© Messe Düsseldorf Genauere Diagnostik dank Digitalisierung
13:3014:00 14. Nov 2018 zu iCal hinzufügen MEDICA TECH FORUM

Classification of Medical Device Software under the new MDR

Session Regulatorisches und praktische Lösungen

The Medical Device Regulation introduced with the Rule 11 a possibility to allow assignment of Class III to software. In order to allow proper application, the EU commission is working on a MDCG guidance. This presentation is intended to share current insights into future classification of Medical Device Software.