What is Class IIb?
Class IIb includes medical devices with a medium-to-high risk potential. They are subject to a conformity assessment by a Notified Body, comprehensive technical documentation, and market surveillance in accordance with the Medical Device Regulation (MDR).
Obligations for Operators
Studios must cumulatively fulfill several requirements to remain compliant:
- Maintenance of an inventory register of all medical devices
- Documented user training and instruction
- Regular safety inspections (STK) as required by law
- Reporting of incidents to the relevant authorities (e.g., BfArM in Germany, BASG in Austria, or Swissmedic)
- Retention of all documentation for a minimum of 10 years
FAQ
Frequently asked questions
What is the difference compared to Class IIa?
Class IIa involves a lower risk potential and less stringent conformity obligations. Active treatment lasers are generally categorized as Class IIb.
Do I need a Safety Officer for Medical Devices?
It is highly recommended for studios with multiple practitioners and is effectively mandatory for larger clinics under specific regional regulations.
These systems put the topic into practice
- Alix Secret Twin C – Twin platform, compact version
- Alix Blueice Hybrid Red – All-in-one system
- Alix Blueice Fusion Red – Combination of several technologies
- All systems for this treatment goal
- Arrange a consultation appointment – system selection based on your utilisation
- Laser equipment for beauty salons
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