Category - Scrutiny


The MDR – where are we now?

There seem to be a lot of misunderstandings in the market about the current status of the MDR. Some think it’s finished (it’s not, at least not formally) and there is a lot of insecurity about when it will enter into force. Currently the MDR and IVDR are in the process of translation. The trilogue […]


The IVD regulation proposal in a nutshell

With this post I would like to make good on a promise I made some time ago: that I would also do an analysis of the proposed IVD Regulation in more or less the same level of detail as I did for the proposed Medical Devices Regulation, so here we go. As a starting point, […]