EU Battery Regulation for medical devices and IVDs: manufacturers and producers

The EU Battery Regulation 2023/1542 is the legislative framework for all types of batteries in the European Union, whether sold separately, built-in, or supplied with a device. This includes batteries incorporated or added to medical devices and IVDs. Manufacturers of medical devices and IVDs must ensure that they are using compliant batteries in their devices and verify weather any of the new obligations apply to them as well. The only batteries excluded from the scope of the EU Battery Regulations are batteries used for military, internal security, as well as batteries used in weapons and space equipment.

Classification of batteries included to medical devices and IVDs

The EU Battery Regulation introduces five battery categories: portable batteries, industrial batteries, electric vehicles (EV) batteries, light means of transportation (LMT) batteries, and starting, lighting and ignition (SLI) batteries. Medical devices and IVDs typically include portable batteries. A “portable battery” is defined in Article 3.9 as “a battery that is sealed, weighs 5 kg or less, is not designed specifically for industrial use and is neither an electric vehicle battery, an LMT battery, nor an SLI battery”.

Identify the manufacturer of the battery

Batteries can be placed on the market only if they meet sustainability, safety, labelling and information requirements established in the Regulation. Batteries shall not present a risk to human health, to the safety of people, or to the environment. The manufacturer is the economic operator responsible for ensuring compliance with these requirements. Specifically, manufacturers of portable batteries shall:

• Ensure that the battery complies with the restrictions on substances
• Label their batteries according to Article 13
• Prepare the technical documentation
• Carry out conformity assessment
• Draw up an EU declaration of conformity and affix the CE marking
• Keep the technical documentation available
• Take the corrective action necessary to bring the battery into conformity, to withdraw it or recall it, as appropriate

According to Article 3.33 of the Battery Regulation, “manufacturer” means “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.” If the medical device manufacturer adds a battery to the medical devices under their own name or trademark or put the battery into service for its own purpose, they likely classify as manufacturer of the battery as well.

Producers: economic operators subject to the EPR provision

One of the key provisions introduced by the new legislative framework is the Extended Producer Responsibility (EPR), a policy scheme addressing the producer’s responsibility throughout the product’s entire lifecycle. The economic operators subject to the EPR provisions are the producers.

According to Article 3.47, “producer” means “any manufacturer, importer or distributor or other natural or legal person that, irrespective of the selling technique used, including by means of distance contracts, either:

• is established in a Member State and manufactures batteries under its own name or trademark, or has batteries designed or manufactured and supplies them for the first time under its own name or trademark, including those incorporated in appliances, light means of transport or other vehicles, within the territory of that Member State;
• is established in a Member State and resells within the territory of that Member State, under its own name or trademark, batteries, including those incorporated in appliances, light means of transport or other vehicles, manufactured by others, on which the name or trademark of those other manufacturers does not appear;
• is established in a Member State and supplies for the first time in that Member State on a professional basis, batteries, including those incorporated in appliances, light means of transport or other vehicles, from another Member State or from a third country; or
• sells batteries, including those incorporated in appliances, light means of transport or other vehicles, by means of distance contracts directly to end-users, whether or not they 4 are private households, in a Member State, and is established in another Member State or in a third country.”

Extended producers responsibility (EPR) for producers of batteries

As EPR schemes address the environmental impact batteries have, producers shall ensure that all waste portable batteries are collected separately in the territory where they are sold (Article 59). To mention some of the main provisions, producers shall:

• Establish a take-back and collection system.
• Offer free collection services to designated entities.
• Provide necessary logistics, including free transport containers.
• Ensure regular, free collection from designated points based on waste volume and hazard levels.
• Collect waste batteries from electronic waste based on waste volume and hazard levels.
• Ensure that collected waste batteries are treated at a permitted facility by a waste management operator in accordance with the waste treatment requirements of Article 70.

Removability and replaceability of batteries in medical devices and IVDs

Manufacturers of medical devices and IVDs could be affected by the removability and replaceability requirements. Article 11 of the EU Battery Regulation specifies obligations on the removability and replaceability of portable and LMT batteries applicable to the natural or legal person who places devices on the market incorporating such batteries as of 18 February 2027. Although some exceptions exist, medical devices and IVDs have to include portable batteries, defined as “any battery that is sealed, weighs less than or equal to 5 kg, is not specifically designed for industrial purposes, and is neither an electric vehicle battery or a light vehicle battery or an SLI battery”.

We can act as your authorised representative for batteries and medical devices. Contact us here or at mdlaw@obelis.net!

References:

EUR-Lex (2023). Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC. Retrieved on 25/03/2026.