Medical Device Safety Guidelines released by MvPI (Materiovigilance Programme of India): MvPI is governing body, which regulates medical device vigilance activity in India. Medical Device Vigilance is an obligation for MAH for approved medical devices per MDR 2017 (Medical Device Rules 2017). PharmXL is emerging life sciences company, which offers Materiovigilance services. We also offer Pharmacovigilance Services, Regulatory Affairs services and Clinical Trials services. For any query, reach us: contact@pharmxl.com Info@pharmxl.com Visit: www.pharmxl.com Linkedin: https://www.linkedin.com/in/pharmxl-international-pvt-ltd-407a77167/

1. welcomes You
Your Materiovigilance
partner

2. Medical device Safety Guidelines
by
Materiovigilance Programme of India
(MvPI)

3. www.pharmxl.com 3
• New Medical device rules 2017
• Materiovigilance Program of India
This training material is prepared with reference to
Reporting safety information
ICSRs
Quality
• Handling of Individual Case Safety Reports
(ICSRs) for marketed products.
• Handling of safety information for
marketed products
• Handling of product quality complaints for
marketed products
• Reporting of serious/non-serious ICSRs to
Regulatory authority
For Purpose of

4. Materiovigilance Programme of India(MvPI)
www.pharmxl.com 4
• Medical device is defined as any instrument, equipment, material or other article
used on its own or jointly, including software required for it to function correctly,
which is intended by the manufacturer to be used on humans for the following
purposes :
• for diagnostic, prevention, control, treating or diminishing an illness or
compensating an injury or handicap
• for studying, replacing or modifying part of the anatomy or a physiological
process
• “MV also known as device safety, is the science and activities relating to the
collection, assessment, detection, monitoring and prevention of adverse events or
any other device-related problem.”
• It enables dangerous devices to be withdrawn from the market and to eliminate
faults in medical devices with the intention of constantly improving the quality of
devices and providing patients and users with increased safety.
• Medical Devices come under Drugs and Cosmetics Act, 1940 and the Drugs and
Cosmetics Rules, 1945
Materiovigilance

5. What is an Adverse Event?
www.pharmxl.com 5
An adverse event caused by a medical device has, or may have,
caused or contributed to a death, serious or non-serious injury.
Includes events resulting from:
• Device failure
• Device malfunction
• Improper or inadequate device design manufacturing
problems
• Labelling problems
• Training issues
• Handling issues/Use error

6. What is Post-market Surveillance for Medical
Device?
www.pharmxl.com 6
2
Detection
4
Address
1
Monitoring
3
Minimization
• Monitoring medical device performance after the
marketing approval of device to identify the
problems and safety issues that occur during
widespread clinical use.
• Minimization of risks
• Address those problems that
may emerge with real-life use
Monitor known risks
• Early detection and evaluation
problems

7. www.pharmxl.com 7
Why Materiovigilance is Important ?
• Medical device failures account for 13% of all type of adverse events in
medicine (Frost & Sullivan)
• Deaths from hospital errors which is a primary cause of adverse events is
estimated to be 98,000 – 440,000 per year (Journal of Patient Safety 2014)
• The total national costs from preventable adverse events range between $20 billion to $75 billion
annually.
• The annual number of medical device recalls increased by 97% from 2003 to 2012 (FDA Medical
Device Recall Report)
• Software failures number 1 reason for recalls (FDA 2018)

8. Why Materiovigilance require for Device?
www.pharmxl.com 8
• Device related adverse events (DAEs) have severe
consequences:
• Mostly caused by human errors and may be
preventable
• Some are related to quality issues.
• The percentage of hospital admissions due to device
related events in some countries is about or more
than 10%
• DAEs leads to hospital admissions (6.4% of all AEs), 83.3%
of these DAEs were preventable.
• For dental implants , titanium dental implants pose serious
health risks due to the allergy sensitive
1
2
3

9. Why Materiovigilance is Important ?
www.pharmxl.com 9

10. Why Materiovigilance is Important ?
www.pharmxl.com 10
• Disposable Syringes: Extravasations, Air Embolus, Sepsis, Vascular Rupture, Stroke
Possible adverse events reported in literatures related to our products:

11. Why Materiovigilance is Important ?
www.pharmxl.com 11

12. Why Materiovigilance is Important ?
www.pharmxl.com 12

13. Why do we need Materiovigilance?
www.pharmxl.com 13
4 • To promoting adequate and rational uses of device
• To avoid regulatory obligations
3 • To protect patients from unnecessary harm
• To reduce healthcare expenses of patients.
2
• It helps to maintains a good relationship between company and consumers
• It helps to keeps product in the market
1 • It gives the company an opportunity to improve the quality of products.
• It helps to reduce the AEs related to PQC.

14. Registered Medical Device Information
Sharing Portal
www.pharmxl.com 14

15. Post-Market Surveillance of Medical Devices
www.pharmxl.com 15
• Medical device adverse event reports of device-associated deaths, serious
injuries, non-serious and malfunctions.
• Reports used to monitor device performance, detect potential device-related
safety issues, and contribute to benefit-risk assessments of these products.
• Adverse event reports submitted by manufacturers, importers, device user
facilities, health care professionals, patients and consumers.
Post-Market Surveillance
• To improve the protection of the health and safety of patients.
• To reduce the reoccurrence of an adverse event associated
with the use of Medical Devices.
Objective of Post-market Surveillance

