- Environmental law Overview: Battery Regulation (BattVO) Regulations for the MedTech industry

Name of the legal act

Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 on batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (Text with EEA relevance).

Status

Consolidated version of 18 July 2024.Externer Link. Öffnet im neuen Fenster/Tab.

Background information

The Battery Regulation came into force on 17 August 2023 and generally applies from 18 February 2024. However, due to additional transitional provisions, most obligations must be complied with no earlier than 18 August 2024. Furthermore, there are numerous other transitional provisions specific to roles and responsibilities that further delay the start of application in some cases. For example, the requirements for extended producer responsibility in Chapter VIII of the Battery Regulation will only apply from 18 August 2025. On this date, the currently applicable Battery Directive 2006/66/EC will also be repealed. By this deadline, EU Member States must have adjusted their national legislation to align with the Battery Regulation. In Germany, a draft billExterner Link. Öffnet im neuen Fenster/Tab. for the adaptation of battery law to Regulation (EU) 2023/1542 is available since 27 May 2025.

Scope of application

The Battery Regulation applies to all categories of batteries, regardless of shape, volume, weight, design, material composition, type, chemical composition, use or purpose, also regardless of whether they are built into other products, are added to them or are designed for this purpose. Battery cells or modules that are made available on the market for final use and are not incorporated or assembled into larger battery packs or batteries are considered batteries placed on the market in accordance with the Battery Regulation. The term "batteries" covers both non-rechargeable and rechargeable batteries and accumulators.

With the two newly introduced battery categories - batteries for light means of transport and electric vehicle batteries - there are now a total of five battery categories. The category of portable batteries will continue to be the most relevant for medical devices, although the new criteria, particularly in relation to industrial batteries and batteries for light means of transport, will have to be considered. For this, see also the ZVEI position paper on the distinction between "portable batteries versus industrial batteriesExterner Link. Öffnet im neuen Fenster/Tab." – this is an informal document, and its statements are not mandatory.

According to Art. 1 (4) of the Battery Regulation, there are two use-related exceptions to the scope of application, which, however, do not specifically concern medical devices.

ATTENTION: Like the Battery Act (BattG), the Battery Regulation is not applicable to electrical and electronic devices. Therefore, there is no direct connection with the RoHS Directive 2011/65/EU or the WEEE Directive 2012/19/EU. For battery-operated electrical and electronic devices, the Battery Regulation and in particular the ElektroG and ElektroStoffV are therefore generally applicable in parallel. However, for battery-operated electrical appliances, Art. 11 of the Battery Regulation regarding the removability and replaceability of batteries must be observed in the future. Details on the distinction by the Stiftung Elektroaltgeräte Register (Stiftung EAR) can be found in the an application guideExterner Link. Öffnet im neuen Fenster/Tab..

Roles

Compared to the Battery Act (BattG), the Battery Regulation introduces several new roles and amends existing definitions.

The central definition for all sustainability, safety, labelling and conformity assessment obligations is the manufacturer in accordance with Art. 3 (1) No. 33 of the Battery Regulation. A manufacturer is therefore defined as any "natural or legal person who manufactures a battery or has a battery designed or manufactured, and markets that battery under its own name or trademark or puts it into service for its own purposes". Placing on the market means the first making available in the EU. Putting into service means the first use of a battery that has not previously been placed on the market in the EU (i.e., especially for own use). Art. 39 (1) of the Battery Regulation and Art. 44 of the Battery Regulation contain scenarios in which other actors are also to be considered as producers.

This is to be distinguished from the producer according to Art. 3 (1) No. 47 of the Battery Regulation. In summary, the producer is always the party who first places a battery on the market in a specific Member State. The producer is the main responsible party for fulfilling the extended producer responsibility obligations.

The importer pursuant to Art. 3 (1) No. 64 of the Battery Regulation will also be subject to comprehensive inspection obligations in the area of sustainability, safety and labeling obligations in the future.

