Software as a medical device - Swiss Federal Administrative Court confirms fertility tracker app is a medical device - Lexology

In a caller decision, the Swiss Federal Administrative Court (FAC) confirms that a mobile exertion intended to show fertility qualifies arsenic a aesculapian instrumentality utilized for contraception taxable to a certification process with a notified body. This ruling confirms the alignment of the classification of contraception apps betwixt Swiss and European authorities.

1. Facts

The taxable of this lawsuit was an interpretive mobile exertion that analyses women's menstrual rhythm utilizing the symptothermal method, successful bid to supply earthy commencement power (the "App").

On February 5, 2020, Swissmedic prohibited the selling of the App, considering that it lacked a valid CE marking. Swissmedic held that, due to the fact that of its contraceptive purpose, the App was a Class IIb aesculapian instrumentality (under the past applicable law), which required a conformity certification from a notified body.

On March 3, 2020, the developer of the App appealed this determination with the FAC, arguing that the earthy contraceptive method offered by the App presents nary risks and cannot beryllium equated with different methods of contraception. Accordingly, the appellant requested the classification of the App successful Class I (for devices that bash not impact a notified assemblage successful the conformity certification).

In a erstwhile landmark determination Sympto C669/2016 of September 17, 2018, the FAC qualified the aforesaid App arsenic a aesculapian device, contempt the developer's statement that the App was a specified acquisition tool.

It is worthy noting that successful the erstwhile proceedings, Swissmedic classified the app successful Class I. However, during a consequent reexamination, Swissmedic reconsidered its practice, reclassifying the app successful people IIb starring to different entreaty and this 2nd determination from the FAC.

2. Classification of a commencement power app

According to the Medical Devices Ordinance ("MedDO"), aesculapian devices are classified successful Switzerland successful accordance with the classification rules applicable successful the EU.

In this caller determination C-1256/2020, the cardinal question was whether bundle tin beryllium "used for contraception" wrong the meaning of Rule 14 of Chapter III of Annex IX of Medical Device Directive (EU) 93/42/EEC (hereafter "Rule 14"), successful unit astatine the clip of the disputed decision. Such bundle are present addressed successful Rule 15 of the caller EU legislation, spot below, III). The FAC besides needed to see whether earthy methods of commencement power specified arsenic the symptothermal method utilized by the App are comprised wrong the conception of "contraception".

Pursuant to Rule 14, each aesculapian devices utilized for contraception beryllium to Class IIb, unless they are implantable oregon semipermanent invasive devices, successful which lawsuit they beryllium to Class III.

According to the FAC, this proviso unequivocally covers each aesculapian devices utilized to forestall gestation oregon facilitate conception, careless of the quality of the aesculapian instrumentality oregon the method of commencement control. The FAC emphasizes that the intended intent of the aesculapian instrumentality (i.e. power of conception) is the lone criterion to determine whether a classification successful Class IIb is justified.

Therefore, insofar arsenic an app whitethorn beryllium utilized for commencement control, it shall beryllium classified successful Class IIb. The placing connected the marketplace of specified bundle frankincense implies its certification by a conformity appraisal body.

This caller mentation constitutes a landmark determination successful the classification of fertility tracker apps. In its erstwhile practice, Swissmedic denied the exertion of Rule 14 to software, connected the grounds that bundle cannot mechanically support from pregnancy, arsenic opposed to accepted methods of contraception. This favoritism led Swissmedic to classify fertility apps arsenic a method of commencement power successful Class I alternatively of Class IIb. With this caller precedent, the FAC overruled the erstwhile criterion, holding that the deficiency of a carnal contraceptive extortion is irrelevant.

It is worthy noting that successful its reasoning, the FAC does not notation astatine each to the erstwhile classification signifier of Swissmedic. Instead, the FAC simply states that Rule 14 is perfectly wide and leaves nary country for mentation (which remains questionable fixed the erstwhile mentation of Swissmedic).

3. New applicable rules

As mentioned above, the FAC decided this lawsuit nether the erstwhile provisions of the MedDO and EU Directive 93/42/EEC, which were successful unit astatine the clip of the disputed decision.

However, it is noteworthy that this alteration successful the classification signifier with respect to contraception apps occurred successful the discourse of the revision of the MedDO and EU aesculapian devices legislation.

The revised MedDo entered into unit connected May 26, 2021, on with the caller EU Medical Devices Regulation 2017/745 ("EU MDR"). This revision introduced peculiar provisions regarding the classification of bundle (see Chapter III of Annex VIII of EU MDR straight applicable successful Switzerland via Article 15 MedDO).

In this context, the question arose arsenic to whether bundle utilized for contraception should beryllium classified pursuant to Rule 11 (dedicated to bundle arsenic aesculapian devices) oregon Rule 15 (dedicated to contraceptive devices, i.e. the erstwhile Rule 14).

It was clarified successful 2019 by the Medical Device Coordination Group that bundle utilized for contraception are governed by Rule 15, starring to their classification successful Class IIb¹.

These clarifications represented the accidental for Swissmedic to align its mentation of the conception of "used for contraception" with the mentation of the EU authorities.

Considering the non-binding quality of the EU guidance connected classification (although usually followed by Swiss authorities and courts), this caller mentation endorsed by the FAC removes the uncertainty near astir the classification of fertility apps successful Switzerland and confirms the alignment with the EU practice.