16. Post-Market Surveillance of Medical Devices
www.pharmxl.com 16
Reporter
Type of
Report
What to Report Report Form To Whom Time duration
Manufacturers
/MAH/Healthcare
service provider/Clinical
establishment
Non-serious
Reports
Final Report (including AE
causality assessment report
and future preventive &
corrective actions)
MDAER + FSCA
Form
MvPI
mvpi@sctimst.ac.in
mvpi.ipcindia@gmail.com
Within 30 calendar days
of awareness date
Manufacturers
/MAH/Healthcare
service provider/Clinical
establishment
Serious
reports and
SUSARs
Final Report (including AE
causality assessment report
and future preventive &
corrective actions)
MDAER + FSCA
Form
MvPI/CDSCO
mvpi@sctimst.ac.in
mvpi.ipcindia@gmail.com
Within 15 calendar days

17. Objectives of Materiovigilance
www.pharmxl.com 17
• Timely communicating information
• Early detection of unknown safety problems
• Detection of increases in frequency
• Identification of risk factors
• Quantifying risks
• Promoting adequate handling of device
To prevent harm from adverse events in human from authorized
marketing medical device by

18. What should be Reported ?
www.pharmxl.com 18
• Deaths
• Serious injuries Malfunctions
• off-label use
• Misuse
• Lack of efficacy
• Product quality issues
• Falsified and counterfeit medical device
• Labelling and/or packaging issues of the product
Manufacturers/MAH/Importer must report:
• Deaths to CDSCO/MvPI and to the manufacturer
• Serious injuries to the manufacturer
• Voluntary Reporting at 1800-180-3024
User Facilities must report:

19. Sources for information
www.pharmxl.com 19
Sourcesfor
information
Healthcare Professionals
Consumers
Company employees
Literature
Regulatory Authority
Social Media
Company sponsored
websites, Marketing Program
Scientific congresses

20. Individual Case Safety Report (ICSR)
www.pharmxl.com 20
ICSR, includes format and content for the reporting of suspect adverse
events in relation to a marketed device that occur in a single patient at
a specific point of time.
Criteria
for valid
ICSR
at least one
identifiable
reporter
one single
identifiable
patient
at least one
suspect
adverse
event
at least one
suspect
device
marketed by
company.

21. Criteria for Seriousness of ICSRs
www.pharmxl.com 21
Serious ICSR
Death
Life-
threatening
Hospitalisation
or prolong
hospitalisation
Disability/
incapacity,
congenital
anomaly/birth
defect
Others:
Important
medical
events
a serious adverse event corresponds to any untoward medical
occurrence due to use of any medical device results:

22. Work flow for Materiovigilance Activities
www.pharmxl.com 22
Writing of safety data exchange agreement (SDEA) between MAH and PharmXL
Writing of Standard Operating Procedures (SOPs) and Training of Materiovigilance employees
Signed the SDEA between all third parties- distributors and MAH
Training of Field force employees/distributors on relevant SOPs for
collection /handling of AEs originated from market
Create specific Materiovigilance database (software) access for MAH
Validation of MVPI database
Routine MVPI work

23. Work flow for Materiovigilance Activities
Handling of ICSRs
Data entry
Primary review
Medical review-
causality assessment
Submission to
Regulatory Authority
Literature
search
Assessment of
Local expectedness
of serious cases
Handling of Medical
Information/Product
Complaints handling
Routine safety
surveillance, signal
detection and
Management
Risk
Management
IFU/Label
Management
Training of Team
(annual refresher
training )
Audit and Inspections
(both internal-every 6
months and external)
Handling of queries
raised by regulatory
authority
Aggregate safety
reports
www.pharmxl.com 23
Routine MVPI work

24. www.pharmxl.com 24
• This report intended to provide an evaluation of the risk-benefit balance of a medical device for submission
at defined time points during the post-authorization phase.
• The PSUR should focus on summary information, scientific safety assessment and integrated benefit-risk
evaluation.
• For new products (first 2 years: 6 monthly, next 2 years: annually)
• As per MDR 2017, The PSUR should be in following structure:
Preparation & Submission of Periodic Safety Update Reports (for new product only)
1. Title Page
2. Introduction
3. Current worldwide marketing authorization status
4. Actions taken in reporting interval for safety reasons
5. Changes to reference safety information
6. Estimated patient exposure
7. Presentation of individual case histories
8. Studies
9. Other Information
10. Overall Safety Evaluation
11. Conclusion
12. Appendix

25. www.pharmxl.com 25
• Risk Management is the process of measuring or assessing risk and then developing
strategies to manage the risk.
• A set of Materiovigilance activities and interventions designed to identify, characterize,
prevent or minimize risks relating to pharmaceutical products, including the
assessment of the effectiveness of those interventions.
Risk Management Plan and submission to regulatory authority
• It is new finding of Adverse events within safety data that requires further
investigation. It includes:
• Collection of ICSRs from database
• Data cleaning & duplicate detection
• Applying quantitative or statistical methods
• Signal interpretation
Signal Detection for Adverse events

26. Medical device Adverse event reporting
Form
www.pharmxl.com 26

27. Medical device Adverse event reporting
Form
www.pharmxl.com 27

28. Field Safety Corrective Action(FSCA)
www.pharmxl.com 28

29. Field Safety Corrective Action(FSCA)
www.pharmxl.com 29

30. Field Safety Corrective Action(FSCA)
www.pharmxl.com 30

31. www.pharmxl.com 31
PharmXL International Pvt. Ltd.
B-3, Sector-6 Gautam Budh Nagar, Noida, Uttar Pradesh -201301, India
Tel.: 0120-4563024; M.: +91-9266665201, 9266665231, 7827323112,
9310040434
E-mail : contact@pharmxl.com info@pharmxl.com
Website : http://www.pharmxl.com