Normally one looks back at the end of the year, but I also like to look ahead because there are a lot of developments in EU law that will affect the medical devices industry next year: new rules on cybersecurity, data protection, mHealth and business compliance will put their mark on 2016, additional to the never-ending […]
In a previous post I promised more on cybersecurity, so here it is. Spoiler alert: the conclusion of this post is that cyber security requirements for medical devices in Europe are currently an overlapping patchwork of different statutes with little attention for system and network security. So the conclusion is: there is nothing specific, except […]
On Thursday 8 May I presented about EU regulation of mobile medical apps at the HIMSS Mobile Medical Apps roadshow in Berlin. The European Commisison’s Green Paper on mHealth has been hotly anticipated for quite a long time (at least by me!), so expectations were high. So high actually that I have not heard exultantly positive […]
You have a lot to look forward to next year unannounced notified body inspections will start (I hope you, your subcontracts and suppliers are prepared – if not, take a look at this instructive MedCert video), we will or will not close the project of the medical devices regulation revision before the elections during the […]
This time I’d like to entertain you with some aspects of some of the dryest matter that I work with as lawyer: technical rules regarding competence and standing under EU law. However, this subject matter is very important for medical devices companies in the light of the large number of delegated and implementing acts for […]
These days I am more and more involved in medical devices software matters: interesting questions about modularisation, whether or not EHRs are medical devices in Europe and negotiation of systems integration agreements within the systems integration clause of the EU medical devices directive, just to mention a few. But so far I have not really […]
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 […]
I had the privilege to preside a session about eHealth and mHealth at the DIA Euromeeting in Amsterdam last week, joined by Mr Tapani Piha, Head of Unit for eHealth, Health Technology Assessment and Science of DG SANCO of the European Commission and Mrs Marianne Fournier of Voisin Consulting. In a lively session we took […]
If you’re active in the medical devices industry in Europe you will no doubt have come across EU data protection regulation. It applies to all personal data (including data concerning health) relating to EU citizens that your company processes. As you may know, the EU is presently revising the current directive and has a proposal […]
If you’re active in the medical devices industry in Europe you will no doubt have come across EU data protection regulation. It applies to all personal data (including data concerning health) relating to EU citizens that your company processes. As you may know, the EU is presently revising the current directive and has a proposal […]