Category - Recast

medicaldeviceslegal

EU Council to meet on Tuesday on MDR and IVDR proposals

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 […]

medicaldeviceslegal

EP debate on devices revision – largely predictable, some surprise

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 […]

medicaldeviceslegal

EU medical devices revision: counting down to the plenary vote

That’s right: it’s 10 minutes to midnight for EU medical devices regulation in the cold war between the ENVI committee and the industry with the upcoming vote in the European parliament’s plenary tomorrow on 22 October. The proponents of the ‘swift and proportionate’ procedure via a centralized EU agency, like currently happens with certain medicinal products […]

medicaldeviceslegal

ENVI vote results out: we have a draft legislative resolution

The ENVI vote results that have already been hotly debated and opined upon are now finally out in the form of a draft European Parliament legislative resolution that the Parliament will vote on on 22 October. Now we can be sure what’s in the text, we can say something about details that are usually lost […]

medicaldeviceslegal

ENVI vote postponed once more

Compromising is time consuming business, that’s for sure. And sometimes it’s not easy to reach compromises. Apparently the ENVI Committee members were not able to reach compromises timely, because the postponed vote on the medical devices regulation proposals that was scheduled for 18 September has now been … postponed, again. The discussion of the regulation […]