Review of packaging artwork and IFU

Before being placed or made available on the market, a medical device must be accompanied by the information necessary to identify the device and the manufacturer, as well as all relevant safety and performance information for users or other persons, as applicable.

A manufacturer must therefore ensure that this information, which may appear on the device itself, on the packaging, and in the instructions for use (IFU), complies with legal requirements.

Manufacturers transitioning from previous directives to Regulation (EU) 2017/745 (MDR) must carefully assess whether the information accompanying the device complies with the new provisions.

The MDR has also introduced new obligations for other economic operators. Specifically, a distributor or an importer, respectively, must verify that certain aspects of the labeling and instructions for use are compliant before making available or placing a medical device on the market.

If this is not the case, they must not make the medical device available or place it on the market until it has been brought into conformity, simultaneously informing the manufacturer and, if applicable, the authorised representative and/or importer, under penalty of penalties under national legislation.

In this context, Di Renzo Regulatory Affairs can support economic operators by providing a review of packaging artwork and IFUs to verify the accuracy of the information included in compliance with the regulatory requirements of the MDR.