Many companies are asking how the new Packaging and Packaging Waste Regulation (PPWR) will affect their EU operations. While it sits outside MDR/IVDR, it introduces important new obligations that medical device manufacturers cannot ignore.
The PPWR (EU) 2025/40 entered into force on 11 February 2025 and will apply from 12 August 2026. It covers all packaging placed on the EU market and aims to reduce waste, increase recyclability, and drive a circular economy.
Why This Matters
Packaging waste in the EU is rising, while reuse and recycling remain insufficient. The PPWR addresses this by requiring:
- All packaging to be recyclable by 2030
- Reduced reliance on virgin materials
- Increased use of recycled content
- Lower overall packaging waste
Healthcare would need to strike the balance between sustainability with strict safety, sterility, and regulatory requirements.
The Critical Shift for Healthcare
The PPWR adds a new layer of compliance alongside MDR/IVDR. While the MDR and IVDR prioritise patient safety, the PPWR prioritises environmental sustainability of packaging. In essence what this means is that packaging must remain safe and sterile yet become more sustainable. While some temporary exemptions exist for healthcare packaging, these are not permanent exclusions.
Key Aspects of PPWR for Medical Device Manufacturers
The PPWR introduces a phased but decisive shift for the healthcare sector, where packaging has historically been optimised almost exclusively for safety, sterility, and regulatory compliance. While these priorities remain unchanged, they must now be balanced with legally binding sustainability requirements that begin applying from 12 August 2026. This creates a dual compliance challenge, requiring manufacturers to align packaging strategies with both MDR/IVDR and PPWR expectations.
In the short term, the first impacts will be financial and immediate. From 2025, EU Member States are required to implement eco-modulated Extended Producer Responsibility (EPR) schemes, meaning healthcare companies are already, or will soon be, paying fees based on the recyclability of their packaging. By 2030, these fees must be clearly linked to recyclability performance. Importantly, healthcare packaging is not exempt from EPR, so even where technical exemptions exist, companies will still face increasing cost pressure if packaging is not designed with recyclability in mind. In parallel, substance restrictions such as the PFAS limits will apply from August 2026, requiring early material assessments and potential reformulation.
Looking towards the 2028–2030 period, the regulation begins to drive more visible operational changes. By 2028, harmonised labelling requirements will apply, requiring packaging to clearly indicate material composition and waste stream categorisation, which may be challenging for healthcare products already constrained by MDR labelling requirements. By 2030, several key obligations come into force simultaneously: packaging must comply with minimisation requirements (including a maximum 50% empty space ratio), EPR fees must reflect recyclability grades, and reuse targets will apply to transport packaging, requiring 40% of shipping packaging to be reusable (and 100% for internal logistics). Even though healthcare packaging is not subject to reuse targets at the product level, logistics and distribution systems will still need to adapt.
The most significant transformation is set for the 2030–2035 horizon. By 2030, all packaging must be designed for recycling, although healthcare packaging benefits from a temporary exemption for contact-sensitive applications such as medical devices and medicinal products. This exemption is not indefinite—it will be reassessed by 2035, at which point packaging is expected not only to be designed for recycling but also to be recycled at scale, meaning it must be effectively collected, sorted, and processed through established infrastructure. This marks a critical turning point, as it signals the likely end of current exemptions and the need for fully sustainable packaging solutions in healthcare.
Authorised Representatives Mentioned within PPWR
When it comes to authorised representatives, there are two main categories that are mentioned within this legislation, these being the Authorised Representative (AR) and the Authorised representative for Extended Producer Responsibility. Although the terminology is similar, they are two distinct roles under the EU Packaging and Packaging Waste Regulation (PPWR). EPR ARs manage, register, and pay for waste in each Member State, while PPWR ARs focus on technical conformity.
Article 17 of the PPWR specifies the responsibilities of the Authorised representative (AR). These can be summarised as below;
- Focus: Product compliance
- Purpose: Ensures packaging meets the sustainability, labelling, and reusability requirements of the PPWR.
- Requirement: Appointed by manufacturers based outside the EU
- Tasks: Acting as a single point of contact for national authorities regarding product technical documentation, conformity assessments, and compliance with recycling targets.
- Scope: Broadly covers product safety and packaging design conformity
Authorised Representative for EPR (EPR AR)
- Focus: Waste management, registration, and payment.
- Purpose: Fulfils the producer’s obligations under Chapter VIII of the PPWR (Extended Producer Responsibility).
- Requirement: Mandatory in each Member State where a producer sells packaging but is not established.
- Tasks: Registration in the national register, reporting packaging quantities, paying eco-fees, and ensuring compliance with take-back requirements.
- Scope: Specifically tied to waste management and EPR obligations
