Medical Devices – Latest Updates

New regulation (EU) 2025/40 on packaging and packaging waste

27 January 2025

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste was published in the Official Journal of the European Union on 22 January 2025. It will enter into force on 11 February 2025 and apply from 12 August 2026.

This regulation replaces the previous Directive 94/62/EC and introduces stricter obligations focused on a circular economy. It applies to all packaging, regardless of the material used, and to all packaging waste, regardless of whether it comes from industry, commerce, offices, services or households.

The aim of the regulation is to regulate the entire life cycle of packaging in order to minimise its impact on the environment and protect human health. This includes measures to prevent packaging waste, promote reuse and recycling and reduce the use of primary raw materials. It also defines the requirements for the design of packaging to improve its reusability and recyclability.

A central element of the regulation is the introduction of harmonised rules for the entire life cycle of packaging, including requirements for environmental compatibility and labelling, to enable it to be placed on the market. It also sets out requirements for extended producer responsibility, the prevention of packaging waste, the reuse or refilling of packaging and the collection and treatment, including recycling, of packaging waste.

The regulation also sets targets for the reuse and recycling of packaging. For example, certain quotas for the reuse of packaging are to be achieved by 2030. In addition, the regulation sets requirements for the minimum content of recycled plastic in certain packaging.

By introducing these harmonised rules, the regulation aims to improve the efficiency of the internal market for packaging and packaged products while reducing the negative impact of packaging and packaging waste on the environment and human health. It therefore an important contribution to the transition to a circular economy and to achieving climate neutrality by 2050 at the latest.

Among others, the regulation (EU) 2025/40 also has an impact on medical devices, as packaging for medical devices will be more strictly regulated. Manufacturers must ensure that the packaging for these products not only meets the hygiene and safety requirements, but also fulfils the new environmental compatibility requirements. This includes requirements for recyclability, the use of recycled materials and the minimisation of packaging waste. Medical device manufacturers must also comply with harmonised labelling requirements to ensure traceability and proper disposal, which poses additional challenges for the industry.

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