86 Inviting stakeholders comments for Invitro Diagnostic Medical Device adverse event reporting form 2025-Feb-17 325 KB

Indian Pharmacopoeia Commission
Materiovigilance Programme of India (MvPI) Ministry of Health and Family Welfare Government of India

Draft In-vitro Diagnostic medical device (IVD-MD) adverse event reporting form for Comments

Published on: 17/02/2025

Last Date for Submission of Comments: 05/03/2025

Subject: Inviting comments from the stakeholders for the draft IVD-MD adverse event reporting form.

Based on the suggestions provided by the stakeholders, MvPI in collaboration with the CDSCO and the IVD manufacturers associations, has created this draft IVD reporting form. This form will help the stakeholders to capture the adverse events related to In-vitro Diagnostic medical device (IVD-MD). The content of this draft reporting form is not final and the text may be subjected to revision before being finalized by the MvPI. Manufacturers, regulatory authorities, healthcare professionals, and other stakeholders are invited to provide their feedback and comments on this draft proposal. Comments received after the last date will not be considered by the MvPI. Please send any comments you may have on this draft document to naveen.v96@gov.in before the last date for comments. Stakeholder Feedback form

S. No. Page No. Section Heading Sub-heading Current Text Proposed Text Explanation

Name: _______________________________________________________________________________

Designation and Affiliation: _______________________________________________________________

Version: 1.0

Page 1 of 4

IN-VITRO DIAGNOSTIC MEDICAL DEVICE ADVERSE EVENT REPORTING FORM Materiovigilance Programme of India (MvPI) This form is intended to collect information on In-Vitro Diagnostic Medical Devices Adverse Event in India. The form is designed to be used by Domestic Manufacturer / Importer / Distributor of In-Vitro Diagnostic Medical Devices, Pathology Laboratory, Blood Donation Centre, Government Program In-charge and Healthcare Professionals with direct/indirect knowledge of In Vitro Diagnostic Medical Devices Adverse Event. Disclaimer Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the adverse event. Submission of a Medical Devices Adverse Event (MDAE) Report does not have any legal implication on the reporter. Confidentiality The patient/reporter’s identity is held in strict confidence and protected to the fullest extent. Programme staff is not expected to and will not disclose the patient/reporter’s identity in response to a request from the public. Primary Information 1. Date of Report : 2. Type of Report : Initial

Follow up

 Final   

Trend

Report Reference No. for MDMC1 only : Centre Location Month – Year Case No. 4. Report Reference No. for MAH2 only : 1MDMC-Medical Device Adverse Event Monitoring Centre, 2MAH-Market Authorisation Holders
Reporter Details 1. Type of Reporter : Manufacturer

Importer

Distributor 

Healthcare Professional

Pathology Laboratory 





Blood Center 






Government Program In charge 




Others  

Specify______________________

In case, Where the Reporter is not the Domestic Manufacturer / Importer of the product, Fill the Following Details: - a) Has the Reporter Informed the Incident to the Domestic Manufacturer / Importer of the product?
Yes

No

b) If Yes, Event reported to Manufacturer / Importer via i) Email

ii) Written communication

iii) Telephonic communication

iv) Other

Specify_______________________ c) Is the Reporter also submitting the report on behalf of the manufacturer?

Yes

No

Reporter Contact Information : a) Name
:

b) Address :

c) Tel./ Mobile :

d) Email
:

Page 2 of 4

A) In-vitro Diagnostic Medical Device Details Category Sub-category

1. Kits

2. Reagents

3. Calibrators

4. Controls

5. Analyzers

6. Self-testing Kit

7. IVD software

8. Others

   Specify_____________________

Hematology

Biochemistry

Microbiology

Immunology

Histopathology

Molecular Biologics

Gastroenterology & Urology

Gynecological

Toxicology

10. Others

Specify_____________________

Generic In-Vitro Diagnostic Medical Device Name:

Trade Name/ Brand Name:

Details Name Address Manufacturer

Importer

Distributor

Marketed by

IVD-MD Risk Classification as per Indian MDR 2017

: A

B

C

D

License No. (Manufacturer/ Importer)

: 3. Model No.

: 4. Catalogue No.

: 5. Lot/ Batch No.

: 6. Serial No.

