Intended use vs. indications for use. Some older products do not have indications for use. Do you need to redefine intended use to include all indications, or can you use a risk-based approach and use evidence for one high risk indication?

Under the MDR regulations, labeling must include “(b) the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;” Given this new requirement, you will need to identify and include indications in the label. Furthermore, your risk management file for the medical device or medical device family must include your assessment of the product risk in the context of the intended use or purpose, as well as any reasonably likely misuse.