Auteur

Dr. Angela Knierim

Salary Partner

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Auteur

Dr. Angela Knierim

Salary Partner

Read More

6 juin 2024

Femtech article series| June 2024 – 2 de 6 Publications

Femtech - what is it and what should manufacturers bear in mind from a regulatory perspective?

  • Briefing

The term "Femtech" (or female technology) describes technologies - both software and other products - that are tailored to women's health. This can include medical devices and in vitro diagnostics as well as lifestyle products. For example, fertility trackers, endometriosis apps, tampons for analyzing menstrual blood and bras equipped with sensors for measuring cardiological parameters are counted as Femtech.

There have hardly been any legal publications from a regulatory perspective to date. This may also be due to the fact that the question arises as to whether there are any special requirements in this area compared to the general regulations. For the most part, this is unlikely to be the case, with the exception of a few pitfalls from an advertising law perspective. Basically, the manufacturer is faced with the same questions as usual before marketing a product with a possible reference to health:

 

Medical device, in vitro diagnostic or lifestyle app?

The starting point is the question of which category the product falls into, which can lead to categorization difficulties, but also opportunities, particularly in the case of software. To a certain extent, it is up to the manufacturer to decide whether or not to market a product as a medical device. This is because the term medical device contains a subjective component: The intended purpose. This refers to the purpose the manufacturer intends for the product according to the product documents (instructions for use, labeling, marketing material, etc.).

What constitutes a medical purpose that can lead to qualification as a medical device is regulated in the definition of a medical device in Article para. 1 of Regulation (EU) 2017/745 (Medical Device Regulation ["MDR"]). For in vitro diagnostic medical devices, a respective regulation based on this can be found in Article para. 2 of Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation ["IVDR"]).

According to the legal definition in the MDR, a medical purpose exists if the device is intended to serve one of the following purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.

It also stipulates that, among other things, products for the control or support of contraception should be considered medical devices.

This gives the manufacturer a certain amount of leeway, which leads to various implications from a business perspective. For example, although marketing as a medical device imposes a program of obligations under the MDR that should not be underestimated (in particular the conformity assessment procedure), it can also pave the way for reimbursement by statutory health insurance (e.g. as a digital health application, so-called DiGA) and thus potentially more attractive marketing. Marketing as a lifestyle product, on the other hand, is easier and can be realized with fewer (financial and time) resources, and advertising is less strictly regulated (both advertising for such a product and "in" the product, namely in the case of DiGAs with regard to the ban on in-app advertising).

Fertility trackers can fall under the MDR as a product to support conception and, depending on their design, can also be an in vitro diagnostic device. In the example of the cycle app also mentioned, three variants in particular come into consideration:

  • Marketing as a medical device for a medical purpose, e.g. the monitoring of hormonal changes as a disease,
  • Marketing as a medical device with a claim as a product to support conception,
  • Marketing as a lifestyle product, for example as a pure period tracker (without reference to disease).

The manufacturer's scope for deciding whether or not to market its product as a medical device ends where the chosen intended purpose clearly does not correspond to the objective circumstances of the product and is no longer scientifically tenable.

 

Advertising for FemTech products

Advertising for FemTech products has only a few particularities. The advertising restrictions of Art. 7 MDR and Art. 7 IVDR and the general requirements under unfair competition law and therapeutic products advertising law must be observed. Of particular practical relevance is the ban on misleading advertising, which requires sufficient scientific evidence for health claims. In the case of DiGAs, the ban on advertising within the app set out in Section 5 para. 4 of the Digital Health Applications Ordinance (DiGAV) must be observed.

The following two points are among the few particularities mentioned that apply to FemTech products:

With regard to the scientific evidence, care must be taken to ensure that the studies used accurately reflect the patient population. It would therefore be inadmissible to base advertising claims relating specifically to women's health on studies whose patient population is purely or predominantly male. However, such a case is likely to be rare in practice anyway. It would also be inadmissible to direct advertising for a FemTech medical device to the public regarding "pathological complications of pregnancy, childbirth and the puerperium" (Annex A No. 4 to Section 12 para. 1 No. 2 of the German Drug Advertising Act – Heilmittelwerbegesetz [HWG]).

Apart from this, it should be noted that advertising can change the intended purpose of the product in the sense of the product categorization outlined above - the intended purpose under medical device law is not static. Caution is therefore always required.

 

Conclusion

FemTech is an exciting area that leaves room for manoeuvre in many cases when it comes to the question of how the product should be categorized and marketed. In borderline cases, it must be weighed up whether the higher costs of marketing as a medical device can be justified by the advantages, for example with regard to possible reimbursement. As far as advertising is concerned, a legal review of marketing materials before they leave the company is recommended, as is always the case.

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