| Classification | Class I | Class IIa | Class IIb | Class III |
| Description | No to negligible risk These devices are typically simple designed and easy to manufacture. Present microscopic risk to the human body i.e. examination gloves or thermometer. | Low risk These devices include short-and long-term devices that represent a low risk to the human body. This can include catheter and infusion pump | Medium risk These devices pose a relatively high risk to the human body i.e. respirators | High risk These devices include long-term surgical invasive devices that may pose a life-threatening risk to patients. Examples are orthopedic implants and coronary stents. |
| Premarket requirements | Manufacturers can declare conformity | Manufacturers submit a dossier of literature supporting claimed safety and performance. Evidence requirements vary by the relevant NB | Manufacturers submit a record of literature supporting alleged safety and performance. Evidence requirements vary by the relevant NB | Recommended with clinical studies, but mostly non-randomized and single arm studies are used to demonstrate safety and performance. Need conformity assessment by an appropriate Notified Body |