria for disposable bags, tubes and accessories for health care has been extended. The new version, 1.5, is valid until December 31, 2017.

Please contact me for more information