The scope of the concept of medical device is in constant flux. The EU amended the definition slightly in 2007 to accomodate for standalone software as medical device, the GHTF changed its definition not that long ago, and currently the EU is working on a new medical devices definition in the medical devices regulation proposal. […]
Further to my recent post about e-labeling and my appeal to take more account of the specific mHealth market needs I had a discussion with another devices expert who suggested that the majority of medical apps will be in class I anyhow, in which case these apps can be used safely without instructions, because the Medical Devices Directive […]
The sale took place in early June and received a big article in Het Financieele Dagblad today read more …
The e-labeling regulation has entered into full force a couple of months ago (1 March 2013), and I thought it would be a nice idea to share some of my experience with the new regulation with you. Stop – step back When the regulation was published in the OJ I wrote that it was a big disappointment […]
While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint Immediate Action Plan You may remember that as soon as the PIP scandal’s implications became clear, the Commission initiated the Joint Immediate Action […]
While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint Immediate Action Plan You may remember that as soon as the PIP scandal’s implications became clear, the Commission initiated the Joint Immediate Action […]
Overwhelmed with amendments to the proposed law to reform the regulation of medical devices in the European Union read more …
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 […]
Food becomes more and more in the center of the public interest. This is for instance demonstrated by the popularity of urban farming initiatives and also of books on food such as The Omnivore’s Dilemma read more …
Here’s some EU legislative procedure fun: do you know the joke about the European Parliament committee that was going to compromise to have an unproblematic vote? – It didn’t! Well, that was a silly lawyer joke to make as a segue to inform you that the ENVI committee is not going to vote on the […]