Medical Devices: Post-Market Surveillance – Global NCAR Exchange Simplified

The International Medical Device Regulators Forum (IMDRF) has released the fifth edition of its guidance titled “Medical Devices: Post-Market Surveillance – National Competent Authority Report (NCAR) Exchange Criteria and Report Form”, published on 1 April 2025.

This comprehensive guidance serves as a globally harmonized framework for sharing post-market safety reports of medical devices among national regulatory authorities.

In a major change, it was reclassified in 2024 from a working guidance into an information document, reflecting its role as a reference standard rather than a mandatory requirement.

NCAR (National Competent Authority Report) is a structured method for sharing serious adverse event reports related to medical devices between regulatory authorities across different countries. It helps ensure timely communication and action to protect patient safety globally.

The main objective of the NCAR guidance is to support timely, structured information exchange between National Competent Authorities (NCAs) regarding serious safety issues linked to medical devices. This helps:

• Prevent duplication of regulatory work

• Enhance global coordination in risk management

• Promote consistency in actions across jurisdictions

According to the guidance, NCARs should be issued in cases such as:

• Serious public health threats

• Death or serious injuries due to device malfunction

• Large-scale Field Safety Corrective Actions (FSCAs)

• Emerging trends or clusters indicating systemic risk

The reporting threshold aims to balance avoiding under-reporting and preventing an overload of irrelevant information.

Each NCAR form is standardized and includes the following key fields:

• Device identifiers (e.g., model, serial number)

• Incident description and cause

• Corrective actions initiated by the manufacturer

• Affected countries and distribution details

• Risk assessment conclusions

• Optional: Public communication links (e.g., Field Safety Notices)

These data fields ensure that receiving authorities can rapidly assess the impact and relevance for their own jurisdictions.

NCAR Form and Submission

Form Structure

The standardized NCAR Form (Annex 2) includes:

1. Report ID: Country code + date + sequence number (e.g., US-2025-04-08-001).

2. Purpose: Checkboxes for public health threats, trend analysis, or information requests.

3. Device Details: Manufacturer, product name, regulatory status.

4. Event Description: Root cause, affected populations, corrective actions.

Submission Process

• Timeline: Reports must be submitted promptly after identifying risks.

• Format: English-language form + optional Common Dataset Excel/DTX files for adverse event data.

• Manufacturer Consultation: NCAs should involve manufacturers to verify technical accuracy before submission.

By adhering to standardized criteria and forms, regulators can collaboratively address emerging threats, ensuring that patient safety remains a shared priority.

For further details, access the full document: IMDRF/NCAR WG/N14 FINAL:2025.