- Environmental law Overview: Regulation on deforestation-free supply chains (EUDR) Regulations for the MedTech industry

Name of the legal act

Regulation (EU) 2023/1115 of the European Parliament and of the Council of 31 May 2023 concerning the making available of certain raw materials and products on the Union market associated with deforestation and forest degradation and their export from the Union and repealing Regulation (EU) No 995/2010.

Status

Version of 23. December 2024.Externer Link. Öffnet im neuen Fenster/Tab.

Background information

To date, the so-called Timber Trade Regulation (EU) No. 995/2010Externer Link. Öffnet im neuen Fenster/Tab. on the obligations of operators who place timber and timber products on the market only lays down timber-related due diligence obligations. However, since the much greater damage is caused by illegal deforestation for purposes other than timber production, the European legislator has decided to adopt a new regulation on deforestation-free supply chains. This must be complied with from 30 December 2025.

The regulation on deforestation-free supply chains stands independently alongside other regulations on due diligence obligations in the supply chain, such as the German Supply Chain Due Diligence Act (LkSG) and the EU Due Diligence Directive (CSDDD).

Scope of application

Compared to the previous EU Timber Regulation, the scope of application has been significantly expanded and includes the following raw materials and certain products made from them: Cattle, cocoa, coffee, oil palm, rubber, soy and wood. The products covered are determined by specified references to the combined nomenclature from Annex I EUDR. In the area of medical products, rubber products, such as gloves, will play a particularly relevant role.

It should be noted that the regulation will not apply to products made entirely from secondary raw materials.

Roles

Primary obligated parties are all companies that make covered products commercially available on the EU market for the first time or export such products commercially from the EU (so-called operators within the meaning of Art. 2 No. 15 EUDR).

Mere traders must be distinguished from this. According to Art. 2 No. 17 EUDR, traders are all those who place covered products on the market on a commercial basis. However, it should be noted that traders who are not SMEs within the meaning of Directive 2013/34/EU are considered operators under Art. 5 (1) EUDR and must fulfil all related obligations.

Duties in bullet points

The central prohibitions are laid down is Art. 3 EUDR. This contains three cumulative requirements, all of which must be met for the products to be marketable:

• Freedom from deforestation since 1 January 2021 - whether deforestation was legal or illegal no longer matters under the new regulation.
• Compliance with relevant legal provisions in the country of production - the relevant provisions here go far beyond the issue of deforestation and concern, for example, land use, environmental protection, requirements relating to forests including forest management and biodiversity conservation, third-party rights, labour law, internationally protected human rights, rights of indigenous groups, tax, anti-corruption, trade and customs law.
• Submission of a due diligence statement - the product-related conclusion of the to be carried out represents due diligence obligations and must contain evidence that there is either no or only a negligible risk that deforestation or forest degradation has occurred in relation to the products concerned.

The due diligence obligations to demonstrate compliance with the aforementioned requirements consist of the procurement of information, a risk analysis and, in the case of existing risks, risk minimisation measures. The obligation to obtain information goes so far that, for example, the geodata of the production areas must be obtained. The EU Commission has published a country benchmarking with Implementing Regulation (EU) 2025/1093Externer Link. Öffnet im neuen Fenster/Tab.. It classifies countries and regions with low or high risk for deforestation. Countries classified as low risk, which includes 140 countries, are subject to reduced due diligence requirements. Four countries are listed as high risk countries: Belarus North Korea, Myanmar and Russia. All other countries can be considered as normal risk countries. The list is subject to change.

Latest news

In April 2025, the EU Commission published a revised version of the guidelinesExterner Link. Öffnet im neuen Fenster/Tab. and FAQsExterner Link. Öffnet im neuen Fenster/Tab. on the Deforestation Regulation. It clarifies amongst others that so-called downstream actors can refer to the reference numbers of declarations already submitted for the same product when submitting their due diligence statements without being subject to in-depth verification obligations.

In addition, there are now supplementary FAQsExterner Link. Öffnet im neuen Fenster/Tab. from the Federal Office for Agriculture and Food.

The Regulation itself has already announced that it may be extended in future to other ecosystems, such as peatlands, and products, such as maize, and that this is to be assessed by the EU Commission.

Imprint

© Bundesverband Medizintechnologie e.V. (BVMed), the German MedTech Association, in cooperation with the law firm "Ahlhaus Handorn Niermeier Schucht Rechtsanwaltsgesellschaft mbH" („Produktkanzlei“).

This overview does not replace an individual case assessment.