Wearables are getting more and more popular and start to move more into the healthcare field by tracking all kinds of data concerning physiological processes and performance. Some companies explicitly want their wearables to be medical devices, others prefer their wearables to stay out of that. Some companies plan their data protection compliance for personal data […]
Rather than streaming our last medical technology seminar on CE Certification of Standalone Software and Apps of 16 October in real time (big hassle and very prone to tech glitches we’ve found), we decided to record a video of it instead, and post that on my firm’s brand new Youtube Channel (watch that space for more […]
If you are active in the medical software field in the Netherlands you may probably be aware already that the the Dutch healthcare Inspectorate IGZ has announced that it will rigorously enforce medical devices law against medical software that they consider a medical device as of 1 January 2014. They have said so pretty clearly […]
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 European Article 29 Working Party has just released its opinion 02-2013 on apps on smart devices. This detailed opinion provides very useful and detailed guidance for companies developing and distributing healthcare apps in the EU, as well as manufacturers of mobile operating systems and devices that run apps. Finally, there is also guidance for […]
The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year with lots of exciting developments ahead. This post will not be the usual regulatory and legal analysis of rules, but something more forward […]
Last week the Commission launched its new eHealth Plan (EHAP). It was announced under the header “Putting patients in the driving seat: A digital future for healthcare”. A nice rundown of the relevant documents is here and a good summary by MedTech Europe (Eucomed and EDMA) is here. Then there is the convenient overview and […]