As they say: this is the first day of the rest of your life, and in a way it is. The MDD is dead, long live the MDR! The (AI)MDD is no more now, but is it? Three important events happened today that are all relevant to this question: the MDR became applicable, the Swixit […]
Many people ask me these days: why the urgency with IVDs? The IVDR’s date of application (26 May 2022) is still almost two years away. Why the hurry? The hurry has everything to do with simply counting back from the date of application and understanding the requirements of the IVDR. Notified bodies are very scarce […]
Many people ask me these days: why the urgency with IVDs? The IVDR’s date of application (26 May 2022) is still almost two years away. Why the hurry? The hurry has everything to do with simply counting back from the date of application and understanding the requirements of the IVDR. Notified bodies are very scarce […]
Last week we went past DoE (Date of Entry into force) of the MDR plus three years, and the date on which the MDR was supposed to have become applicable. As you, my dear readers, will all know by now, the date of application (DoA) has been moved with a year now as the outcome […]
With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […]
It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […]
On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]
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 […]