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 […]
I had the pleasure of being invited to speak at the Health IT forum at the MEDICA conference last week on regulation of in, on and near body networks. Most of my day at the MEDICA I spent in the health IT hall, catching up on developments, particularly in the interesting Wearable Technology Pavillion with […]
Further to my recent posts on unannounced audits I have been thinking about how unannounced audits could play out in an area that becomes more and more important: standalone software. Software medical devices The majority of standalone software under the medical devices directive falls in the scope of rule 12 of Annex IX of the MDD […]
Here is some follow up on the previous Blue Guide post: the new version of the Blue Guide is the first to address software updates to CE marked products, including software. For the purpose of this blog this would typically be standalone software that constitutes a medical device in the meaning of MEDDEV 2.1/6. Harmonised standards […]
A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between the lines of the existing MEDDEV on standalone software (which itself is under revision currently but seems to have been bogged down considerably […]
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 […]
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 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 […]