- Environmental law Overview: Eco-design Regulation Regulations for the MedTech industry

Name of the legal act

Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC.

Status

Consolidated version from 28.06.2024Externer Link. Öffnet im neuen Fenster/Tab..

Background information

The Regulation (EU) 2024/1781 establishes a legislative framework for the setting of ecodesign requirements for sustainable products (ecodesign requirements). The aim of the regulation is to improve the environmental sustainability of products and reduce their carbon footprint and environmental footprint over their entire life cycle. Regulation (EU) 2024/1781 replaces Directive 2009/125/EC.

In Germany, the Energy-related products act (Energieverbrauchsrelevante-Produkte-Gesetz – EVPGExterner Link. Öffnet im neuen Fenster/Tab.) and the Ordinance on the Implementation of the Act on the Environmentally Friendly Design of Energy-Related Products (EVPG-Verordnung – EVPGVExterner Link. Öffnet im neuen Fenster/Tab.) transpose into national law. Directive 2009/125/EC Due to the reform of ecodesign law, is also likely to be the German implementing legislation amended.

Scope of application

Regulation (EU) 2024/1781 does not directly stipulate any specific ecodesign requirements for products. These requirements will follow from product-specific implementing acts that the Commission will draw up. Unlike its predecessor, Regulation (EU) 2024/1781 covers not only energy-related products, but all physical goods, including components and intermediate products. Regulation (EU) 2024/1781 also forms the basis for the so-called Digital Product Passport. Medical devices can in principle be the subject of implementing acts, but ecodesign requirements must not jeopardise the health and safety of patients and users (Recital 19).

The implementing acts created on the basis of Directive 2009/125/EC remain valid until further notice (Art. 79 Regulation (EU) 2024/1781). Currently the following regulations exist, among others, which partially exclude medical devices from the scope of application:

• Regulation (EU) 2019/2021Externer Link. Öffnet im neuen Fenster/Tab. laying down ecodesign requirements for electronic displays: (in accordance with Art. 1(2)(d) Regulation (EU) 2019/2021, medical displays do not fall within the scope of application)
• Regulation (EU) 2023/826Externer Link. Öffnet im neuen Fenster/Tab. laying down ecodesign requirements for off mode, standby mode, and networked standby energy consumption of electrical and electronic household and office equipment (excluding medical devices and wheelchairs No. 5 Annex II)
• Regulation (EU) 2019/1782Externer Link. Öffnet im neuen Fenster/Tab. laying down ecodesign requirements for external power supplies (pursuant to Art. 1 (2) (e) of Regulation (EU) 2019/1782, are external power supplies for medical devices not covered by the scope of application)
• Regulation (EU) 2019/2020 laying down ecodesign requirements for light sources and separate control gear (in accordance with point 1(k) of Annex III of Regulation (EU) 2019/2020, are light sources in medical devices pursuant to Directive 93/42/EEC or Regulation (EU) 2017/745 and in in vitro diagnostic medical devices pursuant to Directive 98/79/EC excluded from the scope of application)
• Regulation (EU) 2023/1670Externer Link. Öffnet im neuen Fenster/Tab. laying down ecodesign requirements for smartphones, mobile phones other than smartphones, cordless phones and slate tablets

An overview of all product-specific ecodesign regulations can be found on the website of the Federal Institute for Materials Research and Testing (BAM)Externer Link. Öffnet im neuen Fenster/Tab..

Roles

The addressees of the obligations are manufacturers within the meaning of Art. 2(42) Regulation (EU) 2024/1781, authorised representatives within the meaning of Art. 2(43) Regulation (EU) 2024/1781 and importers within the meaning of Art. 2(44) Regulation (EU) 2024/1781, distributors within the meaning of Art. 2(45) Regulation (EU) 2024/1781 and dealers within the meaning of Art. 2(55) Regulation (EU) 2024/1781. The primary responsible party is generally the manufacturer.

The ecodesign requirements and the formal marketability requirements must be fulfilled at the time of placing on the market. Placing on the market is "means the first making available of a product on the Union market" (Art. 2(40) Regulation (EU) 2024/1781).

Duties in bullet points

In future, the following requirements and obligations (usually in the annexes to the regulations) will be in the product-specific ecodesign implementing acts enshrined, although the regulation may differ in detail:

• Requirements, e.g. in terms of functional durability, retrofittability, reparability, recyclability, resource utilisation and resource efficiency, recyclate content, etc.
• Duty to inform
• Digital product passport

In addition, Regulation (EU) 2024/1781 lays down overarching obligations that with the creation of an are activated implementing act (e.g. conformity assessment procedure, CE marking, EU declaration of conformity, etc.). Directly, Art. 23 f. Regulation (EU) 2024/1781 requires the prevention of the destruction of unsold consumer products and corresponding reporting obligations. From 19 July 2026, a general ban on the destruction of unsold textiles and footwear for consumers will apply (Art. 25 Regulation (EU) 2024/1781).

Violations of the ecodesign requirements or formal requirements lead to a marketing ban and may result in the imposition of market surveillance measures (e.g. sales ban). Breaches of duty may constitute an administrative offence in accordance with (see EVPG in conjunction with EVPGV).

Latest news

The Commission will draw up the first implementing acts in the near future. In doing so, it is required to prioritise product groups that can contribute to improving the environmental impact. According to Art. 18 para. 5 of Regulation (EU) 2024/1781will be , the following product groups prioritised for regulation Iron and steel; aluminium; textiles, in particular clothing and footwear; furniture, including mattresses; tyres; detergents; paints; lubricants; chemicals; energy-related products for which ecodesign requirements are to be set for the first time or for which existing implementing measures adopted on the basis of Directive 2009/125/EC are to be reviewed under this Regulation; information and communication technology products and other electronic equipment. The first enter into force implementing acts are expected to in 2026/2027. In the meantime, the Commission has published a draft implementing regulationExterner Link. Öffnet im neuen Fenster/Tab. governing the disclosure of information on destroyed consumer products. In connection with the digital product passport to be introduced under the Ecodesign Regulation, the Commission intends to adopt a delegated act laying down rules for the activities of DPP service providersExterner Link. Öffnet im neuen Fenster/Tab., which are an essential part of overall DPP governance; the draft act is scheduled for adoption in Q4/2025.

In mid-April 2025, the Commission presented the 2025-2030 working plan for ecodesign for sustainable products and energy consumption labellingExterner Link. Öffnet im neuen Fenster/Tab.. With regard to medical devices, only recital 19 of Regulation (EU) 2024/1781 is emphasised (see above).

In the context of ecodesign regulation, the "right to repair" should be mentioned, which in the was enshrined. This directive refers to Directive (EU) 2024/1799 ecodesign implementing acts to define the products subject to the right to repair.

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.