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ARTICLE · 27 JULY 2026

The EU Packaging And Packaging Waste Regulation: Why Life Sciences Companies Should Act Now

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The EU Packaging and Packaging Waste Regulation becomes applicable on 12 August 2026, replacing existing directives with a directly applicable regime governing packaging design, documentation, labelling and end-of-life management across the EU market. Life sciences companies manufacturing medical devices, IVDs and pharmaceuticals face significant compliance obligations, with narrow sector-specific exemptions that do not eliminate core requirements for conformity documentation, substance restrictions...

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On 12 August 2026, the EU Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40) (the “PPWR”) becomes applicable. It replaces the long-standing Packaging and Packaging Waste Directive with a directly applicable, EU-wide regime governing the design, documentation, labelling and end-of-life management of virtually all packaging placed on the EU market. Some in the life sciences field may assume that medical device, IVD and pharmaceutical packaging sits outside general packaging rules. That assumption is misguided: the PPWR applies broadly, and the sector-specific exemptions it contains are narrow and conditional.

Non-compliance is not a minor administrative matter. Packaging that does not meet PPWR requirements cannot lawfully be placed on the EU market, and life sciences companies that fail to act risk losing EU market access for their products, regardless of whether those products themselves hold valid CE Certificates of Conformity under the MDR, IVDR or marketing

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