Software as a Medical Device

Software as a Medical Device

Warning! Your software may be a medical device!

Unless you have spent time working with medical device legislation in the past, the idea that software could be a medical device may be rather unexpected — a medical device is perhaps more traditionally viewed as a hardware product. Nonetheless, it is the case. Software is increasingly capable of medical functions such as making or assisting diagnosis, interpreting medical data, forming a prognosis, monitoring disease progression, and many others. It therefore makes sense to regulate software in line with physical medical devices.

Furthermore, the introduction of the Medical Device Regulation (MDR) 2017/745, fully implemented from May 2021, expands the definition of medical device and makes it even more likely that software will fall under its jurisdiction.

The Medical Device Regulation MDR 2017/745 represents the largest overhaul of medical device legislation in decades. The MDR introduces a wide range of changes including an extended definition of what constitutes a medical device. Following significant advances in the complexity and availability of software over the past decade, many types of medical software will fall within this extended definition and be subject to the full scope of the MDR.

So if you have a software product that performs a medical function, how can you determine if your software will be classed as a medical device? And what do you need to do to meet your obligations under the MDR?

Is my software a medical device?

Not all software associated with the provision of healthcare will be classified as a medical device. Medical device legislation is intended to apply only to software whose expected purpose is in line with the definition of “medical device” provided in Article 2 of the MDR. However, because medical software performs such a vast array of purposes across healthcare, working with the Article 2 definition can be challenging.

Understanding whether or not the MDR will apply to a product is a key first step in developing a product compliance strategy beyond May 2021. In this article we set out some basic principles that may help developers understand whether the MDR applies to their products.

First of all, software must have a medical purpose on its own in order to be classified as a medical device. This is important to consider with respect to ‘stand-alone’ software such as a diagnostic app, but even more important when software is an integral part of, or associated with, a hardware device. Determining whether or not software has a medical purpose depends partly upon the intended purpose specified by the manufacturer.

Secondly, it is important to consider the extent to which medical value is added to data entered into the software. For example, simple archive and retrieval software that stores serial blood sugar values without manipulating the data does not add real medical value and would not normally be classed as a medical device; whereas, if that same software highlighted worrying trends in the data and advised when a hospital visit may be needed, this is likely to be held as medical value and class the software as a medical device.

Direct autonomous medical actions performed by software are another factor that will draw a software product under the definition of a medical device. For example, an app that analyses skin rashes to make a diagnosis would clearly be classed as a medical device.

For the purposes of understanding whether or not an individual software product may be subject to the MDR’s rules, it may be helpful to consider several categories of function and purpose:

  • Basic support/admin software
  • Simple archive and retrieval
  • Archive, retrieval and modify
  • Data interpretation, advice and/or call-to-action
  • Independent ‘smart’ diagnosis/prognosis/analysis
  • Mixed purpose/modular software
  • Combined hardware/software
  • Closed loop products
  • Contraceptive support

What needs to be done if software is a medical device?

If a software product is classified as a medical device, then the full range of provisions in the Medical Device Regulation 2017/745 (“The MDR”) will apply to the product. This will mean implementing a number of systems that may be unfamiliar to software companies, including:

  • developing a Quality Management System
  • implementing a Post-Market Surveillance (PMS) system to monitor performance of the product
  • designing Post-market Clinical Follow-up and Vigilance systems as components of PMS
  • performing a Clinical Evaluation of the product and submitting a Clinical Evaluation Report (CER)

It will also be necessary to understand how to work with MDR Annex VIII to determine risk classification for the product, as well as learning how to use MDR Annex I that lists General Safety and Performance Requirements that must be adhered to for every product.

Where can I find help developing an MDR strategy?

Working with the MDR is likely to be a daunting prospect for many software companies. If you find yourself wondering how to meet MDR requirements for your products, Mantra Systems is your ideal MDR compliance partner. We have extensive experience working with medical device legislation for all kinds of medical devices, including and especially software. We have a team of expertly-trained medical professionals who will work with you to build a tailored MDR compliance strategy for your software.

We also have a range of exclusive training products including an EU MDR Compliance Guide written by our medical experts, and a free-to-download White Paper with more information about Software as a Medical Device.

Finally we have an in-depth workshop Software as a Medical Device — a guide to MDR compliance. This workshop covers everything you need to know to build and implement an MDR compliance strategy for software products.

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Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.

Who we work with

Our clients come from across the industry and range from pre-start businesses to stockmarket-listed multinationals. We also have key strategic partners based in the UK and Denmark.

  • It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.

    CEO, EU medical software company
  • Your service surpassed our expectations and added value across our organisation. We now feel much better placed to prepare for the MDR.

    Chief Executive, MedTech pre-start
  • A comprehensive, detailed and highly professional service.

    Regulatory Manager, UK device manufacturer
  • International

    We work with medical device manufacturers based in the UK, Europe, the US and Asia, developing MDR strategies for both physical devices and software as a medical device.

  • Diversified

    Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.

Read more about our team and philosophy


We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our medical device regulatory consulting is built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

  6. Yes. Software as a Medical Device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on Software as a Medical Device.

  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

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