At Advamed’s San Jose MedTech Conference this year it was quite a surprise for me to see how many US companies are still not doing what is necessary to become compliant with the MDR and the IVDR in time. In the EU MDR session at that conference about 5% of the audience raised their hand […]
In my recent post about potential mass extinction in the EU IVD market as a result of the IVDR and the limited number of notified bodies that look to be applying for IVDR status (and the incredulous reactions that I received) I though it would be a good idea to update on notified bodies in […]
Sometimes you have days that you feel like Cassandra. I had a Cassandra moment after moderating the MDR panel at the Advamed MedTech Conference on 25 September. Cassandra was a lady from mythological heritage. She made the Greek god Apollo angry by changing her mind to be his girlfriend after he had granted her the […]
One of the interesting features of the new MDR and IVDR is the new chapter on economic operators (chapter II), which implements a completely new (to the medical devices industry at least) regime of supply chain regulation and related aspects. The new supply chain regime was on the horizon for a long time because it […]
If you have questions about what the MDR will mean for your company and happen to be in San Jose in California on 25 September, consider attending the evening workshop that Factory (the Dutch devices CRO) and I are organizing on Monday, 25 September 2017 from 19:30 to 21:30 (PDT). You may be in San […]
I see in practice that some companies are well on their way with implementing the new MDR and IVDR regulations, while a lot of others are not. It will be interesting where everyone will be by the time the transitional period of the MDR ends and then when the IVDR transitional period ends. This post […]
As Agent Smith said: “You hear that Mr. Anderson?… That is the sound of inevitability…”. Today’s EU Official Journal contains the final final final texts of the MDR (finally numbered as Regulation (EU) 2017/745) and the IVDR (finally numbered as Regulation (EU) 2017/746), downloadable in any language that you could possibly like. I wish you a pleasant […]
Mark 5 May 2017 in your calendar – this date will be a landmark for EU medical devices law because the MDR and IVDR will be published in the EU Official Journal. This means that the MDR and IVDR will enter into force on the twentieth day following that of their publication and from that date […]
Completely in line with expectations the Parliament adopted the texts of the MDR and the IVDR yesterday. I have nothing to add to that in addition to previous posts in this blog. It is what it already was. The texts can be found here. This means that we are now looking at publication in the Official […]
The fat lady has her lines and is about to sing. After the lengthy legal linguist revision process (remember, these texts have to be consistent in 24 languages) the Council published the text for its first reading for the MDR and IVDR. First reading only, after such a lengthy process in which we arrived at […]