atrify supports the European Commission, its Member States and industry leaders to enable compliance to these new regulations which, based on more stringent requirements, will protect patients even further, increase transparency and build trust in healthcare overall.
We have worked hard with our customers to be ready for the registration of device information into EUDAMED, leveraging the experience gained in other UDI regulatory projects such as the GUDID in the US, we will continue interacting with the EU's Medical Device community to address future steps towards MDR compliance, as well as the now imminent IVDR implementation - which brings many similar but its own unique challenges.
The Medical Devices Ordinance (MDR) will come into force on May 26, 2021, replacing the old guidelines from the 1990s. EUDAMED has been live since December 2020 (module actor registration) and the next two modules (UDI and certificates) will go live at the end of September 2021.atrify supports the EU Commission, the member states and the industry in enabling compliance with a regulation that, due to stricter requirements, is supposed to protect patients even better and create more transparency and trust in our legal framework.
We have worked intensively with our customers to prepare the registration of device information in EUDAMED, using the experience from other UDI regulatory projects such as GUDID in the USA; and we will continue to exchange ideas with our community to address the future steps of MDR compliance, as well as the upcoming IVDR implementation - which brings with it many similar, but also very specific challenges.
