The Number of Notified Bodies is Increasing
The EU Commission has authorized today the first notified body for the EU IVDR 2017/746 after the 5 notified bodies which were authorized for the EU MDR 2017/745. With 7 months till the date of the application of MDR, 5 organizations started the certification process.
Although the EU Commission has stated that this number will be increased by the end of 2019, the representatives of the sector have serious concerns as to whether the number will be sufficient for the implementation starting in May 2020.
A list of notified bodies authorized by the Commission is available on the Nando website.