GAIA AG
Die GAIA AG ist ein forschendes Public Health Unternehmen mit Sitz in Hamburg, Deutschland.
ID: 955540094252-19
Lobbying Activity
Meeting with Jana Dabbelt (Cabinet of Commissioner Olivér Várhelyi)
24 Sept 2025 · Digital therapies
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
11 Sept 2025
The current application of MDR Rule 11 leads to a systematic over-classification of Software as a Medical Device (SaMD). Even very low-risk applications, such as self-management or adherence apps, are routinely classified at least as Class IIa under a conservative interpretation. This contradicts the MDRs founding principles, particularly Recitals 58 and 60, which emphasize proportionality and risk-based regulation. Lay-user actions, such as following app reminders, are often treated as therapeutic decisions, although they are not comparable to medical decision-making by healthcare professionals. As a result, even low-risk applications are up-classified. This over-classification creates barriers to innovation, as increased regulatory burdens delay market access, raise costs, and disproportionately affect SMEs, despite evidence that such products are safe. Moreover, the current binary approach between Class I and higher classes does not allow for an appropriate differentiation of risk levels. To address these issues, a targeted adaptation of Rule 11 is necessary. Software should generally be classified as Class I unless specific risks justify a higher category. Higher classifications should only apply in defined cases: Class III in situations with a risk of death or irreversible deterioration, Class IIb when there is a risk of serious deterioration or surgical intervention, and Class IIa in cases of health impairments requiring intervention by a healthcare professional. Monitoring software should default to Class IIa, with only those monitoring vital parameters in situations of immediate danger classified as Class IIb. In addition, contextual factors such as the medical setting, complexity, the users or healthcare professionals ability to intervene, and the time window before foreseeable harm occurs should be considered in the classification process. A revised Rule 11 would maintain high patient safety standards through a genuinely risk-based classification while avoiding unnecessary regulatory burdens for low-risk applications. It would strengthen innovation, particularly for SMEs, and enable faster patient access to safe digital health tools, for example in bridging waiting times in therapy or rehabilitation. Finally, it would align regulatory practice with technological progress and future digital health innovations. In conclusion, the current application of Rule 11 creates inefficiencies that hinder innovation without improving patient safety. A targeted revision introducing a nuanced, risk-sensitive approach will ensure a better balance between patient safety, regulatory proportionality, and innovation, and will create a future-ready framework for medical device software in Europe.
Read full responseMeeting with Peter Van Kemseke (Cabinet of President Ursula von der Leyen)
19 Nov 2024 · digital health