Category - In Vitro Diagnostics

medicaldeviceslegal

IVDR amendment proposal update: moving on up to adoption

I recently reported about the proposal to amend the IVDR immediately when it came out – please excuse the initial inaccuracies in the post on the subject of amendments to article 5 (5) IVDR (in-house produced devices) due to my enthusiasm to get the news out quickly. In the mean time I have fixed these […]

medicaldeviceslegal

IVDR amendment proposal update: moving on up to adoption

I recently reported about the proposal to amend the IVDR immediately when it came out – please excuse the initial inaccuracies in the post on the subject of amendments to article 5 (5) IVDR (in-house produced devices) due to my enthusiasm to get the news out quickly. In the mean time I have fixed these […]

medicaldeviceslegal

Proposal to manage IVDR

It had been been in the works for some time, although it also seemed unlikely for quite some time that this would happen. The implementation of the IVDR had been the slow little, neglected sister of the MDR implementation with greatly insufficient notified body capacity becoming available, and crucial elements of regulatory infrastructure (like the […]

medicaldeviceslegal

The new EU AI regulation proposal, medical devices and IVDs

Now this is fun: at a time just before the date of application of the MDR when we do not even have harmonised standards for the new software requirements in Annex I, section 17 MDR and Annex I, section 16 IVDR, the Commission proposes new mandatory regulation to supplement the the MDR and the IVDR […]

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

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 […]