EU sets 50% threshold for Chinese content in medical device tenders

• From 30 June 2025 , every public-sector medical-device tender in the EU with an estimated value of EUR 5 million or more must apply the International Procurement Instrument (IPI).
• Chinese economic operators are entirely barred from those tenders, while all other bidders—Swiss, US, UK, EU and others—must ensure that no more than 50 % of the contract value originates from goods or components manufactured in China.
• Roughly EUR 1–1.2 billion of annual public-sector spend is expected to shift away from Chinese suppliers, creating a sizeable growth opportunity for compliant Swiss manufacturers.
• Non-compliance can result in bid rejection, contract termination, penalties of up to 30 % of contract value , and reputational damage.
• Immediate actions: map Chinese content at the bill-of-materials level, diversify critical supply chains, prepare auditable origin documentation , and train tender teams.
• PwC Switzerland’s Life Sciences practice offers end-to-end support—from rapid supply-chain diagnostics to hands-on implementation and bid-team coaching.

The European Commission’s first use of the IPI fundamentally reshapes access to high-value EU public tenders for medical devices:

1. Blanket exclusion of Chinese bidders for contracts ≥ EUR 5 million (net of VAT).
2. 50 % ceiling on Chinese-origin content for every other bidder, irrespective of nationality.
3. Automatic, EU-wide application—no need for Member States to enact national laws; contracting authorities must enforce compliance at tender launch.
4. Initial five-year term, renewable by the Commission.

Switzerland already trades with the EU as a “third-country” since mutual recognition under the Medical Device Regulation (MDR) lapsed. Under the IPI , you remain fully eligible—provided your devices carry a valid CE mark and your supply chain respects the 50 % threshold. The upside:

• Market share expansion: Chinese firms previously captured a significant slice of large framework agreements. Their exclusion frees up substantial public-sector revenue.
• Competitive differentiation: A demonstrably resilient, non-Chinese supply chain becomes a concrete bid-scoring advantage.
• First-mover pricing power: Early-adapted suppliers can shape tender specifications and lock in multi-year contracts before competitors re-engineer their sourcing.