Category - ivds

medicaldeviceslegal

Bottleneck of bottlenecks for notified body capacity

People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices and IVDs. This is especially a problem with respect to IVDs, as LRQA is one of the notified bodies traditionally handling a large […]

medicaldeviceslegal

The Council’s IVD regulation proposal for the general approach

As promised yesterday, here is a first impression of the IVD Regulation (IVDR) proposal that may lead to a general approach this Friday in the ESPCO Council. In this post I will try to not repeat what I have blogged about yesterday given the large amounts of overlap between the two regulation proposals. Where things […]

medicaldeviceslegal

The genetic testing amendment in the IVDR

The focus of the EU revision of medical devices regulation is fully on the medical devices regulation. The revision of the IVD directive is sort of happening in the background and is not getting the attention that it deserves, especially because the IVD revision is sparking off volatile things. Medical devices definition First, there is […]

medicaldeviceslegal

IMDRF Software as Medical Device definition document completes

In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number of other documents, after it was adopted at the meeting n Brussels 12-14 November 2013. People that commented on the document will remember that  the […]

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

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 […]