MDSAP · Medium · 14 min lesson
Chapter 4 Adverse events and advisory notices - reportability, timeframes by country and recalls
MDSAP Audit Approach Chapter 4 (2 tasks); ISO 13485:2016 clauses 7.2.3, 8.2.2, 8.2.3 and 8.3.3
What you will learn
- Audit the 2 reporting tasks of Chapter 4.
- Apply the timeframe table by country to a case.
- Test a reportability decision and its record.
Key takeaways
- Chapter 4 has two tasks: notification of adverse events and notification of advisory notices; it is audited with Chapter 3.
- The clock starts at awareness from any source, so the complaint process needs a reportability step for each complaint.
- Keep a dated table of timeframes by country and work to the shortest one when markets overlap; confirm figures against current rules.
- Advisory notices and recalls follow clause 8.3.3, with reports such as 21 CFR 806.10 within 10 working days in the United States.
- Reporting findings map to clause 8.2.3 at base grade 3; non-reportable decisions also need reasoned records.
Free practice question
A hospital phones Quillon on Monday 3 September: a monitor froze for forty seconds and a nurse delayed a treatment. The investigation closes on 8 October. The device is sold in the United States.
From which date does the United States thirty day period normally run?
3 September, when Quillon became aware of the information
Correct. 21 CFR 803.50 starts the clock at awareness, which MDSAP Chapter 4 task 1 checks against the complaint date.
8 October, when the investigation closed
Not quite. The investigation end does not start the clock under 21 CFR 803.50, and MDSAP task 1 treats waiting as a failure.
1 January of the following year
Not quite. A calendar year start has no role in 21 CFR 803.50 or in the MDSAP Chapter 4 timeframe check.
The date the device was manufactured
Not quite. Manufacture date is not the trigger; awareness of the event is, under 21 CFR 803.50 in MDSAP task 1.
Key terms
- adverse event: An event linked to a device that caused or may have contributed to death or serious harm, or could if it recurred (clause 8.2.3).
- awareness date: The date the organization receives information suggesting a reportable event, which starts the reporting clock (21 CFR 803.50).
- advisory notice: A communication to customers about a delivered device, such as a safety notice, return or correction (clause 8.3.3).
- reportability decision: The recorded judgment of whether an event meets a regulator's reporting criteria, including the reason (MDSAP Chapter 4 task 1).
- correction or removal report: A United States report due within 10 working days of starting an action to reduce a health risk (21 CFR 806.10).
Official sources
- MDSAP AU P0002.009 MDSAP Audit Approach (FDA)
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
- 21 CFR 803.50 Medical device reporting: manufacturer reporting requirements (eCFR)
- 21 CFR 806.10 Reports of corrections and removals (eCFR)
- Medical Devices Regulations SOR/98-282, sections 59 to 65 (Justice Laws, Canada)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.