With Regulation (EU) 2025/40 ("Packaging Regulation"), the EU is establishing a new legal framework to strengthen the circular economy and reduce packaging waste. The Packaging Regulation was adopted in December 2024, entered into force on 11 February 2025, and will apply directly in all Member States from 12 August 2026.
The Packaging Regulation also applies to packaging for medical devices and medicinal products – there is no blanket exemption. Affected economic operators should therefore prepare for the new requirements at an early stage.
Key affected economic operators include, in particular, producers, who are required to:
- place only recyclable packaging on the market;
- limit packaging to the minimum necessary;
- ensure proper labelling of the packaging; and
- carry out a conformity assessment procedure.
In addition, producers must maintain technical documentation, issue declarations of conformity, and register in packaging registers. These requirements also apply to producers of medical devices if they place their own packaging on the market.
Focus on Medical Devices – Who Is Affected?
According to Article 2(1), the Packaging Regulation applies to all packaging and packaging waste – regardless of the material used or the sector involved.
However, the Packaging Regulation does recognise sector-specific exemptions within narrow limits for the protection of human and animal health and safety – and therefore partially exempts medical packaging from requirements such as recyclability or minimum recycled content.
From a personal scope perspective, the Regulation applies to all economic operators along the packaging chain. These include producers, suppliers, importers, distributors, authorised representatives, and fulfilment service providers.
Core Obligations for Affected Economic Operators
The Packaging Regulation specifies a variety of requirements that packaging must meet before being placed on the market:
- Article 6 – Design for Recycling: From 2030, all packaging must be recyclable. Technical recyclability is assessed using harmonised EU-wide criteria. This particularly affects multilayer plastic packaging, which is commonly used in the medical field, unless an exemption pursuant to Article 6(11) applies.
- Article 7 – Recycled Content: Certain plastic packaging must contain minimum levels of recycled content. For PET packaging, the minimum content is 30%.
- Article 10 – Packaging Minimisation: Packaging must not have disproportionate empty space. The Packaging Regulation also considers filler materials like paper and polystyrene as empty space.
- Article 12 – Labelling Requirements: Packaging must bear standardised recycling symbols, material identification, and, where applicable, QR codes. These labelling requirements also apply to medical packaging, unless a sector-specific exemption applies.
Exemptions for Medical Packaging – But with Limitations
For particularly sensitive product categories, the Packaging Regulation provides specific exemptions – especially when its requirements would compromise the health and safety of humans and animals. Exemptions apply to:
- Immediate packaging within the meaning of the Human Medicines Directive;
- contact-sensitive packaging for medical devices; and
- outer packaging where necessary to maintain the specific quality requirements of the medicinal product.
For such packaging, the obligations under the Packaging Regulation apply only in a limited way:
- They do not need to be recyclable (Article 6(11)(a);
- Nor must they meet the minimum recycled content requirements (Article 7(4)).
However, Article 7(11) contains a review clause. According to this, the Commission may in the future consider extending recycled content requirements to the medical sector – producers should therefore monitor medium- and long-term developments.
Conclusion: Producers Need to Act
The Packaging Regulation has significant implications for the medical and pharmaceutical sectors. While hygiene and safety exemptions apply in certain cases – particularly to protect human and animal health – producers and other affected economic operators are well advised to proactively adapt their packaging solutions to the new requirements and further develop them in terms of sustainability, compliance, and efficiency.
