Batteries Regulation in MedTech

Batteries are the beating heart of medical technology, and the new EU Batteries Regulation introduces stringent compliance requirements. Our Planning & Environment team examines which batteries are affected, outlines key sustainability and safety obligations, and highlights crucial steps for manufacturers, importers, and distributors. Discover how these rules impact your business and the importance of early compliance planning.

The importance of batteries to medical technology cannot be overstated. Implantable medical devices are powered by batteries. Substantial volumes of other medical equipment also rely on batteries either as their main or back-up power source.

The EU Batteries Regulation aims to ensure that batteries on the EU market are sourced and manufactured in a sustainable manner. The Regulation sets out, amongst other things, rules on the sustainability, performance, safety, collection, recycling and second life of batteries.

It is important that manufacturers, importers, distributors, or any person placing batteries on the EU market or putting them into service are aware of their obligations under the Regulation. While the Regulation applies to all battery categories, this article focuses on its implications for producers of "portable batteries," which are most commonly used in medical devices.

In-scope batteries

Broadly speaking, a battery includes non-rechargeable or rechargeable battery cells or packs of them, as well as batteries that have been re-used, repurposed or remanufactured. Portable batteries must be sealed, weigh 5kg or less, and not be a different category of battery covered by a separate provision of the Regulation.

The Regulation also applies to certain types of ‘battery management systems’, which control certain functions within a battery.

Producers

The Regulation uses the term ‘producers’ to describe persons who have obligations under the regime. The term ‘producer’ includes:

• Manufacturers
• Importers
• Resellers, and
• Distance sellers

Many of the obligations become applicable at the point the batteries are first placed or put into service on the EU market. This extends to producers of medical devices that incorporate batteries. However, if a producer places battery-operated medical devices on the market without the batteries being incorporated into the device at the time it is placed on the market, they may not have obligations under the Regulation. Instead, the obligations would apply to the battery producer that separately places the required battery on the market. If, on the other hand, a producer of a medical device incorporates a third-party’s battery into the device, the producer of the medical device may have obligations under the Regulation.

Obligations on producers

The primary obligation under the Regulation is that batteries placed on the market or put into service shall not present a risk to:

• Human health
• Safety of persons
• Property, or
• The environment

However, the Regulation provides more specific obligations regarding ‘sustainability and safety requirements’ and ‘labelling and information requirements’. We summarise some of these requirements for portable batteries that may be of interest to producers of medical technology.

1. Restrictions on substances

The use of certain substances in the production of batteries is restricted. The Regulation provides that batteries shall not contain more than 0.0005% mercury, 0.002% cadmium, and 0.01% lead, measured by weight. Further restricted substances are set out in Annex XVII of Regulation 1907/2006 and in Article 4(2)(a) of Directive 2000/53/EC. This restriction is in effect.

2. Performance and durability requirements

Portable batteries for general use, excluding button cells, must meet minimum values for the electrochemical performance and durability. These parameters are set out in Annex III of the Regulation. The minimum values will be set out in a delegated act to be adopted by the Commission by no later than 18 August 2027.

The parameters to which the minimum values will apply include things such as rated capacity, resistance to unplanned escape of material, and the capacity a battery can deliver under specific conditions.

This obligation will apply from 18 August 2028. However, this date could potentially be pushed by the Commission in a delegating act.

3. Removability and replaceability of portable batteries

Portable batteries incorporated into products must be readily removable and replaceable by the end-user at any time during the lifetime of the product. This only applies to entire batteries and not to individual cells or other parts included in portable batteries.

A portable battery is considered “readily removable by the end-user” if it can be removed from a product using commercially available tools. Specialised tools are not required, unless they are provided free of charge with the product. However, there is an exemption for appliances including “professional medical imaging and radiotherapy devices” and “in vitro diagnostic medical devices”.

Although this requirement is in effect, the Commission will ultimately publish guidelines so that there is a harmonised approach on its application throughout all Member States.

4. Labelling and marking of batteries

Batteries must bear a label containing the general information set out in Part A of Annex VI. This information includes things such as details on the manufacturer, date of production, and battery information. This obligation will apply from 18 August 2026. However, this date could potentially be pushed out by the Commission in a delegating act.

In addition, all batteries must bear the “crossed-out wheelie bin” symbol from 18 August 2025. This indicates that batteries are to be disposed of in a separate waste stream to regular waste.

5. CE marking

The Regulation establishes a framework for conformity assessment procedures for batteries. Battery manufacturers are required to prepare a declaration of conformity in electronic format since 18 August 2024. This document must be provided in the language(s) specified by each Member State where the batteries are being marketed. By drawing up the declaration of conformity, the manufacturer assumes responsibility for the compliance of the battery with the requirements laid down in the Regulation. It is not sufficient to simply add the Regulation to an existing declaration of conformity.

Conforming batteries must be visibly, legibly, and indelibly marked with the CE marking before the battery is placed on the market. If it is not practically possible for the marking to be on the battery, then the marking must be on any packaging and documents accompanying the battery. The general rules on how to affix the CE marking to a product, including portable batteries, are available in the Commission’s Blue Guide on the implementation of EU Product Rules 2022.

6. Management of waste and producer responsibility

Producers of portable batteries must ensure that all waste portable batteries are collected separately from other waste. This requires producers to:

• Establish a waste portable battery take-back and collection system
• Collect, free of charge, the waste portable batteries collected at collection points, and
• Ensure that the waste portable batteries collected are subject to treatment in a permitted facility by a waste management operator

Producers of portable batteries must attain, and maintain on an ongoing basis, at least the following collection targets for waste portable batteries:

• 45% by 31 December 2023
• 63% by 31 December 2027, and
• 73% by 31 December 2030

7. Due diligence and risk management

Producers having a net annual turnover of €40 million or more have additional obligations under the Regulation. These producers are referred to as “economic operators”. Economic operators must implement battery due diligence policies from 18 August 2025. These policies must be third-party verified. The Commission is to publish guidelines on the requirements of due diligence policies by 18 February 2025.

Comment

In addition to the provisions already in force, the many other provisions of the Regulation will come into force on a gradual, phased basis over the next 12 years or so. The European Commission and Member States will implement secondary legislation to give full effect to the Regulation.

Specific obligations for manufacturers, importers and distributors of batteries are set out in Articles 38, 41, and 42 of the Regulation. Broadly speaking, they are required to ensure compliance with the other provisions of the Regulation.

For more information on the impact of the Regulation on your operations, contact a member of our ESG or Environment teams.

The content of this article is provided for information purposes only and does not constitute legal or other advice.