On 7 December 2017 the Court of Justice of the European Union (“CJEU”) published its decision on the case C-329/16 Snitem and Philips France, the first instance in which the CJEU has ruled on standalone software within the medical device context/sphere.
This was a reference by the French Conseil d’État asking whether prescription support software enabling healthcare practitioners to obtain relevant information relating to a patient (contraindications, drug interactions and dosage limits) may constitute a medical device within the meaning of Article 1(2)(a) of the Medical Device Directive (“MDD”). The CJEU, agreeing with the Advocate-General’s Opinion delivered on 28 June 2017, held that this software can be a medical device notwithstanding the fact that the software does not itself act in or on the human body.
A key factor considered by the Court in reaching its decision was the fact that the software in question (IntelliSpace Critical Care Anaesthesia, or “ICCA”) facilitated calculation of dosage and the proper design of the treatment by the healthcare professional by providing relevant information, therefore suggesting a “medical purpose”, i.e. assisting the “prevention, monitoring, treatment or alleviation of disease”. Indeed, the intended purpose of a software, alongside the action it performs on data are central in determining whether the software might qualify as a medical device.
Whilst the decision of the Court will not be surprising to many, at least within the UK given the extensive UK guidance on this topic and industry practice, it is a useful judgment considering the prominence of digital health apps in the European scene and it is likely to align the position adopted by different national authorities. Despite the publication of non-binding guidance on the classification of standalone software and the determination of when it might constitute a medical device by the European Commission in July 2016, the lack of a completely harmonised approach within the EU has led to different approaches. The introduction of new rules under the Medical Devices Regulation (“MDR”), which has been in force since May 2017 and will become fully effective in May 2020, sets uniform rules and further guidance on its application is expected to be published in mid-2018.
With more novel software apps being developed in the digital health sphere and the blurring of the boundaries between medical regulation and new technologies, more clarity would be welcome by industry and legal practitioners, alike, notably in areas such as autonomous decision-making software and artificial intelligence.
In the meantime, companies would be well-advised to adopt a cautious approach and seek regulatory advice when developing technology with applications in the health sector. In the UK, the MHRA has taken a proactive stance on providing helpful guidance to companies.