导语
On March 28, 2026, the European Commission issued Regulation (EU) 2026/731, mandating standalone CE certification for all calibrators, controls, and reference materials used in IVD testing systems from April 1, 2026. This change impacts over 800 Chinese IVD consumables exporters, particularly those supplying glucose monitoring, coagulation, and infectious disease rapid testing platforms. The update underscores the EU's push for stricter traceability in IVDR compliance.

Event Overview

The EU Commission's (EU) 2026/731 regulation explicitly requires:

• All IVD calibrators, controls, and reference materials must obtain individual CE marks under IVDR, regardless of being OEM-produced
• Intended uses must be clearly specified in certification documents
• Implementation date: April 1, 2026 (no transitional grace period announced)

Impacted Sub-Sectors

1. IVD Consumables Exporters

Chinese manufacturers supplying standalone calibration/control products for EU IVDs face immediate certification costs (estimated €20,000-50,000 per product line). Glucose test strip calibrators and PCR kit controls are particularly affected.

2. IVD System Manufacturers

Companies producing integrated testing platforms must now decouple calibration品 certification from main device submissions. This may delay new product launches by 3-6 months for technical documentation updates.

3. Supply Chain Intermediaries

Distributors handling non-CE marked calibrators/controls must clear existing inventory before April 2026. Customs declarations will require separate certification numbers for these components.

Key Action Points

1. Certification Prioritization

From an industry perspective, companies should first assess high-volume products (e.g., HbA1c controls) for immediate certification, while evaluating cost-benefit for low-margin items.

2. Technical Documentation

Current guidance suggests preparing:

• Performance evaluation reports specific to each calibrator's intended use
• Batch-to-batch consistency data exceeding IVDR Annex XIII requirements

3. Supply Chain Communication

Manufacturers need to clarify certification timelines with EU partners, especially for IVDR Class D products where notified body capacity remains constrained.

Industry Observation

Analysis indicates this move:

• Signals the EU's stricter enforcement of IVDR Article 5(5) on companion diagnostics
• May trigger similar requirements in other regions (e.g., UK MHRA updates expected Q3 2026)
• Creates opportunities for EU-based calibration品 producers at the expense of non-EU suppliers

Conclusion
The regulation represents a operational rather than strategic shift - while increasing compliance burdens, it ultimately standardizes IVDR implementation. Companies should view this as part of the broader IVDR transition rather than an isolated policy change.

Source
• European Commission Delegated Regulation (EU) 2026/731
• Pending: IVDR notified body capacity reports (expected June 2026)