The original Article 11(2) permits independent-professional removal and replacement instead of end-user replacement for two product groups with portable batteries. The first covers appliances specifically designed to operate primarily where they are regularly subject to splashing water, water streams, or water immersion, and intended to be washable or rinseable, but only where the derogation is required for user and appliance safety. The second covers professional medical imaging and radiotherapy devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746.
A separate full derogation removes the paragraph 1 duties where continuity of power is necessary and a permanent connection between the product and portable battery is required for user and appliance safety. It also covers data-integrity cases where collecting and supplying data is the product's main function and the permanent connection is required for data integrity. A secondary data feature, or a design with no risk of data loss, does not satisfy the Commission Notice's interpretation of that test.
The non-binding Commission Notice says an IP rating alone does not establish the wet-environment derogation. The file should show that the appliance is specifically and primarily designed for the stated environment, is washable or rinseable, end-user replacement would compromise safety, and redesign is not feasible with current technology without severely affecting health and safety, performance, or functionality.
On 14 July 2026, the Commission adopted a delegated act adding six product categories, including certain wearables, electric toys and products covered by the ATEX Directive for potentially explosive atmospheres. Its announcement makes entry into force conditional on scrutiny and Official Journal publication. Before relying on an added category, identify the published act, its exact product conditions and its entry-into-force date.