Category - ivd

medicaldeviceslegal

EU companion diagnostics regulatory developments – the movie

Now that my firm Axon Lawyers has a YouTube channel, why not use it more? I was recently invited as speaker to the DIA Meeting on Personalized Medicines and Companion Diagnostics in Washington DC (well, Alexandria, VA, an affluent suburb of DC), on 6 November 2013. However, due to an unfortunate mix of circumstances I had to […]

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

Euro update and Don’t Lose The SME

While the medical devices and IVD regulation proposals trickle through the legislative process and people concentrate on details like I have done on this blog as well, it might be nice to have a higher level picture. So that’s what my UK colleague Alex Denoon and I prepared for a recent webinar, and what we […]

medicaldeviceslegal

ENVI’s IVD regulation amendments

As promised, here is an analysis of the IVD amendments further to the report provided by rapporteur Liese, with numbers 75-237 and 238-399. Not that as many as the medical devices ones, but still a lot – and no less complex. I won’t repeat all the procedural proposals that are both in the medical devices […]