Lessons & Leftover Challenges from MDR Preparations: What Next?
As new device identification and traceability measures become compulsory in 2020, under the new EU Medical Device Regulation, this white paper explores the residual issues that remain for manufacturers, especially with regard to global labelling management. How might they overcome these challenges effectively - so that they do not fall foul of the new requirements, and so that they are better prepared next time regulatory changes are brought in?
Quote from White Paper: "Probably the biggest impact MDR has had on medical device manufacturers relates to the scale of work involved. Many companies drastically underestimated this, leaving projects too late. Dispersed teams and disjointed processes, as well as inevitable duplication between content sources such as translation databases (for instance where these have existed separately for label and IFU creation), make for highly complex scenarios that take time to unravel."