The Medical Device Regulation (MDR), Regulation (EU) 2017/745, was published on Friday 5th May.
This long-awaited milestone that will organise Medical Devices and their related requirements in a completely different way.
Monitoring traceability and Lifecycle Management of Medical Devices will be crucial within the MDR.
The implementation of this new regulation within the EU, will be set in motion to commence by the end of May.
The new law will come into effect after 3 years. During that period the Medical Device Directive and the MDR can co-exist.
Product Lifecycle Management is here to stay and Unitron is your partner.
The Device and the associated Regulations we take serious so that your market position is guaranteed.
Please do not hesitate to contact us to work out what this means for your product.