Bomi Group > The new european regulations will affect your business

The new european regulations will affect your business

New European regulations concerning medical and in-vitro diagnostic devices are closer than you think.

Are you ready for them?
Let's find out.


When and What

The new regulations will replace the three Directives implemented in the 1990s and came into effect on 26/05/2017.

  • There will be a three years transition period in which to implement the new regulations on medical devices;
  • There will be a five years transition period in which to implement the new regulations on in-vitro diagnostic devices.

How can we help you?

Thanks to its state-of-the art proprietary software, BOMI is already capable of guaranteeing full traceability of any type of product, because it complies with the UDI system, and can help your Company to adapt to the new regulations and overcome any challenges in the product supply chain.

MDR 745/2017

IVDR 746/2017