EU Packaging and Packaging Waste Regulation: Packaging Evidence That Survives Audit

You signed the device Declaration of Conformity. Your notified body review went well. Then a distributor questionnaire arrives asking for packaging conformity under Regulation (EU) 2025/40, and the file your procurement team holds is a 94/62/EC supplier letter that never mentioned the ink on your labels. For teams preparing under the EU packaging and packaging waste regulation, that is the moment most RA and QA teams discover packaging is not a subset of the device technical file. It is a second conformity story, with its own deadline.

From 12 August 2026, each packaging type you place on the EU market needs a signed packaging declaration of conformity under Annex VIII, backed by Annex VII technical documentation and Module A internal production control. If you manufacture IVDs or medical devices, this sits next to your MDR or IVDR device DoC, not inside it. For medical device and IVD packaging, the EU packaging regulation creates a separate evidence path unless another economic operator has taken legal responsibility for that packaging on the Union market.

PPWR replaces Directive 94/62/EC. The shift is not only stricter substance limits. This EU packaging waste regulation creates a new documentary architecture: packaging type identification, scoped article declarations, supplier evidence you can defend, and change control that keeps the declaration true after the first signature. The six decisions below are where teams either get ahead of August 2026 or lose months chasing data they should have requested last year.

EU Packaging and Packaging Waste Regulation Decisions Before The First Annex VIII Declaration

• Separate packaging DoC: One Annex VIII packaging declaration of conformity per packaging type. Your MDR Annex IV or IVDR Annex IV device DoC does not cover it.

• Article 5 substances: Heavy metals at or below 100 mg/kg (Pb + Cd + Hg + Cr(VI) combined). PFAS limits apply from August 2026 where packaging has food contact.

• Module A technical file: Annex VII must warrant every line on the declaration: full composition, test reports, risk of non-conformity, and change control.

• Packaging families: Group kits by material stack, not SKU count. One family, one DoC, one evidence chain when the stack is stable.

• Phased obligations: Declare only the Articles 5 to 12 that are legally binding on the issue date. Plan revisions when recycled content and recyclability deadlines arrive.

• Legacy transition: Keep old 94/62/EC letters as supporting evidence only. They do not become an Annex VIII declaration under the EU packaging waste regulation without a written gap analysis.

Key Elements Of EU Packaging Regulation Packaging Conformity

In this article we highlight the practical decisions RA and QA teams face when building packaging conformity under Regulation (EU) 2025/40. These decisions also set the basic path for EU PPWR compliance before August 2026.

Packaging Declaration of Conformity: Device DoC Versus Packaging  DOC

RA teams already maintain an MDR or IVDR Declaration of Conformity for the device. PPWR adds a separate packaging DoC for each packaging type, and the packaging declaration of conformity should not be merged into the device DoC. Conflating them is the fastest route to a gap in audit.

One EU DoC per packaging family or type is usually easier to control than one per finished kit SKU. Map many kits to one family when material stack and Article 5 evidence are identical.

From Directive 94/62/EC To EU Packaging Waste Regulation

Regulation (EU) 2025/40 was adopted on 19 December 2024 and published in the Official Journal on 22 January 2025. The EU packaging waste regulation applies directly from 12 August 2026. The shift from directive to regulation introduces harmonised Annex VII and Annex VIII formats and removes transposition variance for core obligations.

Regulation (EU) 2024/1860 amended IVDR transition provisions but does not substitute for PPWR packaging conformity. Treat the August 2026 PPWR date as an independent milestone in your compliance programme.

Technical Documentation Under The EU Packaging And Packaging Waste Regulation

Article 38 requires conformity assessment based on internal production control, Module A. Annex VII must allow a competent authority to trace from the declared packaging type to material reality, applied standards, test results, risk of non-conformity, and the assessment performed. This EU ppwr compliance file must contain the warrant for every claim, including aggregate heavy metal content below 100 mg/kg under Article 5(4).

A common error is to treat the device technical documentation packaging chapter as sufficient. Device TD answers device safety questions. PPWR Annex VII answers packaging substance and design questions under Articles 5 through 12.

What Evidence Reviewers Actually Weigh For EU PPWR Compliance

Evidence in PPWR conformity is a chain-of-warrant problem, not a volume problem. Each declared requirement needs a path from legal text to packaging reality. Strong EU ppwr compliance depends on traceable supplier data, controlled test evidence, and a clear link to the packaging family declared.

For Article 5(4), conformity is assessed on the sum of lead, cadmium, mercury, and hexavalent chromium across packaging components including inks and adhesives. For Article 5(5) PFAS, applicability follows food-contact status. Marking PFAS as not applicable requires a documented food-contact assessment, not an assumption from device category.

EU Packaging Regulation Phased Requirements And Reduced Scope

Not every Article 5 to 12 obligation applies on day one. A DoC issued in August 2026 should declare only requirements legally applicable at issue date, with a living technical file that expands at later milestones. Under the EU packaging regulation, scope should match the issue date and the evidence then available.

Legacy Directive 94/62/EC data

If you relied on essential requirements under 94/62/EC, do not copy old declarations into Annex VIII format without gap analysis.

Technical file and DoC structure

Annex VIII sets eight mandatory DoC fields: packaging identification, manufacturer, sole responsibility, object of declaration, conformity with Union acts, standards cited, notified body (typically not applicable for Module A), and signature block.

Annex VIII DoC checklist

• Unique identification of packaging (family ID + traceability code)

• Manufacturer name and address (authorised rep if used)

• Statement of sole responsibility

• Object of declaration (type, components, intended use, material summary, products covered)

• Conformity with Union acts (Reg. 2025/40; applicable articles only)

• Harmonised standards / test methods / common specifications

• Notified body (typically Not applicable for Module A)

• Signature, place, date, function

Annex VII technical file (retain with DoC)

• General description and intended use

• Conceptual design, drawings, materials

• BOM with 100% material disclosure

• Supplier declarations and heavy-metal test reports

• PFAS assessment if food-contact

• Standards applied or justification for alternatives

• Description of conformity assessment performed

• Test reports

• Risk assessment of non-conformity

• Change control reference

• QA approval record

Packaging Family Governance

Mature programmes use site assessment per component, supplier questionnaire, gap register, packaging family register, OEM mapping, then one DoC per family. Recommended split for IVD kits: primary plastics, plates or foil, pre-printed labels, in-house thermal labels, kit boxes, paper IFU, and shipping. One DoC per family when the material stack is stable.

Worked scenarios

1. Pre-printed label family (PF-03). Face stock, adhesive, UV ink. Art. 5(4) composite test must include ink and adhesive. PFAS is not applicable if formal food-contact assessment is negative. One DoC covers all kits using this label stack.

2. Food-contact primary container. Art. 5(5) PFAS limits apply from August 2026. Supplier questionnaire on substances is mandatory. DoC cannot state PFAS as not applicable.

3. OEM distribution partner kits. You place packaging on the EU market for partner-branded SKUs. Internal mapping links partner part numbers to packaging family IDs without publishing partner identifiers.

4. Non-EU site shipping to EU. Site assessment flags EU market. Same family ID if material stack matches. TD must show transport and storage do not invalidate Art. 5 evidence.

5. Legacy 94/62/EC letter only. Obtain CEN/TS heavy metal test on full composite before August 2026 DoC signature. Interim letter retained as supporting evidence only.

Common Rejection Reasons And Fixes

Working approach

Frequently asked questions