Risk classes

Please note that neither EU-rules nor national legislation carry out such a classification of medical devices because, in each particular case, a classification has to be conducted with reference to the intended use.


Klasse I Klasse IIa Klasse IIb Klasse III
· Medical instruments· Crutches

· Wheel chair

· Surgical beds

· Bandaging

· Dental filler· Diagnostic ultrasonic


· Hearing aids

· Contact lenses

· Tooth crowns

· Muscle and nerve stimulation

· Anasthetic devices· Respiration devices

· X-ray

· Blood bags

· Defibrillator

· Dialysis devices

· Condoms

· Contact lense cleaner

· Dental implants

· Heart catheter· Endoprothesis

· Coronary stents

· Absorbable surgical suture

· Breast implants

· Heart valves