MILESTONE S.P.A.

Milestone S.p.A. specializes in automated slide staining systems for histopathology laboratories. These devices, such as the HISTODREAM CM and MAGNUS, are designed to process tissue samples efficiently, enabling pathologists to achieve same-day diagnostic results. The systems automate key steps in preparing slides for microscopic examination, improving workflow and accuracy in diagnostic settings.

Milestone S.p.A. is based in Italy, which means its devices are subject to European Union (EU) regulatory requirements. Since the devices are classified as Class A under EU regulations, they fall under the Medical Device Regulation (MDR) or the Medical Device Directive (MDD) depending on the applicable timeline. This classification typically involves less stringent conformity assessment procedures compared to higher-risk classes, but compliance with EUDAMED registration and other regulatory obligations still applies.

Yes, Milestone S.p.A.’s devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices. Listing in EUDAMED demonstrates that the devices have undergone the necessary conformity assessment procedures and are legally placed on the market in the EU. This transparency helps healthcare professionals, regulators, and authorities verify the device’s regulatory status, ensuring trust in its compliance with EU safety and performance standards.

Milestone S.p.A.’s devices are classified as Class A under EU regulations, which is the lowest risk category for medical devices. This classification is based on their intended use—automated slide staining systems for histopathology—where the risk of harm to patients is minimal. Class A devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, but they still must comply with essential safety and performance requirements to ensure their safe and effective use in diagnostic settings.