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.
“Industry maintains that the product standards necessary for compliance with MDR cannot be completed before the deadline.”