After almost four years after the initial proposals the Dutch presidency has shepherded the proposals for the MDR and IVDR across the finish in the trilogue negotiations, as was announced just now today.
This was a quite unexpected result as the first time we expected (or hoped) to hear about this was the EPSCO Council meeting next month.
The current agreement has been reached in the trilogue negotiations and still has to be formally approved by the Council and Parliament ( Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee). But that will be a formality unless one group of delegates exceeded its mandate.
This means that we finally have new regulations, which normally will enter into force this year.
More to follow when the agreed texts become available, because the press release does not tell us very much news.
This does mean that everybody will need to start preparations if they were not doing so already. As I write this I just returned from giving a day long workshop on MDR and IVDR preparedness, but now it is ON – for real. What will all of that involve? See my recent webinar for Advamed members for a general overview:
Hi Erik: Is there any way you can send your presentation on the MDR (described in post: EU agreement on new MDR and IVDR)? This is such a great summary, but it’s hard to read in the blog. Thanks – Mara
Sure, happy to send the presentation if you send me your email address. Best regards, Erik
Hi, could you please send me your presentation as well? Here is my e-mail address : firstname.lastname@example.org. Best Regards.
Could you send your fine presentation also to me? It’s a very good summary of this big regulation.
Thanks a lot!
Please send me your presentation also. Many thanks in advance. Howard
I’m interested to know more. I’m a Biomed tech; an expat working in Hamad General Hospital Doha Qatar. My email is: renerulete@hotmail and RRULETE@hamad.qa.
Thank you very much.
great work – thank you! Unfortunately it is hard to read as Mara said. Could you please send me the presentation, too? Thanks in advance!
Hi, please mail me at
Hi Erick, I would also like to receive your presentation on MDR.
Could you send your presentation?
Hi Erik, Great presentation. May I also obtain a copy?
Hi Eric, I would like to join the queue. Could you send me the presentation too, please. Many thanks.
Dear Erik, fine piece of work, any chance of sending me the slides, please?
Could you please share the slides of your presentation to me as well? This is a very good summary of the new implementation.
Very nice summary!
Could you please send me your fine presentation also to me?
Thank you very much.
Could you please send me the presentation too?
Many thanks in advance,
Hi Erik. I would also love to have a copy of your presentation. Many thanks in advance.
Would you so kind send your presentation to me also.
Thanks a lot