The publication of new European Union (EU) regulations addressing medical devices and in vitro diagnostic devices is now on the horizon.
The EU’s long-awaited Medical Device Regulation (MDR) and InVitro Diagnostic Regulation (IVDR) are now expected to be published in the Official Journal of the European Union sometime in late April or early May of this year. Once published, the MDR will provide manufacturers with a three year transition period, with the regulation coming into force in 2020. The IVDDR, on the other hand, will provide a five year transition period, coming into force in 2022.
English versions of the regulations were expected to be available by the end of January, with translations of the regulations into all EU languages expected sometime in February. Formal adoption of the regulations by the EU Council and the EU Parliament would then follow in March or early April.
To date, the parties involved in the translation of the regulations have reportedly been able to avoid reopening formal negotiations on the regulations’ requirements, resulting in the hoped-for publication by May.
View a detailed timeline of the path to publication of the MDR and IVDR.
