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The Drugs Technical Advisory Board (DTAB) has agreed with a proposal to amend the Medical Devices Rules (MDR), 2017, to include definition of reportable events related to medical devices, in a move to improve the adverse events reporting on medical devices including in-vitro diagnostic (IVD) medical devices.
The recommendation follows an earlier decision of the Board to revisit the proposal, to ensure that there is no overlapping or ambiguity.
In the 93rd DTAB meeting held recently, the Board considered the proposal to amend rule 26 and rule 38 of Medical Device Rules, 2017 to include the intimation of any reportable events of medical devices including IVD medical devices to the Licensing Authority.
"The Board was apprised about the agenda and after deliberation agreed with the proposal to suitably amend the Medical Devices Rules for incorporating the definition of ‘Reportable Events’ along with consequential changes for reporting of such events," said the minutes of the Board meeting.
At present, the manufacturer or importer of medical devices has the mechanism of quality risk management to ensure the quality and safety of medical devices in the country. The government has also established the Meteriovigilance Programme of India (MPvI) for reporting of SAEs.
However, the reporting of reportable events is not clearly prescribed in the MDR and there is no mandatory requirement of reporting of reportable events by the licence holder, it observed.
It was in this backdrop, the DTAB considered the proposal to amend the Rule 3, Rule 26, Rule 38 and Rule 65 of MDR to include the provisions for intimation of any reportable events of medical devices including in-vitro diagnostic medical devices.
The DTAB, in its meeting held in August, 2024, considered the proposal and after discussions, opined that it needs to be revisited to ensure that there is no overlapping or ambiguity.
It may be noted that the MvPI, in the second half of 2024, released the updated version of the medical devices adverse event reporting form, for the use of manufacturers, importers and distributors of medical devices and healthcare professionals. The new version of the form has been released in tune with the central government's efforts to promote timely reporting of adverse events related to the medical devices.
In February, 2025, The Materiovigilance Programme of India (MvPI), under the Indian Pharmacopoeia Commission (IPC), has released the draft in-vitro diagnostic medical device (IVD-MD) adverse event reporting form inviting comments from the stakeholders.
The draft was prepared by MvPI in collaboration with the Central Drugs Standard Control Orgnaisation (CDSCO) and the IVD manufacturers associations, based on the suggestions provided by the stakeholders.
The CDSCO has also earlier requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the MvPI, in the backdrop of shifting the segment to licensing regime.
All the medical devices including in-vitro diagnostic medical devices have come under the regulation under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017, at present, with mandatory license or approval is required for the import or manufacturing for marketing of the devices in the country. The devices have been classified as Class A, B, C and D and all the classes were brought under the licensing regime in the last two years.
The licenses are issued under these rules with certain conditions, to ensure the quality, safety and performance of medical devices available in the market, as well as to ensure compliance of the quality management system. It is also imperative that all medical device license holders establish robust systems and processes for the timely identification, documentation, and reporting of adverse events associated with medical devices, said the drug regulator.
The Post-market Surveillance (PMS) of medical devices is one of the important aspects to ensure safety and performance of the medical devices. PMS supports identification and addressing of any potential risk or adverse event associated with the medical device. Timely reporting of the adverse events allows for the identification of unidentifiable risks, analysing frequency of already identified risks and enabling the manufacturers and regulatory authorities to take appropriate measures to mitigate these risks and safeguard public health.
“As the MvPI is an important programme for reporting of adverse events, coordinated analysis etc., related to the medical devices including in-vitro diagnostic devices, therefore it is suggested that all the license holders should also use the MvPI platform for reporting of any adverse events/serious adverse events associated with the devices to enhance the procedure for identifying risk associated with medical devices,” said the Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi earlier.
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