FDA draft guidance on mobile medical applications

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 . They have said so pretty clearly on an invitational conference , and have now started to collected information from the market to determine the general compliance level in what looks like a pretty large information gathering exercise. Several companies I know have received the same letter that has been drafted from the assumption that the company’s software is a medical device. The information that IGZ scoops up in this information gathering exercise will be used to define their enforcement policy for the period after and of course, to determine whom to enforce against first.


The question of course is if you are obliged to provide this information, and whether if you are perhaps incriminating yourself by providing information in the level of detail requested. At this stage we have no idea what the IGZ is going to requirement as satisfactory compliance benchmark for medical software under medical devices law. We know that some companies are providing the information without giving it a second thought, but I think this may not always be the best idea looking forward.

Practicalities of how-to

Every company that develops or sells software (apps, websites, electronic health records) for the healthcare industry in the Netherlands and/or has its authorised representative in the Netherlands will be affected by this sooner or later. Since the IGZ has determined that it is going to put the medical software market through this process, I though it would be a good idea to organise a seminar about this at my firm in Amsterdam on 16 October 2013, see below for invitation. We have been able to get some of best medical software experts in the Dutch market for presentations.

The seminar will not only discuss what to do in the various enforcement scenarios we expect, but also how to determine if your app, website or other software is a medical device in the first place, and if so, how to design it for compliance. We will also address the practicalities of CE marking of software and the often overlooked other important compliance element of protection of personal health data compliance.

See you there!

We hope to see you there on ;please RSVP to the email address in the below invitation so we can plan resources for the seminar. If you have any questions beforehand, feel free to contact me or my colleague Sofie van der Meulen.

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