The EUDR Is Also Coming for Medical Devices

Regulation (EU) 2023/1115 of the European Parliament and of the Council on deforestation-free products (EUDR) has been in force since 2023. The obligations set out in the Regulation will begin to apply on December 30 of this year. The key is to determine whether a specific product is subject to the obligations under the EUDR—that is, whether the product is among the relevant products listed in Annex I. This assessment can be the most challenging part in practice. As in many other cases, there are numerous exceptions to consider here as well. The applicable obligations are then determined based on the entity’s role. In this article, we will outline the fundamental pillars on which the EUDR is based.

A product is subject to the EUDR if it contains a relevant commodity or is manufactured from it and, at the same time, falls under a customs code listed in Annex I. This classification is based on the product’s objective characteristics.

However, chemical processing of a relevant commodity may result in a product that no longer falls under Annex I. The biological origin of the material is also decisive. For example, natural rubber from Hevea brasiliensis is subject to the EUDR, whereas balata, gutta-percha, guayule, chicle, and similar natural gums from other species are not. The EUDR also does not apply to synthetic rubber, even though products made from these materials may have the same Combined Nomenclature code as products made from a relevant commodity.

Products made exclusively from material that has reached the end of its life cycle and would otherwise become waste are also exempt from the EUDR. Origin in a low-risk country does not mean exemption from the EUDR; it merely allows for simplified due diligence.

Basic Obligations of Supply Chain Actors

An operator is a person that releases a relevant product from a third country for free circulation—that is, the importer. The importer must exercise due diligence, which involves collecting data on the product, its origin, and the geolocation of the plots of land, verifying compliance with the relevant legislation of the country of production, assessing the risk of deforestation, and mitigating that risk where necessary. The importer then submits a due diligence statement; without it, the product must not be placed on the market.

A manufacturer may be a downstream operator if it places a new relevant product on the market that is made from inputs already covered by a due diligence statement. As a rule, the manufacturer does not submit a new statement but must retain data on suppliers, customers, and reference numbers. If any input is not covered, the manufacturer must exercise due diligence itself.

A distributor that makes a relevant product available further down the supply chain is a trader. The distributor retains information on suppliers and customers and, in the event of suspected non-compliance, notifies the competent authorities as well as other actors in the supply chain.

Other important principles of the EUDR include, for example, the registration of most entities in the Information System and ensuring traceability throughout the supply chain.

We will discuss products, entities, obligations, and exemptions in our October webinar.

Author: Markéta Hrubá