- Environmental law Overview: Energy Consumption Labelling Regulation Regulations for the MedTech industry

Name of the legal act

Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU.

Status

Version of 28.07.2017Externer Link. Öffnet im neuen Fenster/Tab..

Background information

Regulation (EU) 2017/1369 (consolidated version of 01.05.2021Externer Link. Öffnet im neuen Fenster/Tab.) establishes a framework for energy labelling in relation to energy-related products. Specifically, it provides for the labelling of these products and the provision of standardised product information on energy efficiency, the consumption of energy and other resources by the products during use and additional information about the products. The aim is to enable customers to opt for more efficient products in order to reduce their energy consumption.

At German level, the Energy Consumption Labelling Act (EnVKG)Externer Link. Öffnet im neuen Fenster/Tab. and the, which is based on it, Energy Consumption Labelling Ordinance (EnVKV)Externer Link. Öffnet im neuen Fenster/Tab. implement the requirements of Regulation (EU) 2017/1369.

Scope of application

Specific labelling requirements and obligations do not arise directly from Regulation (EU) 2017/1369, but from product-specific regulations based on Regulation (EU) 2017/1369, which cover 17 specific product groups at the moment. The following regulations, among others, currently exist, which exclude partially medical devices from their scope of application:

• Regulation (EU) 2019/2013Externer Link. Öffnet im neuen Fenster/Tab. with regard to the energy labelling of electronic displays (in accordance with Art. 1(2)(d) Regulation (EU) 2019/2013, medical displays do not fall within the scope of application)
• Regulation (EU) 2015/1094Externer Link. Öffnet im neuen Fenster/Tab. with regard to the energy labelling of professional refrigerated storage cabinets
• Regulation (EU) No 811/2013Externer Link. Öffnet im neuen Fenster/Tab. with regard to the energy labelling of space heaters, combination heaters, packages of space heaters, temperature regulators and solar devices and packages of combination heaters, temperature regulators and solar devices
• Regulation (EU) No 392/2012Externer Link. Öffnet im neuen Fenster/Tab. with regard to the labelling of household tumble driers with respect to energy consumption
• Regulation (EU) 2019/2018Externer Link. Öffnet im neuen Fenster/Tab. with regard to the energy labelling of refrigerating appliances with a direct sales function
• Regulation (EU) No 1254/2014Externer Link. Öffnet im neuen Fenster/Tab. with regard to the labelling of residential ventilation units in terms of energy consumption
• Regulation (EU) 2019/2014Externer Link. Öffnet im neuen Fenster/Tab. with regard to the energy labelling of household washing machines and washer-dryers
• Regulation (EU) 2019/2015Externer Link. Öffnet im neuen Fenster/Tab. with regard to the energy labelling of light sources (in accordance with point 1(j) of Annex IV to Regulation (EU) 2019/2015, are light sources in medical devices in accordance with Directive 93/42/EEC or Regulation (EU) 2017/745 and in in vitro diagnostic medical devices in accordance with Directive 98/79/EC excluded from the scope of application)
• Regulation (EU) 2023/1669Externer Link. Öffnet im neuen Fenster/Tab. with regard to the energy labelling of smartphones and slate tablets

An overview of all product-specific energy consumption labelling 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 product-specific energy labelling regulations focus on suppliers pursuant to Art. 2(14) Regulation (EU) 2017/1369. This group of persons includes manufacturers established in the Union pursuant to Art. 2(10) Regulation (EU) 2017/1369, authorised representatives of a manufacturer not established in the Union pursuant to Art. 2(11) Regulation (EU) 2017/1369 or importers pursuant to Art. 2(12) Regulation (EU) 2017/1369.

Distributors are also included in the group of addressees of the obligation. According to Art. 2(13) Regulation (EU) 2017/1369, the term "dealer" means "a retailer or other natural or legal person who offers for sale, hire, or hire purchase, or displays products to customers or installers in the course of a commercial activity, whether or not in return for payment".

The relevant point in time for the fulfilment of supplier obligations is the moment of placing on the market. "Placing on the market" means the first making available of a product on the Union market (Art. 2(8) Regulation (EU) 2017/1369). Distributors must fulfil the obligations incumbent on them in the course of making available, i.e. when continuing to supply the products.

Duties in bullet points

Material supplier obligations:

• Design and provision of the energy label
• Design and provision of further technical product information
• Enter technical product information in the product database (EPRELExterner Link. Öffnet im neuen Fenster/Tab.)
• Information obligations in the context of advertising

Essential dealer obligations:

• Indication and provision of the energy label
• Information obligations in the context of distance selling
• Information obligations in the context of advertising

Requirements for the design of the energy label, advertising and sales information are set out in the annexes to the respective product-specific regulations. Violations of the labelling requirements lead to a ban on marketing and can result in the imposition of market surveillance measures by the authorities (e.g. sales ban). Breaches of duty may constitute an administrative offence in accordance with EnVKG in conjunction with EnVKV. EnVKV.

Latest news

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.. In the coming years, the EU will review and adapt existing regulations (e.g. rescaling of energy labels).

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.