Vigilance & Adverse Event Reporting

NMRA · MAH vigilance obligations

What Must Be Reported

The MAH must report to NMRA any adverse event involving an NMRA-registered device where the device has:

• Caused or contributed to death or serious deterioration in patient/user health
• Malfunctioned in a way that, if recurrence occurred, could cause death or serious injury
• Created a serious public health concern

Report potentially reportable events (where classification is uncertain) to the NMRA for guidance.

Reporting Timeframes

Event Type	Timeframe
Events involving death or serious injury	Immediately — as soon as possible (within 10 calendar days)
Serious public health concern	Immediately
Other reportable events (malfunction with recurrence risk)	Within 30 calendar days of MAH becoming aware

Reporting Process

1. MAH becomes aware of adverse event — through user complaint, clinical report, published literature, inspection findings, post-market surveillance data, or other means
2. MAH initiates investigation (in conjunction with manufacturer)
3. MAH files preliminary report to NMRA within the applicable timeframe
4. MAH completes investigation — root cause analysis, corrective actions
5. MAH files final report with investigation conclusions
6. NMRA reviews and may request additional information

Reports are submitted through the NMRA portal or designated reporting channel. Confirm the current reporting form and channel with the NMRA.

Field Safety Corrective Actions (FSCAs)

FSCAs are initiated when a marketed device presents an unacceptable risk:

FSCA Types

Type	Description
Recall	Return of affected devices
Modification	On-site upgrade or repair to resolve safety issue
Labelling correction	Address safety-critical labelling errors
User notification	Safety information without device return

FSCA Obligations

1. MAH notifies NMRA before or simultaneously with user notification
2. MAH prepares and distributes Field Safety Notice (FSN) to all known users
3. MAH maintains complete records: affected devices list, FSN recipients, confirmation of receipt
4. MAH confirms FSCA completion to NMRA
5. NMRA may initiate its own investigation or require additional actions

NMRA-Initiated Safety Actions

The NMRA has authority to:

• Require the MAH to conduct a recall or corrective action
• Suspend the Registration Certificate pending investigation
• Cancel the Registration Certificate for serious safety issues