Critical deadline — 9 December 2026
Legality by Design
Legal-services proposal

EU AI Act & PLD recast
Impact Analysis
for regulated products

Three converging European regulations. A compliance window that is closing. A structured analysis of your company's exposure.

🏛Counsel: Răzvan Alexandru Olaru — Bucharest Bar & Solicitor (England & Wales)
🎯For: companies placing regulated products on the EU market
📅Updated: July 2026
📧 Request a detailed proposal
🤖 AI Act Reg. 2024/1689 🛡️ PLD recast Dir. 2024/2853 🏭 Products EU-regulated ⚡ IMPACT
The timeline

The legal calendars no longer allow delay

Three critical deadlines — one already passed, one in force, one imminent.

✓
Feb 2025
AI literacy mandatory
Art. 4 AI Act — every employee who uses AI systems
⚡
Aug 2026
High-risk AI systems
Full obligations — AI-enabled medical devices included (Annex III)
!
Dec 2026
PLD recast — transposition
9 December 2026 — Member States must transpose Directive (EU) 2024/2853
📍 It is July 2026 — under 5 months to PLD transposition, and already inside the AI Act compliance window
Risk perimeter

Product categories — distinct risk profiles

A diversified portfolio creates a more complex impact surface than a single-product manufacturer. Each category has its own PLD × AI Act profile.

💊
OTC & Rx medicines
Analgesics, anti-inflammatories, prescription and over-the-counter products
PLD: MAXAI Act: High25-year long-stop
🔬
Medical devices
Class I–III, software as a medical device (SaMD), ISO 13485 systems
PLD: MAXAI Act: High-riskMDR × AI Act × PLD
🌿
Food supplements
Vitamins, minerals, botanicals, probiotics
PLD: HighAI Act: Medium25-year long-stop
✨
Dermocosmetics & cosmetics
Skincare, dermo-active products, functional cosmetics
PLD: MediumAI Act: LowStrict liability
The 3 convergences

Why now: three simultaneous legislative pressures

This is not a single obligation. It is three forces acting in parallel.

01
🛡️ PLD recast — strict liability extended to AI
Directive (EU) 2024/2853 explicitly includes software and AI systems as products. Liability is strict — no fault required. The burden of proof is reversed. Deadline: 9 Dec 2026.
02
🤖 AI Act — obligations by risk tier
Medical devices with AI components = automatically high-risk (Annex III). Documentation, data governance, human oversight. AI literacy: mandatory since Feb 2025.
03
❌ AILD withdrawn — no alternative is coming
The European Commission withdrew the AILD proposal (COM(2022) 496). The recast PLD remains the EU's strict-liability instrument applicable to AI. There is no second legislative window.
The service proposal

Impact analysis across three integrated axes

Not a generic legal opinion — a structured analysis whose exact scope and final deliverables are agreed together in the services contract.

The structure below reflects the general approach for this type of project. The concrete activities, the documents produced and the timelines are confirmed on signature of the services agreement and detailed at kick-off.
A
AI Act inventory & classification
Mapping the company's AI ecosystem
  • Full register: ERP, CRM, e-commerce, pharmacovigilance, QMS, chatbots
  • Risk classification per system: unacceptable / high / limited / minimal
  • AI-literacy gap analysis — Art. 4 assessment (already in force)
  • Obligation map: documentation, data governance, human oversight
B
PLD recast exposure
The supply chain and the contracts
  • Supply-chain mapping: suppliers → manufacturer → distribution → consumer
  • Contract analysis across 7 PLD clauses: indemnity, limitation of liability, insurance, recourse, warranty, jurisdiction, recall
  • Risk matrix per product category
  • Concrete scenarios: AI in formulation, pharmacovigilance, chatbot, medical-device software
C
Action plan
Implementation and know-how transfer
  • Ordered priorities: in-force → imminent → critical obligations
  • An AI-governance framework tailored to the company: roles, responsibilities, processes
  • PLD-compliant contract templates for suppliers and distributors
  • Insurance recommendations: assessment + AI/PLD cover
Methodology

5 stages — 8–9 weeks (indicative timeline)

A project structure with clear checkpoints. The exact timeline and the make-up of each stage are agreed at kick-off.

1
Discovery
2 wks
AI-systems inventory, contract collection, interviews
2
Analysis
2–3 wks
AI Act classification, PLD contract analysis, supply-chain mapping
3
Assessment
1 wk
Consolidated risk matrix, scenarios, interim workshop
4
Deliverables
2 wks
Final reports, action plan, governance framework, templates
5
Transfer
1 wk
Final workshop, AI-literacy training, implementation guide
40%
on signature
30%
interim report
30%
final report

The payment structure above is indicative. The final fee and payment terms are set in the services agreement.

