In its decision of 12 September 2022 (C-1256/2020), the Swiss Federal Administrative Court (FAC) confirmed that interpretive software that uses indicators such as calendar days and body temperature to monitor fertile and infertile phases of a menstrual cycle to achieve natural conception or prevent undesired pregnancy, qualifies as a medical device. This means that such software is subject to a conformity certification procedure with a notified body.
In its reasoning, the FAC primarily focused on the intended use of the software being for contraceptive purposes, i.e., “used for contraception” within the meaning of Rule 14 of Chapter III of Annex IX of the European Medical Device Directive (EU-MDD) (“Rule 14“), in force at the time of the disputed decision. Software in this category is now addressed in Rule 15 of Chapter III of Annex VIII of the European Medical Device Regulation 2017/745 (EU-MDR). The FAC made reference to the EU Medical Device Coordination Group (MDCG), which clarified in 2019 that software used for contraception is governed by Rule 15, leading to a classification in Class IIb. The FAC confirmed that through the reference in Article 15 of the Swiss Medical Device Ordinance (“MedDO“), the same applies in Switzerland, leading to an alignment of the classification of software used for contraception between Switzerland and the EU.
The main points regarding decision C-1256/2020 of 12 September 2022 of the FAC include the following:
- It was confirmed that a (standalone) software product used for contraception qualifies as a medical device and is therefore subject to a certification procedure with a notified body.
- Article 15 of the revised MedDO makes reference to Annex VIII of the EU-MDR and in doing so introduces special provisions regarding the classification of software as a medical device.
- In 2019, the MDCG clarified that software used for contraception is governed by Rule 15, leading to the classification of such software in Class IIb. Through the reference in Article 15 of the MedDO, this applies equally in Switzerland, which leads to an alignment of the classification of software used for contraception between Switzerland and the EU.
On 26 May 2021 — the same day the EU-MDR came into force — the revised MedDO entered into effect in Switzerland. The term “medical devices” is defined in Article 3 of MedDO and is aligned with the definition used in the EU-MDR. In brief, a device qualifies as a “medical device” if it is intended for a medical purpose. Medical devices are divided into (i) classical medical devices (e.g., plasters, dental implants, blood pressure monitors, pacemakers and potentially also apps) and (ii) in vitro diagnostic medical devices (e.g., pregnancy tests and urine tests).
Despite the fact that the MedDO and the EU-MDR mention “software” as a potential medical device and despite the existence of specific classification rules for software as a medical device, neither the MedDO nor the EU-MDR contain a definition of “software”. However, the MDCG defines “software” as “a set of instructions that processes input data and creates output data.”
Swissmedic had previously dismissed the application of Rule 14 in its former practice, on the grounds that, unlike traditional contraceptive methods, software cannot mechanically protect against pregnancy. This distinction led Swissmedic to classify fertility tracker apps as a method of birth control in Class I instead of Class IIb. With this new precedent, the FAC put an end to this practice and determined that the lack of physical contraceptive protection is irrelevant.
Consequently, these new considerations represent a landmark decision in the classification of fertility tracker apps.
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