Medical Devices Evaluation Committee (MDEC)
LK-Unique · Expert advisory body for Class IIb and III devices
What Is MDEC?
The Medical Devices Evaluation Committee (MDEC) is an expert technical advisory committee within the NMRA framework. It consists of healthcare professionals (clinicians, engineers, pharmacists), regulatory experts, and other specialists who review registration applications for high-risk devices.
Which Devices Are Referred to MDEC?
| Device Class | MDEC Review? |
|---|---|
| Listed / Class I | ❌ No |
| Class IIa | ❌ Generally not — routine NMRA staff review |
| Class IIb | ✅ Typically referred |
| Class III | ✅ Always referred — even with reliance pathway |
| Complex IVDs (Class C/D with novel claims) | ✅ May be referred |
| Novel/first-of-kind devices | ✅ May be referred at NMRA discretion |
MDEC Process
- MAH submits Consolidated Dossier to NMRA
- NMRA staff conduct administrative and initial technical review
- Complete application referred to MDEC
- MDEC scheduled and meets (frequency depends on NMRA workload — typically monthly or bi-monthly)
- MDEC reviews dossier and may:
- Request additional information from the MAH
- Commission independent expert opinion
- Visit the MAH for clarification
- MDEC issues a recommendation to the NMRA Director General:
- Approve
- Approve with conditions (e.g., restricted indication, post-market surveillance requirement)
- Reject (with reasons)
- NMRA Director General makes the final regulatory decision based on the MDEC recommendation
- MAH notified of decision
Timeline Impact
MDEC review adds substantial time to the registration process. Budget:
- Class IIb: Add 3–6 months beyond the standard dossier review time
- Class III: Add 4–8+ months; complex or novel devices may take longer
The total registration timeline for Class III devices in Sri Lanka can realistically be 12+ months. Plan market entry accordingly.
Preparing for MDEC Review
MAHs and manufacturers can improve MDEC outcomes by:
- Ensuring the clinical evaluation is comprehensive and well-structured
- Including post-market clinical follow-up plans where relevant
- Addressing any known safety concerns proactively in the dossier
- Providing clear, well-organised documentation (MDEC members review multiple applications)
- Being responsive to additional information requests — delays in responding extend the timeline
There is currently no formal pre-MDEC consultation process, but MAHs may contact the NMRA Medical Devices Regulatory Division informally to understand expectations for specific device types.