The function of risk classes for the CE-mark of medical devices
Medical devices are classified into different risk classes (I, Is, Ir, Im, IIa, IIb, III). The medical device is classified according to the intended use as defined by the manufacturer and the thereby resulting risks.
- Risk class I: Products and consumer articles for external, non-invasive use with low risk potential (Is: sterile products, Im: products with measuring function, Ir: Reusable surgical equipment [introduced with the MDR])
- Risk class IIa: Invasive products with short-time application (< 30 days), e.g. catheters, cannulae
- Risk class IIb: Products with general enhanced risk, e.g. ventilators, implants with long-term application
- Risk class III: Products with high risk potential, e.g. endoprosthesis, pacemakers
Dependent on the risk class of the medical device, conformity of the medical device and the respective documentation is assessed by the manufacturer himself or by a notified body.
Notified bodies are companies, which examine the conformity assessment done by the manufacturer. They are commissioned by the manufacturer. The information about which notified body is allowed to examine which conformity assessment is given in a database. Currently, notified bodies are heavily booked. Consequently, manufacturers should search for a notified body timely!
The conformity assessment for simple class I medical devices is performed in self-responsibility of the manufacturer and these devices are labelled with an CE-mark without identification number. The conformity assessment for all other medical devices (classes Is, Ir, I, m, IIa, IIb, III, without customer-made products and products for clinical trials) is performed in collaboration with notified bodies.