Delivering EU Medical Device (MDR 2017/745) & In-Vitro (IVDR 2017/746) Regulatory Compliance
In May 2017 the new EU medical device & in-vitro regulations came into force that sets into motion the three year countdown to the new regulations being fully applied.
If you currently produce and/or sell medical devices or in-vitro medical devices, to continue to do so you will need to be compliant with the new regulations, their processes and be able to present all documentation that is legally required within the respective time frames.