Category - revision

medicaldeviceslegal

ENVI IVD Regulation proposal vote postponed as well

So far it may have looked like the IVD regulation proposal would be put to a vote in the ENVI committee on 10 July because unlike the explicit movement of the date for the vote on the general medical devices regulation proposal the IVD proposal seemed to stay on track. That turns out not to […]

medicaldeviceslegal

EU member states show some of their cards on medical devices revision

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, […]

medicaldeviceslegal

ENVI’s amendments

ENVI’s amendments, following those of IMCO  have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 – 907 on medical devices and 75 – 399 on IVDs), but here is a list of the things that I found particularly interesting. […]

medicaldeviceslegal

Happy New Year – with all those developments

The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year with lots of exciting developments ahead. This post will not be the usual regulatory and legal analysis of rules, but something more forward […]

medicaldeviceslegal

Seminar on the new EU proposal on medical devices regulation

Dear readers, while I am working on the promised blog posts on parts of the new regulation proposal for medical devices, I would like to let you know about the two and a half hour afternoon seminar that my firm will organise this 14 November in cooperation with Philips Healthcare and the Qserve Group. As […]