New EU Green Rules Are Coming – Are Medical Device Manufacturers Ready?
As the EU accelerates its push toward a circular economy and sustainable trade, two major green regulations are set to reshape the landscape for medical device manufacturers:
- Packaging and Packaging Waste Regulation (PPWR) – Regulation (EU) 2025/40
- EU Deforestation Regulation (EUDR) – Regulation (EU) 2023/1115
While these laws don’t explicitly target medical devices, their indirect impact could be transformative – or disruptive – depending on how prepared your organization is.
EU Packaging and Packaging Waste Regulation 2025/40 (PPWR)
This regulation is expected to come into effect from Aug 2026. The regulation aim to have several restrictions on the manufacturing, composition and reusable nature of packaging. They also go into aspects like weight and volume of packaging to minimize unnecessary packaging.
The following are some of the main provisions in this regulation which can impact manufacturers of medical devices and healthcare products:
- Recyclability
A central goal of the PPWR is recyclability. From August 2030, ALL packaging placed on the EU market must be recyclable — and by 2035, it must be recycled at scale, meaning it’s collected, sorted and processed by real-world infrastructure
For medical devices and healthcare products, there is a temporary exemption for “contact-sensitive plastic packaging” until 2035, acknowledging sterility and safety concerns. The recyclability mandate for such packaging will be reviewed in 2035.
- Extended Producer Responsibility (EPR)
The PPWR introduces the concept of EPR. This is the financial contribution paid by the company that places the final packaged product on the market, and the aim is to use this money to cover the net cost of collection, sorting and recycling of packaging. It applies to all packaging material types such as paper, glass, aluminium as well as plastics. You’ll pay based on how recyclable your packaging is. Hard-to-recycle materials = higher fees. There is no exception given to medical devices and other healthcare packaging. Manufacturers therefore must consider redesigning their packaging to reduce financial burden.
- Reduction in packaging waste
There is emphasis on preventing packaging waste at source by eliminating excessive or unnecessary packaging. From 2030, packaging with more than 50% empty space may violate the law.
- Harmonised labelling requirements
PPWR also introduces harmonised labelling requirements. The aim is to make it easier for people to sort their waste correctly. and to crack down on any misleading environmental claims. From 2028, all packaging will need a label showing what material it is made of and clearly identify which parts of the pack can be recycled in which stream. Misleading claims will face fines and other penalties. A set of standardised symbols are being developed that will appear not only on the packaging, but also on the corresponding waste bin.
EU Deforestation Regulation (EU) 2023/1115 (EUDR)
This regulation will come into effect as early as Dec 2025. Its goal is to reduce the EU’s contribution to deforestation and promote sustainable sourcing practices. This regulation applies to trade in the following products and many of their derivatives:
coffee, cocoa, cattle, rubber, timber, soy, and palm oil. A detailed list of the affected products can be found in Annex I of the EUDR regulation.
The EUDR may have impact on the medical device industry by requiring companies to prove their products are deforestation-free, meaning they are not made from raw materials sourced from land deforested after December 31, 2020.
This regulation may affect medical devices containing commodities like rubber, timber and their derivatives. This may include, for example, cellulose for absorbent pads, surgical gowns, hoods and masks, and latex for surgical gloves, condoms and some catheters.
- Traceability and Due Diligence:
The regulation mandates that companies demonstrate the deforestation-free status of their products. This involves establishing traceability of their raw materials from their origin and verifying that the land they were
produced on was not deforested after the specified cutoff date. This can greatly increase input costs for manufacturers.
- Penalties for Non-Compliance:
Not meeting the requirements of the regulation can lead to hefty penalties including financial fines (up to 4% of annual turnover), product confiscation, exclusion from public procurement, and temporary bans on marketing the affected products.
What must manufacturers do now?
- Conduct a packaging and sourcing risk assessment now — don’t wait for 2026 or 2030.
- Work with your suppliers to get traceability documentation in order.
- Evaluate packaging redesign options with recyclability and reuse in mind.
- Prepare for EPR cost modelling as part of your supply chain budgeting.
If you’re unsure where to begin, start by mapping your product and packaging materials to the affected commodities and packaging formats.
Let’s start the conversation: Is your organization preparing for these green compliance challenges.
Contact us if you want help auditing your portfolio or developing a roadmap.
