The EU has published the updated regulation regarding packaging and packaging waste. Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC. Medical Devices and IVD packaging is in scope.
MedTech Europe has achieved some success with obtaining an initial exemption for ‘contact sensitive’ IVD packaging. ‘Contact sensitive’ is not currently defined, but is basically packaging in contact with MD or IVDs that if contaminated or compromised could adversely impact the safety and performance of the device e.g. Primary reagent packaging, sterile barrier packaging etc.
Concerns were raised about the issue of minimum recycled content, and limited availability of chemically recycled materials that can be certified contaminant-free, meaning that the majority of recycled materials are still mechanically recycled which could lead to contamination and or batch-to-batch variation in content and performance.
Extended transition times are planned to allow the recycling sector to develop new technologies and mature before our sector faces significant increases in the recycled content of packaging. However, it should be feasible for manufacturers to use recycled materials for secondary and tertiary packaging, where appropriate.
