Category - MDCG


The MDCG cybersecurity guidance – a helpful rush job

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]


The MDCG MDR joint implementation plan

The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]


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, […]