FullSizeRender.jpgAfter 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: