Something interesting happened in EU tendering on June 30th of 2025. Tenders above €5M that involve certain medical devices now carry origin-based eligibility constraints and caps on restricted-origin content. If your bid can't prove customs origin correctly, or if your subcontracting mix tips over a threshold, you don't just lose points, you risk ineligibility. 

Here's what we've noticed:

The measures aren't generic. They're implemented via specific Commission acts that define scope, the Combined Nomenclature codes (CN codes), thresholds, and timing. Your tender's fine print is the rulebook.

Origin is a customs determination (wholly obtained or substantial transformation), not where you ship from or where your HQ sits.

Teams that operationalize origin evidence and governance during capture - not after award - avoid painful resets.

Which medical devices are subject to the newly-approved International Procurement Instruction measure?

  • Devices defined by CPV codes 33100000-1 to 33199000-1, which cover nearly the entire spectrum of standard medical devices purchased in public tenders;
  • Imaging equipment: X-ray machines, MRI scanners, CT scanners, ultrasound equipment.
  • Diagnostic and laboratory equipment: Laboratory analyzers, recording systems, exploration devices.
  • Implants and prosthetics: Heart valves, artificial joints, pacemakers, dental implants.
  • Consumables: Masks, bandages, medical clothing, surgical gloves, syringes, catheters.

What rules apply to your tender

Confirm the governing instrument

Begin with the document that actually governs your bid: the Commission implementing act referenced in the tender. Identify three elements upfront:

  • Product scope: Which CN codes and device categories are covered?
  • Threshold logic: Does the €5M trigger apply per lot, the overall award, or cumulative call-offs?
  • Timing: What are the effective dates, review windows, and any sunset clauses?

Use a clean interpretation hierarchy: tender documents first, then the specific IPI instrument, then general customs and Union law.

Core constraints

Eligibility by customs origin. For covered medical devices above €5M, the origin must align with the instrument. Under the Union Customs Code, origin is either wholly obtained or determined by substantial transformation - the operation that confers a new tariff heading or the essential character.

Subcontracting and supply-chain caps. Some tenders cap the proportion of restricted-origin inputs or subcontracted value. Two details matter: the denominator (total contract value, manufacturing value, critical components, or per work package) and the time of assessment (at award, per delivery lot, or a rolling period).

Local authority exemptions

Grounds exist - overriding public interest, lack of compliant alternatives, disproportionate competition impact - but they require buyer-side justification and procedural safeguards aligned with Commission guidance.

Decision rule: default to full applicability. Pursue an exemption only when the tender explicitly signals a path and you can supply credible evidence alongside a realistic transition plan to a compliant origin over the contract life.

How to prove and operationalize compliance

Rules of origin for medical devices, made practical

Determining origin. Focus on substantial transformation. Some operations that feel "manufacturing-like" (basic assembly, repacking, simple firmware loading, sterile barrier application) may not confer origin if they don't create a new tariff heading or essential character.

Mixed-origin assemblies. The finished device takes the origin of the place where the substantial transformation occurs. Subcomponent origins still matter for subcontracting caps and disclosure.

Edge cases. For contentious SKUs or where your interpretation is likely to be challenged, Binding Origin Information (BOI) or a customs ruling beats a supplier PDF.

Evidence strategy and supplier assurance tiers

Treat origin evidence like you treat quality: tiered assurance with escalation for risk.

  • Tier 1 (baseline): Signed supplier origin declarations mapped to part numbers and CN codes.
  • Tier 2 (corroboration): Production records, invoices, routings/Bills of Materials (BOMs) that show where and how transformation actually occurs.
  • Tier 3 (independent): Third-party audits, BOI/customs rulings, or equivalent. Deploy this for high-value, high-risk SKUs.

Data operating model and governance

  • Systems: Capture origin at the part and assembly level in ERP/PLM fields. Avoid spreadsheets as the system of record.
  • Ownership: Appoint a Compliance PM. Make responsibilities explicit across procurement, quality/regulatory, legal, and the bid team.
  • Living data room: Maintain a controlled repository with current origin packs, supplier declarations, QMS certificates, and process narratives.

Medical Device Regulation (MDR) /In Vitro Diagnostic Regulation (IVDR) interlocks

Origin-driven changes can trip MDR/IVDR wires: technical documentation updates, notified body notifications, UDI linkages. Put a regulatory impact assessment into your pre-bid and change-control process.

Building a winning bid under IPI

Administrative section

  • Origin compliance statement: Reference the specific IPI instrument and state explicitly that offered devices meet origin requirements.
  • Subcontractor roster and origin mix: Show legal name, scope, site, CN code, customs origin, and value-share by origin.
  • Declarations and certificates: Include supplier origin declarations, ISO 13485, MDR conformity evidence.
  • Traceability and execution plan: Explain how you will maintain origin documentation during delivery.

Technical section

  • Manufacturing narrative: Outline substantial transformation steps, facility locations, and controls that underpin origin claims.
  • Supply resilience and change control: Describe dual-sourcing options and governance that prevents cap breaches.

Commercial section

  • Pricing transparency: If compliant origin choices increase cost, say so plainly.
  • Adjustments and contingencies: Define price-adjustment triggers if you are forced to reconfigure the origin post-award.

Clarifications and bidder Q&A strategy

  • Ask about the math: What's the denominator for caps? Is compliance assessed per lot or per delivery?
  • Ask about operations: Which steps are recognized as substantial transformation for this device family?
  • Ask for templates: Use the buyer's preferred origin declaration format if provided.

Teaming and consortia

Partner choices can rebalance origin without diluting quality. EU or local manufacturing partners can keep restricted-origin content below thresholds. Guardrails: MDR/IVDR compliance intact, QMS intact, and a chain of custody the auditor can follow.

Compete confidently under IPI

When Q4 timelines accelerate, execution becomes a competitive advantage. Under IPI, that advantage looks like this:

  • Legal specificity: the right instrument, CN codes, thresholds, and timing
  • Origin accuracy: proved, not asserted, with tiered evidence ready for scrutiny
  • Clear subcontracting composition: math the buyer can follow without a meeting
  • System durability: governance that survives supplier change and real-world shocks.

One final filter we use with executive teams: if a non-specialist evaluator can trace your origin logic from paragraph to annex without a question, you are in the top decile.

If you want this operational tomorrow, start with three moves: establish the BOM origin matrix for target SKUs. Lock your supplier declaration templates and the escalation path for evidence. Prepare your clarification questions now. Speed matters. Accuracy matters more.


Conclusion

The IPI regime is not an abstract compliance exercise. It’s a competitive filter in high value EU health tenders. Teams that treat origin and subcontracting as an afterthought will see their bids collapse on formality before their device is even assessed. The opposite is also true: companies that institutionalize origin governance, map their subcontracting mix with audit trails and engage with buyers with the right questions will signal reliability long before pricing or features are considered.

In practical terms compliance has become part of commercial positioning. The strongest bidders will not only demonstrate technical competence but will also show they can manage regulatory precision under pressure. That’s what contracting authorities are increasingly rewarding. For executives the question is simple: does your tendering capability already embody this compliance discipline as a standard operating model or are you still treating it as a project by project scramble?