MDStudy object
MD - Definition available in national law
Yes
MD - Definition
Definitions for Medical Devices (intended for clinical investigations) are given in Article 3, DL 145/2009 (pt).
The classification criteria for class I, IIa, IIb, III Medical Devices are provided in Art 4 & Annex IX of DL 145/2009 (pt).
Additional Information
The related definitions and classifications are also available in EN on the INFARMED website in section: Dispositivos Médicos