- Environmental law
Overview: EU Directive on Corporate Sustainability Reporting (CSRD) 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 Directive on Corporate Sustainability Reporting (CSRD) – german version of the article here. You can find more legal acts here
Artikel31.07.2025
Name of the legal act
Status
Consolidated version of 16 April 2025Externer Link. Öffnet im neuen Fenster/Tab..Background information
Certain requirements for non-financial reporting by specific large public-interest companies were already included in the Directive 2013/34/EU. However, the EU legislator deemed these provisions insufficient and significantly expanded them both in terms of content and scope of applicability through the new directive.The Directive should have been transposed into national law by the 6. July 2024. This has not happened in Germany yet.
Scope of application
The EU Member States must, in a phased manner, ensure through national legislation that the following capital companies and partnerships with exclusively limited liability partners fall within the scope of application:- From the financial year 2024: Companies already required to submit a non-financial statement under existing regulations.
- From the financial year 2027: All other large companies.
- From the financial year 2028: Listed small and medium-sized enterprises (excluding micro-enterprises), small and non-complex credit institutions, and captive insurance undertakings.
- From the financial year 2028: Non-EU companies with a net turnover of more than EUR 150 million in the EU, if they have at least one subsidiary or branch in the EU and exceed certain thresholds.
For certain group constellations, there are partial exemptions from reporting obligations for companies that are subsidiaries of a parent company.
Overall, the scope of application has been significantly expanded, meaning that numerous small and medium-sized companies, including those in the medical devices sector, will be obliged to submit sustainability reports for the first time.
Roles
The roles are determined by the personal scope of application, so that no specific role allocation is intended or required further.Duties in bullet points
The existing reporting obligation for certain large companies of public interest will be extended as follows:- More comprehensive and standardized reporting content: Quantification of report content using key figures for better measurability and comparability. In future, content must be based on so-called European Sustainability Reporting Standards (ESRS), which are developed by the European Financial Reporting Advisory Group (EFRAG) and by the published delegated regulations. On 22 December 2023, the Delegated Regulation (EU) 2023/2772Externer Link. Öffnet im neuen Fenster/Tab. of the Commission of 31 July 2023, supplementing Directive 2013/34/EU of the European Parliament and of the Council with standards for sustainability reporting, was published in the Official Journal of the EU, containing the first twelve standards.
- Double materiality: Previously, financial materiality was decisive, i.e. the question of whether external sustainability factors could have an impact on the company's financial situation (outside-in perspective). According to the new requirements, the effects of the company's activities on sustainability aspects outside the company (inside-out perspective) are also relevant and subject to reporting.
- External audit: As is already the case with financial reporting, sustainability reporting is also to be subject to an external audit in future.
- Element of the management report: As a result, sustainability reporting will take place together with financial reporting in future and will be more transparent.
- European Single Electronic Format (ESEF): In this way, as already in the financial context, transparency and accessibility should also be expanded.
Latest news
The CSRD is part of the EU Commission's OMNIBUS I packageExterner Link. Öffnet im neuen Fenster/Tab.. In a first step, the date of application was postponed for most companies by Directive (EU) 2025/794Externer Link. Öffnet im neuen Fenster/Tab. on 16 April 2025. In a second step, substantive changes are planned in accordance with proposal COM(2025) 81 finalExterner Link. Öffnet im neuen Fenster/Tab.. The scope is to be aligned with that of the CSDDD and the amount of information subject to reporting requirements is to be reduced.On 10 July 2025, a new draft billExterner Link. Öffnet im neuen Fenster/Tab. was published for a law implementing Directive (EU) 2022/2464 on corporate sustainability reporting, as amended by Directive (EU) 2025/794, which must now go through the national legislative procedure.
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.
