The MHRA has today provided guidance on medical device software, which includes medical apps. The guidance can be found here.
Briefly, this guidance aims to:
- outline the current regulatory position
- explain what defines a medical device
- help with decisions on whether your stand -alone software or app is a medical device and give examples
- give information about the rules on classification of medical devices and how to meet the regulations
- give links to other useful websites and relevant documents.
This guidance is aimed at those working in healthcare and people who are developing devices.
Readers might wish to refer to our previous recommendations regarding medical apps.
This series of posts covers some work I have been doing over the past three months: attempting to answer the question of how best to improve the perception by clinicians and patients of the efficacy of health-related apps. This work has been done for the i-Focus project, part of the Technology Strategy Board’s dallas programme.
Part I briefly summarised the EU regulations covering health-related apps. The point was made that any health-related app must comply with data protection and consumer protection requirements, irrespective of whether the risk level is sufficient for it to be classified as a ‘medical device’. Where an app is classified as a ‘medical device’ it also has to be classified so that the appropriate adjudication work can be determined for it to receive a CE mark (Class I, lowest risk, requires least investigation; Class III, highest risk, requires greatest investigation).
Part II summarised the principal findings from discussions with a very wide range of potential stakeholders, from patients to consultants, and from individual app developers to chief executives of app curation companies. The key findings were:
- There is currently little academically-endorsed evidence of medical app efficacy, though much anecdotal evidence;
- There are too many bogus apps around;
- There are safety worries – for example where clinicians are using unregulated apps to manage medication dosage;
- The process for obtaining certification is unclear;
- Some app developers are ignoring data privacy legislation;
- The business model for achieving sales via the NHS is not well understood.
In addition, a theme running through both posts is that there is an international dimension to this issue, with some countries, notably the US, well advanced in certain aspects.
From these findings, four key conclusions emerge: (more…)