I’m developing medical software

Last updated on 19 Feb 2019

If you have a concept for a data-driven healthcare technology that you want to develop or are looking at adding additional functionality to an existing system, take a look at our guides below.

How do I do this properly?

The Department of Health and Social Care has published a code of conduct for data-driven health and care technology which outlines 10 key principles for safe and effective digital innovations, and five commitments from the government to ensure that the health and care system is ready and able to adopt new and innovative technology at scale.

Is my software a medical device?

The term medical device is used to cover software and products which have a ‘medical purpose’. These devices can have various functions from diagnostic support to active implantable functionality. If you're not sure if you have a medical device or not, the information below should help.

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK and has recently issued updated guidance to help identify whether software and health apps are medical devices. The guidance details:

  • the evidence requirements and regulatory approvals required for the various classifications of medical device

  • what procedures you need to have in place to get a CE mark, which indicates acceptable safety standards and performance, and what your reporting responsibilities are when things change or go wrong.

What evidence do I need?

The National Institute forHealth and Care Excellence has published an Evidence standards framework for digital health technologies. The Framework classifies devices according to their function and explains what good evidence looks like for each.

Approval and ethics review of your device

The MHRA can help you work out what class of device you have and what approvals are needed. In some cases, a medical device might require a clinical investigation or in vitro diagnostic performance evaluation.

If you are carrying out a clinical investigation to demonstrate the safety and performance of a non-CE marked device, you will need approval from a Research Ethics Committee (REC). This also applies if you have a CE-marked device, but it has been modified or is to be used for a new purpose.

At the HRA, we oversee the Research Ethics Service. We strongly recommended that you apply to a flagged Research Ethics Committee for medical devices research.

Approval from the NHS is facilitated through the Integrated Research Application System (IRAS).

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