d1e638-1-1__para__5 — COMMISSION NOTICE Commission guidelines to facilitate the harmonised…

d1e638-1-1para5

COMMISSION NOTICE Commission guidelines to facilitate the harmonised application of provisions on the removability and replaceability of portable batteries and LMT batteries in Regulation (EU) 2023/1542 · European Union

Additionally, and similar to implanted devices, hearing aids constitute medical devices whose useful lifetime is dictated specifically by medical reasons (i.e., progressive hearing loss). At the same time, replaceability of the battery could pose a safety risk to the patient. Hearing aid devices are therefore considered to be relevant to the derogation in Article 11(3).

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07 · Text as adopted (Official Journal); later amendments are not incorporated in this text.