The European Union is introducing new battery requirements under Regulation (EU) 2023/1542, including those used in medical devices, which aims to enhance the sustainability and safety of batteries in products. A key change is the requirement to ensure that built-in batteries are removable and replaceable. The new rules will take effect on 18 February 2027 and will impact both manufacturers and distributors of medical devices placing products with built-in batteries on the market.
Under this regulation, batteries in certain medical devices must be easily removable and replaceable by end users or independent professionals. This means users or professionals will be able to replace them without damaging the device or the battery itself. If a special tool is required for replacement, it must either be included in the device packaging or be available on the market. Additionally, instructions for the safe and environmentally friendly disposal of old batteries will be required.
In some cases, it will be necessary for the battery to be replaced only by an independent professional – an entity with the technical competence and qualification to repair the product containing the battery, performing this activity on a commercial basis. This exemption applies mainly to devices where user access to the battery could compromise safety or functionality, such as those used in humid environments or professional imaging and radiotherapy devices. The European Commission will have the authority to expand the list of products exempt from the removability and replaceability requirements.
Some medical devices will be entirely exempt from the battery removability requirement. This primarily applies to life-critical devices where power interruption could result in data loss or patient risk, such as pacemakers or diabetic monitoring systems. For these devices, the requirement for easy battery replacement will not apply, as their operation must remain uninterrupted.
The regulation also mandates that batteries and the products they are built into must be designed to accommodate not only original but also approved compatible batteries. Additionally, manufacturers must ensure that batteries for medical devices remain available as spare parts for at least five years after the last model of the device is placed on the market and must be offered at a reasonable and nondiscriminatory price.
Author: Alžběta Frýdlová