More interesting things from the RAPS Convergence conference. If you do anything in the IVD sector in Europe and did not attend that conference, that’s a pity. The program on EU IVD regulation was truly outstanding. I do not often see such a good program on EU IVD regulation in one place – if you […]
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 […]
It has been sort of hanging over the medical devices market for quite a long time: the TÜV Rheinland case about the PIP breast implants. This case is the direct result of the PIP breast implants scandal, which had a profound influence on the new EU MDR in the making. We had the Advocate General’s opinion […]
The year is off to a good start, and so should your company be with its MDR and/or IVDR transition plan. Come again? You haven’t started looking at this yet because the MDR and IVDR are not yet final and the transitional period will run to approximately half 2020? Your management is not interested in […]