EU Battery Regulation: What medical device manufacturers need to know

The EU plans to replace the existing Directive 2006/66/EC with the new EU Regulation on batteries and waste batteries ("Battery Regulation").

This article clarifies,

• which medical device manufacturers and which medical devices are affected by the Battery Regulation,
• what the requirements of this regulation are, and
• how manufacturers can best proceed to meet these requirements.

1. Background

a) Objective

With the Battery Regulation, the EU aims to modernize the legal framework for batteries. The regulation is a response to calls for a comprehensive revision and expansion of EU legislation covering the entire life cycle of batteries.

The objective is to increase resource efficiency and promote circular value creation. The Battery Regulation is an integral part of the European Green Deal.

b) Current status of the Battery Regulation

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 was published by the EU in the Official Journal on July 28, 2023.

2. Scope of the Battery Regulation

a) Which devices are affected?

Article 1 of the Battery Regulation specifies its scope of application.

(1) This Regulation lays down requirements on sustainability, safety, labelling, marking and information to allow the placing on the market or putting into service of batteries within the Union. It also lays down minimum requirements for extended producer responsibility, the collection and treatment of waste batteries and for reporting.

(3) This Regulation applies to all categories of batteries, namely portable batteries, starting, lighting and ignition batteries (SLI batteries), light means of transport batteries (LMT batteries), electric vehicle batteries and industrial batteries, regardless of their shape, volume, weight, design, material composition, chemistry, use or purpose. It shall also apply to batteries that are incorporated into or added to products or that are specifically designed to be incorporated into or added to products.

In this context, the Battery Regulation provides the following definitions.

The regulation defines:

According to Annex I, Directive 2012/19/EU (Waste Electrical and Electronic Equipment) includes all medical devices or accessories, except for all implanted and infectious products.

There is a single exception for medical devices in the requirement in Article 11 for the removability and replaceability of device batteries.

Examples of medical devices that are affected:

• Syringe pump with a backup battery
• Transportable patient monitor
• Removable laryngoscope handle with battery
• Mobile therapy robot with an electric drive powered by a transaction battery
• Ear thermometer with replaceable button cell battery
• Blood pressure monitor for home use with standard AAA cells

Examples of medical devices that are not affected:

• Implantable cardiac pacemakers with rechargeable battery (specifications are included in the MDR)
• Surgical instruments that must be disposed of via hospital waste
• Disposable laryngoscopes with illumination and fixed battery that must be disposed of via hospital waste

Standalone software

For software medical devices installed and operated on general mobile platforms or tablets, the manufacturer of the hardware is responsible for compliance with the regulation. It may be necessary for the manufacturer of the software medical device who delivers the software together with a hardware device to include battery labeling information in the medical device user manual.

b) Which organizations are affected?

First, the Battery Regulation affects all manufacturers who produce or develop a battery (including batteries installed in appliances or vehicles) or have them produced and market that battery under their own name or trademark or put it into service for their own purposes and market it for trade or use for the first time in the territory of a member state.

That the term "manufacturer" is broadly defined is shown by Article 3, paragraph 47, which states that the following activities qualify an organization as a "manufacturer":

1. established in the EU: producing or designing or having produced and distributed in the EU under its own name or trademark
2. established in the EU: reselling batteries produced by other EU manufacturers if the name or trademark of these other manufacturers is not indicated
3. with establishment in the EU: first commercial sale of batteries originating from another member state or a third country
4. with establishment in the EU or a third country: direct sale via distance contracts to end users

Which medical device manufacturers are affected?

Medical device manufacturers fall under the first condition if they

• have a battery developed and produced for their medical device (e.g., a patient transport monitor) to meet their needs and market it with the device under their own name.
• develop and produce a finished usable battery from battery cells for the medical device themselves.

Which medical device manufacturers are not affected?

Manufacturers whose devices are designed for standard batteries and where no batteries are supplied are not affected. However, the instructions for use must contain information on the type of battery to be used. This is already a requirement of the MDR.

3. The main requirements of the regulation

The Battery Regulation comprises 13 chapters and 14 annexes (see Fig. 1).

The requirements for medical device manufacturers are:

1. carbon footprint statement
2. removability and replaceability of device batteries
3. labeling and information requirements
4. obligations of economic operators

a) Statement on the carbon footprint

Article 7 requires manufacturers  for electric vehicle batteries, rechargeable industrial batteries with a capacity greater than 2 kWh and LMT batteries to submit the carbon footprint in the form of a declaration in the future. The methods for calculating the CO2 footprint will be specified by the EU.

The introduction of the regulations over time will take place in three stages:

• Stage 1 - Obligation to provide information on the CO2 footprint in the form of a declaration
• Stage 2 - Classification of batteries into performance classes
• Stage 3 - Introduction of maximum values for the CO2 footprint over the entire life cycle

Initially, only manufacturers of certain types of batteries will be affected by the requirements:

• Rechargeable industrial batteries with internal storage and a capacity greater than 2 kWh
• Electric vehicle batteries
• LV batteries (light transportation)

The deadlines for the different battery types are regulated in Article 7, subsections 2 and 3. The requirements do not apply to portable batteries.

b) Removability and replaceability of device batteries

The Battery Regulation requires that the batteries can be removed and replaced:

Any natural or legal person that places on the market products incorporating portable batteries shall ensure that those batteries are readily removable and replaceable by the end-user at any time during the lifetime of the product. That obligation shall only apply to entire batteries and not to individual cells or other parts included in such batteries.

