PPWR and Medical Devices: What Manufacturers Need to Know

Hany Mahmoud

Sep 6

2 min read

On 12 August 2026, the EU Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40, the "PPWR") became fully applicable, replacing the long-standing Packaging and Packaging Waste Directive with a single, directly applicable regime across all 27 Member States. Many in the medical device and IVD sector assumed packaging rules sat outside their world. They do not.

No blanket exemption for medical devices

The PPWR applies to the packaging of medical devices and in vitro diagnostic devices (IVDs) just as it applies to consumer goods. The sector-specific exemptions it contains are narrow and conditional; there is no complete carve-out. In practice, the regulation now sits alongside your MDR and IVDR obligations, not instead of them: packaging must remain safe and sterile while also becoming more sustainable.

What applies from day one

Packaging Declaration of Conformity: a separate EU Declaration of Conformity is required for each packaging type, supported by technical documentation. Keep it distinct from your device DoC; merging the two is a common route to an audit gap.
Substance restrictions: limits on heavy metals apply to medical device packaging like any other. The PFAS restriction is targeted at food-contact packaging, so most device packaging falls outside it unless it also contacts food.
Extended Producer Responsibility (EPR): eco-modulated EPR fees are already being levied by Member States. Non-EU manufacturers selling online directly to EU end users may need to appoint an EPR representative in each Member State.
Role determination: there is no grace period for identifying your role (manufacturer, importer, distributor) or for the conformity framework.

Where medical devices get partial relief

Because sterility and patient safety come first, contact-sensitive primary packaging of medical devices and IVDs benefits from conditional exemptions, notably from the design-for-recyclability requirement and minimum recycled-content targets. These reliefs are temporary and are due to be reviewed around 2035. Secondary and tertiary packaging (shipping cartons, grouped packaging) receives no such relief and must comply in full.

The phased timeline

While the core obligations apply now, the more demanding technical requirements arrive in stages:

Around 2028: harmonised material-composition labelling, once the implementing acts are adopted.
From 2030: recyclability performance grading, minimum recycled-content targets for plastic packaging, packaging minimisation and empty-space limits, and reuse targets for certain formats.
By 2035: real-world recycling "at scale" criteria, and review of the contact-sensitive exemptions.

What to do now

The "large box, small device, excessive cushioning" pattern common in medtech is exactly what the minimisation rules are designed to scrutinise. Manufacturers should:

Map every packaging type placed on the EU market against the PPWR timeline.
Build the packaging Declaration of Conformity and technical documentation now, separate from the device file.
Confirm your role and EPR obligations per Member State, especially for e-commerce sales.
Start a gap assessment across primary, secondary and tertiary packaging.

For non-EU manufacturers, aligning the PPWR with existing MDR/IVDR compliance is now a dual challenge, but one that rewards early planning. EUCEREP supports manufacturers with EU regulatory compliance, including packaging conformity, EU Authorised Representative services and registration. Get in touch to start your PPWR gap assessment.