EU - Adopts New Derogations for Portable Battery Removability and Replaceability

By way of derogation from the general rule (end-user removability and replaceability), the following products incorporating portable batteries may be designed so that the battery is removable and replaceable only by independent professionals:

(a) 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;

(b) Professional medical imaging and radiotherapy devices (as defined in Article 2(1) of Regulation (EU) 2017/745) and in vitro diagnostic medical devices (as defined in Article 2(2) of Regulation (EU) 2017/746);

(c) 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 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;

(d) Until July 31, 2030, 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 when used in accordance with Article 10(2) of Directive 2009/48/EC;

(e) Wireless thermometer probes specifically designed for food contact during food preparation processes;

(f) Products falling within the scope of Article 1 of Directive 2014/34/EU (ATEX – equipment and protective systems intended for use in potentially explosive atmospheres);

(g) On-body delivery systems specifically designed for the subcutaneous administration of medicinal products;

(h) 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.

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. ​