Digital health applications (DiGA) have so far been limited to low-risk class I and IIa medical devices. This means that products for the self-management of certain diseases are currently excluded from reimbursement. As part of the current digitization strategy, the German Federal Ministry of Health recently announced that reimbursement via DiGA listing will be extended to medical devices in risk class IIb in the future.
But which software medical devices fall into risk class IIb?
The classification of medical devices is defined by the rules of the European Medical Devices Regulation (MDR). Rule 11 applies to software medical devices and specifies that if software provides information for therapeutic and diagnostic decisions, it falls at least into risk class IIa; if the decisions could lead to potential harm, the risk class increases. Corresponding criteria and also examples of classification can be found in MDCG 2019-11 guidance.
In contrast to software medical devices in risk class IIa, class IIb devices can also be used for serious diseases or for decision making in critical situations.
Can you give examples?
- Software-assisted dosing of insulin. If the software helps the patient suffering from diabetes calculate the dose of insulin to be injected, this falls into the category of “treatment of a serious condition” and is therefore a class IIb product
- Software that continuously analyzes pulse data and initiates an alarm if, for example, there is a potentially life-threatening cardiac arrhythmia. The pulse device alone would not be a class IIb medical device – but the software, which is designed to alert a patient with a pre-existing condition in a critical situation, meets the criteria for a Class IIb device.
What does the change mean for DiGA manufacturers?
The opening for risk class IIb is clearly to be welcomed, as it also opens up the possibility for patients with more severe diseases to self-manage their disease with the help of software reimbursed by the health insurance and incentivises manufacturers to provide such devices to the market.
For the future, it should be considered whether the opening should not even apply to the highest risk class – to risk class III. Such medical devices are already individually tested by the notified bodies before they can even be placed on the market to determine whether they are suitable for the intended purpose.
DiGA for all of Europe?
In addition to Germany, similar concepts for the reimbursement of digital medical devices already exist in Belgium and France. A working group of the EU Commission, the EU Digital Medical Device (DMD) Working Group, is working out to what extent EU-wide harmonized criteria for the reimbursement of medical devices can be introduced, similar to the EU-wide CE mark (see also Prof. Klucken – Annual Meeting SVDGV). An essential step towards facilitating patient access to digital solutions throughout Europe!
