d1e409-1-1__para__7

Intravenous (IV) bags and syringes do not fall within the definition of packaging under Article 3(1), point (1), including where they are placed on the market pre-filled with medicines or saline. Although they may physically contain a substance, IV bags and syringes are not placed on the market merely to contain, protect, transport or present a product. Rather, they are designed, manufactured and regulated as integral delivery devices that enable safe, sterile and accurate administration of fluids or medicines to patients. When supplied pre-filled, the IV bag or syringe forms an integral part of the medicinal or medical product itself, such that the product cannot perform its intended function independently of the device. In this context, the IV bag or syringe is not a packaging component that is discarded to access its contents, but a functional part of the product placed on the market.

← d1e409-1-1__para__6 · All articles · 2. Definition of a manufacturer of packaging →

Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.