EU MDR Labeling Compliance: Learning The Lessons From UDI

The European medical device industry is in the grip of the biggest changes the market has seen in decades. Significant new rules to ensure the safety of medical devices became active in June 2017, imposing major new requirements on anybody involved in the design, manufacture, approval and commercialization of devices that are sold in the EU. As organizations struggle to meet the challenges of EU MDR – which is broader and more complex than UDI regulation – there are many lessons to be learned from that UDI experience. This paper presents those learnings, primarily through the lens of the labeling function, but with an appreciation of the wider context of the full regulations. Download the full paper for more information.