On 19 December 2024, the European Union formally adopted the Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40), commonly referred to as PPWR across the industry. For medical device manufacturers exporting to the EU, PPWR introduces special targeted exemptions tailored to the unique characteristics of medical devices, alongside universal mandatory rules governing hazardous substances, packaging minimisation, Extended Producer Responsibility (EPR), and circular logistics packaging.
https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng
Per Article 6(11) of the Regulation, the following packaging is not subject to the A/B/C recyclability grading requirements effective 2030, nor the 2038 rule that all packaging must achieve Grade B recyclability or higher for market access:
Under Article 7(4), the below plastic packaging is exempt from binding recycled content proportion targets (including tiered benchmarks such as 35% recycled content for non-contact plastic packaging and 30% for sensitive-contact PET packaging by 2030):
As stipulated in Article 12(11), primary and secondary medical device packaging may be exempt from the EU unified material classification labelling requirement if mandatory labelling information mandated by MDR/IVDR occupies the full available packaging surface area.
Medical device / IVD packaging solely for professional end-user use in healthcare or industrial settings (e.g., bulk hospital procurement packs, clinical dedicated consumable packaging) is fully exempt from consumer-facing waste sorting labels. This delivers significant benefits for miniature, information-dense packaging for implantable devices and single-use consumables, prioritising complete compliance with medical device safety and regulatory labelling obligations.
For medical packaging intended for food-contact applications (e.g., oral-use devices, nutritional accessory packaging), strict PFAS restrictions take effect from 12 August 2026: individual PFAS substances capped at 25 ppb, with total PFAS concentration limited to 250 ppb.
Industry Impact: Packaging inks, adhesives, coatings and masterbatches represent the highest risk sources of excess heavy metals. Manufacturers must communicate concentration limits clearly to upstream suppliers, update procurement technical specifications, and demand material test reports and declarations of compliance to avoid product detention at EU borders due to non-compliant packaging auxiliary materials.
Multi-pack plastic carrier rings
Industry Impact: EPS foam currently widely used as transit cushioning for medical devices requires early transition to alternative materials such as moulded pulp, honeycomb board, reusable cushion structures and inflatable air pillows to prevent material supply shortages ahead of the 2030 deadline.
PPWR strengthens EPR frameworks across all EU Member States:
All producers or importers that first place packaged goods (including device-attached packaging) on the EU market must register with the national producer registry of the relevant Member State. Producers bear full end-to-end costs for packaging waste collection, sorting and treatment, typically fulfilled via membership and fee payments to Producer Responsibility Organisations (PROs). E-commerce platforms will validate sellers’ EPR registration status and block listings of non-compliant products.
The rollout of PPWR signals the EU’s extension of green regulatory oversight from consumer goods into the medical sector. While medical device manufacturers benefit from targeted exemptions reflecting product-specific safety needs, full lifecycle packaging compliance has become an irreversible industry standard – packaging governance is no longer a peripheral supply chain task, but a mandatory precondition for market access in the EU.
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