The Central Drugs Standard Control Organization (CDSCO) has released a new version of the Medical Device Adverse Event Reporting Form under the Materiovigilance Program of India (MvPI), i.e. version 1.2. This form was released on October 8, 2024.
What is the MvPI?
The Materiovigilance Programme of India (MvPI) is a national program for monitoring and reporting adverse events associated with medical devices. This article provides a guide to filling out the MvPI reporting form (Version 1.2).
Who Should Report?
- Manufacturers
- Importers
- Distributors
- Healthcare Professionals
- Others (specify)
It also worthwhile to note that submitting a report does not imply fault on the part of the healthcare professional, manufacturer, or product. Additionally, patient confidentiality must be strictly maintained.
Filling Out the Form
A. Primary Information
- Date of Report (current date)
- Type of Report (Initial, Follow-up, Final, Trend)
- Reference Numbers (if applicable)
B. Reporter Details
- Type of Reporter (tick appropriate box)
- Contact Information (name, address, phone, email)
C. Medical Device Category
- Select applicable categories (therapeutic, invasive, etc.)
- In Vitro Diagnostics (IVD) categories (if applicable)
D. Medical Device Description
- Common Name, Trade Name/Brand Name
- Manufacturer/Importer/Distributor Information
- Device Risk Classification
- Refurbished Device Information (if applicable)
- License No., Model No., Catalogue No., Lot/Batch No., Serial No. (if applicable)
- Software Version (if applicable)
- Associated Devices/Accessories
- Nomenclature Code (if applicable)
- Unique Device Identification Number (UDI No.) (if applicable)
- Installation Date, Expiration Date (if applicable)
- Last Preventive Maintenance/Calibration Date (if applicable)
- Year of Manufacturing
- How Long Device Was in Use
- Availability of Device for Evaluation
- Usage as per Manufacturer Instructions
E. Event Description
- Date of Event/Near Miss Incident
- Type of Event (adverse event, product problem)
- For Implantable Devices Only: Implantation/Explantation Dates (if applicable)
- Location of Event
- Device Operator
- Device Disposition/Current Location
- Device Use After Incident
- Serious or Non-Serious Event
- Other Medical Devices Used Concurrently
- Event Outcome and Reoccurrence Information (abated/reappeared after use stopped/reintroduced)
- Detailed Description of Event (including any attachments)
F. For Manufacturer/Authorized Representative Use Only
- Frequency of Similar Events in India/Globally (past 3 years)
- Investigation Needed (Yes/No)
- Investigation Action Taken with Timeline
- Root Cause of Problem (follow-up/final reports)
- Corrective and Preventive Action (CAPA) Taken
G. Patient Information, History & Outcome
- Hospital ID, Patient Initials, Age, Gender, Weight
- Relevant Medical History, Treatment Details, Patient Outcome
- Name, Address, Contact Information of healthcare facility
H. Medical Device Adverse Event Assessment
- Immediate Action Taken
- Suspected Root Cause of Problem
- Association Between Device and Event
The informant shall submit a soft copy of the report via email to mvpi-ipc@gov.in or shatrunjay.ipc@gov.in Alternatively, a hard copy can be submitted to Indian Pharmacopoeia Commission, Ghaziabad-201002.
