The Ministry of Health and Welfare recently updated the Medical Device Regulation India 2017, by the inclusion of eIFU for medical devices. These changes have beneficial advantages whereas as well as challenges in their implementation also exist.
IFU stands for Instructions for Use. These are a set of guidelines and operating procedures, supplied with the medical device to give the operator an understanding of their functionality. In short, it can also be termed as a sort of user manual.
Till now, the GOI had provisions for hard copy IFU for medical devices. But with the recent amendments, the government has granted the use of Electronic Instructions for Use (eIFU) for medical devices. These changes have come into effect from 15 January 2019.
This means that instructions for the use of medical devices can now take an electronic form(video, text file or any other format) rather than just being in the printed form.
Advantages of using eIFU for the Indian Medical Industry
Accessibility: electronic devices are easier to be kept and accessed as compared to printed instructions. The eIFU eliminates the chances of being separated from the device or being damaged under the influence of any adverse conditions.
Ease of Updation: Electronic instructions can be easily updated for any changes using online or offline procedures. Whereas printed instructions don’t offer such flexibility.
Interactive: Electronic instructions can use graphics and videos to offer a more interactive and easy to understand approach for the user. This fully eliminates any chances of error or mishandling, compared to paper instructions.
Multi-faceted access - eIFU allows the manufacturer to store instructions in multiple languages and formats so it is easy for the user of any region or comprehension levels to understand.
Some Probable Disadvantages
Cost: Adding eIFU will require the manufacturers to spend some extra money for the development of the interface, graphics or videos. Plus, some devices might require adding a new set of the display to play the instructions
Parallel Access: For devices with a single screen, it might become difficult for the user to switch back and forth among different screens, especially when the machine is performing a medical procedure.
This decision made by the GOI has brought Indian Medical Regulations at par with those of more advanced countries like the USA and UK. These rules shall now be called the Medical Devices (Amendment) Rules 2019 and the words “instructions for use” will be followed by “or electronic instructions for use
The update/amendment in the Medical Device Rules has paved the way for the implementation of eIFU with the medical devices. These new procedures will have certain advantages and disadvantages, but it will help the medical device industry for sure.