MENU menu

Patient information management (IFU, Labelling and Cartons)



A ‘Label’ is the identity of the product. It is through the label and contents of the label that an end user identifies the product and could be the first point of information. Different regulations enlist various requirements for labelling. Our experts can support this entire process and ensure that your product/innovation has the correct label with all required information.


Many manufacturers ask our experts  –


What are the labelling requirements for medical devices?



As we all know, the label represents the printed, written, and graphic information that appears on the medical device itself or its packaging. To avoid problems, manufacturers must ensure their product labels contain the following elements:



Why is this label a big deal?



Well, a small error on the label can lead to a product recall. Protect your product with the correct labelling practices designed by our experts!


Apart from labelling, manufacturers also need to comply with IFU requirements.


What is IFU?


IFU stands for “Instructions for Use” and every medical device must have one and it must be accessible to the end-users of the product.


Medical device manufacturers must comply with several requirements regarding the information provided with their devices. Each medical device must be accompanied by the information required to identify the device and its manufacturer and any safety and performance information relevant to the user.


Any misprint, misinformation or missing element can lead to a product recall.


Our experts provide you with comprehensive labelling, IFU and other regulatory affairs solutions.

Contact us for a FREE 30 Minute Consultation by dropping an email at


Med-Di-Dia – Your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!








Get access to the Med-Di-Dia’s newsletter, where industry experts help you to stay on top of shifting global markets.

Stay updated with the latest Trends in the world of Medical Devices!


* indicates required