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Software as a Medical Device

When is software a medical device?

Information technology and software is increasingly becoming a feature of modern healthcare; some may say that the medical sector is belatedly catching up with the implementation of ICT in other service and manufacturing industries at the end of the twentieth century. However, healthcare is a highly regulated activity; are there particular challenges facing software developers seeking to develop products for the medical market?

We spoke to Dr David Kershaw of Kershaw Technology Services, a consultancy firm which specialises in helping companies comply with appropriate regulation.

 The first question would be; is the product considered to be a medical device?

Consider the following scenarios:

  1. Software used to plan dosage for cancer treatment and to control, for example, a radiotherapy device.
  2. Software used to design a medical device or control a manufacturing process.
  3. Software embedded in a pacemaker.
  4. Software to store and transfer patient information generated in association with the patient’s intensive care treatment (a Clinical Information System – CIS or Patient Data Management System - PDMS).

The answers to the examples above are yes, no, yes, no. However, the exercise shows the difficulty of determining whether software is a medical device and, if applicable, which classification rule to apply under the European Medical Device Directive.

Example 4 illustrates the subtlety of the decision, since CIS/PDMS containing information such as patient identification, vital intensive care parameters and other documented clinical observations would not qualify as medical devices but modules that are intended to provide additional information that contributes to diagnosis, therapy and follow-up (e.g. generate alarms) are qualified as medical devices.

In general, electronic patient record systems may archive all kinds of documents and data related to a specific patient. The electronic patient records themselves are not computer programs, therefore, they should not be qualified as a medical device i.e. an electronic patient record that simply replaces a patient’s paper file does not meet the definition of a medical device. The modules used with electronic patient record system modules that might be qualified in their own right as medical devices are for example:

  • an image viewer with functionality for diagnosis based on digital images;
  • a medication module.

A further complication is that specific modules might qualify as medical devices whereas the rest of the system does not.

Dr Kershaw recommends that if an innovator is in doubt about whether or not their product would classify as a medical device then they should seek advice.

But my software is for mobile phones and tablets….

The rules are platform independent so it does not matter if the application is running on a server, desk top PC or a mobile device, the regulations will still apply. However, the underlying general purpose infrastructure is not considered to be a medical device.

What is meant by the infrastructure ?

Examples of the infrastructure would be the devices operating system, the telecommunication communication infrastructure, computer hardware and mobile device hardware. These items are not considered to be medical devices.

But my product is for consumers to use not medical professionals……

Medical device can be for either medical or professional use. If the product falls within the definition of a device given in the directive then it is a device regardless of the intended user.

It is not just the function of the device, but what the manufacturer claims for it which is taken into account when deciding if a product is a medical device. It is possible for (a non-medical device) consumer product to become a medical device, if the manufacturer or retailer makes a medical claim for the product, an example might be that it relieves pain.

But I never intended my product to be used as a medical device…

‘Intended purpose’ is the term used in medical device regulations to describe the function of the product according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials relating to the product.

A manufacturer cannot be held accountable for abnormal use or misuse of its product, but when abnormal use occurs repeatedly, there is an obligation on the manufacturer to change the design or add appropriate limitations, restrictions, cautions and warnings in its instructions for use to prevent misuse. If, despite labelling, a product not intended for medical use is repeatedly used for medical purposes, the Competent Authorities may ask a manufacturer to comply with the Medical Devices Directive, pull the product off the market or provide an alternative solution.

Abnormal use observed for medical devices must be reported to the national Competent Authority*.

The interesting point to note here is that the obligation is on the manufacturer (not the user) to put in place controls that prevent persistent misuse, or if this fails take steps to comply with the medical device regulations.  It is therefore important that product developers monitor how the product is being used in the field to ensure that it is not used in a way for which it was not intended – or face the consequences in terms of product withdrawal or regulatory compliance.

*Competent authorities and the National Ministries of Health, in each EU member state, enforce the medical device directives which have been transposed into the state’s national law. The competent authority for the UK is the Medicines and Healthcare products Regulatory Agency (MHRA).

I'm still not sure whether ot not my product is a medical device.

The development of products, which have medical uses, can result in products, which are border line in their classification. In these cases it is best not to leave the resolution until the late stages of development. The later it is left, the more difficult it can be to demonstrate compliance with the device directive. It is quicker and easier to meet the requirements of the regulation by considering them early on in the development process rather than trying to meet the requirements later.

In all cases it is recommended that the innovator seeks advice.

 

Useful links:

 

www.mhra.gov.uk

www.bsigroup.co.uk

www.kershawtechnologyservices.co.uk

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