On 18 November 2024, the European Union published in the Official Journal Directive (EU) 2024/2853 on liability for defective products, ending 40 years of unchanged rules dating back to Directive 85/374/EEC. The deadline for EU Member States to transpose it into national law: 9 December 2026. From that date, every product placed on the market falls under the new regime.
For a general counsel, CIO or quality manager in a manufacturing business, the question is not “does this apply to us?” — it does. The real question is: “what records can our ERP produce today if a court asks for them?”
What Is PLD 2024/2853 and Why Does It Matter for Manufacturers?
Replacing the 1985 Directive After 40 Years — What Changes
Directive 85/374/EEC had a gap that the digital economy made untenable: it only covered physical goods. A defective embedded software component causing an injury? Out of scope. An AI update degrading the performance of a connected medical device? Not addressed.
PLD 2024/2853 fixes this by redefining “product” in Article 4: “any movable item, even when integrated into another movable or immovable item; the term includes electricity, digital manufacturing files, raw materials and software”. All software is now a product for civil liability purposes, whether installed locally, delivered as SaaS, or deployed in the cloud.
Extension to Software, AI and Integrated Digital Services
Article 8 identifies the economic operators liable: the product manufacturer, the manufacturer of a defective component integrated into the finished product, and — for manufacturers outside the EU — the importer, authorised representative, or, failing those, the fulfilment service provider.
The critical point for companies embedding AI in their products: the directive explicitly covers defects caused by software updates under the manufacturer’s control and by continuous learning of AI systems. This means decision logs for any AI module embedded in a product — or in the ERP itself — become potential legal evidence.
The Partial Reversal of the Burden of Proof — What It Means for Manufacturers
Article 10 introduces disclosure obligations that ease the burden of proof for claimants. A court may presume a product is defective in three situations:
- Non-compliance with mandatory safety requirements
- Obvious malfunction under foreseeable use
- The manufacturer refuses to disclose the evidence requested
That third scenario is the one that changes the ERP equation. If your system cannot produce batch records, CAPA history, or bill-of-materials versions as of a given production date, a judge may infer that the product was defective. Missing data becomes a presumption of fault.
Transposition Timeline and Key Dates for Your ERP
Entry into Force: 8 December 2024
The directive was published in the EU Official Journal on 18 November 2024 and entered into force on 8 December 2024. However, it applies only to products placed on the market or put into service from 9 December 2026 onwards.
National Transposition Deadline: 9 December 2026
Member States have until 9 December 2026 to transpose the directive into national law. Directive 85/374/EEC is repealed on the same date but continues to apply to products placed on the market before 9 December 2026.
The window is approximately 15 months from the date of this article. That is enough time to audit your ERP, identify gaps, and address them — provided you do not wait until Q4 2026.
Limitation Periods: 10 Years Standard, 25 Years for Latent Harm
Article 16 sets a 10-year limitation period from the date a product is placed on the market, and 25 years for bodily harm with a slow onset (occupational cancers, degenerative conditions). Claimants have 3 years from awareness of the damage to bring a claim.
The direct ERP consequence: quality records (batch, BOM as of the production date, test results, CAPA) must be archived for at least 10 years — and ideally 25 years for products carrying bodily injury risk.
What the Directive Requires in Practice: Evidence and Traceability
Obligation to Disclose Evidence (Article 9) — What You Must Be Able to Produce
Article 9 establishes evidence disclosure rights for both parties. Courts may order manufacturers to produce information in a “readily accessible and understandable format”. Trade secret protections exist, but they do not permit blanket refusals.
In practice, this means your ERP must be able to reconstruct the full traceability chain for any given batch at any given date:
- Manufacturing record and BOM active at the time of production
- Quality control results (incoming, in-process, outgoing)
- Non-conformance records and corrective actions (CAPA)
- Conformity certificates for critical components
- History of specification or process changes
If this information is scattered across the ERP, an external QMS, spreadsheets and scanned paper archives with no indexing, responding to a court order becomes a project in itself — and the time it takes will be interpreted as obstruction.
Data Retention Duration for Compliance Records
The directive does not set an explicit retention period. However, the combination of the 10-year (or 25-year) limitation period and the disclosure obligation creates an implicit long-term retention requirement, consistent with what some sectors already practise (pharmaceutical GMP: 5 years minimum; aerospace AS9100: aircraft life + 10 years).
For general manufacturers, the recommended minimum target is 10 years of active retention for quality records linked to each commercialised batch.
What “Evidence of Damage” Means in the AI and Digital Context
For products embedding AI (recommendation engines, predictive maintenance modules, automated scoring), the question is different: if an automated decision causes harm, who produces evidence of the model state at the time of that decision?
The answer lies in your ERP or your MLOps stack, depending on your architecture. In either case, you need an AI decision audit log (which model version, which training dataset, which active parameters) retained with the same rigour as a quality record.
