Het toenemend gebruik van medische apps door zorgprofessionals kan de patiëntenzorg verbeteren, maar heeft ook potentiële gevaren. Regels en protocollen ontbreken nog. Lees meer
Bradley Merrill Thompson and Erik Vollebregt argue in the October issue of Scrip Regulatory Affairs that draft guidance from the US Food and Drug Administration on mobile medical applications could apply in the EU too.
On 21 July, the US Food and Drug Administration released draft guidance on mobile medical applications, a document we think has great significance for the regulation of EU eHealth and medical device markets, even while in draft form.
Important developments for the medical devices and medicinal products industry: clarification of EU law about the borderline between these groups of products is currently in the making at the European Court of Justice.
In a previous post I gave a number of practical tips for drafting ISO 14155 clinical trial agreements. In this post I will give another few. Additional points will surely come to mind and if so, I will devote a next post to those.
Yesterday the European Commission’s Working Group on Borderline and Classification issued the new version (1.10) of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This manual has been around for some years and is gradually amended and updated from time to time.
In my day-to-day legal practice I see a number of points related to clinical investigation that seem to return and repeat all the time and thought it a good idea to share my thoughts on these. This list is not exhaustive and just a start (it will be extended in future postings), but it will give you some important pointers to avoid commonly made mistakes that can be costly to fix, may cause your sales to collapse and/or lead to investigation by the authorities. Of course all these point are intended to lead to ISO 14155 compliant agreements.
On 21 July the FDA released Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications, a document that I think has great significance for the regulation of the EU eHealth and medical device markets, even if it is presently only a draft. If adopted by the FDA its importance will only increase. You can download a copy of the document with my annotations in it over here.
In a previous post I have analysed the consequences of the European Court of Justice's Ker-Optika judgment for e-commerce in physical medical devices. This post extrapolates the reasoning of the European Court in that case with respect to the provision or sale of medical devices as services in the context of eHealth services. My conclusion is that eHealth services constituting medical devices are regulated identically under EU law to physical medical devices and analyses the consequences of this.