The Higher Regional Court of Hamburg on the risk classification of medical device software

by Daniel Wurm

Introduction of MDR and Rule 11 in the software sector

With the introduction of Regulation (EU) 2017/745 (“MDR”), there have been major changes, particularly in the software sector. Due to the introduction of the new “Rule 11” (Annex VIII of the MDR) as a special classification rule for software, the risk classifications of many products that were still authorised under the old legal situation (the Medical Devices Directive) cannot be seamlessly transferred to the MDR. In most cases, Rule 11 results in a higher classification than the previous provisions of the Directive. Rule 11 is thus worded as follows:

OLG Hamburg zur Risikoklassifizerung von Medizinsoftware

“Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

  • death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or
  • a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I.”

This rule is highly controversial in the industry. In its decision of 22 September 2023 (case reference: 3 W 30/23), the Higher Regional Court of Hamburg was the first higher German court to take up the classification of software medical devices in accordance with the MDR.

Decision and reasoning of the OLG Hamburg

The reason for the lawsuit was a competition law case in the form of an injunction. The parties to the proceedings were two competitors from the medical sector. The subject matter of the dispute was software that was marketed by the defendant as a medical device in risk class I in accordance with the MDR. According to the instructions for use, images were to be sent to dermatologists via the software, which they could “assess” in the form of a “visual diagnosis”. The applicant objected to this, as a higher risk class would be necessary due to the way the software works.

The Senate ruled in favour of the applicant and, referring to the wording of Rule 11, stated in its decision that it depends on whether the transmitted information is used for diagnostic or therapeutic purposes. It did not matter whether the software itself carried out a diagnosis or analysis. The wording of Rule 11 is unambiguous and not, as claimed by the defendant, “unclear”. There is no room for a restriction such as that imposed by the defendant due to the inherent assurance of a high level of health protection for patients and users in the MDR.

In addition, the Senate rejected the view that the classification of a medical device in risk class IIa or higher should be based on the risk to the patient compared to conventional treatment, as there is no indication of this in the MDR.

Additionally to the comments on Rule 11, it is interesting to note that the Senate waived the granting of a period for use or conversion, within which the defendant could have continued to leave the software on the market if it had been granted, while at the same time going through the certification process of the product with a notified body. With reference to health protection, the Senate argued that the defendant could have already taken the necessary measures with the warning (preparation of a distribution ban or initiation of a conformity assessment procedure involving a notified body).

Reactions and criticism of the ruling and possible effects

The judgement is not uncontroversial in the world of law. In the specialist journal “Medizin Produkte Recht” (MPR), Prof. Dr Gassner criticised an overly broad interpretation of the wording. Rule 11, for example, is “due to an anti-innovation safety mania” and criticises the fact that the Senate does not take into account the risk-based approach of the MDR. This is also intended to protect manufacturers from excessive regulation. In particular, Prof. Dr Gassner criticises the rejection of this approach with reference to Art. 51 para. 1 sentence 1 MDR and recital (5) MDR (which in turn refers to the regulations of the IMDRF, on the basis of which a risk matrix is used to classify software).

Although it can be assumed that the judgement will not initially have any precedential effect, it does show how important it is to carry out a risk classification in accordance with the law in order to avoid legal disputes and possible subsequent distribution bans. BAYOOCARE will be happy to help you with this.