The distributor is also made more accountable. Due to the definition in Art. 3 (1) No. 65, this does not only mean the final distributor, but anyone who makes batteries available on the market, except for manufacturers and importers.

Duties in bullet points

Sustainability, safety and labelling obligations (producer responsibility):

• Substance restrictions (Art. 6 of the Battery Regulation)
• Carbon footprint (Art. 7 - not for portable batteries)
• Minimum recycled content (Art. 8 - not for portable batteries)
• Performance and durability (Art. 9 and 10 - not for portable batteries (applicable for portable batteries of general use)
• Removability and replaceability - (Art. 11; obligation applies to producers of devices with built-in batteries from 18 February 2027) - see the Commission guidelinesExterner Link. Öffnet im neuen Fenster/Tab. on this topic
• Safety of stationary battery energy storage systems (Art. 12)
• Labelling (Art. 13)
• Information on the state of health and expected lifetime of batteries (Art. 14 - not for portable batteries)
• Digital battery passport (Art. 77, 78 - not for portable batteries)
• Conformity assessment, including technical documentation, EU declaration of conformity and CE labelling (Art. 15 et seq.)

Obligations of economic operators:

• Manufacturer obligations (Art. 38)
• Importer obligations (Art. 41)
• Distributor obligations (Art. 42)

Due diligence obligations in the supply chain (Art. 47 et seq.)


Extended producer responsibility:

• Producer registration (Art. 55)
• Take-back, collection and further treatment (Art. 59, 60)
• Distributor obligations, in particular take-back (Art. 62)
• Information obligations for producers and distributors (Art. 74)
• Reporting by producers (Art. 75)

In addition to this brief summary, the Battery Regulation contains numerous detailed obligations that must be observed in individual cases.

Latest news

The Battery Regulation is currently entering uncharted regulatory territory in many areas and a lot of questions on interpretation and application remain unanswered. The text of the regulation itself also contains obvious contradictions and regulatory gaps in some places. The EU Commission is currently in the process of preparing some of the numerous delegated acts to the Battery Regulation, which should be closely monitored, as they often contain the detailed content necessary for implementation.

In addition, there are three new draft legal acts to amend the BattVO that are currently in the consultation process and have not yet been finally adopted:

• Proposal amending the Batteries Regulation (EU) 2023/1542 as regards battery due diligence obligationsExterner Link. Öffnet im neuen Fenster/Tab. - this postpones the date of application of the due diligence obligations (Art. 47 et seq. BattVO) from 18.08.2025 to 18.08.2027; the guidelines originally announced for 18.02.2025 are to be postponed to 26.07.2026
• Burden reduction and simplification for competitiveness of small mid-cap enterprises - Omnibus RegulationExterner Link. Öffnet im neuen Fenster/Tab. - in which the turnover threshold for the application of EU due diligence obligations is to be raised from €40 million to €150 million
• Omnibus Regulation Aligning product legislation with the digital ageExterner Link. Öffnet im neuen Fenster/Tab. - this is intended to amend various requirements for the provision of digital contact details, including in the BattVO; in addition, the obligation to provide operating instructions and safety information is to be restricted to stationary battery energy storage systems and therefore no longer applies to all other battery categories (in particular portable batteries)

At the national level, a draft billExterner Link. Öffnet im neuen Fenster/Tab. for the adaptation of battery law to Regulation (EU) 2023/1542 is available since 27 May 2025.

In addition to the requirements set out in the Battery Regulation, other legal acts will also deal with batteries and define requirements for them - for example, the eco-design legislation, which defines requirements for battery-powered devices and creates the basis for digital product passports. Additionally, the general due diligence obligations from the LkSG (and, in future, the EU Due Diligence Directive) and the raw material-specific due diligence obligations from the EU Conflict Minerals Regulation (EU) 2017/821 are also relevant in parallel to the Battery Regulation.

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.