- Environmental law Overview: Forced Labour Regulation (FLR) Regulations for the MedTech industry

Name of the legal act

REGULATION (EU) 2024/3015 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 November 2024 on prohibiting products made with forced labour on the Union market and amending Directive (EU) 2019/1937.

Status

Version of 12 December 2024Externer Link. Öffnet im neuen Fenster/Tab..

Background information

The FLR (Forced Labour Regulation) entered into force on 13 December 2024 and will apply in full from 14 December 2027. However, some provisions to enable the authorities to prepare for its implementation have been in force since 13 December 2024. As a regulation, the legal act does not require transposition into national law but is directly applicable (Art. 288(2) TFEU). Nevertheless, there will be a corresponding implementing law in Germany to specify the responsibilities and powers of the authorities and to define sanctions in the event of violations.

Scope of application

The FLR applies across all industries and products to all economic operators, Art. 1 FLR. ‘Economic operator’ refers to
“any natural or legal person or association of persons placing or making available products on the Union market or exporting products”, Art. 2 Nr. 9 FLR.

The Regulation therefore applies comprehensively and is not limited to large market players or particular branches with high risks of forced labour. This is let by the intention to combat forced labour comprehensively as one of the worst forms of human rights violations.

The FLR does not cover the withdrawal of products that have already reached the end user in the Union market.

Roles

The roles are determined by the scope of application, so that no further specific role assignment is provided for or required.

Duties in bullet points

In Article 1(3) FLR, the Regulation clearly states that it does not impose any additional due diligence obligations on economic operators beyond those already provided for in EU or national law. The regulation thus embeds itself in the human rights responsibility framework for companies created by existing regulations such as CSDDD/LkSG and the Conflict Minerals Regulation. The FLR complements the existing regulations in two respects:

1. The prohibition on placing products made using forced labour on the market, Art. 3 FLR.
2. Far-reaching provisions on cooperation between authorities to ensure compliance with the prohibition.

Re 1): According to Art. 2 Nr. 7 FLR, “product made with forced labour”
“means a product for which forced labour has been used in whole or in part at any stage of its extraction, harvest, production or manufacture, including in the working or processing related to a product at any stage of its supply chain”.

The definition of forced labour refers to Article 2(1) of Convention No. 29 of the International Labour Organisation (ILO) and means
“all work or service which is exacted from any person under the menace of any penalty and for which the said person has not offered himself voluntarily.”

If a risk-based preliminary investigation (Art. 17 FLR) and, if a suspicion is further substantiated, an investigation (Art. 18 FLR) is initiated against economic operators on suspicion of a violation of the prohibition under Art. 3 FLR, economic operators are obliged to provide information on the relevant measures they have taken to identify, prevent, minimize, end or remedy the risk of forced labour in their business processes and supply chains in relation to the products to be assessed. There are strict legal deadlines and obligations to cooperate. Under certain circumstances, the authorities may also question suppliers and other parties involved, meaning that economic operators affected by a (preliminary) investigation should establish a functioning communication and coordination structure.

If a violation is found, the authority shall issue a decisions with the following, cumulative orders in accordance with Art. 20 FLR:

• prohibition on the placing on the market or export of the product concerned
• order to withdraw products already placed on the market from the Union market.
• order to dispose the products concerned.

Re 2): The ban is to be enforced by a ‘Union Network Against Forced Labour Products.’ The network is intended to serve as a platform for cooperation between the competent authorities. For this reason, the Regulation lays down differentiated provisions for Member States on the administrative organisation, in particular to strengthen cooperation between Member States within the network.

In addition, the Regulation provides for the establishment of a set of guidelines until 14. June 2026, Art. 11 FLR. These are intended to help economic operators fulfil their due diligence obligations with regard to the prevention of forced labour under other legal acts. The guidelines to be drawn up under the FLR can therefore also help companies to strengthen and specify measures to fulfil their due diligence obligations generally. Like all other information, the guidelines will be made available to the public on a ‘Central Portal against Forced Labour’ that is yet to be established. Any decision to prohibit a product will also be published there.

Latest news

At present, no current developments at legislative level are discernible. In particular, the FLR is not (yet) subject of the various OMNIBUS procedures to simplify the due diligence regime.

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.