After entering into force on May 25, 2017, the European Union (EU) Medical Device Regulation (MDR) EU 2017/745 will be applied to all Member States from May 26, 2021, after a one-year extension due to the ongoing pandemic. In a previous blog post, we discussed the key aspects of the regulation, namely the stricter regulatory […]
New European Union regulations for medical devices and in vitro devices — Are you ready to thrive in the new landscape?
On May 26th, 2020, the new Medical Devices Regulation (MDR) will be fully enforced and applied to the approximately 500,000 medical devices being sold in the EU. Soon after the MDR comes into full force, the In Vitro Devices Regulation (IVDR) will also replace the old directive, in May 2022. These new regulations put a […]