Disposable bags, tubes and accessories for health care
Criteria
Prices
Products that can be labelled are disposable products and accessories for dialysis, intravenous infusion treatment, treatment of urinary retention and incontinence, blood bags and ostomy pouches.
A Nordic Swan Ecolabelled disposable product for healthcare meets strict chemical requirements. These include adhesive used in the product and additives to the plastic, such as plasticisers, dyes and antioxidants. Quality and safety requirements are set to ensure that the products are safe to use and work as intended.
The requirements include:
- Prohibition of the materials PVC and latex
- The siloxanes D4, D5 and D6 is not allowed in silicone, but can be in the silicone as contaminants in limited amounts
- Adding phthalates to the plastic is prohibited
- Chemicals classified as environmentally harmful, toxic, allergenic, endocrine disruptors and CMR (carcinogenic, mutagenic, toxic for reproduction) cannot be added to the plastic or be part of the adhesive
- Product and parts must comply with EU Medical Products Directive (2001/83/EC) and/or Medical Devices Regulation (2017/745/EU)
Nordic fee
Valid from 01-01-2025 til 31-12-2025
Publish date: 12-09-2024
| Application fee (incl. inspection visit within the Nordic region**)* | 3,348 € |
| Annual licence fee based on turnover in the Nordic region: | |
| Turnover 0-30,9 million € | 0.30 % |
| Turnover > 30,9 million € | 0.05 % |
| Minimum fee | 2,232 € |
| Extra fee for sales outside the Nordic region (only if revenue > 300.000 €/year) | 2,232 € |
| Renewal fee - by new generation of requirements*/*** | 1,673 € |
| Inspection visits (per visit):** | |
| More than one inspection visit within the Nordic region | 557 € |
| Inspection visit within Europe | 1,673 € |
| Inspection visit outside Europe | 2,790 € |
| Extension/change of existing licence:**** | |
| Case handling < 4 hours | 418 € |
| Case handling < 8 hours | 836 € |
| Case handling ≥ 8 hours | 1,673 € |
* When both the applicant and the manufacturer are micro-enterprises, the fee is reduced by 50%. The definition of company size is based on EU recommendation 2003/361.
** Where audits require more than one day away from the office including travelling, Nordic Ecolabelling can invoice an additional fee of 1,115 € per extra day. Other extraordinary costs induced by the audit can also be invoiced the applicant.
*** The renewal fee only applies if the application has been signed and submitted before end of the validity of the licence. Else the normal application fee will apply.
**** Administrative tasks that takes less than 1 hour will not be invoiced.
All fees are exclusive of VAT. All information related to fees is subject to a disclaimer for errors and omissions.
The recipient is liable for the VAT according to article 56 of the Council Directive 2006/112/EC
Nordic fee
Valid from 01-01-2026 til 31-12-2026
Publish date: 26-09-2025
| Application fee (incl. inspection visit within the Nordic region**)* | 3,401 € |
| Annual licence fee based on turnover in the Nordic region: | |
| Turnover 0-31,394 million € | 0.30 % |
| Turnover > 31,394 million € | 0.05 % |
| Minimum fee | 2,267 € |
| Extra fee for sales outside the Nordic region (only if revenue > 309.000 €/year) | 2,267 € |
| Renewal fee - by new generation of requirements*/*** | 1,699 € |
| Inspection visits (per visit):** | |
| More than one inspection visit within the Nordic region | 565 € |
| Inspection visit within Europe | 1,699 € |
| Inspection visit outside Europe | 2,834 € |
| Extension/change of existing licence:**** | |
| Case handling < 4 hours | 424 € |
| Case handling < 8 hours | 849 € |
| Case handling ≥ 8 hours | 1,699 € |
* When both the applicant and the manufacturer are micro-enterprises, the fee is reduced by 50%. The definition of company size is based on EU recommendation 2003/361.
** Where audits require more than one day away from the office including travelling, Nordic Ecolabelling can invoice an additional fee of 1,132 € per extra day. Other extraordinary costs induced by the audit can also be invoiced the applicant.
*** The renewal fee only applies if the application has been signed and submitted before end of the validity of the licence. Else the normal application fee will apply.
**** Administrative tasks that takes less than 1 hour will not be invoiced.
All fees are exclusive of VAT. All information related to fees is subject to a disclaimer for errors and omissions.
The recipient is liable for the VAT according to article 56 of the Council Directive 2006/112/EC
Nordic fee
Valid from 01-01-2024 til 31-12-2024
Publish date: 25-09-2023
| Application fee (incl. inspection visit within the Nordic region**)* | 3,251 € |
| Annual licence fee based on turnover in the Nordic region: | |
| Turnover 0-30 million € | 0.30 % |
| Turnover > 30 million € | 0.05 % |
| Minimum fee | 2,167 € |
| Extra fee for sales outside the Nordic region (only if revenue > 300.000 €/year) | 2,167 € |
| Renewal fee - by new generation of requirements*/*** | 1,625 € |
| Inspection visits (per visit):** | |
| More than one inspection visit within the Nordic region | 541 € |
| Inspection visit within Europe | 1,625 € |
| Inspection visit outside Europe | 2,709 € |
| Extension/change of existing licence:**** | |
| Case handling < 4 hours | 406 € |
| Case handling < 8 hours | 812 € |
| Case handling ≥ 8 hours | 1,625 € |
* When both the applicant and the manufacturer are micro-enterprises, the fee is reduced by 50%. The definition of company size is based on EU recommendation 2003/361.
** Where audits require more than one day away from the office including travelling, Nordic Ecolabelling can invoice an additional fee of 1,083 € per extra day. Other extraordinary costs induced by the audit can also be invoiced the applicant.
*** The renewal fee only applies if the application has been signed and submitted before end of the validity of the licence. Else the normal application fee will apply.
**** Administrative tasks that takes less than 1 hour will not be invoiced.
All fees are exclusive of VAT. All information related to fees is subject to a disclaimer for errors and omissions.
The recipient is liable for the VAT according to article 56 of the Council Directive 2006/112/EC
How to apply for a certification
This product group is not digitized.
You will find the application form and tools to get started with your application under the CRITERIA tab on this page.The application form must be completed, signed and submitted together with the documentation to application@ecolabel.dk.
You can read more about the application process here:
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