EU medtech labeling compliance and the competitive advantage of a digitalized process
Rowan Nidd, a regulatory affairs and labeling expert at PA Consulting, and Maggie Chan, a life sciences and regulatory expert at PA, authored an article for Med Device Online discussing EU medtech labelling compliance, and explaining how labeling optimization and digitalization could reduce lead times for placing devices on the market.
Optimizing and digitalizing labels can provide the medtech industry with a significant competitive advantage by enhancing speed to market, ensuring products remain on the market, reducing costs, and alleviating resource burdens. In an industry where time and regulatory compliance are crucial, efficient labeling processes are essential for bringing medical devices to market quickly and play a vital role in keeping products available to patients and healthcare providers. According to MedTech Europe’s survey on the availability of medical devices in 2022 in connection to Medical Device Regulation (MDR) implementation, there is an average lead time of 13 to 18 months for a labeling change to be fully implemented.
Below we examine the key challenges within labeling that are playing into these long lead times and how labeling optimization and digitalization could reduce lead times and costs of placing – and maintaining – a device on the market.