d1e1437-1-1__para__10
COMMISSION NOTICE Guidance document for Regulation (EU) 2025/40 on packaging and packaging waste · European Union
As regards the derogation provided for in Article 12(11), for medical devices and in vitro diagnostic medical devices there are no definitions for inner and outer packaging in Regulations (EU) 2017/745 and (EU) 2107/746. To ensure the derogation is correctly applied for those products, the reference to immediate packaging should be understood as referring to the packaging in contact with the device while the outer packaging should be understood as referring to the sales packaging of the device.
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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.