New EU regulation for medical devices will have major implications for the labelling operations of every manufacturer that trades in the EU. EU MDR, which began a five-year pre implementation period in May 2017, will be fully adopted in 2022. However, the first major milestone – the introduction of an EU Database for Medical Devices (EUDAMED) – is on track to launch in 2020. Mark Cusworth, PRISYM ID looks at labelling challenges wrapped up in the regulation.