After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […]
It’s hard to keep up with all the work and the new publications of guidance these days. Abundance creates its own problems one could say, so that’s why this blog was slightly delayed. Due to the COVID-19 epidemic I have had to home quarantine the family, move the whole law firm to a virtual platform […]
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 […]
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 […]
You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on. After some pretty mysterious statements of Commission officials in public […]