What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]
I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described. The new guidance The MDCG has […]
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 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 […]
Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]
Welcome to 2020 – happy new year everyone. I don’t care if your conventions do not allow me to wish you best wishes after a certain date anymore. I wish you a happy 2020 because I genuinely hope you will have it. If you are a reader of this blog and you have a happy […]
Just before the Christmas holidays the Commission updated its rolling plan and the MDCG ongoing guidance overview. As the year draws to an end, the date of application of the MDR is very close now and I see more and more things happen that everybody could see coming for a long time, I would like […]
I have written about the PRRC before, when the MDCG PRRC guidelines came out earlier this year. With more experience with the subject in the mean time and everybody working to understand the subject, I thought it was a good idea to revisit the subject. And another good reason was that I had to look […]
The public part of the Employment, Social Policy, Health and Consumer Affairs Council meeting on last Monday, 9 December 2019 gave an interesting peek into how the Commission and the Council see the state of affairs with the MDR and IVDR implementation at the moment, and notably as well the delay of Eudamed implementation. The […]
Everybody has been in enormous suspense about how the second corrigendum to the MDR and IVDR would turn out. The version that came out of the European Parliament’s ENVI committee vote contains a number of very technical points that I will not elaborate on. But it also contains the big break for certain class I […]