On 7 December 2017, the Court of Justice of the European Union (CJEU) rendered its judgment in case C-329/16 essentially concerning the question of when software qualifies as medical device within the meaning of the Medical Devices Directive (Directive 93/42).
The CJEU’s judgment was made following a referral for a preliminary ruling on the interpretation of the Medical Devices Directive by the French Council of State (Conseil d’État).
In the main proceedings the French association of the medical technology industry together with Philips France challenged French national statutory provisions requiring a national certification for drug prescription assistance software and dispensation assistance software. They assert that the software in dispute qualifies as medical device within the meaning of the Medical Devices Directive which is also why the software is CE marked. In their view, making the application of such software subject to additional national certification requirements that go beyond what is required under the Medical Devices Directive is inadmissible and violating EU law.
Since the dispute depends on the interpretation of the Medical Devices Directive, the French Council of State decided to stay the proceedings and referred the following question to the CJEU for preliminary ruling:
‘Must Directive [93/42] be interpreted as meaning that software, the purpose of which is to offer to prescribers practising in towns, a health establishment or a medico-social establishment support for determining a drug prescription, in order to improve the safety of prescription, facilitate the work of the prescriber, encourage conformity of the prescription with national regulatory requirements and reduce the cost of treatment at the same quality, constitutes a medical device within the meaning of that directive, where that software has at least one function that permits the use of data specific to a patient to help his doctor issue his prescription, in particular by detecting contraindications, drug interactions and excessive doses, even though it does not itself act in or on the human body?’
2. The CJEU’s Judgment
In its decision, the CJEU first reiterated that software is expressly included in the ‘medical devices’ definition of Art. 1(2)(a) Medical Devices Directive. Software constitutes a medical device if it satisfies the two cumulative conditions relating to the objective pursued and the action resulting therefrom. Thus, the software (i) needs to be intended to be used for one of the purposes listed in Art. 1(2)(a) Medical Devices Directive (i.e. needs to pursue a specifically medical objective) and (ii) must not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.
With regard to the first requirement, the CJEU found that the software in dispute pursues a specifically medical objective as it cross-references patient-specific data with the drugs that the doctor is contemplating prescribing, and is thus able to provide the doctor, in an automated manner, with an analysis intended to detect, in particular, possible contraindications, drug interactions and excessive dosages. The court also clarified that software – although being used in a medical framework – does not qualify as medical device has the sole purpose of archiving, collecting and transmitting data.
As concerns the second requirement, the CJEU explained that although Art. 1(2)(a) Medical Devices Directive refers to the medical device’s principal intended action ‘in or on the human body’ it does require such a device to act directly in or on the human body. To the contrary, the legislator’s reasoning makes clear that it does not matter whether the software acts directly or indirectly on the human body. According to the court, the essential criterion for being classified as medical device is the software’s purpose. With this, the CJEU also confirmed the Commission Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices.
The CJEU therefore concluded that
‘software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device, within the meaning of Article 1(2)(a) of Directive 93/42, even if such software does not act directly in or on the human body.’
The full text of the judgment can be accessed here.
3. Practical Implications
After all, the CJEU’s decision shows that the scope of the definition of medical devices – in particular with regard to software – is interpreted rather broad whereas basically just the purpose of the software and not its manner of application is decisive. As soon as software goes beyond the mere storage, archiving, lossless compression or simple search and preforms any modification or interpretation of the data, it is likely to be recognized as medical device. Having this in mind, it should be even more carefully assessed of whether software in the medical field qualifies as medical device and thus needs to comply with the requirements under the Medical Devices Directive.