Regulatory roadmap
Current status
Klinovant is currently a prototype under development and is not an approved medical device. There is no CE marking and no regulatory approval in place. The ongoing clinical pilot serves solely as a feasibility demonstration, not as evidence of clinical efficacy.
Klinovant is designed as a Class IIa software medical device under the EU Medical Device Regulation (MDR). Self-certification is not possible for this class — CE marking requires assessment by a Notified Body.
Planned steps
- Building a quality management system under ISO 13485.
- Software lifecycle processes under IEC 62304.
- Risk management under ISO 14971.
- Clinical evaluation in line with MDR requirements.
- Conformity assessment with a Notified Body and CE marking as a Class IIa medical device.
The current business plan estimates roughly three years for this path.