The document outlines the reporting requirements for manufacturers regarding medical devices under FDA regulations, specifically detailing when to report incidents that suggest a device caused or contributed to death, serious injury, or a device malfunction. It defines serious injury, device malfunction, and outlines a decision tree for determining the necessity of filing a Medical Device Report (MDR) based on customer complaints and device performance. Key criteria include life-threatening consequences, permanent impairment, and the essential functions of the device.

1. MDR Reporting
FDA Title 21 [§803.3(q)]
Chapter 9 Subchapter V Part A- Drugs and Devices Sec. 360-
Records and reports on devices

2. TAREK ELNEIL
Quality Management Tools
Principal Consultant
telneil@msn.com
Mobil: (805)732-1739

3. WHENAND WHATTO REPORT[§803.3(q)]
• A report is required when a manufacturer becomes aware
(see definition) of information that reasonably suggests that
one of their marketed devices has or may have caused or
contributed to a
• death
OR
• serious injury
OR
• Device malfunctioned
and that the device or a similar device marketed by the
manufacturer would be likely to cause or contribute to a death or
serious injury if the malfunction were to recur.

4. WHENAND WHATTO REPORT[§803.3(q)]
Serious injury/(Serious illness) [§803.3(aa)(1)] is an injury or
illness that:
• is life threatening, even if temporary in nature;
• results in permanent impairment of a body function or
permanent damage to a body structure; or
• necessitates medical or surgical intervention to preclude
permanent impairment of a body function or permanent
damage to a body structure.

5. WHENAND WHATTO REPORT[§803.3(q)]
A malfunction [§803.3(m)]
• is a failure of the device to meet its performance specifications or otherwise
perform as intended. Performance specifications include all claims made in the
labeling for the device. A malfunction should be considered reportable if any one
of the following is true:
• the chance of a death or serious injury occurring as a result of a recurrence of
the malfunction is not remote;
• the consequences of the malfunction affect the device in a catastrophic manner
that may lead to a death or serious injury;
• it causes the device to fail to perform its essential function and compromises the
device’s therapeutic, monitoring or diagnostic effectiveness which could cause or
contribute to a death or serious injury, or other significant adverse device
experiences. The essential function of a device refers not only to the device’s
labeled use, but for any use widely prescribed within the practice of medicine;
• it involves an implant malfunction that would be likely to cause or contribute to
death or serious injury, regardless of how the device is used;
• the device is considered life-supporting or life-sustaining, and thus essential to
maintaining human life; or

6. Risk to Health
Evaluate Risk
to Health
Serious
Injury
Death

7. Serious Injury Definition
Serious
Injury
Life Threatening
Permanent impairment or
damage to body function
and structure
Necessitates medical or
surgical intervention to
preclude permanent
impairment or damage to
body function or structure

8. Device Malfunction
Medical Device
Malfunction
Device caused
Death or Serious
Injury
Device likely to
cause Death or
Serious Injury
Device
contributed to
Death or Serious
Injury
Functional

9. NO
Yes
MDR Decision Tree 1
Customer Complaint was
received with the
information suggest that
the MD might be required
Caused or
contributed
to Death
File MDR
Yes
NO
Caused life
threatening
Injury?
File MDR
1
Start

10. MDR Decision Tree 2
Yes
NO
Resulted in
permanent
Impairment /
damage to body
function?
File MDR
1
Yes
NO
Necessitate medical
or surgical
intervention to
preclude permanent
Impairment /
damage to body
function?
File MDR
2
NO

11. NO
MDR Decision Tree 3
2
Yes
NO
Necessitate medical or
surgical intervention to
preclude permanent
Impairment / damage
to body function?
File MDR
NO
Was the device
returned (3
attempts) ?
YesInspect the device and
review the DHR
3
4

12. Yes
MDR Decision Tree 4
3
4
Was the returned
device
manufactured by
us?
Do not file MDR, close
the investigation with
justification
NO
NO
NO Do not file MDR, close
the investigation with
justification
Yes
Was the returned
device part of
other
competitor‘s
system?
Yes
Is it possible to
determine if our
device was
malfunction?
5
6

13. Yes
NO
MDR Decision Tree 5
5
6
NO
Yes
NO
Yes File MDR
Investigate (CAPA)for a
new risk or a trend?
Do not file MDR, close
the investigation with
justification
Was the device
malfunctioning
caused or likely to
cause or contributed
to serious injury?
Was the device
malfunction?

14. Questions?