EU MDR Class I Medical Devices

View 10000 EU MDR Class I Medical Devices on BEUDAMED, the Better Database on Medical Devices. Class I devices are considered low-risk under the EU MDR and are typically self-declared by the manufacturer with a Declaration of Conformity and CE marking. However, Class I subcategories such as Is (sterile), Im (measuring) and Ir (reusable surgical instruments) require notified body involvement for the specific aspects of sterilization, metrological performance or reprocessing validation.

Listings include manufacturer details, intended purpose, risk classification and available conformity information to help identify compliant Class I devices. This information supports clinical procurement, regulatory compliance checks and basic safety comparisons within low-risk device categories. Users should still consult technical documentation and notified body certificates where applicable for full conformity evidence.