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

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

The unfinished internal market for medical devices

The EU market for medical devices is not fully harmonized, which means that you cannot rely on a medical device being a medical device everywhere in the EU. That, essentially, is what the European Court’s recent judgment in the Lycocentre case confirms. Confirms? Yes, it basically confirms what we already knew and that is that […]

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 […]

Axon news

Presentations Medical Software & Apps Seminar

Axon Medical Software & AppsPresentations can be downloaded by clicking on the titles:How to design medical software for compliance by Robert Houtenbos, Independent mHealth consultantDevelopments in regulation and enforcement regarding medical sof…

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 […]