Software can be considered a medical device under EU law. Although guidance has been issued by the European Commission and national authorities to assist in legal classification, factors or criteria that are considered as relevant in such guidance have not been validated by European or national courts. The recent decision of the Court of Justice of the European Union (CJEU) on legal classification of software medical device is therefore instructive.
The European Court’s first decision on the classification of software in the context of medical devices legislation
On 7 December 2017, the CJEU issued its judgment in Case C-329/16. The CJEU agreed with the Advocate General’s opinion (discussed in our previous advisory), and held that software can be classified as a medical device under EU law if the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing or calculating the dosage for treating the underlying condition. It does not matter whether the software acts directly or indirectly on the human body. The decisive factor is whether the software is specifically intended by the manufacturer to be used for one or more medical objectives specified in Article 1(2) of Directive 93/42/EEC (the Medical Devices Directive), including the diagnosis, prevention, monitoring, treatment or alleviation of disease.
The decision is in line with the existing national and European guidance, and aligns with the generally accepted understanding of the meaning of the relevant legislative provisions. Therefore, the decision ought not be surprising to many who operate in the field of digital health. However, we note the following:
- It is the first time that Europe’s highest court has confirmed the proper interpretation of these legislative provisions insofar as they apply to software. The decision is particularly relevant to the research and development of digital health and mobile health devices.
- In reaching its decision, the CJEU relies considerably on the so-called ‘MEDDEV Guidelines’ which have been considered as useful tools to interpret the legal requirements relating to medical device, as they set out the agreed position of the European Commission in collaboration with national authorities, industry and national accredited bodies following a period of internal and external consultation.
- The CJEU decision validates the criteria set out in the specific MEDDEV for classification of software medical devices. While the MEDDEV Guidelines are explicitly stated to be non-legally binding, industry and regulatory authorities may now rely on these to a greater extent for the purpose of assessing classification.
A revised edition of the ‘Manual on borderline and classification in the Community regulatory framework for medical devices’ (the Borderline Manual)
In the broader regulatory context, the decision on whether or not a particular software program constitutes a medical device (and is therefore subject to a conformity assessment) may also be guided by reference to the Borderline Manual (version 1.18), the most recent version of which was published on 7 December 2017.
As a general matter, a case-by-case assessment is required to decide whether a software program can be properly classified as a software medical device in view of its characteristics and functionality.
The Borderline Manual provides that the following types of software should generally be classified as medical devices:
- picture archiving and communication systems;
- mobile apps for processing ECGs;
- software for delivery and management of cognitive remediation and rehabilitation programs;
- software for information management and patient monitoring; and
- mobile apps for the assessment of moles (e.g. making a recommendation about any changes).
In contrast, the following types of software should generally not be classified as medical devices:
- mobile apps for the communication between patient and caregivers while giving birth;
- mobile apps for viewing the anatomy of the human body;
- software that allows for faster interpretation of particular guidelines (e.g., faster consulting/ reading of an international guideline regarding the Classification of Malignant Tumors issued by the International Union Against Cancer); and
- mobile apps for managing pictures of moles (e.g. recording changes over time).