Articles by Emergo

1. MDSAP: Ready for Prime Time? 12/1/2016

   With MDSAP’s multi-year pilot set for completion at the end of December, followed by full implementation early in 2017, manufacturers may question whether the program actually is ready. Ongoing gaps in coordination between some participating regulators, as well as low to middling participation rates so far among device manufacturers, may result in a less than auspicious launch.

2. Preparing For New European Medical Device And IVD Regulations 7/18/2016

   Although final publication of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) is unlikely to occur before early 2017, companies now can map out transition and compliance plans with more certainty. Here, we’ll discuss the crucial considerations that firms should weigh in the meantime.

3. Preparing For The New EU Medical Device Regulations — A Eudamed Sneak Peek 3/29/2016

   When European lawmakers and regulators first indicated plans to overhaul legislation on how the union oversees medical devices and in vitro diagnostics (IVDs) in 2010 and 2011, industry participants knew such changes to the world’s second-largest device market would be anything but sudden.