The document discusses medical device adverse event reporting requirements, including definitions of reportable events and timelines for submitting reports to regulatory agencies. It provides an overview of the classification system for medical devices and regulations around reporting malfunctions, deaths and serious injuries caused by devices. Reporting requirements and challenges involving software as a medical device are also reviewed.

1. 1
Medical Device Reporting
Presented by:
Dr. Joyce de Langen, Doctor of Pharmacy
Sr Solution Manager Pharmacovigilance
Elsevier Life Sciences
Date: 27th of September 2016

2. 2
Outline
• What is a medical device?
• Classification of Medical Devices
• Regulations
• Medical device adverse event reporting
• How does Elsevier support your Medical Device Development and
monitoring?

3. 3
What is a medical device?
• A medical device is "an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other similar
or related article, including a component part, or accessory
which:
− Is intended for use in the diagnosis, treatment/cure, mitigation or
prevention of disease in humans or animals
− Does not act through chemical actions or which does not need to
be metabolized before acting >> that means which is no drug
− Is recognized in official National Formulary or USP
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm

4. 4
Types of Medical Devices
Capital
Equipment
Instruments
Disposables
&
Accessories
Implantable
devices
Monitoring
systems
Reagents
Computerized
Medical
systems

5. 5
Levels of FDA Medical Device Classification
Class I
Low Risk
Bandages, dental floss,
examination gloves
Class II
Medium Risk
Electric wheelchair,
Infusion pumps,
Class III (life-sustaining)
High Risk
Pacemakers, heart valves, brain stimulators,
coronary stent

6. 6
US Approval Process for medical devices
http://www.presentationeze.com/presentations/medical-device-validation/medical-device-validation-full-details/validation-requirements-medical-
device-design-manufacture-processing/

7. 7
Medical Device Market is Growing
https://www.zionmarketresearch.com/news/global-medical-device-coatings-market

8. 8
Increase in Medical Device Revenue leads to increase in
adverse event reports for medical devices

9. 9
Origin of Medical Device Adverse Event Reports
https://www.tga.gov.au/sites/default/files/medical-devices-post-market-vigilance-statistics-2014.pdf

10. 10
US: FDA Medical device Reporting 21 CFR 803
A MDR Reportable Event is defined as:
• An event that user facilities become aware of that
reasonably suggests that a device has or may have
caused or contributed to a death or serious injury of a
patient
OR
• An event that manufacturers/importers become aware of
that reasonably suggests that one of their marketed
devices
– May have caused or contributed to a death or serious injury
– Has malfunctioned and that may potentially cause or
contribute to death or serious injury when the event would
recur

11. 11
Another few definitions…
• Becomes aware:
– An employee of the manufacturer/importer or device user facility who is
required to report medical device events has received/acquired information
that reasonably suggests a reportable event has occurred
• Caused or contributed also includes events occurring as a result of:
– Failure, malfunction, improper or inadequate design, manufacture, labelling
or user error
• Serious injury or illness includes any event that:
– Is life-threatening
– Results in permanent disability of patient or impairment of body functions
– Requires medical /surgical intervention to prevent permanent disability/
impairment
• Malfunction refers to failure of a medical device to meet its performance
specifications

12. 12
Medical Device Problems or Adverse Events
• An event whereby a medical device has, or may have, caused or
contributed to a death or serious injury.
• Includes events resulting from:
– Problems with Instructions/labeling/packaging
– Failure to work as intended/malfunction
– Improper or inadequate device design
– Manufacturing problems
– Interactions with other devices
– Defects
– Software problems
– Use errors
– Combinations of the above

13. 13
Mandatory MDR reporting requirements
Reporter What to report To whom Timelines for
reporting
Manufacturer Reports of deaths, serious
injuries and malfunctions
FDA Within 30 days of
becoming aware
Manufacturer -Specific type of events
upon request by FDA
-Event that requires
remedial action to prevent
an unreasonable risk of
substantial harm to the
public health
FDA Within 5-days of
becoming aware
(5-day report)
Importer Reports of deaths and
serious injuries
FDA and
manufacturer
Within 30 days of
becoming aware
Importer Reports of malfunctions Manufacturer Within 30 days of
becoming aware

14. 14
Summary of mandatory reporting requirements- Continued
Reporter What to report To whom Timelines for
reporting
Device User
facility#
Device-related Death FDA and
manufacturer
Within 10 work
days of becoming
aware
Device User
facility
Device related Serious
Injury
Manufacturer
(FDA only
when
manufacturer
is unknown)
Within 10 work-
days of becoming
aware (5-day
report)
Device User
facility
Annual summary of death &
serious injury reports
FDA January 1st of the
preceding year
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm#2
# hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical
facilities.

