It is widely known that in some circumstances, software may fall within the category of medical device and so have to comply with the associated regulations as regards its marketing. But deciding exactly when software will be categorised as such a device is not so straightforward. An Opinion from an Advocate General of the Court of Justice of the European Union (CJEU) looks set to provide welcome clarity on this issue.

Background

The Medical Devices Directive stipulates that in order to be a medical device, a software product must be intended by the manufacturer to be used specifically for diagnostic and/or therapeutic purposes in humans, but this definition comes in the middle of a longer and more complex definition of medical devices in general. This definition includes all products to be used for the “diagnosis, prevention, control, treatment or mitigation of a disease“.

So it is not surprising that the CJEU has recently been asked to rule on the question, in a dispute arising in France.

Facts: the CICA software

The software in question was a prescription support tool for healthcare professionals. It provides information as to contra-indications for various powerful drugs, such as anaesthetics, their dosage limits and the known drug interactions they were susceptible to. It analyses patient-specific data prior to surgery and delivers real-time information to the anaesthetist during surgery, and can also be used in an intensive care setting to facilitate medical decision-makers to take the patient’s specific characteristics into account.

The question of whether or not it should be classified as a medical device arose because French national law required the software developer to obtain a national certification for the software. This, the software developer argued, was incompatible with the Medical Devices Directive’s objective of harmonising the regulatory landscape across the European Union. The French government, on the other hand, argued that because the software did not itself act on the human body it should not be classified as a medical device.

The Advocate General has now given his Opinion as to how the CJEU should respond to the French court’s questions.

AG Sanchez-Bordona concluded that a prescription support tool, such as the one in this case, does indeed fall within the category of a medical device. He pointed out that it improves medical practice, in that it helps practitioners prescribe the drugs properly and avoid errors. It analyses patient data in order to calculate appropriate drug dosages. It therefore is instrumental in helping to prevent, control, treat or relieve illness.

Such a tool can be distinguished from a general purpose software application being used in the healthcare context. Applications such as databases, or even email, may be used in healthcare, but will not be instrumental in the decisions healthcare professionals take; they will not therefore be medical devices. However, any software which creates or changes medical information in order to help the healthcare professional use the information may fall within the classification of a medical device.

Conclusions

This Opinion looks likely to be followed by the CJEU when it eventually gives its ruling. It is consistent not only with the wording of the Directive but also the European Commission’s guidelines MEDDEV 2.1/6 on the qualification of autonomous software used in the health sector (although these guidelines do not lay down any absolute ‘bright lines’ as to what software will or will not qualify as a medical device). As the Advocate General noted, the guidelines of the competent authorities of various EU Member States also point to the same conclusion. In the circumstances, it would be surprising if the CJEU decided to follow the more restrictive analysis argued for by the French government.

Although the consequence, if the CJEU does indeed accept this reasoning, is that a wide range of medical software will now be classified as a medical device and have to obtain CE marking before being placed on the market in the EU, manufacturers and developers will welcome the clarification of what has previously been a difficult set of provisions to interpret. It is far better to be certain of the regulatory regime which applies to a product, and ensure that it complies, than to be at risk of investigation and potential product recall if the belief that a product is not a medical device turns out to be unfounded.