The MDCG has issued an update to a guidance document in the form of a position paper initially released in 2022 regarding a notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements.
The updated position paper sees the addition of a new section entitled Call to notified bodies to streamline the certification process this section specifically calls on Notified Bodies to make the certification process more efficient, transparent and predictable. In addition to this, the MDCG also calls for the continuous monitoring of the progress of the implementation of MDR and IVDR by providing data concerning the certification of devices on a regular basis.
There has also been a revision in the section Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay.
The updated position paper can be accessed using the following link