15. 15
Manufacturer MDR Requirements
• Supplemental reports are required when
-New information comes available after the submission of the initial
report
-Report within 30 days after receiving the additional/corrected
information
• Submit required information on FDA MedWatch Form 3500A or in
electronic equivalent as approved.
• Implement a complaint procedure to ensure that complaints are
evaluated to determine whether the complaint represents in fact an
event which should be report under 21CFR803
• Develop, maintaine, implement MDR Standard operating procedures

16. 16
Medical Device Non-compliance issues during FDA Inspections

17. 17
FDA- Sent warning letters to 12 Medical Device Companies
http://www.massdevice.com/fda-sends-warning-letters-12-medical-device-companies/

18. 18
Poll: Multiple adverse events on different days in same
patient with same device
How you report adverse events involving the same patient and
same device but occurring on different days?
A) Submit one report describing all occurrences of the reportable
event in the patient.
B) Submit one report describing all the reportable events in the patient
for each day the event occurred.
C) Submit one report describing the reportable event for the patient
for each occurrence

19. 19
Poll: Multiple adverse events on different days in same
patient with same device
How you report adverse events involving the same patient and
same device but occurring on different days?
A) Submit one report describing all occurrences of the reportable
event in the patient.
B) Submit one report describing all the reportable events in the patient
for each day the event occurred.
C) Submit one report describing the reportable event for the patient
for each occurrence

20. 20
EU Directives for Medical Devices
• Active Implantable
Medical Device Directive
AIMD
90/385/EEC
• Medical Device Directive
MDD
93/42/EEC
• In Vitro Diagnostic Device
Directive
IVDD
98/79/EC

21. 21
Stakeholders Medical Device Marketing
• Manufacturing Medical device
Manufacturers
Subcontractors
• Local entities implementing MDD at national level in each
EU member state
Competent
authorities
• Organizations that are authorized to perform audits
manufacturers QMS and test/assess the compliance of
medical devices
Notified bodies
• Any Manufacturing company that has no affiliate in EU
Authorized
representatives
• Companies distributing Medical Devices in EUDistributors

22. 22
Post-marketing Surveillance (PMS) of Medical Device
Reporting in EU
• Implementation of PMS is required for all Medical devices sold in EU
• PMS should include a systematic review and analysis of
postproduction information including:
– Clinical follow-ups
– Quality complaints
– Customer feedback,
– Vigilance
– New scientific Information
– Literature
• Manufacturers need to develop proactive plans for PMS
• Systematic record management of PMS data

23. 23
Vigilance Reporting for Medical Devices in EU
• Notification of Competent Authorities about Incidents occurring with
medical devices
• Qualified Representative to submit Medical Device Incident Reports
Incident is defined in the EU Medical Device Regulatory Documents as
• Any Malfunction or deterioration in the characteristics and/or performance
of a device, including also insufficient labeling, insufficient instructions for
use , that may lead to the death of a patient or to a serious deterioration of
his/her health
• Any technical or medical reason in relation to the characteristics or
performance of a device leading to systematic recall of devices of the same
type

24. 24
Software as Medical Device
• Software becomes a medical device when the
manufacturer or supplier intends for the software to be
used in:
– Diagnosis
– Prevention
– Monitoring
– Treatment or alleviation of disease

25. 25
Examples of events with Software Medical Devices
• Software problems
– Vital signs monitor did not transmit information to
central station
– Software glitches with new software installation
– Virus infects device operating software
– Day-light savings software considerations

26. 26
Software verification and validation is an essential tool for
ensuring medical device software is safe.
http://medicaldeviceacademy.com/category/software-verification-and-validation/

27. 27
Literature as source of MDR reportable events
…..Reports of deaths or serious injuries. You must
submit a report to us, and a copy of this report to
the manufacturer, as soon as practicable, but no
later than 30 calendar days after the day that you
receive or otherwise become aware of information from
any source, including user facilities, individuals,
or medical or scientific literature, whether
published or unpublished, that reasonably suggests
that one of your marketed devices may have caused or
contributed to a death or serious injury. …
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803&showFR=1

28. 28
How does Elsevier R&D Life Sciences Portfolio support
MDR Reporting?
Embase supports Medical Device
Development and PMS
Quosa PV support triage and review of
literature to identify reportable events
Journals like Smart Health

29. 29
Introducing QUOSA PV : Elsevier’s GxP-compliant PV-
solution for literature management
Conference
Documents
Online literature
database
Journal RSS
Feeds
PSURs
ICSRs
OTHER
SAFETY &
COMPLIANCE
REPORTS
A combination of software and services that allows customers to
reduce risk, remain compliant and ensure that workgroups have
the latest scientific literature
Supervisors
Track deadlines
And bottlenecks
• Automatic alerts import
• Article deduplication
• E2B case data export
• Document listing
exports in Vancouver
format for PSURs
Administrators
View all aspects of
the review process

30. 30
Embase supporting Medical
Device Development and Post
Marketing Surveillance

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Thank you!
For more information about
Embase and Quosa PV visit also
https://www.elsevier.com/rd-
solutions
Dr. Joyce de Langen
Sr Solution Manager Pharmacovigilance
j.delangen@elsevier.com