Implications for Portable Batteries and Medical Devices under the EU Battery Regulation

The European Union's Regulation (EU) 2023/1542, which went into effect in August 2023 and will be progressively enforced beginning from February 2024, establishes a harmonised, legally binding framework for the whole lifecycle of batteries placed on the EU market. 

The legislation represents a significant shift in regulatory expectations for medical device producers and economic operators. Portable battery integration is now subject to stringent design, sustainability, labelling, and end-of-life requirements that must be met concurrently with the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). To avoid non-conformity penalties, exclusion from the EU market, or disruption in notified body evaluations, internal compliance processes, technical documentation, and supplier supervision mechanisms must be recalibrated.

Scope and classification of portable Batteries

The regulation defines “portable batteries” as sealed batteries that do not exceed 5 kg and are not designed for industrial use or electric vehicles. Medical device manufacturers must properly classify the embedded power sources. For instance, a glucose meter powered by a built-in lithium-ion battery and other devices like infusion pumps, surgical hand tools, and battery-powered diagnostics designed for home or ambulatory care all fall under this category.

Furthermore, if a battery is placed on the market with a device, whether built-in or offered in packaging, the device manufacturer becomes the "battery producer" under this regulation. This classification entails the entire set of regulatory requirements, including conformity assessment, labelling, removability design, EPR, and carbon footprint disclosure (where applicable).

Portable batteries regulation requirements timeline

Removability and replaceability of batteries in medical devices

Article 11 requires all portable batteries to be "readily removable and replaceable" by the end user with commonly accessible tools. This design responsibility applies unless the product falls under a carefully defined exemption.

The consequences for medical equipment are enormous. Implantable devices (for example, pacemakers) and certain in vitro diagnostic equipment may be exempt if battery removal could risk patient safety or essential device functionality. Nonetheless, even in these situations, manufacturers must build for replaceability by independent professionals, ensuring access without permanently compromising the housing or circuit integrity. Wet environment derogations apply to devices designed for regular water exposure (e.g., sterilisable surgical tools), but manufacturers must still ensure that battery replacement is possible through expert servicing.

Importantly, the European Commission emphasised that "commonly available tools" do not include proprietary fasteners or specialist equipment. This drives the industry toward open-access mechanical design, standardised interfaces, and the removal of obstructive adhesives and solvent-based sealants.

Non-compliant products will be prevented from entering the EU market after February 2027, putting manufacturers under time pressure to redesign, test, and coordinate with notified bodies.

Dual conformity and CE Marking: MDR/IVDR + Battery Regulation

Under the battery regulation, all batteries must carry a CE marking starting from August 2024, accompanied by a Declaration of Conformity and comply with technical documentation.

Medical device manufacturers must demonstrate dual conformity under the MDR/IVDR for the entire device and under Regulation 2023/1542 for the embedded battery. This entails combining two regulatory frameworks into a single Quality Management System (QMS) and ensuring that clinical evaluation methods consider battery safety, performance, and removability.

Any change to enable battery access in Class IIa/IIb/III devices will necessitate a conformity update and possibly a new certificate, subject to notified body evaluation. Early risk planning, standard mapping, and supplier declarations are strongly recommended.

Carbon footprint declarations 

While most portable batteries are exempt from carbon footprint requirements, manufacturers of medical systems that utilise rechargeable industrial batteries >2 kWh, such as CT scanners or backup power systems, will be required to report carbon footprint data by 2027.

The assessment must adhere to the EU Product Environmental Footprint (PEF) methodology and span the full battery lifecycle: extraction, processing, manufacturing, transport, and end-of-life recycling. Independent third-party verification is mandatory.

Given the complexity of global supply chains, particularly lithium and cobalt sourcing from third countries, manufacturers should begin engaging their upstream partners to collect emissions and traceability data. Over time, carbon performance may become a competitive factor in procurement contracts, especially within public health tenders governed by green criteria.

Performance and electrochemical standards

Portable batteries for general use, excluding button cells, shall meet the minimum electrochemical performance and durability requirements. From August 2028, portable batteries, including those embedded in medical equipment, must meet minimum capacity, retention, charge/discharge cycles, and leakage resistance standards.

While battery producers will carry the majority of the compliance enforcement burden, device integrators will be held legally liable if non-compliant batteries are placed on the European market. As a result, quality assurance teams must update supplier qualification criteria and conduct periodic product conformity evaluations against changing thresholds.

By December 2030, the European Commission will also decide whether to phase out non-rechargeable general-use portable batteries, such as button cells, based on a lifetime analysis. Manufacturers relying on disposable formats should plan for potential shifts toward rechargeable alternatives, especially in wearable or diagnostic devices.

Extended Producer Responsibility (EPR)

Regulation 2023/1542 provides specific Extended Producer Responsibility (EPR) responsibilities, requiring producers to finance and oversee the collection, treatment, and recycling of batteries placed on the EU market. Collection targets for portable batteries are set at 45% by the end of 2023, rising to 63% by 2027 and 73% by 2030.

Manufacturers must provide end-users with clear disposal instructions, publish annual reports on collection and recycling performance, and design batteries to facilitate safe disassembly and materials recovery. Recovery targets for essential minerals, such as lithium, cobalt, nickel, and lead, will be introduced gradually, with mandated minimum recycled content thresholds beginning in 2031.

Labelling and information requirements

According to Annex VI of Regulation 2023/1542, all batteries, including those in medical devices, must bear standardised labels containing general information, such as manufacturer data, capacity, chemistry, dangerous compounds, and critical raw materials. Starting in August 2025, a separate collecting symbol will be required, and it must meet particular size standards based on battery type and capacity. 

Batteries must include a high-contrast QR code that can be read by common devices beginning in February 2027. The QR code for portable, industrial (<2 kWh), and SLI batteries must include information on capacity, performance, hazardous compounds, separate collection, Declaration of Conformity, due diligence policies, and waste management practices. These regulations enable increased openness and traceability throughout the battery's lifecycle, which is critical for preserving EU market access.

The EU Battery Regulation 2023/1542 establishes a comprehensive legal framework that redefines the responsibilities of medical device manufacturers integrating battery systems into their products. With enforceable requirements spanning removability, performance, labelling, carbon transparency, and end-of-life management, the regulation necessitates a proactive and integrated compliance approach. For manufacturers, this means aligning device design with new technical standards, reassessing supplier relationships, and ensuring full conformity under both battery regulation and sector-specific medical device laws.