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,
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.
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.
Download EU Battery Regulation, first reading status June 14, 2023, English
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.
a battery that is sealed, weighs 5 kg or less.
The regulation defines:
means any electrical or electronic equipment, as defined in Article 3(1), point (a), of Directive 2012/19/EU, which is fully or partly powered by a battery or is capable of being so;
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.
The Battery Regulation thus affects all medical devices (implantable and infectious devices excepted) in which device batteries are installed.
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:
Examples of medical devices that are not affected:
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.
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.
Manufacturers also count as producers, importers, or distributors!
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":
Medical device manufacturers fall under the first condition if they
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.
The Battery Regulation comprises 13 chapters and 14 annexes (see Fig. 1).
The requirements for medical device manufacturers are:
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:
Initially, only manufacturers of certain types of batteries will be affected by the requirements:
The deadlines for the different battery types are regulated in Article 7, subsections 2 and 3. The requirements do not apply to portable batteries.
Medical device manufacturers who produce batteries or have them developed or produced are also considered manufacturers. They are, therefore, subject to these regulations.
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:
For the following devices, battery replacement may be limited to independent professionals:
It is unclear why the EU includes all IVDR devices in the exemption but only professional medical imaging and radiation therapy devices in the medical devices. Perhaps it is a mistake, and all medical devices are meant?
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.
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.
Chapter VI of the new Battery Regulation sets out the obligations of economic operators.
Note: Manufacturers/producers must ensure that they receive this information
Tab. 1: Requirements for the individual operators
Manufacturers who purchase and use ready-to-use batteries must comply with the following requirements:
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 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.
Provide information to the end user on safe disposal and replacement with the necessary tools where appropriate.
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 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
Manufacturers should perform the following activities:
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).
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).
The transition periods only affect producers of batteries:
The deadlines depend on the battery type and are regulated in Article 7, Sections 2 and 3. Example: For electric vehicle batteries, the deadline is 18 February 2025 or 12 months after the date of entry into force either of the delegated act or of the implementing act respectively.
General information according to Annex VI, Part A for all batteries: Article 13, paragraph 1: From 18 August 2026 or 18 months after the date of entry into force of the implementing act referred to in paragraph 10, whichever is the latest.
Symbol referred to in Annex VI, Part B for all batteries: From 18 August 2025.
QR code, Annex VI, Part C for all batteries: Article 13, paragraph 6: From 18 February 2027.
For certain types of batteries, further labels and their deadlines are regulated in Article 13, paragraphs 3 to 10.
Digital battery pass
42 months after the date of entry into force of this regulation
Tab. 2: Transition periods
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.
The Johner Institute helps manufacturers find out if they are affected by the regulation and helps define and implement a regulatory strategy.
Get in touch if you want to find out how this support can be provided and how it can help you get your medical devices into all markets quickly and in compliance with the law.