As announced, the IMDRF is on the case for software, which shows how important this subject is becoming in the medical devices field. I notice this everyday in my medical devices practice, as more and more medical devices software work comes in. That is great for me, as I grew up around software engineers in […]
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 […]
Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did) there is absolutely no change compared to the last version that was available among stakeholders. For that reason, I will not repeat all […]