Inviting stakeholders comments for Invitro Diagnostic Medical Device adverse event reporting form

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 Section Proposed S. No. Page No. Sub-heading Current Text Explanation Heading Text Name: _______________________________________________________________________________ Designation and Affiliation: _______________________________________________________________Version: 1.0 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 3. 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______________________ 2. 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 3. Reporter Contact Information : a) Name : b) Address : c) Tel./ Mobile : d) Email : Page 1 of 4A) In-vitro Diagnostic Medical Device Details Category Sub-category 1. Kits 1. Hematology 2. Reagents 2. Biochemistry 3. Calibrators 3. Microbiology 4. Controls 4. Immunology 5. Analyzers 5. Histopathology 6. Self-testing Kit 6. Molecular Biologics 7. IVD software 7. Gastroenterology & Urology 8. Others Specify_____________________ 8. Gynecological 9. Toxicology 10. Others Specify_____________________ Generic In-Vitro Diagnostic Medical Device Name: Trade Name/ Brand Name: Details Name Address Manufacturer Importer Distributor Marketed by 1. IVD-MD Risk Classification as per Indian MDR 2017 : A B C D 2. 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 2 of 4B) Event Description 1. Date of Event (DD/MM/YYYY) : 6. Serious Event: Yes If yes, tick the appropriate reason 2. Type of Adverse Event: a) Death (DD/MM/YYYY) Malfunction b) Life Threatening Use error c) Disability or Permanent Damage Insufficient or Inadequate labelling or Instructions for use Insufficient Reagent d) Hospitalization/ Prolongation of Existing Hospitalization False Positive e) Congenital Anomaly False Negative f) Required Medical Intervention/ Permanent Impairment or Invalid Test Damage Wrong Result Other g) Other (Important Medical Event) Specify____________________________ Specify____________________________________________ 3. Location of Event: 7. Non-serious Event Hospital Blood Centre 8. Whether other in-vitro diagnostic medical devices were used at Pathology Lab Home same time with the above device: Yes No Other specify_________________________ If yes, specify the name(s)/ use(s) 4. IVD/Instrument/Analyser Operator: Healthcare Professional Problem noticed prior to use Laboratory operator Patient Others specify______________________ 9. Event outcome and reoccurrence information a) Event abated after use is stopped/ reduced? 5. IVD/Instrument/Analyser in use after incidence: Yes No 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 Year No. of Similar Adverse Events Total No. Supplied Frequency of Occurrence (%) Similar Adverse Event in India in Past 3 Years 12. Frequency of Occurrence of Year No. of Similar Adverse Events Total No. Supplied Frequency of Occurrence (%) Similar Adverse Event Globally in Past 3 Years Page 3 of 4C) Patient Information, History and Outcome 1. Patient Hospital ID : 7. Patient outcomes a) Death (DD/MM/YYYY) _______________ 2. Patient Initial : b) Recovered (DD/MM/YYYY) _______________ 3. Age : c) Not yet recovered 4. Gender : Male Female Transgender d) Stable 5. Weight : e) Other Specify______________________________________ 6. Other relevant history : (including pre-existing conditions, treatment, allergy) D) Healthcare Facility Information (If available) 1. Name : 2. Address : 3. 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: 2. Suspected Root Cause of Problem: 3. 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 2. Investigation Action Taken with Timeline: 3. Root Cause of Problem (Applicable for follow up/ final reports): 4. 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 Page 4 of 4List of Document to be attached Healthcare Domestic Government Pathology Importer Blood Centre professionals Manufacturer Program 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