The 5 ERP Modules to Strengthen for PLD 2024/2853 Compliance
Quality Module (QMS): Batch/Serial Traceability, CAPA, Non-Conformances
This is the most directly exposed module. For every batch or serial number placed on the market, the ERP must be able to reconstruct:
- All quality controls performed (and their results)
- All non-conformances detected and their resolution
- Associated CAPA (Corrective and Preventive Actions)
- Any hold or conditional release decisions
Key risk: CAPA cases closed “on deadline” with no documented resolution are a direct legal liability under PLD 2024/2853. A court will check whether the corrective action was actually completed, not just closed in the system.
PLM/BOM Module: Revision History, Specification Changes, Effectivity Dates
PLD 2024/2853 covers design defects. If your BOM was revised following a quality incident, and you cannot prove that the product in question was manufactured under the pre-correction BOM, you are in a legally exposed position.
The ERP must maintain a versioned BOM history with effective dates for each revision. Engineering Change Notices (ECNs) must be linked to the affected batches. This is not a new requirement, but it is one that many manufacturers have only partially configured.
Customer Service and Warranty Module: Product Incident History, Recalls
Claims history is double-edged evidence: it shows the company responded (positive), but it also documents prior knowledge of a defect (neutral to negative if corrective action was slow).
The ERP or after-sales CRM must capture: date reported, defect description, affected batch, action taken, response time. In the event of a product recall, the exact scope of the recall (batches, markets, channels) must be archived with evidence of notification to customers and authorities.
Document and Archive Module: Technical Files, Test Reports, Certifications
Documentary compliance is no longer just a quality issue — it is now a direct legal obligation. Technical documents (product data sheets, CE technical files, declarations of conformity, test reports) must be:
- Linked to each product reference in the ERP
- Versioned with approval date and signatory
- Archived with guaranteed access for at least 10 years
- Exportable in a structured format independent of any specific vendor (consider software obsolescence)
That last point is frequently overlooked: if your document management system depends on a platform you will have migrated in 7 years, accessing 2026 archives may become problematic.
Supply Chain and Procurement Module: Supplier Traceability, Material Declarations of Conformity
Article 8 of the directive includes manufacturers of defective components “integrated under the main manufacturer’s control”. If a sub-component is defective, the question will be: did the manufacturer verify that this component was compliant at the time of purchase?
The procurement ERP must record, for every delivery: supplier declaration of conformity, material or analysis certificate, and supplier lot number linked to finished goods lots. The link supplier lot → finished goods lot must be navigable in the ERP to support a targeted recall or respond to a court request.
What Changes for Importers and Marketplaces
Importer = Manufacturer When the Non-EU Manufacturer Is Unreachable
Article 8 is explicit: if the manufacturer is established outside the EU and cannot be identified or does not respond, the EU importer assumes the manufacturer’s obligations. This includes the obligation to disclose evidence.
The implication for importers is clear: you must contractually require your non-EU suppliers to provide all quality and technical documentation for imported products, and archive it in your own system. “The supplier holds the documents” will not be accepted by a European court if the supplier is unreachable or refuses to cooperate.
Marketplace Platforms: New Obligations on Origin Information
Marketplace providers are now included in the liability chain when a manufacturer cannot be identified from the information available on the platform. For companies selling through third-party B2B marketplaces (industrial procurement portals, sector-specific platforms), this strengthens the obligation to maintain complete and verifiable supplier information in the ERP.
ERP Compliance Checklist: 10 Points to Verify
- Full batch traceability: Can your ERP produce, for a given batch, the exhaustive list of all components used with their supplier origin?
- Versioned BOM history: Is every BOM revision dated and archived with the batches produced under each version?
- Documented and verified CAPA: Are CAPA cases closed with evidence of effectiveness, not just administratively?
- Claims linked to batches: Is every customer complaint linked to the affected batch in the ERP?
- Supplier declarations of conformity: Is every delivery accompanied by a conformity document archived in the ERP?
- 10-year minimum retention: Does your ERP archiving policy cover 10 years of active quality records?
- Archive exportability: Can you export quality data for a batch in an open format without the current ERP interface?
- AI decision logs archived: If automated decisions are produced by your systems, are the model version and active parameters logged?
- Non-EU supplier contracts: Do your purchasing terms explicitly require quality documentation transmission and cooperation in the event of a dispute?
- Recall scenario tested: Can you identify in under one hour all shipments containing a specific supplier component?
Get Ahead of Transposition — Don’t Wait for It
PLD 2024/2853 does not create a pre-certification obligation. It creates an obligation of evidentiary outcome: in the event of a dispute, you must be able to prove what you knew and what you did. Manufacturers that have invested in a well-configured ERP — batch traceability, integrated QMS, structured document archiving — have no revolution to undertake. They have an audit to run and some gaps to close.
Those still operating with quality modules disconnected from production, CAPA managed in spreadsheets, and document archives unlinked from ERP batches have until end of 2026 to fix that. The window is real, but it is closing.
The directive also intersects with other active obligations: Product Safety Regulation (EU) 2023/988 (general product safety, applicable since December 2024), CE marking requirements for relevant product categories, and GDPR for any personal data contained in audit logs.
To go further on the ERP quality and document compliance dimensions, see our ERP QMS and CAPA non-conformance management guide, our article on ERP data archiving and legal retention obligations, and our ERP warranty and after-sales management guide.
