Clinical Evidence
NMRA · CER for general devices · Performance evaluation for IVDs
Why Clinical Evidence Is Required
The NMRA requires clinical evidence to establish that a device performs safely and as intended when used in patients in clinical practice. Clinical evidence is distinct from bench testing — it addresses the device's actual clinical behaviour, not just its physical or chemical properties.
General Devices — Clinical Evaluation Report (CER)
For general medical devices, the clinical evidence is compiled into a Clinical Evaluation Report (CER) following a systematic methodology:
CER Process
- Define scope — device description, intended purpose, clinical claims
- Identify applicable clinical data — from three possible sources:
- Clinical investigations of the subject device
- Equivalent device data (with justified equivalence)
- Published clinical literature (systematic literature review)
- Appraise data quality — assess relevance, methodological quality, and risk of bias
- Analyse and conclude — evaluate whether the data supports the safety and performance claims
- Document residual uncertainties — and how they are addressed (e.g., by PMCF)
CER Depth by Class
| Class | CER Depth |
|---|---|
| Listed/I | Abbreviated review may suffice for well-established technologies |
| IIa | Literature-based CER with systematic review methodology |
| IIb | Comprehensive CER; clinical data from investigations may be required for novel technologies |
| III | Robust clinical data including clinical investigations where no equivalent device exists |
IVDs — Performance Evaluation
IVD registration requires performance evaluation data rather than a clinical evaluation report:
Analytical Performance
| Parameter | Description |
|---|---|
| Analytical sensitivity | Limit of detection and limit of quantification |
| Analytical specificity | Cross-reactivity and interference testing |
| Precision | Repeatability and reproducibility |
| Accuracy / trueness | Comparison to reference method |
| Linearity/measuring range | For quantitative assays |
| Stability | Shelf life and open-vial stability |
Clinical Performance
- Sensitivity and specificity compared to reference method or gold standard
- Positive and negative predictive values in the intended use population
- Results from clinical studies or specimen bank evaluations
Overseas Clinical Data
NMRA accepts clinical data generated outside Sri Lanka, provided:
- Device used in the overseas study is identical (or equivalence is properly justified)
- Study population is representative of the Sri Lankan patient population
- Clinical conditions and intended use are comparable
For the reliance pathway, the reference NRA's clinical assessment is a key part of the reliance evidence package, and NMRA may accept the reference NRA's clinical conclusions as part of the reliance review.
Post-Market Clinical Follow-Up (PMCF)
For Class IIb and III devices, the NMRA may require a PMCF plan as part of the registration dossier. PMCF collects clinical data after registration to:
- Confirm long-term safety and performance
- Detect rare or late-emerging adverse events
- Address residual uncertainties identified in the pre-market CER