In July 2026, the German Federal Ministry of Health launched a comprehensive "prevention offensive". The goal is for preventive healthcare and promoting healthy living to be a cornerstone of the healthcare system. This political signal will likely further stimulate the market for offers in preventive healthcare: wearables that measure the wearer's heart rate or sleep phases; apps that make lifestyle recommendations based on biomarkers; genetic tests that promise to inform individuals of their risk profile; cancer check-up apps, cardiological screening tools and preventive blood diagnostics.
Products like these are technologically innovative, economically attractive – and legally complex. Whether preventive healthcare products can be placed on the market as wellness/consumer products or are subject to strict regulatory requirements such as those in the EU Medical Devices Regulation (MDR) as medicinal products is no small matter. Their legal classification depends on many different factors, particularly the purpose intended by the manufacturer.
When preventive healthcare products count as medical devices
The EU Medical Devices Regulation or MDR for short (Regulation (EU) 2017/745) ties classification as a medical device primarily to the purpose intended by the manufacturer (see Article 2 no. 1 and no. 12 MDR). Simply put, a product is a medical device if according to the manufacturer's data it is intended to identify, prevent, monitor, predict, prognosticate, treat or alleviate diseases – regardless of whether it looks like a smart watch, an app or a traditional diagnostic device.
"Intended purpose" means the use for which a device is intended according to the data supplied by the manufacturer (Article 2 no. 12 MDR). This is determined by the data supplied by the manufacturer not just on the label and in the instructions for use, but in promotional and sales materials, on the website, in the app store, on social media and in other public statements by the manufacturer.
The decisive factor generally is therefore the subjective intended purpose of the manufacturer and not the technical function. However, this is only the case to the extent that the intended purpose is objectively scientifically sound and not contradictory. This means there are two factors at play: The manufacturer's intended purpose counts, but has to be in alignment with the product's actual suitability and function.
What this means in practice: If a manufacturer positions its product as a "wellness tool" meant to promote healthy living generally, it actually moves outside the scope of the MDR to begin with on the basis of this intended purpose. By contrast, if it states that the device identifies "early signs of cardiac arrhythmias" or helps "prevent type 2 diabetes", it can quickly end up within the regulatory scope of the MDR. If a manufacturer declares its product to be just a wellness tool even though it is objectively clearly designed to identify or treat diseases, the manufacturer runs the risk of public authorities or courts correcting the subjective intended purpose and applying medical devices law.
Medical devices under the MDR: Consequences for market access and manufacturers
If a product falls under the MDR, extensive requirements take effect, such as a conformity assessment, consultation with a notified body in many cases, a CE marking, a comprehensive technical dossier, a post-market surveillance system and registration in the European EUDAMED database.
These requirements are not trivial. For a start-up trying to enter a market quickly, having its product classified as a medical device against its predictions can have far-reaching implications, including delays caused by introducing a comprehensive quality management system and performing a conformity assessment procedure, significant additional costs and, in the worst-case scenario, the need to redesign the product entirely.
How marketing can affect classification as a medical device
What is particularly tricky is that companies can manoeuvre themselves into the scope of application of the MDR through their own communications. Poorly formulated medical claims in the app store, claims on the website or product packaging, product documentation that shows the product in a medical context – all of these can be taken by competitors, public authorities or courts as signs that the product has a medical intended purpose.
Developing and marketing preventive healthcare in compliance with the law
Classifying a preventive healthcare solution under regulatory law is no small formality to be worked out at the end of the development process. It is a strategic decision that has a decisive effect on the product design, marketing communications, market access and sales channels.
Though products outside the scope of the MDR typically require less regulatory effort, classifying a product as a medical device frequently opens up opportunities that are denied to other product categories, such as better access to the health market, cooperation with service providers and payers, other potential remuneration and reimbursement channels and marketing with health-related promotional claims.
Examining the legal implications early – ideally during the design phase – protects manufacturers against expensive course corrections and creates the foundation for a market entry that is in compliance with the law. Particularly in a market that is growing as dynamically as preventive healthcare and longevity are, the only way to succeed reliably is to know the regulatory rules of play and not wait until after the fact to figure them out.
