With the May 2020 EU Medical Device Regulation (MDR) now less than nine months away, we have hit a critical milestone in what already promises to be a challenge for the global healthcare industry. 

As of now, in early September 2019, there are four Notified Bodies (NB) that are designated under the EU MDR: Italy's IMQ, Germany's Dekra and TÜV SÜD, and the UK's BSI. Beside the fact that Brexit could potentially nullify product certifications from BSI, the nine month window is a concern because NBs take six to nine months to certify a medical device. If companies have not begun the process to get their Class I devices (as Class II and III have a grace-period) certified with these NB's, they could miss the May deadline.  

Therefore, the U.S. as well as a number of industry groups have asked for a delay in the implementation, or at the very least, an expansion of the grace-period for more devices. Now that we have entered the window of the critical path for certification, the concern and calls for change around MDR will only increase.