The European Commission is seeking views on the proposed delegated regulation on derogations for the removability and replaceability of portable batteries. The list covers in vitro diagnostic medical devices as well as some medical devices.
The draft is open for feedback until 26 May 2026 (more information here).
Background information to derogations
Article 11 of the EU Battery Regulation specifies obligations on the removability and replaceability of portable batteries applicable as of 18 February 2027. Specifically, portable batteries incorporated into devices have to be removable and replaceable by the end users. However, to ensure the safety of end users certain products are exempted from this rule.
In the draft, the list of products whose battery can be removed and replaced only by independent professionals covers:
- Professional medical imaging and radiotherapy devices as well as in vitro diagnostic medical devices.
- On-body delivery systems specifically designed for the subcutaneous administration of medicinal products.
The list also includes other products:
- Appliances, including wearable devices, specifically designed to operate primarily in an environment that is regularly subject to splashing water, water streams or water immersion, and that are intended to be washable or rinseable.
- Wearable devices for which the safety, durability, or water resistance may be compromised by user access to the battery and which:
- due to their nature, size or form, are considered to be too small to allow the end-user to properly and safely handle a battery replacement; or
- rely on a compact, sealed enclosure to maintain functional integrity, including protection against dust, and shock.
- Electric toys that incorporate rechargeable batteries when, due to the nature or size of the toy, the derogation is necessary to ensure the safety of the toy (until 31 of July 2030).
- Wireless thermometer probes designed for food contact during food preparation processes.
- Products in the scope of the Directive for equipment and protective systems intended for use in potentially explosive atmospheres (ATEX).
- Telematics devices intended for roof mounted installation in agricultural and construction machinery and designed to be exposed to harsh vibrations, dust, and wet conditions during their intended use.
More useful tools
For any questions on compliance with the EU Battery Regulation, contact us here or at mdlaw@obelis.net.
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