The question MDR-trained teams ask

Manufacturers who have built clinical evaluation reports (CERs) only under EU MDR often treat the state-of-the-art (SOTA) analysis as a standard step of any clinical evaluation. When they prepare an NMPA submission, they find no equivalent requirement. Their first reaction is usually to ask whether something has been missed.

Nothing has been missed. The two regulatory systems use structurally different evidence models.

What SOTA does in an MDR CER

Under MEDDEV 2.7/1 Rev. 4, the SOTA section is not a general literature review. It is a systematic search of the whole treatment field: comparable devices, alternative therapies and relevant clinical studies. The results are pooled into benchmark values for performance and safety.

These benchmarks become the acceptance criteria for the subject device’s own clinical data. SOTA therefore defines what “acceptable” means for the indication, independent of any single comparator device. It requires a detailed analysis and a complete list of included and excluded literature.

What NMPA requires

NMPA’s clinical evaluation route is built on comparison with a same-variety device already legally marketed in China. The question is not what the whole field has achieved. The question is how the subject device differs from that device, and whether the differences are controlled.

Each difference is analysed separately: known adverse events, materials, mechanism of action and foreseeable misuse. If the differences do not affect safety or effectiveness, or can be managed through risk controls, the devices can be concluded to be equivalent or similar.

This is a device-to-device comparison, not a device-to-field comparison. The acceptance criteria come from the safety and effectiveness record of the comparator device, not from a pooled benchmark.

Where the SOTA question goes

Under MDR, SOTA answers whether the subject device performs well enough compared with what is currently achievable. Under NMPA, this question is answered when the comparator device is chosen. An approved comparator with an established safety record represents a level the Chinese market has already accepted. Showing equivalence to that comparator shows that the subject device reaches the same level.

The difference reflects two regulatory approaches. The MDR benefit-risk framework is designed to stand on its own, exhaustive evidence. The NMPA framework is designed for efficiency and anchors the evaluation to devices already reviewed in China.

What this means for an existing MDR CER

An MDR CER usually contains a thorough SOTA analysis. Most of that analysis cannot be moved directly into an NMPA submission, because NMPA follows a different evidence logic. NMPA needs a complete, well-supported difference analysis, based on a detailed understanding of the comparator device.