The new Regulation on Medical Devices i.e. EU MDR, which entered into force in May 2017 and has now been enforced after 4 years of transition period on 26 May 2021, which makes it mandatory for every manufacturer of medical devices to comply with added requirements. The IVDR shall be enforced on 26th May 2022 and imposes similar requirements on In-Vitro Diagnostic devices.
Obligations under the new regulation also apply to products already authorized and placed on the market based on Medical device or In-Vitro Diagnostic device directive.
One such requirement include Registration on EUDAMED.
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. Now the concept of EUDAMED is not completely new, it already existed under MDD/IVDD, however now under the MDR/IVDR; there is a much larger database with improved transparency and coordination of information regarding medical devices/IVD devices available on the EU market. The system will be multipurpose. It will function as a registration system, a collaborative system, a notification system and a dissemination system (open to the public) and will be interoperable.
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