Under the EU PPWR, Is Medical Device Packaging Truly Exempt?

On 12 August 2026, the EU Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR) will become fully mandatory and enforceable. As a core regulation of the EU's circular economy, the PPWR imposes on all companies placing packaging on the EU market a full chain of obligations spanning substances, design, and recyclability. Medical device companies are no bystanders — although, given the special nature of their products, the primary packaging in direct contact with the product enjoys certain relaxations with regard to "recyclability" and "recycled content," core responsibilities such as minimization, hazardous substances, labeling, EPR, and the Declaration of Conformity apply in full. There is therefore no such thing as a complete exemption for medical device packaging under the PPWR framework.

I. Obligations of Medical Device Companies Under the PPWR Framework

II. Detailed Key Obligations (Most Relevant to Medical Devices)

1. Substance Compliance: Heavy Metals Are the First Red Line

• Heavy metals — full coverage: The sum of lead, cadmium, mercury, and hexavalent chromium shall be ≤ 100 mg/kg, covering all packaging components including outer cartons, liners, labels, inks, adhesives, cushioning foam, plastic bags, trays, etc. Effective on 2026-08-12, with no exemptions.
• PFAS boundary: The PPWR's PFAS limit applies only to food-contact packaging; medical device packaging generally falls outside this scope, unless the packaging also contacts food. Where required by customers or for forward-looking compliance, voluntary additional testing may be performed.

2. Packaging Minimization: A Frequent Blind Spot for Medical Devices

• Requirement: From 2030, the void-space rate for transport / e-commerce / grouped packaging shall be ≤ 50%; the weight and volume of sales packaging must be reduced to the minimum functionally necessary, and designs such as false thickening, double-layer hollow walls, and false bottoms are prohibited.
• Note for medical devices: Minimization applies equally to packaging in contact with sensitive medical devices — the industry's common pattern of "large box, small product, excessive cushioning" will be subject to scrutiny, and this is a blind spot most companies tend to overlook.

3. Labeling and Digital Carriers: Integration with UDI

• Requirement: From 2028, all packaging must bear a harmonized material label and a sorting pictogram; packaging containing substances of concern must be equipped with a digital carrier (watermark / RFID) by 2030.
• Note for medical devices: Where medical device packaging has no space left due to UDI, sterilization symbols, etc., a limited exemption from the harmonized label is available, but product and packaging information must be conveyed together through a single digital carrier. Article 12 also strictly governs environmental claims such as "eco-friendly" and "degradable" — they must be specific, accurate, and substantiated.

4. Declaration of Conformity and Technical Documentation

• Requirement: The manufacturer must issue an EU Declaration of Conformity (DoC) for the packaging and maintain a technical dossier: bill of materials and material specifications, hazardous-substance test reports, design documentation (including the recyclability assessment), EPR registration evidence, EU Authorized Representative appointment letter, etc. Retain for 5 years for single-use packaging and 10 years for reusable packaging.

5. EPR Registration and Authorized Representative

• EPR: Packaging placed on the EU market requires EPR registration, annual reporting, and fee payment in the target country. Fees are eco-modulated (higher for hard-to-recycle packaging); there is no exemption for medical devices, and simplified reporting is available below 10 tonnes.
• EU Authorized Representative:

1. 1. Where there is an EU importer: the importer registers as the local producer, and the factory cooperates by providing packaging data.
   2. For cross-border direct sales (with no local importer): the foreign manufacturer is the legal entity responsible and must appoint an EU Authorized Representative to handle registration and reporting.

III. Key Timeline

IV. Compliance Pathway for Medical Device Companies

STEP 1 — Inventory: All packaging exported to the EU — distinguish contact-sensitive primary packaging / secondary / transport / e-commerce packaging; build a ledger by material, weight, and supplier.

STEP 2 — Substance compliance: Heavy-metal testing across all packaging components; assess whether PFAS applies and test additionally if necessary.

STEP 3 — Design optimization: Design non-contact packaging for recyclability; minimize all packaging (void space, right-sizing, removal of redundant layers).

STEP 4 — EPR and EU Authorized Representative: Confirm the EPR registration entity or sign an EU Authorized Representative; initiate registration in the target countries; allow 2–6 weeks.

STEP 5 — DoC and dossier: Issue the Declaration of Conformity (DoC), integrate test reports and compliance documents, and build and archive the technical dossier.

STEP 6 — Long-term tracking: Incorporate the PPWR into supplier qualification and incoming inspection; track the long-term milestones of 2028 / 2030 / 2035 / 2038.

V. Why Choose CIRS for PPWR Compliance

Holding dual CMA and CNAS accreditations, CIRS Testing has built a one‑stop PPWR compliance service matrix to help companies achieve efficient, cost‑effective compliance:

√ Packaging hazardous-substance testing (four heavy metals, PFAS, etc.), with separate reports issued for each component

√ Packaging recyclability assessment and safety testing of contact-sensitive packaging materials

√ EPR registration and annual reporting, EU Authorized Representative appointment

√ Issuance of the PPWR Declaration of Conformity (DoC) and compilation of the technical dossier

√ Compliance and packaging recyclability consulting

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

• Mandatory Enforcement in Less Than 2 Months! Is Your Packaging Ready to Pass the "PPWR Checkpoint"?
• EU PPWR: What Packaging Businesses Need to Do Now