: 7. Software Version (If applicable)

: 8. Associated IVDs / Accessories

: 9. UDI No. (If applicable)

: 10. Manufacturing Date (If applicable)

: 11. Expiration Date (If applicable)

: 12. Last Calibration Date (DD/MM/YYYY) (If applicable)

: 13. How long the IVD/ Instrument/ Analyser was in use

: 14. Availability of IVD/ Instrument/ Analyser for evaluation

: Yes

No

If no, was the IVD/ Instrument/ Analyser

:
Destroyed

Still in use

Returned to the Manufacturer/ Importer/ Distributor

Other Specify________________________________ 15. Is the IVD/ Instrument/ Analyser used as per Manufacturer claim/
Instruction for use/ User manual

: Yes

No

If no, Specify usage_______________________________________________________________________________________________________

Page 3 of 4

B) Event Description 1. Date of Event (DD/MM/YYYY) : 2. Type of Adverse Event: Malfunction

Use error

Insufficient or Inadequate labelling or Instructions for use

Insufficient Reagent

False Positive

False Negative

Invalid Test

Wrong Result

Other

Specify____________________________

Location of Event: Hospital

Blood Centre

Pathology Lab

Home

Other specify_________________________

IVD/Instrument/Analyser Operator: Healthcare Professional Problem noticed prior to use

Laboratory operator

Patient

Others

specify______________________

IVD/Instrument/Analyser in use after incidence: Yes No

Serious Event:
Yes If yes, tick the appropriate reason a) Death (DD/MM/YYYY)

b) Life Threatening

c) Disability or Permanent Damage

d) Hospitalization/ Prolongation of Existing Hospitalization

e) Congenital Anomaly

f) Required Medical Intervention/ Permanent Impairment or
Damage

g) Other (Important Medical Event)

Specify____________________________________________

Non-serious Event

Whether other in-vitro diagnostic medical devices were used at same time with the above device: Yes

No

If yes, specify the name(s)/ use(s)

Event outcome and reoccurrence information a) Event abated after use is stopped/ reduced? Yes

No

NA

b) Event reappeared after reintroduction? Yes

No

NA

10. Detail Description of Event:

Note: Do you have any relevant diagnostics test/laboratory data/pictures/videos related to the events Yes

No

If yes then kindly provide them while submitting the filled application form.

For Manufacturer/Authorized Representative Use Only

11. Frequency of Occurrence of Similar Adverse Event in India in Past 3 Years Year No. of Similar Adverse Events Total No. Supplied Frequency of Occurrence (%)

12. Frequency of Occurrence of Similar Adverse Event Globally in Past 3 Years Year No. of Similar Adverse Events Total No. Supplied Frequency of Occurrence (%)

Page 4 of 4

C) Patient Information, History and Outcome 1. Patient Hospital ID

: 2. Patient Initial

: 3. Age

: 4. Gender

: Male Female Transgender

Weight

: 6. Other relevant history

:
(including pre-existing conditions, treatment, allergy)

Patient outcomes a) Death (DD/MM/YYYY) _______________ b) Recovered (DD/MM/YYYY) _______________ c) Not yet recovered

d) Stable

e) Other

Specify______________________________________ D) Healthcare Facility Information (If available) 1. Name

: 2. Address

:

Contact Person Name at the Site of Event
: 4. Tel. No. /Mobile No.

: 5. Email

: E) IVD Medical Device Adverse Event Assessment / False Positive / False Negative / Invalid Test / Wrong Result 1. Immediate Action Taken:

Suspected Root Cause of Problem:

In Your Opinion, Which of the Following Best Describe the Association between Suspected In vitro diagnostic Medical Device(s) and Adverse Event? a) Not related

b) Possible

c) Probable

 d) Related  

F) For Manufacturer/Authorized Representative / Pathology Laboratory, Blood Donation Center, Government Program In charge, Healthcare Professionals and License Holder Only 1. Investigation Needed? Yes

No

Investigation Action Taken with Timeline: 3. Root Cause of Problem (Applicable for follow up/ final reports):

Corrective and Preventive action (CAPA) taken:

Where to report?

Duly filled Medical Device Adverse Event Reporting Form can be send to Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Sector-23, Rajnagar, Ghaziabad-20002, Tel-0120-2783400, 2783401 and 2783392, or email to mvpi-ipc@gov.in , shatrunjay.ipc@gov.in or Call on Helpline no. 1800 180 3024 to report Adverse event.

Partnering Organizations

List of Document to be attached

Healthcare professionals Domestic Manufacturer Importer Government Program Blood Centre Pathology Laboratory Product/ premises license copy

√ √ √ √

Copy of Invoice

√ √ √ √ Copy of purchase bill

√ √ √ IFU/ Operator Manual/ Product Brochure/ Product labels √ √ √ √ √ √ Video/ Photograph of used/ tested kit √ √ √ √ √ √