ODT editorial advisory board members share their thoughts on the most significant events of 2019 and what they expect to watch in 2020.
Thor Rollins, Director of Toxicology and E&L Consulting, Nelson Laboratories
A Look Back—For me, it’s been the implementation of MDR and the change its had on the European regulatory arena. Companies are spending millions and scrambling to update device files to be ready for either an up classification or when they have to submit for renewal of their CE mark. The problem isn’t just the fact that many of these devices have been on the market for decades and have huge gaps per current standards but also that the Notified Bodies are struggling to be ready. Previously, there were as many as 75 different notified bodies to choose from; now we are looking to have under 40 that will apply for designation under MDR. As of right now, we only have 5 that are designated to approve devices under MDR and the deadline is May 2020. We have heard from companies that their notified bodies are telling them that it could take up to 6 months to even hear back from them, so unless we get an injection of designated notified bodies, I am not sure how we will be ready by May.
Gazing at 2020—Besides the circus of MDR designation and up classed devices, I am interested in the movement away from animal testing. We are working with the FDA to get approval of in vitro tests for irritation and thrombosis that will hopefully reduce the dependence on antiquated animal tests.
