May 3, 2021 | Classification System, e-Labeling, EMA, Health, Medical Translation, Quality, Regulatory
It has been almost four years since the European Commission passed the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 on May 26, 2017. With the new regulation set to be implemented in 2022, medical device manufacturers looking to market their products...
Apr 24, 2020 | News, Regulatory
In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...
