Medical devices and in-vitro diagnostic medical devices

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

Professional medical imaging and radiotherapy devices, which are medical devices as defined in Article 2 (1) of Regulation (EU) 2017/745 (10), and in-vitro diagnostic medical devices, as defined in Article 2 (2) of Regulation (EU) 2017/746 (11), may be designed in such a way as to make portable batteries removable and replaceable only by independent professionals.

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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.