Article 11, Paragraph 1

This means that manufacturers must ensure the following characteristics of the batteries:

• Replaceable if the life of the batteries is shorter than that of the device
• Removable at the latest at the end of the service life
• End users or independent economic operators must be able to remove or replace the battery
  Any natural or legal person that places on the market products incorporating portable batteries shall ensure that those products are accompanied with instructions and safety information on the use, removal and replacement of the batteries.

For the following devices, battery replacement may be limited to independent professionals:

•  Appliances specifically designed to operate primarily in an environment that is regularly subject to splashing water, water streams or water immersion, where such derogation is required to ensure the safety of the user and the appliance (e.g., sterilizable medical devices).
• Appliances where the battery can only function if it is integrated into the device structure (e.g., shared enclosure, hearing aids where applicable)
• Professional medical imaging and radiotherapy devices as defined in Article 2, No. 1 of Regulation (EU) 2017/745 and in vitro diagnostic medical devices as defined in Article 2, No. 2 of Regulation (EU) 2017/746

If the reading is applied to all medical devices as well as IVDR products, the requirement for removability and interchangeability does not affect medical device manufacturers. Nevertheless, other requirements may be applicable.

c) Label and information requirements

A Article 13 specifies various transition periods within which batteries must be visibly, legibly and indelibly marked. Labeling includes the indication of certain key characteristics such as lifetime, charge capacity, obligation for separate collection, the presence of hazardous substances, and safety risks.

A permanent QR code is to be placed on batteries (printed or engraved), which must provide access to information relevant to the battery in question, the battery passport, and carbon footprint information, depending on the battery type.

 Stationary battery energy storage systems, LMT batteries and electric vehicle batteries shall include a battery management system (BMS) that stores the information and data necessary to determine the aging status and expected lifetime of batteries manufactured in accordance with the parameters set out in Annex VII. This requirement can already be derived from the MDR (see MDR Annex I, paragraph 18.2).

Paragraphs 1 and 2 of the new Battery Regulation concern only producers of batteries. Paragraph 3 concerns manufacturers using battery types for which the BMS is mandatory and who must provide an interface for the readability of the information.

d) Obligations of the economic operators

Chapter VI of the new Battery Regulation sets out the obligations of economic operators.

Tab. 1: Requirements for the individual operators

4. Battery Regulation and medical device manufacturers

a) Applicability to medical device manufacturers

Manufacturers who purchase and use batteries ready for use

Manufacturers who purchase and use ready-to-use batteries must comply with the following requirements:

• Check the label

Verify that sufficient information is available on the intended use of the battery to enable it to be properly commissioned, used, and managed at the end of its life. These requirements are indirectly contained in IEC 60601-1, clause 4.8 on the use of components.

• Verify compliance

Verify that the battery bears the CE marking and ensure that the distributor provides the information (operating instructions and safety information) in accordance with its obligations. Manufacturers should take appropriate measures to ensure that they only make batteries available on the market that comply with this regulation.

• Providing information

Provide information to the end user on safe disposal and replacement with the necessary tools where appropriate.

• Design and layout

Design equipment so that batteries (provided safety and performance are not affected) are removable and replaceable; provide means in the equipment to display or read information from the battery management system (BMS).

Manufacturers who (have) develop batteries

Manufacturers who produce batteries or have batteries developed or produced and who market these batteries under their own name or trademark must observe the following requirements:

These manufacturers (producers), when placing on the market and putting into service batteries (including for their own purposes), must ensure that

• the battery meets the sustainability and safety requirements described in Chapter II,
• the battery is labeled in accordance with Article 13,
• the technical documentation has been prepared in accordance with Annex VIII,
• a conformity assessment procedure has been carried out in accordance with Article 17, and
• the CE marking is affixed in accordance with Articles 19 and 20.

b) Implementation of the Battery Regulation

What should manufacturers do?

Manufacturers should perform the following activities:

• Check whether their activities fall within the scope of the regulation or whether the requirements for removability and replaceability of portable batteries apply to their own devices
• Check if the obligations for distributors or importers apply to them and implement the additional obligations in the QM management system, if applicable
• Check if the exemptions for removability and replaceability of batteries in Article 11 apply. If not, manufacturers must design the equipment and batteries so that the batteries are easily removable and replaceable
• Provide means in the device to display or read the information from the battery management system (BMS)
• Implement interfaces and protocols. To our knowledge, there is no standard. There is a fact sheet from the VDE
• Integrate the information from the battery's producer into your own user manual or include the information

The regulation places great emphasis on transparency and traceability to promote an environmentally friendly circular economy. Non-European manufacturers may not want to fully comply with the required requirements, especially on transparency. Therefore, manufacturers should assess long-term supply availability for batteries at an early stage. If necessary, they should consider seeking a manufacturer within the EU (which was the intention of the EU Commission).

What should manufacturers avoid?

The Commission wants to regulate the use of rechargeable and non-rechargeable general-purpose portable batteries (e.g., AAA batteries) by setting parameters for their electrochemical performance and shelf life.

The objective is to reduce the use of non-rechargeable general-purpose portable batteries. The Commission is even considering a ban.

Manufacturers should consider whether the use of a non-rechargeable general-purpose portable battery is environmentally justified over a rechargeable battery (e.g., because only limited recycling is possible).

c) Transition periods

The transition periods only affect producers of batteries:

Tab. 2: Transition periods

5. Summary and conclusion

With the Battery Regulation, the EU wants to contribute to environmental protection. If your medical devices contain batteries, you should check carefully whether you are affected by the regulation and comply with the legal requirements.

Irrespective of this, you can contribute to environmental protection by, for example, refraining from using non-reusable batteries.