When is a product a medical device? Two court cases bring (some) clarity

Two recent proceedings from Germany highlight key questions of interpretation of the MDR that are crucial for many manufacturers. The Bochum Regional Court has referred the question to the European Court of Justice as to whether unprinted patient wristbands, which are intended to help prevent errors in everyday clinical practice, should be classified as medical devices even though they have no direct effect on or in the body. It is therefore a question of the significance of the intended purpose and whether a purely organizational benefit is sufficient for classification. An ECJ ruling is not expected until the end of 2025 at the earliest.

The ruling by the Hanseatic Higher Regional Court on a teledermatology app is even more far-reaching. Although the app itself does not make a diagnosis, but only transmits structured health data to specialists, it was classified as a medical device in risk class IIa. The court interprets Rule 11 of the MDR broadly: It is sufficient for software to contribute to the basis of medical decisions; an active diagnostic function is not necessary. This makes it clear that software no longer automatically falls into the lowest risk class.

Both cases show that MDR-relevant issues such as intended purpose and risk classification are increasingly being clarified in court – with major implications for approval obligations, competitive conditions and market opportunities. Manufacturers who invested in compliance at an early stage are increasingly finding themselves in a regulatory imbalance compared to less compliant competitors. Uniform and binding standards are therefore urgently required.