The two texts that will form the basis for the Council’s attempt to arrive at a general approach at the EPSCO Council meeting on 19 June that would allow it to start the trilogue have been published for the medical devices regulation proposal and for the IVD regulation proposal. Only part of the picture Unfortunately […]
Some time ago I promised you a follow up on the 20 June Council meeting, but I also mentioned that it could wait for a while at the time because the outcome was not that spectacular or even unexpected. On 20 june the Council had its last deliberation on the medical devices and IVD regulation […]
Well, we had the Council meeting last Tuesday on among other things Health, in which the medical devices regulation proposal was debated at quite a length. Where are we now and where are things going? My impression is that it’s a mixed bag or rather a wheelbarrow of frogs and it really depends on who you […]
This Tuesday morning 10 December the EU Council will meet to discuss the dossier of medical devices and IVDs revision for the last time during the Lithuanian Presidency, from 10:00 to 12:00. It looks like live coverage by video feed is available, but you can also download the coverage afterwards, see the links in this […]
Today was an interesting day for medical devices in Europe. We had the EU Parliament’s plenary debate on the medical devices and IVD regulation proposals, and the subsequent vote on the highly appropriate or potentially devasting (depending on who you ask for comments) ENVI committee proposals. You can watch the whole debate video here, the […]
The EU member states have so far been the dark horse in the discussions surrounding the revision of the EU medical devices directives, keeping their cards close to their chest and not getting involved in the largely fact free politics surrounding the ENVI rapporteurs’ drafts for the medical devices and IVD regulations. Council of Employment, […]