In its judgment of 20 June 2024 (Case No. 3 U 3/24) the Higher Regional Court of Hamburg ruled that asynchronous telemedicine software must also be certified as a medical device in risk class IIa if it does not collect its own data to determine a medical diagnosis but rather transmits patient data in a structured manner. This decision could have significant implications for the field of telemedicine and the broader market for health apps.
Facts of the case
The decision is based on accelerated proceedings under competition law between two companies that offer health apps. The defendant's app allows patients with skin conditions to provide dermatologists with relevant medical information, which is used to make a diagnosis. The app enables patients to send photographs of the affected skin area and a completed medical history form to a dermatologist. The medical history form completed by the patient varies according to the respective skin problem, which the patient must specify from a selection provided by the app. Based on the information provided, the patient receives a medical diagnosis and, if necessary, treatment suggestions and a prescription. The defendant had classified the app as a Class I medical device, whereas the applicant considered that the app should be classified as a Class IIa or higher medical device, given its functionality.
Regulatory background of the risk classification of medical devices
In accordance with Regulation (EU) 2017/745 (hereinafter: MDR), medical devices are assigned to different risk classes. The classification of medical devices and their accessories is carried out in accordance with Article 51 para. 1 of the MDR and the provisions of Annex VIII of the MDR. The classification is based on the risk potential of the medical devices and is divided into four risk classes (Classes I, IIa, IIb and III). In accordance with Recital 58 of the MDR, the classification is based on the vulnerability of the human body and takes into account the potential risks associated with the technical design and manufacture of the devices.
The classification of the product into one of the four risk categories forms the basis for selecting the appropriate conformity assessment procedure for the specific medical device. This is because according to Article 5 para. 1 MDR, a medical device may only be placed on the market if it complies with the provisions of this regulation when used in accordance with its intended purpose. Before placing a medical device on the market, the manufacturer is obliged to provide proof of conformity as part of a conformity assessment procedure, as outlined in Article 10 para. 6 MDR. The question of which conformity assessment procedure applies in each case then arises from the four-stage risk classification in Article 52 MDR. In the case of medical devices in the lowest risk class (Class I), the manufacturer is permitted to determine conformity. Consequently, the conformity assessment procedure can be carried out by the manufacturer alone. In the case of higher risk classes, the involvement and participation of a notified body is a prerequisite.
Content of the decision of the Higher Regional Court of Hamburg
In the previous instance, the Regional Court of Hamburg, in its judgment of 10 January 2024 (Case No. 416 HKO 64/23), determined that the app in dispute could not be classified as a medical device in Class IIa or above. However, in the appeal proceedings, the Higher Regional Court ruled that the app in dispute, with the intended purpose of ‘asynchronous examination of skin changes by recording, storing, displaying and transmitting digital image material of the affected skin areas, as well as answering an anamnesis questionnaire and communicating (chatting) with medical specialists' cannot be made available on the market unless it is certified as a class IIa, IIb or III medical device in accordance with Annex VIII, Rule 11 of the MDR.
The Higher Regional Court's decision is based on its interpretation of classification rule 11 in Annex VIII of the MDR, which states:
‘Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa (…) All other software is classified as class I’.
The interpretation of the term ‘provide’ was at the pivotal point of the decision. The Higher Regional Court has ruled that the term 'provide' in the context of the classification rule does not require that the software itself creates diagnoses or generates, produces, brings forth or manufactures information, for example, by the software undertaking an independent evaluation/analysis or assessment of the communicated, measured or photographed data and images.
The Higher Regional Court based its decision on the grounds that such a restrictive interpretation of the wording was not appropriate, particularly in view of the purpose of the regulation, which is to ensure a high level of health protection for patients and users. The Higher Regional Court considers the app to be a structured collection of medical data. This is because the patient's own diagnostic assessment, in the form of their given answers, influences the further questions asked in the context of the anamnesis. This then provides the dermatologist with the information they require. The app thus affects the content of the medical history and the diagnosis of an illness, which the patient must initially categorise themselves. This is not a medical decision made on an individual basis. Therefore, the software is designed to influence the diagnostic process and has an impact on it.
Practical significance of the judgment in terms of competition law
The ruling of the Higher Regional Court is therefore of considerable practical significance for health apps. The ruling provides manufacturers of medical software with a clear directive to exercise caution when classifying their products. It emphasises the importance of accurately defining the specific purpose of the digital product and outlining its functionalities. If the software is to be classified as a medical device in line with its intended purpose, the manufacturer must then conduct a detailed risk assessment to ensure compliance with the regulatory requirements of the MDR. It is also crucial to comply with these regulatory requirements in order to avoid any potential issues under competition law. This is because a risk classification of the medical device that is too low can result in competitors making claims under competition law, among other things by claiming that the medical device in question has misled the relevant public.
If a manufacturer advertises its medical device software on the market without it having been assigned to the correct risk class according to the MDR classification rules and without having undergone the correct conformity assessment procedure, this constitutes a violation of competition law according to Section 3a of the German Unfair Competition Act (UWG). This is because the prohibition under Article 5 para. 1 of the MDR on placing medical devices on the market without fulfilling the requirements of the MDR constitutes a regulation of market behaviour.
The objective of a conformity assessment procedure under medical device law, with subsequent CE marking, is to guarantee the safety, suitability and performance of medical devices, thereby protecting the health and safety of individuals who may come into contact with them. At the same time, however, it serves to create equal conditions for economic operators in the European Union internal market. The legitimate interests of competitors are affected to the extent that as they can only place their products on the market with a considerable additional financial and time effort due to the necessary and possibly complex conformity assessment procedure involving a notified body. This allows the manufacturer, who carries out a conformity assessment procedure for his product only in accordance with the lower requirements of risk Class I on his own responsibility, to gain a significant competitive advantage over his competitors.
