- Environmental law
Overview: EU Due Diligence Directive (CSDDD) Regulations for the MedTech industry
The MedTech industry is directly or indirectly affected by numerous environmental regulations. With our information service on environmental law, BVMed provides an overview of the most important national (Germany) and European legal acts as well as the resulting obligations. This article focuses on the EU Due Diligence Directive (CSDDD) – german version of the article here. You can find more legal acts here
Artikel31.07.2025
Name of the legal act
Status
Version of 16 April 2025Externer Link. Öffnet im neuen Fenster/Tab..Background information
The CSDDD (Corporate Sustainability Due Diligence Directive) came into force on 25 July 2024 and must be transposed into national law by the Member States by 26 July 2027. As a directive, the CSDDD has no direct effect on companies (Art. 288 (3) TFEU).In Germany, implementation is expected to take place (as far as possible) in the Supply Chain Due Diligence Act (LkSG), which must be adapted to the CSDDD by the aforementioned date at the latest.
Scope of application
The CSDDD applies to all companies based in the EU that had an average of more than 1,000 employees and a global net turnover of more than € 450 million in the previous financial year, regardless of sector or product. In principle, this applies to each individual, independent company, although there are attribution rules for the ultimate parent company. In addition, there are also attribution rules and adjusted turnover thresholds in franchise and licence constellations. Finally, companies without a registered office in the EU are also included if they had a net turnover of more than € 450 million in the EU.In terms of timing, Art. 37 CSDDD provides for the following staggering: Applicable from 26 July 2028 for companies with more than 3,000 employees and a net turnover > EUR 900 million and from 26 July 2029 for companies with more than 1,000 employees and a net turnover > EUR 450 million.
Roles
The obligations of the CSDDD apply directly to those companies that fall within the scope of application and fulfil the definition of an undertaking in accordance with Art. 3 (1) lit. (a) CSDDD (in Germany, therefore, particularly in the legal forms of AG, KGaA, GmbH, OHK and KG).Direct and indirect business partners as defined in Article 3 (1) lit. (f) CSDD themselves do not fall within the scope of application (unless they themselves fulfil the criteria above) but are affected by the due diligence measures of the covered companies in the chain of activities.
Duties in bullet points
Since the CSDDD does not establish directly applicable obligations for companies, the following summarizes key aspects that will need to be amended in the German Supply Chain Due Diligence Act (LkSG) in light of the CSDDD:- Supplementary human rights and environmental concerns: biodiversity, species protection (CITES), Rotterdam Convention on the import and export of chemicals, protection of the ozone layer (Vienna Convention and Montreal Protocol), natural heritage under the World Heritage Convention, wetlands under the Ramsar Convention, pollution from ships, pollution of the seas under the Convention on the Law of the Sea, prohibition of arbitrary interference with private life, family, home and correspondence, prohibition of interference with thought, conscience freedom of and belief and general children's rights
- Unrestricted inclusion of all indirect suppliers
- Reversal of negative effects or, in any case, financial compensation for damage incurred (Art. 12 CSDDD in conjunction with Art. 3 (1) lit. (t) CSDDD)
- Simplification of the reporting obligation by linking it to sustainability reporting in accordance with the CSRD. Only those companies that are not (yet) subject to the CSRD reporting obligation will have to prepare a separate LkSG report in future.
- Plan to minimise the consequences of climate change (Art. 22 CSDDD)
- Civil liability (Art. 29 CSDDD)
The obligations arising from the CSDDD are intended, in their future national implementation, to exist alongside and complement the obligations from other due diligence regimes.
Latest news
The CSDDD is part of the EU Commission's OMNIBUS I packageExterner Link. Öffnet im neuen Fenster/Tab., which aims to reduce obligations for companies. In a first step, the implementation deadline for Member States and the date by which the first companies must comply with the obligations of the national implementation acts has already been postponed by one year. In a second step, the EU Commission is proposing substantive changes, among other things,- restriction of general due diligence obligations to direct suppliers,
- stakeholders will be less involved than previously intended in the preparation of action plans and the prevention and mitigation of negative impacts
- civil liability for the impairment of protected interests due to breaches of the obligations under CSDDD will only exist in accordance with the applicable provisions of the Member States.
The proposal is part of an ongoing legislative process that is expected to be completed by the end of the third quarter of 2025.
The current German Federal Government is currently making different statements as to whether it intends to ‘abolish’ the CSDDD as a whole by exerting influence at European level or whether it merely wishes to implement it as little as possible. However, abolition is not to be expected due to the position of other Member States and parts of the EU Parliament.
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.
