EU MDCG, MDR, IVDR, is this just acronym bingo? What does it mean for Cybersecurity and Medical Devices?
Posted: Dec 24, 2020
Back in May 2017 the EU, through its Medical Device Coordination Group (MDCG) published the Medical Device Regulation (MDR) (EU) 2017/745, which came into effect on 25th May 2017. The regulation was put together to ensure high standards of quality and safety for medical devices being produced in or supplied into the EU. Manufacturers of currently approved medical devices have until May 26th, 2021 to meet the requirements of the regulations. Even if a product is Medical Devices Directive (MDD) compliant, they still need to meet these new regulations.