There’s a new EU Medical Device Regulation (MDR) that will be effective in 2020

This article goes into the “6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation”:
1. Plan Ahead
2. Conduct a Thorough Review
3. Invest Time and Resources
4. Start Small
5. Adopt Early
6. Address Reclassification if Necessary

“Under the new EU regulatory approach, there will be no grandfathering of legacy or pre-MDR devices. This means that by the end of the transition process, every CE marked device must by fully compliant with the MDR. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that more than half a million different devices currently CE marked under the MDD must transition to fully comply with the MDR.”

https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/6/6-things-you-need-to-do-to-prepare-for-the-new-eu-medical-devices-regulation
It will be interesting to see how this new MDR regulation will play out. It should be interesting what large international companies do in the next few years.