d1e638-1-1__para__2 — COMMISSION NOTICE Commission guidelines to facilitate the harmonised…

d1e638-1-1para2

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

Article 11(2) mentions professional medical imaging and radiotherapy devices where it is sufficient that portable batteries can be removed and replaced by independent professionals. Nevertheless, medical devices and in vitro diagnostic medical devices, as defined respectively in Regulations (EU) 2017/745 and (EU) 2017/746, cover a wide range of products which are used in applications with different levels of criticality. The uninterrupted operation of some medical devices is key when delivering care to a patient, and a risk-averse approach to medical devices is therefore proposed as appropriate.

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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.