MHRA guidance about standalone software
MHRA, the regulatory authority of the UK, published in march a guidance on medical device standalone software.
This guidance is a prime source of information about software in medical devices in the European Union. It gathers all existing information about the way medical device software is regulated in the EU.
It should be noted that there is no equivalent guidance at the EU level, like a MEDDEV. Even if it is published by a member state of the EU, it should be still applicable in other member states, as it is not conceivable that a member state establishes regulations which contradict European laws (even if it already happened but this is not the subject of this blog!). MHRA can't go against MD, AIMD and IVD directives.
Thus most of the guidance repeats information already available elsewhere. But it has the advantage of gathering in a single document that information. Yet, the document is four pages long only. Compared to what the FDA has already published about standalone software, this is quite short!
Given the lack of awareness of companies developing mobile apps about medical devices regulations, this short guidance is worth reading it. It gives explanations about the criteria which help to qualify a mobile app as a medical device.
Especially, it draws a list of words and sentences, which, if they are found in the intended purpose of the app, are likely to qualify is as a medical device.
This list is new (not seen in any other EU document, as far as I know) and is very helpful.
The guidance also tries to cover all possible cases of software, which are likely to be medical devices: telehealth, software making recommendations based on patient data, software combined with non-medical products. There are eight specific cases covered by the guidance. Probably most of cases encountered by MHRA.
But software is so versatile that some new cases should come up soon. We can bet that the guidance will be updated to follow the pace of changes brought by such technologies as cloud, quantify self, and future mobile platforms.
When a MEDDEV?
The only drawback of this guidance is to be published at UK level and not EU level.
When a true MEDDEV about standalone software?
Second document: BSI white pater
Second document born the the UK, the BSI notified body published last month a white paper about the proposed regulations on MD and IVD. This document is of high quality. It is the first one of a series of white papers that will be published this year. We hope that the next ones will be as valuable the first issue.