RAC Device Prep: Postmarket Surveillance
& Vigilance Mastery
Terms in this set (9)
A manufacturer becomes A. Immediately, but no later than 15 calendar days
aware of a serious incident
involving a CE-marked Class
Explanation:
IIb ventilator that resulted in
Under EU MDR Article 87(1), the manufacturer must report
patient harm. According to
serious incidents to the Competent Authority:
EU MDR Article 87, within
“Immediately after establishing a causal relationship or
what timeframe must the
reasonable probability,” but no later than 15 calendar
incident be reported to the
days after becoming aware of the incident.
Competent Authority?
A. Immediately, but no
later than 15 calendar
days
B. Within 7 calendar days
C. Within 10 calendar days
D. Immediately, but no later
than 2 calendar days
, A manufacturer receives C. EU MDR: 2 days | FDA: 5 working days
reports of a malfunction in a
Class III ventilator that could
Explanation:
seriously compromise
✅ EU MDR – Article 87(4):
multiple patients due to oxygen
For events that pose a serious public health threat,
delivery failure. No injuries have
manufacturers must report within 2 calendar days.
occurred yet, but the issue
Examples: widespread malfunction, high-risk exposure,
affects a widely distributed
device affecting critical care like ventilators.
lot.
✅ FDA – 21 CFR 803.53 (5-Day Reports):
What are the reporting
If a malfunction is likely to cause or contribute to a death or
timelines under EU MDR and
serious injury, and: It's a public health threat, or
FDA rules?
The FDA or internal procedures require reporting within
A.
5 days →🕔 Report within 5 working days
EU MDR: 2 days
FDA: 30 calendar
days B.
EU MDR: 15 days
FDA: 5
working days
C.
EU MDR: 2 days
FDA: 5
working days
D.
EU MDR: 10 days
FDA: 10 working days
A U.S. manufacturer C. 15 calendar days
& Vigilance Mastery
Terms in this set (9)
A manufacturer becomes A. Immediately, but no later than 15 calendar days
aware of a serious incident
involving a CE-marked Class
Explanation:
IIb ventilator that resulted in
Under EU MDR Article 87(1), the manufacturer must report
patient harm. According to
serious incidents to the Competent Authority:
EU MDR Article 87, within
“Immediately after establishing a causal relationship or
what timeframe must the
reasonable probability,” but no later than 15 calendar
incident be reported to the
days after becoming aware of the incident.
Competent Authority?
A. Immediately, but no
later than 15 calendar
days
B. Within 7 calendar days
C. Within 10 calendar days
D. Immediately, but no later
than 2 calendar days
, A manufacturer receives C. EU MDR: 2 days | FDA: 5 working days
reports of a malfunction in a
Class III ventilator that could
Explanation:
seriously compromise
✅ EU MDR – Article 87(4):
multiple patients due to oxygen
For events that pose a serious public health threat,
delivery failure. No injuries have
manufacturers must report within 2 calendar days.
occurred yet, but the issue
Examples: widespread malfunction, high-risk exposure,
affects a widely distributed
device affecting critical care like ventilators.
lot.
✅ FDA – 21 CFR 803.53 (5-Day Reports):
What are the reporting
If a malfunction is likely to cause or contribute to a death or
timelines under EU MDR and
serious injury, and: It's a public health threat, or
FDA rules?
The FDA or internal procedures require reporting within
A.
5 days →🕔 Report within 5 working days
EU MDR: 2 days
FDA: 30 calendar
days B.
EU MDR: 15 days
FDA: 5
working days
C.
EU MDR: 2 days
FDA: 5
working days
D.
EU MDR: 10 days
FDA: 10 working days
A U.S. manufacturer C. 15 calendar days
