Labeling and IFU Compliance Soon to Follow EU MDR Transition

Multiple manufacturers are seeing postponement of the EU MDR as a boon. This one-year delay has helped them in organizing the labeling and instructions for use associated with their medical devices. Manufacturers are of believe that similar regulations related to medical device labeling and IFUs would be soon following this transition and hence preparing ahead of time is bound to bring more benefits.

Medical Device Labeling Requirements:

Product lifecycle management (PLM) would not be of much help in assuring compliance to EU MDR. The main reason behind this is geographical variations and this might lead to differentiation in product packaging sizes and even labeling artwork. There is very little scope of correction and hence dependency is more to ensure efficacy. Cloud-based labeling allows manufacturers to have a taste of the future. The extended time that is required to gain compliance in this transition will be excessively reduced with the introduction of a cloud-based system. Medical device labels will be more transparent when both labeling content, as well as IFU content, will be generated from a single source. This would further ensure security along with complete traceability.  

General Labeling Requirements under EU:

MDR has certain generalized norms for labelling that needs to be followed by medical device manufacturers in Europe. Every label needs to possess the trade name and name of the device. Complete instruction for use (IFU) for the users, registered address of manufacturer along with the registered trademark.  Every label should contain the lot and serial number with proper heading. In case a manufacturer is operating from outside then the label must contain the name of the authorised representative. Moreover, the mention of the date of manufacturing, as well as expiration, needs to present on the label, wherever it might be applicable.

Upcoming Medical Device Labeling Regulations:

The transition from EU MDD to EU MDR is not the end it is bound to be followed by a series of other changes. Labeling changes are next that need special attention from the manufacturers. If you are a manufacturer of medical devices then it is time to buckle up so that you do not fall prey to non-compliance in the future. As per Brexit every medical device that would be entering the UK market after June 2023 need to be UKCA market to remain operative. In addition, products reaching Northern Ireland to undergo conformity assessments are required to possess UKNI marking since January 2021. If a label is impactful then its identification, upgradation, and approval are necessary under EU MDR. 

There is something more, countries like China and Australia are not far behind as they too are implementing new regulations similar to EU MDR.