The EU MDR regulations includes five classes of medical devices in Annex VIII. This annex classifies products according to 22 rules. Below is a short summary, with some examples of each:
Class I (Low Risk): Non-sterile devices, or devices without a measurement function. These devices can be self-certified. For example: reusable surgical equipment (e.g., scalpel), stethoscopes, wheelchairs.
Class I Special Function (Low/Medium Risk): Sterile devices, or devices with a measurement function. Non-invasive devices that do not meet the requirements of other classes, and invasive devices that are intended for transient use. For example: reprocessed devices, measurement devices, devices delivered sterile.
Class IIa (Medium Risk): Invasive devices intended for short-term use. For example: tooth implants, tracheotomy tubes, syringe, X-ray device.
Class IIb (Medium/High Risk): Invasive devices intended for long-term use. For example: implantable birth control, blood bags.
Class III (High Risk): Implantable medical devices intended for long-term use. For example: pacemakers, breast implants, spinal disc implants, drug-coated stents.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
