Packaging compliance needs two different representatives: one for the whole EU, one for every member state you sell into

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• 2026-11-13

Regulation (EU) 2025/40 on packaging and packaging waste has applied directly in all 27 member states since 12 August 2026, replacing Directive 94/62/EC. There is no blanket exemption for medical device packaging — only the sterile barrier system receives conditional relief on two sustainability metrics. The mistake Chinese exporters make most often is not a failed test report: it is treating an existing MDR authorised representative as the PPWR representative.

1. Three "representatives", three different roles

This is the table to remember. Different legal bases, different duties, different territorial scope. One mandate does not substitute for another.

One rumour to read carefully: in December 2025 the Commission proposed COM(2025) 982, suspending the Article 45(3) obligation until 1 January 2035. That relief is drafted for EU-established producers only; third-country exporters are expressly left out. As of publication the proposal has not been adopted and not been published in the OJEU. "I heard it is being suspended" is not a plan.

2. What device packaging is actually exempt from

The premise first: PPWR contains no "medical packaging is out of scope" clause. The sterile barrier system is packaging, and Annex I lists it as such. Relief applies to two metrics only, and it is conditional.

3. What is actually being checked since 12 August

• Heavy metals: lead, cadmium, mercury and hexavalent chromium combined ≤ 100 mg/kg, across every packaging component — cartons, inserts, printing inks, adhesives, laminating film, labels, cushioning. A finished-device RoHS report does not substitute for packaging material testing, and this is the most common gap. Authorities expect testing per homogeneous material with reports retained.
• Declaration of Conformity: Art. 39 with Annex VIII, issued per packaging model. Identical parameters may share one DoC; different parameters may not. Technical documentation per Annex VII must be kept 5 years for single-use and 10 years for reusable packaging. Reports and self-assessments from the old Directive do not replace the PPWR conformity file.
• EPR registration: Art. 44 requires entry in the national producer register of each member state of first making available — LUCID in Germany, Citeo in France, CONAI in Italy. There is no single EU-wide certificate. From the same date, online marketplaces must verify registration and can delist unregistered sellers.

On PFAS: PPWR limits apply to food-contact packaging only. Ordinary medical device packaging falls outside them unless the packaging also contacts food. Worth knowing when a supplier uses PFAS to sell you testing you do not legally need — though inks, coatings and adhesives remain subject to the general duty under Art. 5 to minimise substances of concern.

On stock: the reference point is release into free circulation by customs. Packaging placed on the market before 12 August 2026 and still in the channel may continue to be sold without recall; anything produced but not yet placed must meet the new rules. Goods on the water are not "not yet placed".

4. 2028 and 2030: not urgent yet, but slowest to fix

• 12 August 2028: harmonised material-composition labelling showing material and disposal route.
• 1 January 2030: recyclability grade A/B/C (≥70% recyclable, grade D barred), minimum recycled content in plastic packaging, minimisation and the 50% empty-space cap, plus the single-use formats banned under Annex V.
• 1 January 2038: only grade A/B (≥80%) packaging may be placed on the market.

For device manufacturers the item to watch today is plastic lamination on folding cartons: film and board are permanently bonded, cannot be separated in paper recycling, and it is the single biggest drag on your 2030 grade. Removing it, switching to a water-based varnish or changing carton geometry involves tooling, supplier changes and re-validation of sterilisation compatibility — typically 12 to 18 months. Starting in 2029 is too late.

5. Who carries the duty depends on how you ship

6. The 90-day sequence

• Days 0–30: build packaging BOMs for your main SKUs layer by layer, and send homogeneous materials for heavy-metal testing to close the August gap.
• Days 30–60: confirm the route to market for each product line — with or without an EU importer — because that decides whether you supply data or appoint representatives. Then count your countries of sale: that number is how many Art. 45(3) mandates you need.
• Days 60–90: issue DoCs, build Annex VII technical files, register country by country. Start the 2030 structural workstream in parallel, beginning with your three highest-volume SKUs.