Indicative quotes

Three tracks, one ladder

From a free scan to a full audit and retainer — across three packages: PLD only, AI Act only, or both. Indicative prices, in euro, excluding VAT.

PLD only
PLD Readiness
Directive (EU) 2024/2853 — strict liability for products & AI
  • Scan + Guide
    Quick exposure triage + PDF guide
    Free
  • Flash Report
    Written report, ~1 week
    €490
  • Core Audit
    Full audit — standard / extended
    €3,400–€6,900
  • Retainer & redlines
    Subscription + contract redlining
    On request
Most complete
Bundle PLD × AI Act
Integrated impact
A single analysis across both regimes — at a saving versus the separate packages
  • Scan + Guide
    Combined PLD & AI Act triage + guide
    Free
  • Flash Report
    Unified report across both regimes
    €790
  • Core Audit
    Integrated audit — standard / extended
    €5,900–€11,900
  • Retainer & governance
    Subscription + compliance framework
    On request
AI Act only
AI Act Readiness
Reg. (EU) 2024/1689 — classification, documentation, AI governance
  • Scan + Guide
    Quick AI inventory + PDF guide
    Free
  • Flash Report
    Written report, ~1 week
    €590
  • Core Audit
    Full audit — standard / extended
    €3,900–€7,400
  • Retainer & governance
    Subscription + AI-governance framework
    On request
⏳
Why PLD now: with under 5 months to the deadline, only about a third of Member States have published transposition drafts, and Hungary is the only state to have adopted transposing legislation. In Romania, per the Foreign Ministry's plan, ANPC and the Justice Ministry have declined competence, and the institutional assignment is still under review. Five months of uncertainty — that is the product.
Market reference: engagements at large firms start at €200K and reach €2M; fixed-price boutique sessions start at €990. The positioning here — fixed price, clear deliverable, short timeline — sits deliberately between those extremes.

All prices are indicative, in euro, excluding VAT. The exact scope, the deliverables and the final fee are confirmed in the services agreement.

Empirical evidence

AI risk is real, documented and quantifiable

Empirical research and the literature show that AI hallucination is not a mere bug — it is a structural property.

17–33%
Hallucination rate in commercial legal-research tools
Stanford HAI, Magesh et al., 2025
25yrs
The long-stop period under the recast PLD for medicines and supplements
Dir. (EU) 2024/2853, art. 14
Art.8
The AI integrator answers as manufacturer for defects in the embedded component
Dir. (EU) 2024/2853
⚠️
A concrete example — a chatbot on the company website
A chatbot that recommends a product to someone with allergies — on the basis of a hallucinating AI — can constitute a product defect under the recast PLD. Moffatt v. Air Canada (2024) showed that a company cannot exonerate itself by arguing that “the chatbot is a separate entity.” Under the PLD, the consequence tends toward strict liability — no fault, no defence.
Why this approach

Legal counsel anchored technically and empirically

Dual qualification, proprietary risk-mapping tools and applied research — not just a generic opinion.

" Legality by Design "

Compliance is not achieved through retroactive documentation. It is built ahead of time — with the right tools, at the right moment.

⚖️
Dual qualification — RO & England/Wales
Advocate at the Bucharest Bar and Solicitor of England & Wales. A dual perspective — Romanian/EU law and common law — useful on EU regulation with cross-border ramifications.
🗺️
Proprietary PLD-exposure mapping
Tools that map the supply chain and exposure under Directive (EU) 2024/2853. They visualise the contractual risk at every node of the chain — not just text.
🔬
Grounded empirical research
The grounded thesis: AI hallucination is a systemic product defect under the PLD — structural, not accidental. Anchored in the literature (Stanford HAI and others).
📐
Honesty of position
Transparent methodology, stated assumptions, acknowledged limits. The same standards I ask of clients.
Next steps

How we get to kick-off

Four steps — from first contact to the start of the analysis.

1
Intro call
30 min — walkthrough of the proposal, clarifications, scope calibration
2
Team validation
Naming the points of contact: Executive sponsor, Legal, IT, QA, Regulatory
3
Services agreement
Terms, final fee, confidentiality — signed digitally
4
Kick-off
Stage 1 begins. Initial 2h session with all departments involved
Request a detailed proposal, tailored to your company
The exact scope, deliverables and fee are set together. First step: a 30-minute preliminary conversation.
📧 Request a proposal
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