Regulatory Status: EU MDR Class IIa
What our classification actually means, what it does not mean, and what we are working toward in 2026.
BSerum's clinical formulation is registered as an EU MDR Class IIa medical device. The AI Guardian is a separately conformity-assessed software-as-a-medical-device (SaMD) component under the same regulation. Our Geneva and Zurich clinics operate under ISO 13485 quality management, and our notified body conducts unannounced audits at a frequency we are required to disclose to patients.
1. What Class IIa means
Class IIa is a medium-risk classification appropriate for therapeutic and diagnostic devices that involve transient or short-term contact with the patient and pose a defined but manageable risk profile. It requires CE marking, technical documentation under MDR Annex II, and post-market clinical follow-up — all of which we file.
| Component | Classification | Standard |
|---|---|---|
| Formulation (peptide) | MDR Class IIa | Annex II, CE-marked |
| AI Guardian (SaMD) | MDR Class IIa | Annex II + IEC 62304 |
| Clinic QMS | n/a | ISO 13485:2016 |
| Information security | n/a | ISO 27001:2022 |
2. What it does not mean
Class IIa is not the same as a pharmaceutical authorisation. BSerum makes no therapeutic indication claim that requires EMA review, and our marketing materials are constrained accordingly. If you have seen anyone — including a partner clinic — describe BSerum as 'approved for' a specific disease state, that is a misstatement and we want to know about it.
3. What is next
In 2026 we open the first prospective registered trial targeting a specific dermatological indication. That filing will require an entirely different regulatory pathway and a year of additional data. We are funded for it.