Article

A wave of MDR and IVDR rollout coming our way

25 Nov 2017, Erik Vollebregt With the clock for the countdown to the end of transitional periods for the MDR and IVDR ticking away, everyone is of course very interested what the competent authorities are doing regarding…

Article

MDR and IVDR workshop at Advamed on 4 December

14 Nov 2017, Erik Vollebregt 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…

Article

The notified body conundrum

08 Nov 2017, Erik Vollebregt 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…

Article

EU MDR / IVDR Regulatory Cassandra

02 Oct 2017, Erik Vollebregt 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…

Article

IVDR, IVDs and mass extinction

13 Sep 2017, Erik Vollebregt 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…

Article

Supply chain and economic operator regulation under the MDR and IVDR

12 Sep 2017, Erik Vollebregt 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)…

Article

San Jose CA workshop: Everything You Always Wanted to Know about the EU Medical Devices Regulation, but Were Afraid to Ask

10 Sep 2017, Erik Vollebregt 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…

Article

MDR and IVDR transitioning – where are you in your process?

03 Aug 2017, Erik Vollebregt

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 […]

Article

MDR and IVDR transitioning – where are you in your process?

03 Aug 2017, Erik Vollebregt 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…