Innovative Medicine: Law and Regulation for FemTech Products

What does ‘FemTech’ mean?

The “FemTech” industry, short for “Female Health Technology”, creates technical solutions for women’s health. The FemTech categorisation thus includes a range of topics and products related to pregnancy, menstruation, female sexual health and fertility that have received less attention from historically male-dominated research and development in recent decades. FemTech products often follow innovative approaches such as apps or smart devices developed by start-ups in the health sector.

The three most frequently asked legal questions about “FemTech” products

As lawyers for innovative and digital projects in the field of medicine, we feel the growing “trend” towards FemTech products in our daily work. We have identified three typical problem areas in particular that are (or have to be) addressed on a recurring basis:

  • Do I have a medical device?

The almost “classic” initial question of legal advice in the health sector focuses on the classification of a product as a medical device or not. This is basically determined by the EU Medical Devices Regulation, also known as the “Medical Device Regulation” or “MDR” for short. Art. 2 No. 1 MDR stipulates that a product is a medical device if it has a specific medical purpose. Incidentally, both embodied and software products, such as an app, are covered.

The purpose of the product may be defined by the manufacturer of the product within the scope of a intended purpose. However, this does not only result from the declaration entitled “intended purpose”, but also from advertising material, product presentation, instructions for use and all information that the manufacturer makes available for its product and is thus responsible for.

FemTech’s focus on “women’s health” reveals a number of discussions and starting points that have not been discussed much before and that must be taken into account in the legal assessment: Is PMS a disease? When is the app-supported monitoring of pregnancy “medicine”? Does a smart device for tracking female fertility make a “diagnosis”? These are all questions that we have already met in the context of innovative FemTech products. These questions can and should be addressed with a targeted and focused delimitation and classification in order to place a product on the market in the way the manufacturer wants to implement it strategically and economically.

  • Cosmetics, dietary supplements or medicines?

The delimitation of these three categories is nothing but a “minefield”. For Germany, the difficult background can be well summed up by the legal term “presentation medicinal product”. Such a product has no pharmacological properties and thus does not function as a “real”, so-called “functional medicinal product”, but is advertised or presented as such by the manufacturer with corresponding effective claims.

Often the “false” advertising focuses on a certain ingredient of the food supplement or cosmetic, for which e.g. a “healing effect” is promised. It is precisely this promotional representation of a drug-like effect that can then lead to a product being treated as a drug by the authorities. Immediate sales bans can be the result. Pre-produced packaging, instructions for use and advertising materials have to be taken back because of the misleading texts and the financial efforts of the previous production are in vain. To avoid falling into this trap, it is advisable to have advertising texts, websites, folding boxes and other representations of the product groups mentioned legally checked beforehand. The motto here is often: “Caution costs less than indulgence!

  • Certification and reimbursement of my medical device

If a medical device is intended to be placed on the market, a medical device certification is required. The effort required for this depends on the risk class of the product. The risk class ranges from I to III, whereby the software sector for low-threshold healthcare products often lies in the I to IIa range. It is precisely this demarcation between classes I and IIa that has a special feature. While a Class I product does not require an audit procedure by a so-called “Notified Body” such as the TÜV, this does not apply to Class IIa. Often, therefore, the delimitation of the risk classes is focussed on. With the appropriate legal expertise, a decisive course can be set in good time to steer a product in the desired direction and to make the market entry for certification more calculable.

The question of reimbursement of a product by the statutory health insurers is a different matter. Here, in addition to the possibility of reimbursement as an “aid”, the “DiGA” has recently made a name for itself in German law. This is a “digital health application”, i.e. a software medical product that a doctor can prescribe and which is then reimbursed by the SHI. Whether reimbursement should be considered as a DiGA or as an aid and how this goal can be achieved is a mostly very specific question that should be answered in detail for a specific product. Only this much: listing as a reimbursable DiGA requires proof of a positive supply effect.

In cooperation with the Institute for Quality and Regulation of Digital Medicine (, we provide overall solutions and cover both the legal issues of product evaluation and delimitation, as well as the procedure that may be necessary for certification and inclusion as a DiGA or aid.